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/May/202425/4 DATED: 06/06/2024

Please Note

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

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

Meeting No. NC/3/MEET/May/202425/4 dated 06/06/2024 of Norms Committee - III for the year 2024-25 was held on 06/06/2024 under the Chairmanship of Shri Rakesh Kumar,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy-2023.

The following members were present in the meeting:-

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

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 24-06-2024 10:04:17.

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

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 24-06-2024 10:04:17.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009045AM24
RA File Number	039404000337 AM12
Licence No and<br>Date	0310646104/03/08/2011
Norms Committee Decision:
The committee considered the request of firm for review of ad-hoc norms and as per the advise of the TE,
it was decided to call for following information/documents from the firm:-
Particle sixe of import item is not mentioned in Certificate of Analysis (CoA) to show any<br>1.
manufacturing activity (Micronization) in the process.
Above details alongwith Bill of Entry of import may be furnished in support of its claim.<br>2.

Particle sixe of import item is not mentioned in Certificate of Analysis (CoA) to show any manufacturing activity (Micronization) in the process.

Case No.	2 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009259AM24
RA File Number	039504000262 AM13
Licence No and<br>Date	0310705888/22/08/2012
Norms Committee Decision:
The case is under consideration for want of comments of TE.

REVIW00009259AM24| |RA File Number|039504000262 AM13| |Licence No and Date|0310705888/22/08/2012| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||


Case No.		3 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED
Meeting Number an	d Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM REVIW00009069AM24
RA File Number		072404000207 AM15
Licence No and Da	te	0710106682/16/09/2014

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Norms Committee Decision:

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

Export Product	Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.
ADCO DOL TABS -<br>Paracetamol 450mg + Codeine<br>Phosphate 10mg+ Caffeine<br>45mg + Doxylamine Succinate<br>5mgTablets ((No.ofTablets-<br>99033310) (Para-<br>44564.990+Codeine-<br>990.333+Caff-<br>4456.499+Doxy-<br>495.167Kgs+ColQuiYelLake-<br>451.592+ Col Qui Yel WS -<br>240.651 KGS))	1<br>Million<br>Tablets	1<br>	DOXYLAMINE<br>SUCCINATE<br>USP /Ph. Eur Grade	<br>5.10 kg.
		2	COLOUR<br>QUINOLINE<br>YELLOW WS (SPECTRACOL)	<br>10.2 kg.
		3	COLOUR<br>QUINOLINE<br>YELLOW<br>LAKE<br>IH<br>(SPECTRACOL)	<br> <br>2.43 kg.
		4	CODEiNE PHOSPHATE BP / EP<br>/ USP / PH.EUR	<br>4.56 kg.
		5	PARACETAMOL<br>GRANULES<br>DC 83S (KRISOPAP - 83S)	<br>454.5 kg.

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

Case No.	4 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009043AM24
RA File Number	522404000058 AM15
Licence No and<br>Date	5210041428/13/02/2015
Norms Committee Decision:

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5| |Licence No and Date|5210041428/13/02/2015| |Norms Committee Decision:||

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The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import items in meeting No. NC/3/MEET/Sep/202324/13 dated 14/09/2023 against advance authorization No.5211000803 dated 01/06/2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
1,(3<br>CL<br>PHENYL)-4-(3-CL<br>PHENYL) PIPERAZINE HCL -<br>99% MIN.	<br> <br>1 kg.	1	1,3-BROMO CHLORO<br>PROPANE - 99.5% MIN.	1.045 kg.

Case No.	Case No.	5 / NC/3/MEET/May/202425/4	5 / NC/3/MEET/May/202425/4	5 / NC/3/MEET/May/202425/4	5 / NC/3/MEET/May/202425/4	5 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		HERBOCHEM
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM REVIW00009084AM24
RA File Number		092404000148 AM16
Licence No and<br>Date		0910062238/23/06/2015
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

|Licence No and Date||0910062238/23/06/2015||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Extract Ipecacuanha (Ipecac Conc.8% alkaloid) 1 kg. 1 Ipecacuanha (Ipecac) Roots (Dry Roots) containing minimum 2 % Alkaloids 4.00 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Extract Ipecacuanha (Ipecac Conc.8% alkaloid)||1 kg.|1|Ipecacuanha (Ipecac) Roots (Dry Roots) containing minimum 2 % Alkaloids| 4.00 kg.|

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Case No.	6 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	SHREE BANKEY BEHARI LAL AROMATICS
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008908AM24
RA File Number	NA
Licence No and<br>Date	0510402031/21/03/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.10/82-ALC4/2019 dated 29/11/2019against advance<br>authorizationNo.0510403552 dated 01/08/2019, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

product in meetingNo.10/82-ALC4/2019 dated 29/11/2019against advance authorizationNo.0510403552 dated 01/08/2019, 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. CARVACROL 1 kg. 1 D-LIMONENE (LIMONENE CITRUS TERPENE, ORANGE TERPENE, BRAZILIAN CITRUS TERPENE, STANDARD CITRUS TERPENE, ORANGE OIL) 1.48 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	7 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024

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and Date	and Date
HQ File Number		HQRNORM REVIW00009048AM24
RA File Number		522404000068 AM19
Licence No and<br>Date		5210042870/18/12/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import items in meetingNo. NC/3/MEET/Oct/202324/15 dated 13/10/2023against advance<br>authorizationNo.5210042870 dated 18/12/2018; 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.

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 Acetyl Salicylic Acid (For Industrial Use) 1.56 kg. 4-HYDROXY COUMARIN (by Acetyl Salicylic Acid route) 1 kg. 2 Ethyl Aceto Acetate 1.147 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4-HYDROXY COUMARIN (by Acetyl Salicylic Acid route)||1 kg.|1|Acetyl Salicylic Acid (For Industrial Use)|1.56 kg.| |||||2|Ethyl Aceto Acetate|1.147 kg.| |||||per above decision of NC.|||

Case No.	8 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	VDH ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00008896AM24
RA File Number	052404000721 AM19
Licence No and<br>Date	0510410010/20/03/2019
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Percentage wise yield not given.

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ion of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Percentage wise yield not given.||

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Case No.	9 / NC/3/MEET/May/202425/4
Case Status	Case Rejected
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009294AM24
RA File Number	082404000026 AM20
Licence No and<br>Date	0810145127/30/04/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo.

Case No.	10 / NC/3/MEET/May/202425/4
Case Status	Case Rejected
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009291AM24
RA File Number	082404000005 AM20
Licence No and<br>Date	0810145144/01/05/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, it was decided to<br>rejectthe case maintaining thestatus quo.

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

Case No.	11 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	RAVESHIA ORGANICS LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009054AM24

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RA File Number	039504000204 AM20
Licence No and<br>Date	0310829355/30/05/2019
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix 4E for chemical products.

Case No.	Case No.	12 / NC/3/MEET/May/202425/4	12 / NC/3/MEET/May/202425/4	12 / NC/3/MEET/May/202425/4	12 / NC/3/MEET/May/202425/4	12 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM REVIW00000046AM25
RA File Number		318304000051 AM20
Licence No and<br>Date		3110067490/02/08/2019

r>and Date||NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024||||| |HQ File Number||HQRNORM REVIW00000046AM25||||| |RA File Number||318304000051 AM20||||| |Licence No and Date||3110067490/02/08/2019||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import items in meetingNo. NC/3/MEET/Dec/202324/19 dated 05/01/2024against advance authorizationNo.3111001358dated17/05/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 OCP 50 1.100 kg. 2 Methanol 0.66 kg. 3 Catalyst (Katalco 715) 0.004 kg. DNOVO BP818 (Tetra Methyl Bisphenol F) 1 kg. 4 Paraformaldehyde 0.141 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||DNOVO BP818 (Tetra Methyl Bisphenol F)||1 kg.|1|OCP 50|1.100 kg.| |||||2|Methanol|0.66 kg.| |||||3|Catalyst (Katalco 715)|0.004 kg.| |||||4|Paraformaldehyde|0.141 kg.| ||||||||

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818 (Tetra Methyl Bisphenol F)||1 kg.|1|OCP 50|1.100 kg.| |||||2|Methanol|0.66 kg.| |||||3|Catalyst (Katalco 715)|0.004 kg.| |||||4|Paraformaldehyde|0.141 kg.| ||||||||

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Case No.	13 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00000048AM25
RA File Number	318304000087 AM20
Licence No and<br>Date	3110067548/30/09/2019
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>The stage wise percentage yield of the reaction and to calculate the requirement of OCP on the<br>basis of constituent ratio.<br>1.<br>Justification of yield of the reaction with calculation of requirement of all the raw materials<br>with Annexure to Appendix-4E<br>2.

on the** basis of constituent ratio. 1. Justification of yield of the reaction with calculation of requirement of all the raw materials with Annexure to Appendix-4E 2.||

Case No.	Case No.	14 / NC/3/MEET/May/202425/4	14 / NC/3/MEET/May/202425/4	14 / NC/3/MEET/May/202425/4	14 / NC/3/MEET/May/202425/4	14 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		REFLUX PHARMACEUTICALS
Meeting Number and<br>Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM REVIW00008045AM24
RA File Number		039504000931 AM20
Licence No and Date		0310833815/01/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to review ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

Case No.	Case No.	14 / NC/3/MEET/May/202425/4	14 / NC/3/MEET/May/202425/4	14 / NC/3/MEET/May/202425/4	14 / NC/3/MEET/May/202425/4	14 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		REFLUX PHARMACEUTICALS
Meeting Number and<br>Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM REVIW00008045AM24
RA File Number		039504000931 AM20
Licence No and Date		0310833815/01/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to review ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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TOLFENAMIC ACID	1 kg.	1	ORTHO CHLOROBENZOIC ACID	1.255 kg.
(BULK DRUG)
		2	3-CHLORO-2-METHYLANILINE	0.750 kg.

tems**|Qty. allowed.|

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TOLFENAMIC ACID	1 kg.	1	ORTHO CHLOROBENZOIC ACID	1.255 kg.
(BULK DRUG)
		2	3-CHLORO-2-METHYLANILINE	0.750 kg.

Case No.	15 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009300AM24
RA File Number	052404000670 AM20
Licence No and<br>Date	0510413367/17/01/2020
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.

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

ndigenous input with quantity.** v.||

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

Case No.	16 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009301AM24
RA File Number	052404000729 AM20
Licence No and	0510413656/19/02/2020

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Date

Norms Committee Decision:

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

Step wise manufacturing process.
i.
ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
iii. Complete technical details as per Annexure to Appendix 4E for chemical products.
iv. Stoichiometric balance between import and export on molar basis.
Details of indigenous input with quantity.
v.

Case No.	17 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009299AM24
RA File Number	052404000071 AM21
Licence No and<br>Date	0510414288/29/05/2020

D| |Meeting Number and Date|NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024| |HQ File Number|HQRNORM REVIW00009299AM24| |RA File Number|052404000071 AM21| |Licence No and Date|0510414288/29/05/2020| |Norms Committee Decision: The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Step wise manufacturing process. i. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis. ii. Complete technical details as per Annexure to Appendix 4E for chemical products. iii. Stoichiometric balance between import and export on molar basis. iv. Details of indigenous input with quantity. v.||

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

Case No.	18 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	KOSHA CHEMTECH PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024

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|18 / NC/3/MEET/May/202425/4| |---|---| |Case Status|Case Deferred| |Party Name|KOSHA CHEMTECH PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024|

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and Date
HQ File Number	HQRNORM REVIW00000014AM25
RA File Number	039404000306 AM21
Licence No and<br>Date	0310837580/10/08/2020
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.

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

ndigenous input with quantity.** v.||

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

Case No.	19 / NC/3/MEET/May/202425/4	19 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	CONCORD BIOTECH LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009181AM24
RA File Number	NA
Licence No and Date	0810149102/23/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import itemt in meetingNo. NC/3/MEET/Apr/20232419 dated 28/04/2023against advance<br>authorizationNo. 0810145581dated27/06/2019, 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 Item<br>Qty Allowed<br>(3S 6R 7E 9R 10R 14S 15E 17E 19E 21S 23S 26R 27R<br>34 AS) 9 10 12 13 14 21 22 23 24 25 26 27 32 33 34<br>34A-HEXADECAHYDRO – 9 27 – DIHYROXY - 3-<br>((1R) – 2 - ((1S,3R,4R) - 4- HYDROXY – 3 -<br>METHOXYCYCLOHEXYL) - 1 METHYLETHYL) -<br>10 21 – DIMETHOXY – 6 8 12 14 20 26 –<br>EVEROLIMUS<br>PREMIX 9.09<br>(PERCENTAGE )<br>(POWDER FOAM)<br>20.65 kg<br>1<br>25.0 Kg
	Qty	Sl.

DROXY – 3 - METHOXYCYCLOHEXYL) - 1 METHYLETHYL) - 10 21 – DIMETHOXY – 6 8 12 14 20 26 – EVEROLIMUS PREMIX 9.09 (PERCENTAGE ) (POWDER FOAM) 20.65 kg 1 25.0 Kg||||| ||Qty|Sl. No.|Import Item|Qty Allowed| ||20.65 kg|1|(3S 6R 7E 9R 10R 14S 15E 17E 19E 21S 23S 26R 27R 34 AS) 9 10 12 13 14 21 22 23 24 25 26 27 32 33 34 34A-HEXADECAHYDRO – 9 27 – DIHYROXY - 3- ((1R) – 2 - ((1S,3R,4R) - 4- HYDROXY – 3 - METHOXYCYCLOHEXYL) - 1 METHYLETHYL) - 10 21 – DIMETHOXY – 6 8 12 14 20 26 –|25.0 Kg|

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HEXAMETHYL – 23 27 – EPOXY - 3H – PYRIDO (2 1C) (1 4) OXAAZA CYCLOHENTRIACONTINE 1 5 11 28 29 (4H 6H 31H) - PENTONE (SIROLIMUS CRUDE)

Case No.	20 / NC/3/MEET/May/202425/4
Case Status	Case Rejected
Party Name	ORGANIC INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00000057AM25
RA File Number	06AA04002281 AM21
Licence No and<br>Date	0611000019/16/12/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has surrendered the<br>license to RA, Kanpur. The Committee, therefore, decided torejectthe case.

ion: The Committee considered the case as per agenda and it was observed that the firm has surrendered the license to RA, Kanpur. The Committee, therefore, decided torejectthe case.||

Case No.	21 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	REFLUX PHARMACEUTICALS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00007988AM24
RA File Number	NA
Licence No and Date	0311001445/03/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
TOLFENAMIC ACID	1 kg.	1	3 CHLORO 2 METHYLANILINE 99<br>PERCENT MIN	<br>0.750 kg.
		2	ORTHO CHLORO BENZOIC ACID 99<br>PERCENT MIN	<br>1.255 kg.
		3	DIMETHYL FORMAMIDE 99 POINT<br>9 PERCENT	<br>4.77 kg.

CID|1 kg.|1|3 CHLORO 2 METHYLANILINE 99 PERCENT MIN| 0.750 kg.| ||||2|ORTHO CHLORO BENZOIC ACID 99 PERCENT MIN| 1.255 kg.| ||||3|DIMETHYL FORMAMIDE 99 POINT 9 PERCENT| 4.77 kg.|

Case No.	22 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	MAHIMA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00000099AM25
RA File Number	05AA04029372 AM21
Licence No and<br>Date	0511001191/09/02/2021
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>The Assay of import and export item is not matching.<br>1.<br>Particlesize of import item is not given.<br>2.<br>Copy of Bill of Entry for import item.<br>3.

Case No.	23 / NC/3/MEET/May/202425/4
Case Status	Case Approved

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of import item is not given.** 2. Copy of Bill of Entry for import item. 3.||

Case No.	23 / NC/3/MEET/May/202425/4
Case Status	Case Approved

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Party Name	Party Name	INDOCO REMEDIES LIMITED	INDOCO REMEDIES LIMITED	INDOCO REMEDIES LIMITED	INDOCO REMEDIES LIMITED	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM REVIW00004407AM24
RA File Number		03AA04023340 AM21
Licence No and<br>Date		0311001698/16/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Brimonidine<br>Not imported<br>2<br>Bottle<br>Relevant as per Packing<br>Policy & General Notes.<br>3<br>Cap<br>Relevant as per Packing<br>Policy & General Notes.<br>4<br>Dropper<br>Relevant as per Packing<br>Policy & General Notes.<br>8<br>Bottle<br>Relevant as per Packing<br>Policy & General Notes.<br>9<br>Cap<br>Relevant as per Packing<br>Policy & General Notes.<br>10<br>Dropper<br>Relevant as per Packing<br>Policy & General Notes.<br>14<br>Timolol Maleate<br>25.50 mg / bottle<br>15<br>Bottle<br>Relevant as per Packing<br>Policy & General Notes.<br>Brimonidine Tartrate and Timolol<br>2mg/ml 5mg/ml Eye Drops<br>solution (5 ml Bottle) (Each ml<br>Contains : BrimonidineTartrate 2<br>mg

Bottle Relevant as per Packing Policy & General Notes. Brimonidine Tartrate and Timolol 2mg/ml 5mg/ml Eye Drops solution (5 ml Bottle) (Each ml Contains : BrimonidineTartrate 2 mg and Timolol Maleate equivalent toTimolol 5 mg) (Each 5 ml Contains: Brimonidine Tartrate10 mg and Timolol Maleate25mg) 1 Number||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Brimonidine Tartrate and Timolol 2mg/ml 5mg/ml Eye Drops solution (5 ml Bottle) (Each ml Contains : BrimonidineTartrate 2 mg and Timolol Maleate equivalent toTimolol 5 mg) (Each 5 ml Contains: Brimonidine Tartrate10 mg and Timolol Maleate25mg)|| 1 Number|1|Brimonidine|Not imported| |||||2|Bottle|Relevant as per Packing Policy & General Notes.| |||||3|Cap|Relevant as per Packing Policy & General Notes.| |||||4|Dropper|Relevant as per Packing Policy & General Notes.| |||||8|Bottle|Relevant as per Packing Policy & General Notes.| |||||9|Cap|Relevant as per Packing Policy & General Notes.| |||||10|Dropper|Relevant as per Packing Policy & General Notes.| |||||14|Timolol Maleate|25.50 mg / bottle| |||||15|Bottle|Relevant as per Packing Policy & General Notes.|

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0|Dropper|Relevant as per Packing Policy & General Notes.| |||||14|Timolol Maleate|25.50 mg / bottle| |||||15|Bottle|Relevant as per Packing Policy & General Notes.|

UDIN00267029AM25

		16	Cap	Relevant as per Packing<br>Policy & General Notes.
		17	Dropper	Relevant as per Packing<br>Policy & General Notes.
Brimonidine Tartrate and Timolol<br>2mg/ml<br>5mg/ml<br>Eye<br>Drops<br>solution (10 ml Bottle) ((Each ml<br>Contains : Brimonidine Tartrate 2<br>mg and Timolol Maleate equivalent<br>to Timolol 5mg) (Each 10ml<br>Contains:<br>Brimonidine<br>Tartrate<br>20mg and Timolol Maleate 50mg)	<br> <br> <br> <br> <br> <br> <br>1 Number	5	Bottle	Relevant as per Packing<br>Policy & General Notes.
		6	Cap	Relevant as per Packing<br>Policy & General Notes.
		7	Dropper	Relevant as per Packing<br>Policy & General Notes.
		11	Bottle	Relevant as per Packing<br>Policy & General Notes.
		12	Cap	Relevant as per Packing<br>Policy & General Notes.
		13	Dropper	Relevant as per Packing<br>Policy & General Notes.
		18	Brimonidine	Not imported
		19	Timolol Maleate	51.00 mg / bottle
		20	Bottle	Relevant as per Packing<br>Policy & General Notes.
		21	Cap	Relevant as per Packing<br>Policy & General Notes.
		22	Dropper	Relevant as per Packing<br>Policy & General Notes.

UDIN00267029AM25

king Policy & General Notes.| ||||21|Cap|Relevant as per Packing Policy & General Notes.| ||||22|Dropper|Relevant as per Packing Policy & General Notes.| |||||||

UDIN00267029AM25

Case No.	24 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00000359AM25
RA File Number	52AA04007931 AM21
Licence No and Date	5211000485/16/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>1<br>PARA CHLORO PHENOL<br>2.42 kg.<br>2<br>TETRAHYDROFURAN<br>1.00 kg.<br>ORGANIC CHEMICAL-<br>ORGANIC-PHENOLS, PHENOL<br>ALCOHOLS AND THEIR<br>DERIVATIVES<br>PHENOLALCOHOLS, THEREOF:<br>4-(2-METHOXYETHYL)<br>PHENOL<br>1 kg.<br>3<br>MAGNESIUM<br>METAL<br>TURNING<br>0.37 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	25 / NC/3/MEET/May/202425/4
Case Status	Case Rejected
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024

UDIN00267029AM25

ET/May/202425/4| |---|---| |Case Status|Case Rejected| |Party Name|ASCENT FINECHEM PRIVATE LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024|

UDIN00267029AM25

HQ File Number	HQRNORM REVIW00009292AM24
RA File Number	08AA04009431 AM22
Licence No and<br>Date	0811001850/25/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has surrendered the<br>license to RA, Kanpur. The Committee, therefore, decided toclosethe case.

Case No.	Case No.	26 / NC/3/MEET/May/202425/4	26 / NC/3/MEET/May/202425/4	26 / NC/3/MEET/May/202425/4	26 / NC/3/MEET/May/202425/4	26 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		SUNDYOTA NUMANDIS PROBIOCEUTICALS PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM REVIW00000168AM25
RA File Number		08AA04021121 AM22
Licence No and Date		0811002324/16/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 BIFIDOBACTERIUM LONGUM W11 ID 1114 76.5 kg. 2 FRUCTO OLIGOSACCHARIDE 1912.5 kg. 3 ISOMALT 44.16 PERCENTAGE 1689.12 kg. 4 ORANGE CITRUS POWDER FLAVOUR 70477 57.375 kg. 5 COLLOIDAL SILICON DIOXIDE 38.25 kg. 6 MAGNESIUM SULPHATE ANHYDROUS 38.25 kg. PROTEFLOR IBS SACHET (BIFIDOBACTERIUM LONGUM W11 + Fructo oligosaccharide) 3750 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||PROTEFLOR IBS SACHET (BIFIDOBACTERIUM LONGUM W11 + Fructo oligosaccharide)|| 3750 kg.|1|BIFIDOBACTERIUM LONGUM W11 ID 1114| 76.5 kg.| |||||2|FRUCTO OLIGOSACCHARIDE|1912.5 kg.| |||||3|ISOMALT 44.16 PERCENTAGE|1689.12 kg.| |||||4|ORANGE CITRUS POWDER FLAVOUR 70477| 57.375 kg.| |||||5|COLLOIDAL SILICON DIOXIDE| 38.25 kg.| |||||6|MAGNESIUM SULPHATE ANHYDROUS| 38.25 kg.|

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7 STEVIOL GLYCOSIDE 13.005 kg.

Note: RA will check the number of Sachet to overall weight of export product.

||6|MAGNESIUM SULPHATE ANHYDROUS| 38.25 kg.|

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7 STEVIOL GLYCOSIDE 13.005 kg.

Note: RA will check the number of Sachet to overall weight of export product.

Case No.	27 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	SUMAR BIOTECH LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00000315AM25
RA File Number	08AX04000034 AM22
Licence No and<br>Date	0811003488/20/12/2021
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	Case No.	28 / NC/3/MEET/May/202425/4	28 / NC/3/MEET/May/202425/4	28 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		AMI ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
	Date
HQ	File Number	HQRNORM	REVIW0000904	4AM24
RA	File Number	52AX04000	016 AM22

Lice<br>Date	nce No and<br>	5211001759	/23/12/2021
Nor<br>Th<br>pro<br>aut<br>HB	ms Committee Decision:<br>e Committee considered<br>duct/import itemt in m<br>horizationNo.52110008<br>P Vol. I as per details gi		the case as per<br>eeting**No.

|| |Nor Th pro aut HB|ms Committee Decision: e Committee considered duct/import itemt in m horizationNo.52110008 P Vol. I as per details gi||the case as per eetingNo. NC 03dated01/06 ven below or as|||| |||||agenda /3/ME /2021,|and taking cue from the earlier deci ET/Sep/202324/13 dated 14/09/20 it was decided to fix ad-hoc norms|sion for same export 23against advance under Para 4.07 of| |||||applied|by the firm, whichever is less:-|| ||||||||

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Export Product	Qty.	Sl. No.	Import Items	Qty.
				allowed.
1-(3-CHLORO<br>PHENYL)4-(3-CHLORO	<br>1 kg.	1	1,3-BROMO CHLORO	1.045 kg.
PROPYL) PIPERAZINE HCL			PROPANE 99% min

Case No.	29 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	GUPTA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009287AM24
RA File Number	05AX04001230 AM22
Licence No and<br>Date	0511010862/10/03/2022
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of
the TE, it was decided to call for following information/documents from the firm:-
The chemical reaction indicating molecular weight of both reactants and products with yield<br>1.
and calculation.

The chemical reaction indicating molecular weight of both reactants and products with yield and calculation.

ht of both reactants and products with yield** 1.|| |and calculation.||

The chemical reaction indicating molecular weight of both reactants and products with yield and calculation.

Case No.	30 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	GUPTA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009288AM24
RA File Number	05AX04001267 AM22

UDIN00267029AM25

Licence No and 0511010970/14/03/2022 Date Norms Committee Decision: The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:1. The chemical reaction indicating molecular weight of both reactants and products with yield and calculation.

The chemical reaction indicating molecular weight of both reactants and products with yield and calculation.

Case No.	31 / NC/3/MEET/May/202425/4
Case Status	Case Rejected
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00009049AM24
RA File Number	52AX04000101 AM22
Licence No and<br>Date	5211002273/30/03/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo.

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

Case No.	32 / NC/3/MEET/May/202425/4
Case Status	Case Rejected
Party Name	ORGANIC INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00000058AM25
RA File Number	06AX04000155 AM22
Licence No and<br>Date	0611001257/31/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm vide e-mail dated<br>09/08/2023 has informed that they had paid customs duty and will surrender the licence. The Committee,

22 This document has been digitally signed by Raman Kumar, Deputy DGFT on 24-06-2024 10:04:17.

UDIN00267029AM25

therefore, decided to withdraw the application of the firm.

Case No.	33 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00000422AM25
RA File Number	30AX04000065 AM23
Licence No and<br>Date	3011002150/23/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Urokinase (purified) 1043.46 mg. 2 Mannitol 0.5% 128.52 gm. 3 Sodium Chloride (50 mg/vial) 128.52 mg. Injection Urokinase (Each vial contains 500000 IU of Urokinase) 1000 Vials 4 Sodium Hydroxide 3.06 gm RA concerned may take further necessary action as per above decision of NC.||

Case No.	34 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	USV PRIVATE LIMITED

UDIN00267029AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00002501AM23
RA File Number	03AX04002642 AM23
Licence No and<br>Date	0311016913/05/08/2022
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.<br>allowed.<br>Doxycycline Hyclate DR Tablets<br>USP 200 mg , 60'S US((2,333<br>Bottles X 60 Per Bottles =<br>1,39,980 Tablets)<br>1 Number<br>1<br>Doxycyclin e Hyclate USP<br>230.80 mg<br>RA concerned may take further necessary action as per above decision of NC.

(2,333 Bottles X 60 Per Bottles = 1,39,980 Tablets) 1 Number 1 Doxycyclin e Hyclate USP 230.80 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	35 / NC/3/MEET/May/202425/4
Case Status	Case Rejected
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00003064AM23
RA File Number	05AX04001671 AM23
Licence No and<br>Date	0511014757/12/09/2022
Norms Committee Decision:<br>The firm vide e-mail dated 08/05/2024 has informed that they have surrendered their above license. In view<br>of e-mail of firm, the Committee decided towithdrawthe application of the firm.

UDIN00267029AM25

Case No.	36 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	SHREE MAHADEV INTERMEDIATE
Meeting Number and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00005358AM24
RA File Number	34AX04000640 AM23
Licence No and Date	3411002862/04/10/2022
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms 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.<br>Sl. No.	Import Items	**Qty.

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.|| |TETRAHYDRODICYCLOPENTADIENE IN 1 kg. 1||DICYCLOPENTADIENE|0.995 kg.|| |HEXANE SOLUTION||||| |(97.4% purity)||||| |RA concerned may take further necessary action as per above decision of||NC.|||

Case No.<br>37 / NC/3/MEET/May/202425/4
Case Status<br>Case Approved
Party Name<br>BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number<br>HQRNORM REVIW00009183AM24
RA File Number<br>31AX04000194 AM23
Licence No and Date<br>3111001751/18/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking	cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Feb/202324/25 dated 11/03/2024against advance
authorizationNo. 3111000876 dated 14/01/2022, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Sl.<br>Export Product<br>Qty.<br>Import Items		Qty. allowed.

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BP Vol. I as per details given below or as applied by the firm, whichever is less:-|||| |Sl. Export Product Qty. Import Items||Qty. allowed.||

UDIN00267029AM25

		No.
ETHYLENEDIAMINE	1 kg.	1	MONO ETHANOL AMINE	1.06 kg.
		2	AMMONIA ANHYDROUS	0.294 kg.
DI ETHYLENE TRI AMINE	1 kg.	3	MONO ETHANOL AMINE	1.184 kg.
		4	AMMONIA ANHYDROUS	0.165 kg.
AMINO ETHYL ETHANOL AMINE	1 kg.	5	MONO ETHANOL AMINE	1.173 kg.

Case No.<br>38 / NC/3/MEET/May/202425/4
Case Status<br>Case Approved
Party Name<br>PANACEA BIOTEC LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number<br>HQRNORM REVIW00000471AM25
RA File Number<br>05AX04002301 AM23
Licence No and<br>Date<br>0511015737/10/11/2022
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms 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.
Easyfive TT Vaccine DTwP-Hep<br>100000 Vials	1	Diphtheria Bulk	13.33 Litre
B-Hib- Pentavalent Vaccine
	2	Tetanus Toxoid	5.23 Litre

UDIN00267029AM25

Items**|Qty. allowed.|| |Easyfive TT Vaccine DTwP-Hep 100000 Vials|1|Diphtheria Bulk|13.33 Litre|| |B-Hib- Pentavalent Vaccine||||| ||2|Tetanus Toxoid|5.23 Litre||

UDIN00267029AM25

3	Pertussis Bulk		86.46 Litre
4	Aluminium Phosphate G	el	6.875 kg.

5	Electronic Temperature	Data	<br>126.25
	Logger		Numbers

6	Rubber Stopper		1015000<br>Numbers

7	VVM Dot 14		1015000<br>
			Numbers
8	A Hb Pifii	b	<br>54 Li
	gs urcaton as<br>Column		<br>. tre
9	Tetanus<br>Toxoid<br>for<br>Conjugation		<br>6.15 Litre

Dot 14||1015000 | ||||||||||Numbers| |||||||8|A Hb Pifii|b| 54 Li| ||||||||gs urcaton as Column|| . tre| |||||||9|Tetanus Toxoid for Conjugation|| 6.15 Litre| |||||||||||



Case No.	39 / NC/3/MEET/May/202425/4

Case Status	Case Approved

Party Name	CANPEX CHEMICALS PRIVATE LIMITED
Meeting Number<br>	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
and Date

HQ File Number	HQRNORM REVIW00009170AM24

RA File Number	31AX04000319 AM23
Licence No and	3111001972/19/01/2023
Date
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Feb/202324/23 dated 19/02/2024against advance<br>authorizationNo. 3111001583 dated 22/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-

UDIN00267029AM25

Export Product	Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.
CYANAMIDE 50% SOLUTION	1 kg.	1	CALCIUM CYANAMIDE<br>(Purity 63% as per CoA)	1.913 kg.

ort Product**	Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.
CYANAMIDE 50% SOLUTION	1 kg.	1	CALCIUM CYANAMIDE<br>(Purity 63% as per CoA)	1.913 kg.

Case No.	40 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	SYNERGIA SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00006312AM23
RA File Number	03AX04005369 AM23
Licence No and<br>Date	0311021429/14/02/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Specific quantity of raw material used alongwith copy of Bill of Entry.<br>1.<br>Copy of Shipping Bills of export product.<br>2.

Case No.	41 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001083AM24
RA File Number	09AX04000105 AM24
Licence No and	0911005109/24/05/2023

UDIN00267029AM25

Date

Norms Committee Decision:

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

ion:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
(3R)-TETRAHYDRO-3-FURANYL-4-<br>METHYLBENZENE SULFONATE<br>(Diloxanide furoate, Cimetidine,<br>Oxyclozanide, Famotidine: )	1 kg.	1	Tetra Hydro Furan	4.00 kg.

Case No.	Case No.	42 / NC/3/MEET/May/202425/4	42 / NC/3/MEET/May/202425/4	42 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM APPLY 00001120AM24
RA File Number		08AX04000305 AM24
Licence No and<br>Date		0811008290/25/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>CAPTOPRIL TABLETS 12.5 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CAPTOPRIL PH.<br>EUR. 12.5 MG)<br>1 Number<br>1<br>CAPTOPRIL EP / BP / IP /<br>USP / PH. EUR.<br>12.75 mg.
	Export Product		Qty.	**Sl.

TS 12.5 MG (EACH UNCOATED TABLET CONTAINS: CAPTOPRIL PH. EUR. 12.5 MG) 1 Number 1 CAPTOPRIL EP / BP / IP / USP / PH. EUR. 12.75 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CAPTOPRIL TABLETS 12.5 MG (EACH UNCOATED TABLET CONTAINS: CAPTOPRIL PH. EUR. 12.5 MG)||1 Number|1|CAPTOPRIL EP / BP / IP / USP / PH. EUR.|12.75 mg.|

Case No.	Case No.	42 / NC/3/MEET/May/202425/4	42 / NC/3/MEET/May/202425/4	42 / NC/3/MEET/May/202425/4	42 / NC/3/MEET/May/202425/4	42 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM APPLY 00001120AM24
RA File Number		08AX04000305 AM24
Licence No and<br>Date		0811008290/25/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>CAPTOPRIL TABLETS 12.5 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CAPTOPRIL PH.<br>EUR. 12.5 MG)<br>1 Number<br>1<br>CAPTOPRIL EP / BP / IP /<br>USP / PH. EUR.<br>12.75 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	CAPTOPRIL TABLETS 12.5 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CAPTOPRIL PH.<br>EUR.

EUR. 12.75 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CAPTOPRIL TABLETS 12.5 MG (EACH UNCOATED TABLET CONTAINS: CAPTOPRIL PH. EUR. 12.5 MG)||1 Number|1|CAPTOPRIL EP / BP / IP / USP / PH. EUR.|12.75 mg.|

UDIN00267029AM25

CAPTOPRIL TABLETS 25 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CAPTOPRIL PH.<br>EUR. 25 MG)<br>1 Number<br>2<br>CAPTOPRIL EP / BP / IP /<br>USP / PH. EUR.<br>25.50 mg.<br>CAPTOPRIL TABLETS 50 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CAPTOPRIL PH.<br>EUR. 50 MG [IN<br>WHICH ACTIVE INGREDIENT<br>CAPTOPRIL USED IS 48.375 KGS]<br>)<br>1 Number<br>3<br>CAPTOPRIL EP / BP / IP /<br>USP / PH. EUR.<br>51.00 mg<br>RA concerned may take further necessary action as per above decision of NC.	CAPTOPRIL TABLETS 25 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CAPTOPRIL PH.<br>EUR. 25 MG)	1 Number	2	CAPTOPRIL EP / BP / IP /<br>USP / PH. EUR.	25.50 mg.
	CAPTOPRIL TABLETS 50 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CAPTOPRIL PH.<br>EUR. 50 MG [IN<br>WHICH ACTIVE INGREDIENT<br>CAPTOPRIL USED IS 48.375 KGS]<br>)	1 Number	3	CAPTOPRIL EP / BP / IP /<br>USP / PH. EUR.	51.00 mg

Case No.	43 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	AGRO SOLVENT PRODUCTS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001107AM24
RA File Number	56AX04000449 AM23
Licence No and<br>Date	5611001909/25/05/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	44 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001099AM24
RA File Number	05AX04000523 AM24

UDIN00267029AM25

Licence No and 0511018990/25/05/2023 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Jun/202324/8 dated 24/04/2023 against advance authorization No. 0511018482 dated 24/04/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

dvance authorization No. 0511018482 dated 24/04/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Di Iso Butyl Phthalate (DIBP)<br>(Oily Liquid Phthalate Easter)	1 kg.	1	Phthalic Anhydride	0.560 kg.
		2	Iso Butanol	0.560 kg.

Case No.	45 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001097AM24
RA File Number	03AX04000687 AM24
Licence No and<br>Date	0311023887/25/05/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it<br>was decided to call for following information/documents from the firm:-<br>Justification for low yield of 61%.<br>1.<br>Production/Consumption data certified by Auditor of the firm.<br>2.

UDIN00267029AM25

llowing information/documents from the firm:- Justification for low yield of 61%. 1. Production/Consumption data certified by Auditor of the firm. 2.||

UDIN00267029AM25

Case No.	46 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001095AM24
RA File Number	03AX04000858 AM24
Licence No and<br>Date	0311023883/25/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Nov/202324/16dated17/11/2023against advance<br>authorizationNo.0311015227dated03/06/2022; it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>3 AMINO PYRIDINE<br>1.0 kg.<br>2<br>HYDROGEN PEROXIDE 50 %<br>0.637 kg.<br>3<br>SODIUM NITRITE<br>0.687 kg.<br>2,3 DI CHLORO PYRIDINE<br>1 kg.<br>4<br>CAUSTIC SODA LYE (SODIUM<br>HYDROXIDE LYE)<br>6.33 kg.<br>RA concerned may take further necessary action as per above decision of NC.

RITE 0.687 kg. 2,3 DI CHLORO PYRIDINE 1 kg. 4 CAUSTIC SODA LYE (SODIUM HYDROXIDE LYE) 6.33 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	47 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001091AM24
RA File Number	03AX04000834 AM24
Licence No and Date	0311023871/25/05/2023

UDIN00267029AM25

Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
AMANTADINE<br>HYDROCHLORIDE 100 MG	1 Number<br>Capsule	1	AMANTADINE<br>HYDROCHLORIDE	102 mg.

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

Case No.	Case No.	48 / NC/3/MEET/May/202425/4	48 / NC/3/MEET/May/202425/4	48 / NC/3/MEET/May/202425/4	48 / NC/3/MEET/May/202425/4	48 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		ASG BIOCHEM PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM APPLY 00001122AM24
RA File Number		05AX04001792 AM23
Licence No and Date		0511019003/26/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import product in meetingNo. NC/3/MEET/June/202122/2 dated 02/07/2021against<br>advance authorizationNo.0511002814dated26/05/2021; it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Allylestrenol (Steroidal hormones) 1 kg. 1 Norandrostenedione 1.45 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Allylestrenol (Steroidal hormones)||1 kg.|1|Norandrostenedione|1.45 kg| ||||||||

UDIN00267029AM25

Case No.	49 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001153AM24
RA File Number	03AX04000851 AM24
Licence No and Date	0311023981/26/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Sep/202324/14dated27/09/2023against advance<br>authorizationNo. 0311026363 dated 16/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 9H FLUORENE 0.90 kg. 2 Di N Butylamine 0.50 kg. 3 Sodium Borohydride 0.060 kg. 4 Para Chloro Benzaldehyde 0.3476 kg. LUMEFANTRINE 1 kg. 5 Di Methyl Formamide 0.555 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 50 / NC/3/MEET/May/202425/4

UDIN00267029AM25

Case Status	Case Deferred
Party Name	VASISTA PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001152AM24
RA File Number	26AX04000028 AM24
Licence No and<br>Date	2611000961/26/05/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00001152AM24| |RA File Number|26AX04000028 AM24| |Licence No and Date|2611000961/26/05/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	51 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001166AM24
RA File Number	05AX04000563 AM24
Licence No and Date	0511019054/29/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Cynacobalamin Injection USP,<br>1000mcg/ml,<br>3625000<br>Numbers<br>1<br>CYANOCOBALAMIN USP<br>3987.5 gm.<br>Cynacobalamin Injection USP,<br>10000mcg/10ml (1000mcg/ml),<br>56250<br>Numbers<br>2<br>CYANOCOBALAMIN USP<br>608.75 gm<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00267029AM25

Case No.	52 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001158AM24
RA File Number	03AX04000849 AM24
Licence No and<br>Date	0311024010/29/05/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00001158AM24| |RA File Number|03AX04000849 AM24| |Licence No and Date|0311024010/29/05/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	53 / NC/3/MEET/May/202425/4	53 / NC/3/MEET/May/202425/4	53 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM APPLY 00001161AM24
RA File Number		07AX04000277 AM24
Licence No and Date		0711007675/29/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202324/20dated18/01/2024against advance<br>authorization No.0711004714dated20/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>ASCORBIC ACID DC 97<br>Percentage -SF. I.H<br>63.087 mg.<br>FERROUS FORTE<br>TABLETS((Vitamin C (as<br>Ascorbic Acid) -71mg<br>(248.500 KGS) +Iron (From<br>Ferrous Bisglycinate<br>Chelate-<br>126mg<br>(441.000<br>KGS) With Other Essential<br>Vitamins & Minerals (No of<br>Tabs-3500000))<br>1 Number<br>2<br>IRON BISGLYCINATE<br>122.400 mg.
	Export Product		Qty.	**Sl. No.

126mg (441.000 KGS) With Other Essential Vitamins & Minerals (No of Tabs-3500000)) 1 Number 2 IRON BISGLYCINATE 122.400 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||FERROUS FORTE TABLETS((Vitamin C (as Ascorbic Acid) -71mg (248.500 KGS) +Iron (From Ferrous Bisglycinate Chelate- 126mg (441.000 KGS) With Other Essential Vitamins & Minerals (No of Tabs-3500000))|| 1 Number|1|ASCORBIC ACID DC 97 Percentage -SF. I.H|63.087 mg.| |||||2|IRON BISGLYCINATE|122.400 mg.|

UDIN00267029AM25

Case No.	54 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001167AM24
RA File Number	05AX04000581 AM24
Licence No and<br>Date	0511019057/29/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Tobramycin Inhalation Solution,<br>300mg/ 4ml<br>170000<br>Numbers<br>1<br>TOBRAMYCIN USP<br>56.57 kg.<br>RA concerned may take further necessary action as per above decision of NC.

llowed.** Tobramycin Inhalation Solution, 300mg/ 4ml 170000 Numbers 1 TOBRAMYCIN USP 56.57 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	55 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	UNITED MUD-CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001185AM24
RA File Number	03AX04000897 AM24
Licence No and<br>Date	0311024056/30/05/2023

UDIN00267029AM25

Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No.	56 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001205AM24
RA File Number	03AX04000864 AM24
Licence No and<br>Date	0311024068/31/05/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Copy of Export Orders showing the product is exported to US.

Case No.	Case No.	57 / NC/3/MEET/May/202425/4	57 / NC/3/MEET/May/202425/4	57 / NC/3/MEET/May/202425/4	57 / NC/3/MEET/May/202425/4	57 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM APPLY 00001206AM24
RA File Number		03AX04000854 AM24
Licence No and Date		0311024069/31/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202323/6dated09/09/2022against advance<br>authorizationNo. 0311010761dated21/01/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

duct in meetingNo.NC/3/MEET/Aug/202323/6dated09/09/2022against advance authorizationNo. 0311010761dated21/01/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Case No.	Case No.	57 / NC/3/MEET/May/202425/4	57 / NC/3/MEET/May/202425/4	57 / NC/3/MEET/May/202425/4	57 / NC/3/MEET/May/202425/4	57 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM APPLY 00001206AM24
RA File Number		03AX04000854 AM24
Licence No and Date		0311024069/31/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202323/6dated09/09/2022against advance<br>authorizationNo. 0311010761dated21/01/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty. allowed.

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

UDIN00267029AM25

1<br>SENTRY POLYOX WSR<br>COAGULANT NF<br>56.8 mg.<br>2<br>EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP)<br>33.12 mg.<br>Nifedipine Extended-Release Tablets<br>30mg.(Each tablet contains (i) Sentry<br>Polyox WSR Coagulant NF - 56.80 mg<br>(ii) Eastman<br>(TMCelluloseAcetate(CA398-<br>10NF/EP)-33.12mg<br>(iii)SENTRYPOLYOXWSRN80FPNF-<br>118.40mg.<br>1 Number<br>3<br>SENTRY POLYOX WSR<br>N80 FP NF<br>118.40 mg.<br>4<br>SENTRY POLYOX WSR<br>COAGULANT NF<br>113.60 mg.<br>5<br>EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP)<br>42.32 mg.<br>Nifedipine Extended-Release Tablets<br>60mg.(Each tablet contains (i) Sentry<br>Polyox WSR Coagulant NF - 113.60<br>mg (ii) Eastman<br>(TMCelluloseAcetate(CA398-<br>10NF/EP)-42.32mg<br>(iii)SENTRYPOLYOXWSRN80FPNF-<br>236.80mg<br>1 Number<br>6<br>SENTRY POLYOX WSR<br>N80 FP NF<br>236.80 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Nifedipine Extended-Release Tablets<br>30mg.(Each tablet contains (i) Sentry<br>Polyox WSR Coagulant NF - 56.80 mg<br>(ii) Eastman<br>(TMCelluloseAcetate(CA398-<br>10NF/EP)-33.12mg<br>(iii)SENTRYPOLYOXWSRN80FPNF-<br>118.40mg.	1 Number	1	SENTRY POLYOX WSR<br>COAGULANT NF	56.8 mg.
			2	EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP)	33.12 mg.
			3	SENTRY POLYOX WSR<br>N80 FP NF	118.40 mg.

Number|1|SENTRY POLYOX WSR COAGULANT NF|56.8 mg.| |---|---|---|---|---|---| ||||2|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|33.12 mg.| ||||3|SENTRY POLYOX WSR N80 FP NF|118.40 mg.| ||Nifedipine Extended-Release Tablets 60mg.(Each tablet contains (i) Sentry Polyox WSR Coagulant NF - 113.60 mg (ii) Eastman (TMCelluloseAcetate(CA398- 10NF/EP)-42.32mg (iii)SENTRYPOLYOXWSRN80FPNF- 236.80mg|1 Number|4|SENTRY POLYOX WSR COAGULANT NF|113.60 mg.| ||||5|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|42.32 mg.| ||||6|SENTRY POLYOX WSR N80 FP NF|236.80 mg.|

Case No.	58 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001208AM24
RA File Number	34AX04000142 AM24
Licence No and<br>Date	3411003764/31/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00267029AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Diclofenac Sodium Topical Solution 2%	1 Number	1	Diclofenac Sodium	2.2838 gm
112 gm			USP
Diclofenac Sodium Topical Gel 3 % 100	1 Number	2	Diclofenac Sodium	3.06 gm
gm			USP

--|---|---| |Diclofenac Sodium Topical Solution 2%|1 Number|1|Diclofenac Sodium|2.2838 gm| |112 gm|||USP|| |Diclofenac Sodium Topical Gel 3 % 100|1 Number|2|Diclofenac Sodium|3.06 gm| |gm|||USP||

Case No.<br>59 / NC/3/MEET/May/202425/4
Case Status<br>Case Approved
Party Name<br>ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number<br>HQRNORM APPLY 00001209AM24
RA File Number<br>34AX04000143 AM24
Licence No and<br>Date<br>3411003766/31/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was	decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
Fluorouracil Injection USP 2.5 gm 50 ML<br>1 Number	1	Fluorouracil USP	2.60 gm
Fluorouracil Injection USP 5 gm 100 ML<br>1 Number	2	Fluorouracil USP	5.20 gm
RA concerned may take further necessary action as per above decision of NC.

UDIN00267029AM25

.60 gm|| |Fluorouracil Injection USP 5 gm 100 ML 1 Number|2|Fluorouracil USP|5.20 gm|| |RA concerned may take further necessary action as per above decision of NC.|||||

UDIN00267029AM25

Case No.	60 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00001225AM24
RA File Number	30AX04000609 AM23
Licence No and<br>Date	3011003608/31/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-
Technologyfor obtaining their comments.

Case No.	61 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	GITANJALI CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00004784AM24
RA File Number	03AX04001927 AM24
Licence No and<br>Date	0311025944/02/08/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it
was decided to call for following information/documents from the firm:-
Stoichiometric material balance of the reaction on a molar basis.<br>1.
Justification of low yield of the reaction and how to prevent side products formed during<br>2.
reaction.
The norms fixed in the past by the norms committee, for the same export and import of the<br>3.
item.

action and how to prevent side products formed during** 2.|| |reaction.|| |The norms fixed in the past by the norms committee, for the same export and import of the 3.|| |item.||


Case No.	62 / NC/3/MEET/May/202425/4
Case Status	Case Deferred

UDIN00267029AM25

Party Name	DAFFODIL PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00004908AM24
RA File Number	08AX04000865 AM24
Licence No and<br>Date	0811009026/07/08/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.		63 / NC/3/MEET/May/202425/4
Case Status		Case Deferred
Party Name		AKUMS DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM APPLY 00006789AM24
RA File Number		05AX04002288 AM24
Licence No and<br>Date		0511022010/09/11/2023
Norms Committee	Decision:
The committee	considered the request of firm for fixation of ad-hoc norms and as per the advise of the
TE, it was decided to call for following information/documents from the firm:-
UOM of export	quantity may be indicated in ‘Number’.

on of ad-hoc norms and as per the advise of the|| |TE, it was decided to call for following information/documents from the firm:-||| |UOM of export|quantity may be indicated in ‘Number’.||

Case No.	64 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	AKUMS DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00006849AM24
RA File Number	05AX04001479 AM23
Licence No and<br>Date	0511021951/15/11/2023
Norms Committee Decision:

42 This document has been digitally signed by Raman Kumar, Deputy DGFT on 24-06-2024 10:04:17.

UDIN00267029AM25

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.
MOXCOR-500mg (Amoxicillin)	1 Number	1	Amoxicillin Trihydrate	585.36 mg
(Amoxicillin-500MG CAPSULES			COMP BP
(Amoxicillin VN-21840-19)

Items**|Qty. allowed.| |---|---|---|---|---| |MOXCOR-500mg (Amoxicillin)|1 Number|1|Amoxicillin Trihydrate|585.36 mg| |(Amoxicillin-500MG CAPSULES|||COMP BP|| |(Amoxicillin VN-21840-19)|||||

Case No.<br>65 / NC/3/MEET/May/202425/4
Case Status<br>Case Approved
Party Name<br>GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number<br>HQRNORM REVIW00009345AM24
RA File Number<br>03AX04004079 AM24
Licence No and<br>Date<br>0311029276/12/12/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to review 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.	Import Items	Qty. allowed.
FLUCORT N SKIN CREAM 0.025% (Pack	322660 Packs	FLUOCINOLONE	16.915 kg.
Size 5 gms) (( Net Wt.of FLUOCINOLONE		ACETONIDE BP
ACETONIDE BP is 0.403 Kgs.))
FLUCORT SKIN CREAM 0.025% (Pack	322660 Packs
Size 15 gms)(( Net Wt.of

UDIN00267029AM25

|Size 5 gms) (( Net Wt.of FLUOCINOLONE||ACETONIDE BP||| |ACETONIDE BP is 0.403 Kgs.))||||| |FLUCORT SKIN CREAM 0.025% (Pack|322660 Packs|||| |Size 15 gms)(( Net Wt.of|||||

UDIN00267029AM25

	FLUOCINOLONE ACETONIDE BP is<br>1.210 Kgs.))
	FLUCORT N SKIN CREAM 0.025% (Pack<br>Size 15 gms)(( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is<br>9.075 Kgs.))	2420000 Packs
	FLUCORT SKIN CREAM 0.025% (Pack<br>Size 5 gms)(( Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 1.210 Kgs.))	968000 Packs
	FLUOCINOLONE CREAM (TDR) ET<br>0.025% (Pack Size 10 gms)(( Net Wt.of<br>FLUOCINOLONE ACETONIDE<br>BP is 0.242 Kgs.))	96800 Packs
	CYNOZET CREAM 0.025% (Pack Size 5<br>gms)((Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.242 Kgs.))	193600 Packs
	CYNOZET CREAM 0.025% (Pack Size 15<br>gms)((Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.242 Kgs.))	64532 Packs
	SUPRICORT CREAM 0.025% (Pack Size 5<br>gms)(( Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.726 Kgs.))	<br>580800 Packs
	SUPRICORT CREAM 0.025% (Pack Size<br>15 gms)(( Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.726 Kgs.))	193596 Packs
	SUPRICORT CREAM 0.025% (Pack Size<br>250 gms)(( Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.242 Kgs.))	3873 Packs
	SUPRICORT N CREAM 0.025% (Pack<br>Size 5 gms)(( Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.242 Kgs. ))	193600 Packs

UDIN00267029AM25

ONE ACETONIDE BP is 0.242 Kgs.))|3873 Packs||| ||SUPRICORT N CREAM 0.025% (Pack Size 5 gms)(( Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs. ))|193600 Packs|||

UDIN00267029AM25

SUPRICORT N CREAM 0.025% (Pack<br>Size 15 gms)(( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is<br>0.242 Kgs.))<br>64532 Packs<br>Flucort C Cream 0.01% (Pack Size 15<br>gms)((Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.095 Kgs))<br>63332 Packs<br>FLUCORT C OINTMENT 0.025% (Pack<br>Size 15 gms)(( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is<br>0.605 Kgs.))<br>161330 Packs<br>GLENCORT GEL 0.025 % (Pack Size 5<br>gms)((Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.452 Kgs.))<br>361600 Packs<br>GLENCORT GEL 0.025 % (Pack Size 30<br>gms)((Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.484 Kgs.))<br>64535 Packs<br>FLUCORT MZ SKIN OINTMENT 0.01%<br>(Pack Size 15 gms)(( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is<br>0.145 Kgs.))<br>96798 Packs<br>RA concerned may take further necessary action as per above decision of NC.	SUPRICORT N CREAM 0.025% (Pack<br>Size 15 gms)(( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is<br>0.242 Kgs.))	64532 Packs
	Flucort C Cream 0.01% (Pack Size 15<br>gms)((Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.095 Kgs))	63332 Packs
	FLUCORT C OINTMENT 0.025% (Pack<br>Size 15 gms)(( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is<br>0.605 Kgs.))	161330 Packs
	GLENCORT GEL 0.025 % (Pack Size 5<br>gms)((Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.452 Kgs.))	361600 Packs

15 gms)(( Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.))|161330 Packs||| ||GLENCORT GEL 0.025 % (Pack Size 5 gms)((Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.452 Kgs.))|361600 Packs||| ||GLENCORT GEL 0.025 % (Pack Size 30 gms)((Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.484 Kgs.))|64535 Packs||| ||FLUCORT MZ SKIN OINTMENT 0.01% (Pack Size 15 gms)(( Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.145 Kgs.))|96798 Packs|||

Case No.	66 / NC/3/MEET/May/202425/4
Case Status	Case Rejected
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM REVIW00000462AM25
RA File Number	05AX04003662 AM24
Licence No and	0511024074/26/02/2024

UDIN00267029AM25

Date

Norms Committee 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.

Case No.	67 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	VIMAGE PARENTERAL LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008849AM24
RA File Number	50AX04000104 AM24
Licence No and<br>Date	5011001310/01/03/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00008849AM24| |RA File Number|50AX04000104 AM24| |Licence No and Date|5011001310/01/03/2024| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	68 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008851AM24
RA File Number	08AX04002088 AM24
Licence No and<br>Date	0811010935/01/03/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	69 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	SHARP MINT LIMITED

46 This document has been digitally signed by Raman Kumar, Deputy DGFT on 24-06-2024 10:04:17.

UDIN00267029AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008852AM24
RA File Number	05AX04003809 AM24
Licence No and<br>Date	0511024175/01/03/2024
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of
the TE, it was decided to call for following information/documents from the firm:-
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.

formula and molecular weights along with** ii.|| |stage wise percentage yields on molar basis.|| |Complete technical details as per Annexure to Appendix 4E for chemical products. iii.|| |Stoichiometric balance between import and export on molar basis. iv.|| |Details of v.|indigenous input with quantity.|

Case No.<br>70 / NC/3/MEET/May/202425/4
Case Status<br>Case Approved
Party Name<br>AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number<br>HQRNORM APPLY 00008878AM24
RA File Number<br>08AX04002161 AM24
Licence No and<br>Date<br>0811010941/02/03/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Fen/202324/23dated19/02/2024against advance
authorizationNo. 0811009509 dated 03/10/2023, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
Phenylephrine Hydrochloride<br>1 Number	1	Phenylephrine HCl	110.00 mg/vial
Injection USP, 10 mg/mL (10 mL)		USP/Ph.Eur

UDIN00267029AM25

|Import Items|Qty. allowed.|| |Phenylephrine Hydrochloride 1 Number|1|Phenylephrine HCl|110.00 mg/vial|| |Injection USP, 10 mg/mL (10 mL)||USP/Ph.Eur||| ||||||

UDIN00267029AM25

Case No.	71 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008891AM24
RA File Number	07AX04001899 AM24
Licence No and Date	0711010690/04/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance<br>authorizationNo.0711003428 dated 15/03/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Chlordiazepoxide<br>Hydrochloride<br>BP/EP/USP/IP<br>5.1 mg.<br>Chlordiazepoxide Hydrochloride and<br>Clidinium Bromide Capsules 5mg/2.5 mg<br>(15.75 kgs))<br>1 Number<br>2<br>Clidinium Bromide<br>BP/EP/USP/IP<br>2.55 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	72 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008892AM24

UDIN00267029AM25

UDIN00267029AM25

RA File Number

08AX04002171 AM24

Licence No and Date

0811010967/04/03/2024

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Jan/202324/21 dated 24/01/2024against advance authorizationNo.0811008135 dated 10/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No.Import Items Qty. allowed. PROPAFENONE TABLETS 150MG (PROPRAFENON150HEUMANN) (EACH FILM COATED TABLET CONTAINS: PROPAFENONE HYDROCHLORIDE PH. EUR. 150 MG 1 Number 1 PROPAFENONE HYDROCHLORIDE EP 153 mg/ tablet PROPAFENONE TABLETS 300MG (PROPRAFENON 300 HEUMANN) (EACH FILM COATED TABLET CONTAINS:PROPAFENONE HYDROCHLORIDE PH. EUR. 300 MG 1 Number 2 PROPAFENONE HYDROCHLORIDE EP 306 mg/ tablet RA concerned may take further necessary action as per above decision of NC.

:PROPAFENONE HYDROCHLORIDE PH. EUR. 300 MG 1 Number 2 PROPAFENONE HYDROCHLORIDE EP 306 mg/ tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	73 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008890AM24
RA File Number	05AX04003801 AM24
Licence No and<br>Date	0511024319/04/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

UDIN00267029AM25

product/import product in meeting No.NC/3/MEET/Dec/202324/19 dated 05/01/2024 against advance authorization No.1311000462 dated 22/07/2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Meropenem for Injection	1 kg.	1<br> <br>	Meropenem Trihydrate<br>(Non Sterile)	0.8968 kg.

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Meropenem for Injection	1 kg.	1<br> <br>	Meropenem Trihydrate<br>(Non Sterile)	0.8968 kg.

Case No.	74 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008899AM24
RA File Number	03AX04005541 AM24
Licence No and<br>Date	0311031703/05/03/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>To give nomenclature of each reactant and product formed in reaction, without using<br>abbreviation.<br>1.<br>Justification of low yield of the reaction.<br>2.<br>The norms fixed in the past by the norms committee, for the same export and import of the<br>items.<br>3.<br>End use of export item.<br>4.

UDIN00267029AM25

action.** 2. The norms fixed in the past by the norms committee, for the same export and import of the items. 3. End use of export item. 4.||

UDIN00267029AM25

Case No.	75 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008919AM24
RA File Number	05AX04003769 AM24
Licence No and<br>Date	0511024342/06/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Tazobactam Acid<br>0.1075 kg.<br>Piperacillin Sodium and Tazobactam Sodium<br>Sterile (8:1)<br>1 kg.<br>1<br>Piperacillin Acid<br>0.890 kg.<br>RA concerned may take further necessary action as per above decision of NC.

5 kg. Piperacillin Sodium and Tazobactam Sodium Sterile (8:1) 1 kg. 1 Piperacillin Acid 0.890 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	76 / NC/3/MEET/May/202425/4	76 / NC/3/MEET/May/202425/4	76 / NC/3/MEET/May/202425/4	76 / NC/3/MEET/May/202425/4	76 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		AVIK PHARMACEUTICAL LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM APPLY 00008936AM24
RA File Number		52AX04000378 AM24
Licence No and Date		5211007594/06/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Qty.<br>Export Product<br>Qty.<br>Sl. No. Import Items
	Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00267029AM25

					allowed.
CLOBETASOL PROPIONATE CP	1	kg.	1	BETAMETHASONE	1.00 kg.

Note: The committee decided to fix the SION for inpute ‘Clobetasol Propionate’.

Case No.	77 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	SRI KRISHNA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008937AM24
RA File Number	09AX04001083 AM24
Licence No and<br>Date	0911006881/06/03/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	78 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	RITSA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008938AM24
RA File Number	09AX04001035 AM24
Licence No and<br>Date	0911006882/06/03/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

UDIN00267029AM25

Case No.	79 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008940AM24
RA File Number	09AX04001061 AM24
Licence No and<br>Date	0911006884/06/03/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00008940AM24| |RA File Number|09AX04001061 AM24| |Licence No and Date|0911006884/06/03/2024| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	80 / NC/3/MEET/May/202425/4	80 / NC/3/MEET/May/202425/4	80 / NC/3/MEET/May/202425/4	80 / NC/3/MEET/May/202425/4	80 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number		HQRNORM APPLY 00008957AM24
RA File Number		07AX04001905 AM24
Licence No and Date		0711010708/07/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against advance<br>authorizationNo.0711007283 dated 06/04/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>DIRECT COMPRESSION<br>GRANULES OF<br>PHLOROGLUCINOL 160MG ODT<br>PREMIX(DIRECT COMPRESSION<br>GRANULES OF<br>PHLOROGLUCINOL 160MG ODT<br>1 kg.<br>1<br>PHLOROGLUCINOL<br>DIHYDRATE Ph.EUR<br>0.359 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

ECT COMPRESSION GRANULES OF PHLOROGLUCINOL 160MG ODT 1 kg. 1 PHLOROGLUCINOL DIHYDRATE Ph.EUR 0.359 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||DIRECT COMPRESSION GRANULES OF PHLOROGLUCINOL 160MG ODT PREMIX(DIRECT COMPRESSION GRANULES OF PHLOROGLUCINOL 160MG ODT||1 kg.|1 |PHLOROGLUCINOL DIHYDRATE Ph.EUR|0.359 kg.|

UDIN00267029AM25

PREMIX (EACH 450mg Premix Contains 160mg Phloroglucinol) contents 224.28 kg)

Case No.	Case No.	81 / NC/3/MEET/May/202425/4
Case Status		Case Approved
Party Name		AVIK PHARMACEUTICAL LIMITED

Meeting Number an<br>	d	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
Date

HQ File Number		HQRNORM APPLY 00008946AM24

RA File Number		52AX04000379 AM24
Licence No and Da	te	5211007605/07/03/2024

Norms Committee	Decision:
The Committee	considered the case as per agenda and taking cue from the earlier decision for same export

5211007605/07/03/2024||||||||| ||||||||||||| |Norms Committee||Decision:|||||||||| |The Committee||considered the case as per agenda and taking cue from the earlier decision for same export|||||||||| | product/import authorizationN|| product in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance 5211004531dated 31/03/2023it was decided to fix ad-hoc norms under Para 407 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. TRIAMICINOLONE IP/EP/BP/USP 1 kg. 1 3,20-DIOXOPREGNA- 1,4,9(11),16 - TETRAEN - 21- YLACETATE (3 TR) 1.00 kg. RA concerned may take further necessary action as per above decision of NC.|||||||||||| ||Export Product|||Qty.||Sl. No.||Import Items|||Qty. allowed.| ||||||||||||| ||TRIAMICINOLONE IP/EP/BP/USP|||1 k|g.|1||3,20-DIO 1,4,9(11)|XOPREGNA- ,16 - TETRAEN - 21-||1.00 kg.| |||||||||YLACET|ATE (3 TR)||| ||||||||||||| ||concerned may take further necessary action as per above decision of NC.||||||||||| |||||||||||||

Case No.	82 / NC/3/MEET/May/202425/4
Case Status	Case Approved

UDIN00267029AM25

ned may take further necessary action as per above decision of NC.||||||||||| |||||||||||||

Case No.	82 / NC/3/MEET/May/202425/4
Case Status	Case Approved

UDIN00267029AM25

Party Name	SANJIVANI PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008951AM24
RA File Number	34AX04000872 AM24
Licence No and<br>Date	3411004694/07/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Clobetasol 17 Propionate<br>1 kg.<br>1<br>Betamethasone<br>1.00 kg.<br>Note: The committee decided to fix the SION for inpute ‘Clobetasol Propionate’.<br>RA concerned may take further necessary action as per above decision of NC.

br>Betamethasone 1.00 kg. Note: The committee decided to fix the SION for inpute ‘Clobetasol Propionate’. RA concerned may take further necessary action as per above decision of NC.||

Case No.	83 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008953AM24
RA File Number	52AX04000377 AM24
Licence No and Date	5211007606/07/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance<br>authorizationNo. 5211004531 dated 31/03/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00267029AM25

Export Product	Qty.	Sl. No.	Import Items	Qty.
				allowed.
TRIAMICINOLONE ACETONIDE	<br>1 kg.	1	3,20-DIOXOPREGNA-	1.00 kg.
IP/EP/BP/USP			1,4,9(11),16 - TETRAEN -
			21- YLACETATE (3 TR)

Items**|Qty.| |---|---|---|---|---| |||||allowed.| |TRIAMICINOLONE ACETONIDE| 1 kg.|1|3,20-DIOXOPREGNA-|1.00 kg.| |IP/EP/BP/USP|||1,4,9(11),16 - TETRAEN -|| ||||21- YLACETATE (3 TR)||

	Export Product	Export Product	Qty.	Sl. No.	Sl. No.	Import Items	Import Items	Import Items	Qty.<br>lld	Qty.<br>lld
									aowe.

	TRIAMICIN	OLONE ACETONIDE	<br>1 kg.	1		3,20-DIOXOPREGNA-			1.00 kg.
	IP/EP/BP/US	P				1,4,9(11),16 - TETRAEN -<br>21- YLACETATE (3 TR)



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


Cas	e No.	84 / NC/3/MEET/May/202425/4
Cas	e Status	Case Approved
Par	ty Name	MANKIND PHARMA LIMITED
Me<br>and	eting Number	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/20			4
	Date
HQ	File Number	HQRNORM APPLY 00008965AM24
RA	File Number	05AX04003839 AM24
Lic<br>Dat
	ence No and<br>e	0511024393/07/03/2024
Nor<br>Th<br>pr<br>au<br>H	ms Committee Decision:<br>e Committee considered the case as per agenda and ta				king cue from		the ea	rlier decision for		same export
	<br>oduct/import product in meetingNo.NC/3/MEET/Ma<br>thorizationNo. 0511023265 dated 15/01/2024, it was<br>BP Vol.

d ta|||||king cue from||||the ea|rlier decision for||same export| || oduct/import product in meetingNo.NC/3/MEET/Ma thorizationNo. 0511023265 dated 15/01/2024, it was BP Vol. I as per details given below or as applied by th||||| r/202324/26 decided to f e firm, which|||| dated ix ad-h ever is| 22/03/2024agai oc norms under less:-|| nst advance Para 4.07 of| ||||||||||||||| ||Export Product|||Qty.|||**Sl. No. **||Import Items||||Qty. allowed.| ||||||||||||||| ||Tobramycin Inhalation Solution, 300mg/ 5ml|||1 Number|||1||TOBRAMYCIN USP||||306 mg.| ||||||||||||||| ||||||||||||||| ||||||||||||||| |RA concerned m||ay take further necessary action as per above decision of NC.|||||||||||| ||||||||||||||| |||||||||||||||

UDIN00267029AM25



Case No.		85 / NC/3/MEET/May/202425/4
Cas	e Status	Case Approved
Par	ty Name	JUBILANT GENERICS LIMITED
Me<br>and
	eting Number<br>Date	NC/ 3/ MEET/ May/ 2	02425/ 4 a	nd 06/06/20	24
HQ	File Number	HQRNORM APPLY	00008966A	M24
RA	File Number	05AX04003851 AM2	4
Lic<br>Dat	ence No and<br>	0511024394/07/03/20	24
	e

nd 06/06/20|||24|||| |HQ|File Number|HQRNORM APPLY||00008966A|||M24||||||| |RA|File Number|05AX04003851 AM2||4|||||||||| |Lic Dat|ence No and |0511024394/07/03/20||24|||||||||| ||e||||||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Feb/202324/23 dated 19/02/2024against advance authorizationNo 3411004140dated 21/09/2023it was decided to fix ad-hoc norms under Para 407 of|||||||||||||| |. , . HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|||||||||||||| ||||||||||||||| ||Export Prod|uct|Qty.|||**Sl. No. **||Import Items||||Qty. allowed.|| ||||||||||||||| ||||||||||||||| ||Amantadine 100m|HCL|1 Number|||1 ||Amantadine Hydrochloride||||102.00 mg./Tablet|| ||g||||||||||||| ||||||||||||||| |RA d||tk fth ti b dii f NC|||||||||||| |concerne may ae urer necessary acon as per aove ecson o .|||||||||||||| ||||||||||||||| |Cas|||||||||||||| ||e No.|86 / NC/3/MEET/May/202|||425/4||||||||| |Cas|e Status|Case Deferred|||||||||||| |Par|ty Name|MANKIND PHARMA LI|||MITED||||||||| ||||||||||||||| |Me and|eting Number Date|NC/ 3/ MEET/ May/ 20242|||5/ 4 and 06/0||||6/2024||||| |HQ|File Number|HQRNORM APPLY 00008983AM24|||||||||||| |RA|File Number|05AX04003903 AM24|||||||||||| |Licence No and Date||0511024411/08/03/2024|||||||||||| |Norms Committee Decision:||||||||||||||

File Number|HQRNORM APPLY 00008983AM24|||||||||||| |RA|File Number|05AX04003903 AM24|||||||||||| |Licence No and Date||0511024411/08/03/2024|||||||||||| |Norms Committee Decision:||||||||||||||

Case No.	86 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00008983AM24
RA File Number	05AX04003903 AM24
Licence No and<br>Date	0511024411/08/03/2024
Norms Committee Decision:

UDIN00267029AM25

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

Copy of Master Batch Formula (MBF). 2. Copy of Drug Manufacturing Licence (DML).

Case No.	87 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009001AM24
RA File Number	03AX04005652 AM24
Licence No and Date	0311031952/11/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>DOXYLEB CAPSULE<br>(DOXYCYCLINE<br>HYCLATE CAPSULE BP)<br>100MG(IN PACKING OF<br>10X10'S, 10X100'S &<br>1000'S.

- Export Product Qty. Sl. No. Import Items Qty. allowed. DOXYLEB CAPSULE (DOXYCYCLINE HYCLATE CAPSULE BP) 100MG(IN PACKING OF 10X10'S, 10X100'S & 1000'S. QTY CONSUMED OF EXEMPT MATERIAL DOXYCYCLINE HYCLATE BP- 115.400MG/CAPSULE) 1 Number 1 DOXYCYCLINE HYCLATE BP 115.40 mg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00267029AM25

Case No.	88 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009016AM24
RA File Number	03AX04005612 AM24
Licence No and<br>Date	0311031972/11/03/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.<br>	89 / NC/3/MEET/May/202425/4
Case Status<br>	Case Approved
Party Name<br>	ANNORA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number<br>	HQRNORM APPLY 00009019AM24
RA File Number<br>	09AX04000658 AM23
Licence No and<br>Date<br>	0911004281/11/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 DIATRIZOATE MEGLUMINE USP 693.00 mg. DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION USP 660mg/ml &100 mg/ml 1 Number 2 DIATRIZOATE SODIUM USP 105.00 mg RA concerned may take further necessary action as per above decision of NC.||

UDIN00267029AM25

Case No.	90 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	MAXMED LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009025AM24
RA File Number	05AX04003876 AM24
Licence No and<br>Date	0511024356/11/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Amoxycillin oral suspension<br>(Amoxycillin Syrup) 250 mg/5 ml,<br>60 ml bottle (Each 5 ml contains<br>Amoxycillin Trihydrate equivalent<br>to 250 mg of Amoxycillin))<br>1500000<br>Numbers<br>1<br>Amoxycillin Trihydrate<br>5423.0 kg.<br>RA concerned may take further necessary action as per above decision of NC.

hydrate equivalent to 250 mg of Amoxycillin)) 1500000 Numbers 1 Amoxycillin Trihydrate 5423.0 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	91 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	FREESIA CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009031AM24
RA File Number	03AX04005613 AM24
Licence No and<br>Date	0311032018/12/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

UDIN00267029AM25

product/import product in meeting No. NC/3/MEET/Mar/202324/26 dated 22/03/2024 against advance authorization No. 0311029806 dated 01/01/2024 , 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	Qty.	Sl. No.	Import Items	Qty. allowed.
Cyclopentanone(CAS NO. 120-92-3)	1 kg.	1	Adipic Acid	1.93 kg.

Case No.	92 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009059AM24
RA File Number	03AX04005628 AM24
Licence No and<br>Date	0311032047/12/03/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00009059AM24| |RA File Number|03AX04005628 AM24| |Licence No and Date|0311032047/12/03/2024| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	93 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009032AM24
RA File Number	08AX04002174 AM24
Licence No and Date	0811010987/12/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance

UDIN00267029AM25

authorization No. 0811009097 dated 16/08/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

AM25

authorization No. 0811009097 dated 16/08/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
ISOSORBIDE MONONITRATE<br>EXTENDED RELEASE<br>TABLETS USP 60 MG (EACH<br>FILM COATED EXTENDED<br>RELEASE TABLETS<br>CONTAINS: DILUTED<br>ISOSORBIDE MONONITRATE<br>(50% DILUTED WITH<br>LACTOSEMONOHYDRATE)<br>USPEQUIVALENT TO<br>ISOSORBIDE MONONITRATE<br>60 MG,	1 Number	1<br> <br> <br> <br>	Isosorbide Mononitrate 50<br>percent Assay. Diluted ISMN<br>(50% diluted with lactose<br>monohydrat e) USP	<br>122.40 mg
ISOSORBIDE MONONITRATE<br>EXTENDED RELEASE<br>TABLETS USP 120 MG(EACH<br>FILM COATED EXTENDED<br>RELEASE TABLETS<br>CONTAINS: DILUTED<br>ISOSORBIDE MONONITRATE<br>(50% DILUTED WITH<br>LACTOSEMONOHYDRATE)<br>USP EQUIVALENT TO<br>ISOSORBIDE MONONITRATE<br>120 MG,	1 Number	2<br> <br> <br> <br>	Isosorbide Mononitrate 50<br>percent Assay. Diluted ISMN<br>(50% diluted with lactose<br>monohydrat	<br>244.80 mg.

Case No.	94 / NC/3/MEET/May/202425/4
Case Status	Case Deferred
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024

UDIN00267029AM25

and Date
HQ File Number	HQRNORM APPLY 00009076AM24
RA File Number	08AX04002209 AM24
Licence No and<br>Date	0811011004/13/03/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00009076AM24| |RA File Number|08AX04002209 AM24| |Licence No and Date|0811011004/13/03/2024| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	95 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009083AM24
RA File Number	03AX04005645 AM24
Licence No and<br>Date	0311032129/13/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>HALQUNOL BP 80<br>1 kg.<br>1<br>8 HYDROXY QUINOLINE<br>0.77 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	96 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009085AM24
RA File Number	03AX04005648 AM24

UDIN00267029AM25

Licence No and Date 0311032134/14/03/2024 Norms Committee Decision:

UDIN00267029AM25

Licence No and Date 0311032134/14/03/2024 Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Mar/202122/16 dated 08/04/2022 against advance authorization No. 0311008136 dated 01/11/2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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

Case No.	97 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009106AM24
RA File Number	03AX04005708 AM24
Licence No and<br>Date	0311032153/14/03/2024
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00267029AM25

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:-||

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Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Co-dydramol 10/500 tablets	1 Number	1	Dihydrocodeine Tartrate	10.2 mg
(Dihydrocodeine Tartrate 10mg
and Paracetamol 500mg
Tablets)(Each Tablet contains
Dihydrocodeine Tartrate 10mg
and Paracetamol 500mg

Case No.<br>98 / NC/3/MEET/May/202425/4
Case Status<br>Case Approved
Party Name<br>SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number<br>HQRNORM APPLY 00009140AM24
RA File Number<br>05AX04003925 AM24
Licence No and<br>Date<br>0511024521/15/03/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from		the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Apr/202223/1		dated 29/04/2022	against advance
authorizationNo. 0511006574 dated 02/12/2021, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No. Import Items		**Qty.

to fix ad-hoc norms under Para 4.07 of||||| |HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||||| |Export Product Qty.|Sl. No. Import Items||Qty. allowed.|| |Nepafenac Ophthalmic Suspension, 0.1% 90000|1 Nepafenac||459 gm.|| |w/v Sterile Eye Drops, 5ml) Numbers||||| |((Each ml contains Nepafenac 1.0 mg||||| |(Equivalent to 450.000 Gram of Bulk||||| |Drug))|||||

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Case No.	99 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024
HQ File Number	HQRNORM APPLY 00009315AM24
RA File Number	09AX04001149 AM24
Licence No and Date	0911006981/26/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty. Sl. No. Import Items<br>Qty. allowed.<br>Benzyl<br>(1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR)-<br>3-hydrazineyl-2-hydroxy-1,6a,8,10a-<br>tetramethyl-8-((R)-3-methylbutan. (-2-<br>yl)- 1,3,4,6,6a,7,8,9,10,10a,10b,11,12,12a-<br>tetradecahydro-2H-1,4a-<br>(methanooxymethano)chrysene-7-<br>carboxylate(Drug Intermediate of<br>Ibrexafungerp Citrate))<br>1 kg.<br>1<br>ENFUMAFUNGIN<br>2.086 kg.<br>RA concerned may take further necessary action as per above decision of NC.

rysene-7- carboxylate(Drug Intermediate of Ibrexafungerp Citrate)) 1 kg. 1 ENFUMAFUNGIN 2.086 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	100 / NC/3/MEET/May/202425/4
Case Status	Case Approved
Party Name	SHREE MAHADEV INTERMEDIATE
Meeting Number and Date	NC/ 3/ MEET/ May/ 202425/ 4 and 06/06/2024

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HQ File Number	HQRNORM APPLY 00000037AM25
RA File Number	34AX04000967 AM24
Licence No and Date	3411004750/02/04/2024
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>TETRAHYDRODICYCLOPENTADIENE IN<br>HEXANE SOLUTION<br>(97.4% purity)<br>1 kg.<br>1<br>DICYCLOPENTADIENE<br>0.995 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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