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/Jul/202425/7 DATED: 06/08/2024

Please Note

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

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

Meeting No. NC/3/MEET/Jul/202425/7 dated 06/08/2024 of Norms Committee - III for the year 2024-25 was held on 06/08/2024 under the Chairmanship of Shri Rakesh Kumar,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2023.

The following members were present in the meeting:-

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

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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2	Shri Raman Kumar,Deputy DGFT	DGFT(HQ)
3	Shri Uttam Dey Sarkar, Assistant Section Officer	DGFT (HQ)
4	Shri SHAISH KUMAR,Technical Consultant	DGFT
5	Shri DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT
6	Shri Nand Lal,Technical Consultant	DGFT

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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3 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	TROIKAA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00001967AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Export quantity in number of Injections.<br>1.<br>Export description as per Drug ManufacturingLicence (DML).<br>2.<br>Copy of DML.<br>3.<br>Master-Batch Formula with net content of inputs in export item.<br>4.

Case No.	2 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	BIOLOGICAL E. LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00007891AM24
RA File Number	NA
Licence No and<br>Date	NA
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>Deptt.

891AM24| |RA File Number|NA| |Licence No and Date|NA| |Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the Deptt. of Bio-Technology, it was decided to call for the following information/documents from the firm:- Technical process flow diagram of manufacturing of export product involving all the imported items and wastages involved at each step. 1. Batch manufacturing record and material reconciliation sheet duly signed by the dealing executive/manager. 2. Drug Manufacturing Licence 3.||

Technical process flow diagram of manufacturing of export product involving all the imported items and wastages involved at each step.
Batch manufacturing record and material reconciliation sheet duly signed by the dealing executive/manager.

4 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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and material reconciliation sheet duly signed by the dealing executive/manager.**

4 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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Case No.	Case No.	3 / NC/3/MEET/Jul/202425/7	3 / NC/3/MEET/Jul/202425/7	3 / NC/3/MEET/Jul/202425/7	3 / NC/3/MEET/Jul/202425/7	3 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00009177AM24
RA File Number		NA
Licence No and<br>Date		NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.1/82-ALC4/2018 dated 01/05/2018against advance authorization<br>No.0910064564dated 09/01/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

01/2017**, 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 Penicillin G Potassium First Crystal 1.61 kg. 2 Acetone 1.971 kg. 3 Isopropyl Alcohol 0.66 kg. 4 Methylene Chloride (MDC) 3.29 kg. 5 2 Mercapto Benzo Thiazole (MBT) 0.511 kg. GCLE(7-Phenyl Acetamideo-3- Chloromethyl Cephalosporanic Acid Para-Methoxy Benzyl Ester) 1 kg 6 Methanol 1.971 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||GCLE(7-Phenyl Acetamideo-3- Chloromethyl Cephalosporanic Acid Para-Methoxy Benzyl Ester)|| 1 kg|1|Penicillin G Potassium First Crystal|1.61 kg.| |||||2|Acetone|1.971 kg.| |||||3|Isopropyl Alcohol|0.66 kg.| |||||4|Methylene Chloride (MDC)|3.29 kg.| |||||5|2 Mercapto Benzo Thiazole (MBT)|0.511 kg.| |||||6|Methanol|1.971 kg.| |||||per above decision of NC.|||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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(MBT)|0.511 kg.| |||||6|Methanol|1.971 kg.| |||||per above decision of NC.|||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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Case No.	Case No.	4 / NC/3/MEET/Jul/202425/7	4 / NC/3/MEET/Jul/202425/7	4 / NC/3/MEET/Jul/202425/7	4 / NC/3/MEET/Jul/202425/7	4 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00009180AM24
RA File Number		NA
Licence No and<br>Date		NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.1/82-ALC4/2018 dated 01/05/2018against advance authorization<br>No.0910064564dated 09/01/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

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lcohol|0.66 kg.| |||||4|Methylene Chloride (MDC)|3.29 kg.| |||||5|2 Mercapto Benzo Thiazole (MBT)|0.511 kg.| |||||6|Methanol|1.971 kg.| |||||per above decision of NC.|||

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Case No.	Case No.	5 / NC/3/MEET/Jul/202425/7	5 / NC/3/MEET/Jul/202425/7	5 / NC/3/MEET/Jul/202425/7	5 / NC/3/MEET/Jul/202425/7	5 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00009184AM24
RA File Number		NA
Licence No and<br>Date		NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.1/82-ALC4/2018 dated 01/05/2018against advance authorization<br>No.0910064564dated 09/01/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

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lcohol|0.66 kg.| |||||4|Methylene Chloride (MDC)|3.29 kg.| |||||5|2 Mercapto Benzo Thiazole (MBT)|0.511 kg.| |||||6|Methanol|1.971 kg.| |||||per above decision of NC.|||

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Case No.	Case No.	6 / NC/3/MEET/Jul/202425/7	6 / NC/3/MEET/Jul/202425/7	6 / NC/3/MEET/Jul/202425/7	6 / NC/3/MEET/Jul/202425/7	6 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00009186AM24
RA File Number		NA
Licence No and<br>Date		NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.1/82-ALC4/2018 dated 01/05/2018against advance authorization<br>No.0910064564dated 09/01/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

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lcohol|0.66 kg.| |||||4|Methylene Chloride (MDC)|3.29 kg.| |||||5|2 Mercapto Benzo Thiazole (MBT)|0.511 kg.| |||||6|Methanol|1.971 kg.| |||||per above decision of NC.|||

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Case No.	Case No.	7 / NC/3/MEET/Jul/202425/7	7 / NC/3/MEET/Jul/202425/7	7 / NC/3/MEET/Jul/202425/7	7 / NC/3/MEET/Jul/202425/7	7 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00009191AM24
RA File Number		NA
Licence No and<br>Date		NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.1/82-ALC4/2018 dated 01/05/2018against advance authorization<br>No.0910064564dated 09/01/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

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lcohol|0.66 kg.| |||||4|Methylene Chloride (MDC)|3.29 kg.| |||||5|2 Mercapto Benzo Thiazole (MBT)|0.511 kg.| |||||6|Methanol|1.971 kg.| |||||per above decision of NC.|||

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Case No.	8 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	SMS LIFESCIENCES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00009304AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.13/82-ALC4/2019 dated 31/01/2020against advance authorization<br>No.0910067021dated 01/01/2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>BIS IV(Hexa Hydro Furo [2,3- B]<br>Furan-3-OL)<br>1.61 kg.<br>(3R,3aS,6ar)-Hexa Hydro<br>Furo-[2,3-b]- Furan-3-YL-4-<br>Nitro Phenyl Carbonate<br>(DAV-IIA)(Intermediate of<br>Darunavir)<br>1 kg.<br>2<br>Methylene Di Chloride<br>5.32 kg.<br>Note: No repeat licence will be allowed on above norms.<br>RA concerned may take further necessary action as per above decision of NC.

) 1 kg. 2 Methylene Di Chloride 5.32 kg. Note: No repeat licence will be allowed on above norms. RA concerned may take further necessary action as per above decision of NC.||

Case No.	9 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00001977AM25

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RA File Number	NA
Licence No and Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo. 33/82-ALC4/2012dated 21/03/2013against advance authorization<br>No.0810118232 dated 06/02/2013, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>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>CALCITRIOL BP<br>11,601.463 mg.<br>CALCITRIOL CAPSULES<br>BP 0.25 MCG<br>45496000<br>Number<br>2<br>TRIGLYCERIDES,<br>MEDIUM CHAIN PH EUR<br>7049.868 kg.<br>RA concerned may take further necessary action as per above decision of NC.

RA File Number

Licence No and Date

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo. 33/82-ALC4/2012dated 21/03/2013against advance authorization No.0810118232 dated 06/02/2013, 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 CALCITRIOL BP 11,601.463 mg. CALCITRIOL CAPSULES BP 0.25 MCG 45496000 Number 2 TRIGLYCERIDES, MEDIUM CHAIN PH EUR 7049.868 kg. RA concerned may take further necessary action as per above decision of NC.

CITRIOL CAPSULES BP 0.25 MCG 45496000 Number 2 TRIGLYCERIDES, MEDIUM CHAIN PH EUR 7049.868 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	10 / NC/3/MEET/Jul/202425/7	10 / NC/3/MEET/Jul/202425/7	10 / NC/3/MEET/Jul/202425/7	10 / NC/3/MEET/Jul/202425/7	10 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00001756AM25
RA File Number		NA
Licence No and Date		NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/May/202425/4 dated 06/06/2024against advance<br>authorizationNo. 0511024521 dated 15/03/2024it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

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Nepafenac Ophthalmic Suspension, 0.1%<br>w/v NEPALACT Sterile Eye Drops, 5ml)<br>(PRANAYAM)((Each ml contains<br>Nepafenac 1.0 mg (Equivalent to 100.000<br>Gram of Bulk Drug))<br>20000<br>Numbers<br>1<br>Nepafenac<br>102 gm<br>RA concerned may take further necessary action as per above decision of NC.	Nepafenac Ophthalmic Suspension, 0.1%<br>w/v NEPALACT Sterile Eye Drops, 5ml)<br>(PRANAYAM)((Each ml contains<br>Nepafenac 1.0 mg (Equivalent to 100.000<br>Gram of Bulk Drug))	<br>20000<br>Numbers	1	Nepafenac	102 gm

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

Case No.	11 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00001755AM25
RA File Number	NA
Licence No and<br>Date	NA
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 TIMOLOL MALEATE 17.94 mg. Latanoprost and Timolol Maleate Ophthalmic Solution 0.005% w/v/0.5% w/v, 2.5ml Each ml contains Latanoprost 0.05 mg (Net 7.500 Gm) and Timolol Maleate 6.83 mg = Timolol 5 mg (Net 1024.5 Gm)) 1 Number 2 LATANOPROST 0.1275 mg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	12 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00001277AM25
RA File Number	NA
Licence No and<br>Date	NA
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>(i) Step wise manufacturing process.<br>(ii) Complete chemical reactions with molecular and structural formula and molecular<br>weights along with stage wise percentage yields on molar basis.<br>(iii) Complete technical details as per Annexure to Appendix 4E for chemical products.<br>(iv) Stoichiometric balance between import and export on molar basis.<br>(v) Details of indigenous input with quantity.<br>**(vi) FFA content in import item Refined Rapese

mical products. (iv) Stoichiometric balance between import and export on molar basis. (v) Details of indigenous input with quantity. (vi) FFA content in import item Refined Rapeseed Oil. (vii) Why refined oil is used to manufacture oleochemical?**||

Case No.	13 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00000017AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:

13 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
				allowed.
Sofosbuvir	1 kg.	1	(2R)-N-BenzoyL-2-Deoxy-2-Fluoro-2-Methyl	1.567 kg.
			cytidine 3,5-Dibenzoate (or) Cytidine,N-
			Benzoyl-2-Deoxy-2-Fluoro-2-Methyl-3,5-
			Dibenzoate-(2R)
		2	N-[(S)-(2,3,4,5,6-Pentafluoro phenoxy)	1.467 kg.
			phenoxy phosphinyl]-L-Alanine 1-Methyl Ethyl
			Ester (or ) Propan-2-yl(2S)-2-{[(Penta
			fluorophenoxy) Phenoxy) Phosphoryl]
			Amino}Propanoate
		3	Tetrahydrofuran	6.75 kg.

g.| ||||phenoxy phosphinyl]-L-Alanine 1-Methyl Ethyl|| ||||Ester (or ) Propan-2-yl(2S)-2-{[(Penta|| ||||fluorophenoxy) Phenoxy) Phosphoryl]|| ||||Amino}Propanoate|| |||3|Tetrahydrofuran|6.75 kg.|

Case No.		14 / NC/3/MEET/Jul/202425/7
Case Status		Case Deferred
Party Name		SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00000291AM25
RA File Number		NA
Licence No and<br>Date		NA
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:-

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As per flow chart item of export is shown as Pine oil while in the application item of export is Terpineol, please clarify.
Certificate of Analysis (CoA) of export Terpineol.
Quantity and value of by-products obtained with copy of invoices.
Justification of 50% wastage in manufacture process (stage wise).

ficate of Analysis (CoA) of export Terpineol.**

Quantity and value of by-products obtained with copy of invoices.
Justification of 50% wastage in manufacture process (stage wise).

As per flow chart item of export is shown as Pine oil while in the application item of export is<br>Terpineol please clarify<br>1.	As per flow chart item of export is shown as Pine oil while in the application item of export is<br>Terpineol please clarify<br>1.	As per flow chart item of export is shown as Pine oil while in the application item of export is<br>Terpineol please clarify<br>1.	As per flow chart item of export is shown as Pine oil while in the application item of export is<br>Terpineol please clarify<br>1.	As per flow chart item of export is shown as Pine oil while in the application item of export is<br>Terpineol please clarify<br>1.	As per flow chart item of export is shown as Pine oil while in the application item of export is<br>Terpineol please clarify<br>1.	As per flow chart item of export is shown as Pine oil while in the application item of export is<br>Terpineol please clarify<br>1.
<br>Certificat<br>2.		, .<br>e of Analysis (CoA) of export Terpineol.
<br> <br>Quantity<br>3.		<br>and value of by-products obtained with copy of invoices.
<br>Justificati<br>4.		<br>on of 50% wastage in manufacture process (stage wise).





Case No.		15 / NC/3/MEET/Jul/202425/7

||||| | Justificati 4.|| on of 50% wastage in manufacture process (stage wise).||||| |||||||| |||||||| |||||||| |||||||| |||||||| |Case No.||15 / NC/3/MEET/Jul/202425/7||||| |||||||| |Case Status||Case Deferred||||| |Party Name||SUPERMINT EXPORTS PRIVATE LIMITED||||| |Meeting Number and Date||NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024||||| |HQ|File Number|HQRNORM APPLY 00000293AM25||||| |RA|File Number|NA||||| |||||||| |Lic Dat|ence No and e|NA||||| |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:- Manufacture details furnished is for export of Pine Oil while export is Dihydromyrcenol. Please furnish relevant details.|ms Committee Decision: e committee considered the request o||f firm for fixati|on of ad-h|oc norms and as p|er the advise of the| ||, it was decided to call for following i||nformation/docu|ments fro|m the firm:-|| ||||||||

mmittee considered the request o||f firm for fixati|on of ad-h|oc norms and as p|er the advise of the| ||, it was decided to call for following i||nformation/docu|ments fro|m the firm:-|| ||||||||

Case No	16 / NC/3/MEET/Jul/202425/7
.
Case Status	Case Approved

Party Name	OPTRIX LABORATORIES PRIVATE LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00000325AM25

RA File Number	NA

Licence No and
<br>Date	NA
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:-

15 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

UDIN00399699AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Eplerenone	1 kg.	1	(7A,17A)-17-Hydroxy-3-oxo-pregna-4,9(11)-	1.42 kg.
			diene-7,21-dicarboxylic acid g-lactone methyl
			ester

*|Import Items|Qty. allowed.| |---|---|---|---|---| |Eplerenone|1 kg.|1|(7A,17A)-17-Hydroxy-3-oxo-pregna-4,9(11)-|1.42 kg.| ||||diene-7,21-dicarboxylic acid g-lactone methyl|| ||||ester||

Case No.	Case No.	Case No.	17 / NC/3/MEET/Jul/202425/7	17 / NC/3/MEET/Jul/202425/7	17 / NC/3/MEET/Jul/202425/7	17 / NC/3/MEET/Jul/202425/7	17 / NC/3/MEET/Jul/202425/7	17 / NC/3/MEET/Jul/202425/7	17 / NC/3/MEET/Jul/202425/7	17 / NC/3/MEET/Jul/202425/7	17 / NC/3/MEET/Jul/202425/7
Case Status			Case Approved
Party Name			BALAJI AMINES LIMITED
Meeting Number
<br>and Date			NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number			HQRNORM APPLY 00000412AM25
RA File Number			NA
Licence No and<br>Date			NA
Norms Committee			Decision:

The Committee<br>product/import			considered the case as per agenda and taking cue from the earlier decision for same export<br>item in meetingNo. NC/3/MEET/Jun/202223/5dated08/07/2022against advance
authorizationNo.3111000428dated 29/06/2021, 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.

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 METHANOL 0.370 kg. 2 AMMONIA ANHYDROUS 0.160 kg. N-METHYL-2-PYRROLIDONE (ORGANIC CHEMICAL) 1 kg. 3 14 BUTANEDIOL 1.044 kg. RA concerned may take further necessary action as per above decision of NC.|||||||||||| |||Export Product||Qty.||Sl.|**No. **|Import Items||Qty. allowed.|| ||||||||||||| ||N (|-METHYL-2-PYRROLIDONE ||1 k|g.||1|MET|HANOL||0.370 kg.| ||||||||||||| |||RGANIC CHEMICAL)|||||2|AMM|ONIA ANHYDROUS||0.160 kg.| ||||||||3|14 B|TANEDIOL||1044 k| ||||||||||||. g.| |||concerned may take further necessary|||action as p||||||| ||||||||er above d||ecision of NC.|||

UDIN00399699AM25

Case No.	18 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00000350AM25
RA File Number	NA
Licence No and Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. 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. FAVIPIRAVIR 1 kg. 1 6-Fluoro-3-Hydroxypyrazine-2-Carbonitrile Dicyclohexylaminesalt 1.282 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	19 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00000344AM25
RA File Number	NA
Licence No and Date	NA
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:-

UDIN00399699AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
FAVIPIRAVIR	1 kg.	1	6-Fluoro-3-Hydroxypyrazine-2-Carbonitrile	1.282 kg.
			Dicyclohexylaminesalt

ort Product**	Qty.	Sl. No.	Import Items	Qty. allowed.
FAVIPIRAVIR	1 kg.	1	6-Fluoro-3-Hydroxypyrazine-2-Carbonitrile	1.282 kg.
			Dicyclohexylaminesalt

Case No.	20 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00000345AM25
RA File Number	NA
Licence No and Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>FAVIPIRAVIR<br>1 kg.<br>1<br>6-Fluoro-3-Hydroxypyrazine-2-Carbonitrile<br>Dicyclohexylaminesalt<br>1.282 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	21 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024

UDIN00399699AM25

NC/3/MEET/Jul/202425/7| |---|---| |Case Status|Case Approved| |Party Name|OPTRIX LABORATORIES PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024|

UDIN00399699AM25

and Date
HQ File Number	HQRNORM APPLY 00000346AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>1<br>3,4-Difluoro Nitrobenzene OR 3,4 Di<br>FluoroNitrobenzene<br>0.80 kg.<br>LINEZOLID<br>1 kg.<br>2<br>(s)-Epichlorohydrin (OR) (s)-(+)-2-<br>(chloromethyl)oxirane<br>0.80 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	22 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	NECTAR LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001482AM25
RA File Number	222404000083 AM14
Licence No and<br>Date	2210015019/15/07/2014
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and as per the advise of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Certificate of Analysis (CoA) of export item showing content of API and coating material.

UDIN00399699AM25

was decided to call for following information/documents from the firm:- Certificate of Analysis (CoA) of export item showing content of API and coating material.||

UDIN00399699AM25

Case No.	Case No.	23 / NC/3/MEET/Jul/202425/7	23 / NC/3/MEET/Jul/202425/7	23 / NC/3/MEET/Jul/202425/7	23 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		MEGHMANI INDUSTRIES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM REVIW00001542AM25
RA File Number		082404000293 AM17
Licence No and Date		0810139050/22/11/2016
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<br>item<br>in<br>meeting<br>No.<br>07/AM21dated24.12.2020against<br>advance<br>authorization<br>No.0810139050dated 22.11.2016, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2,4 DichloroAceteophenone<br>0.546 kg.<br>2<br>1,2 Pentandiol<br>0.326 kg.<br>BROMOKETAL<br>1 kg.<br>3<br>Cychlohexane<br>0.100 kg.

	Export Product<br>		Qty.	Sl.	**No.

loroAceteophenone 0.546 kg. 2 1,2 Pentandiol 0.326 kg. BROMOKETAL 1 kg. 3 Cychlohexane 0.100 kg.|||||||||||| ||||||||||||| ||Export Product |||Qty.|Sl.|**No. **|Import I|tems||Qty. allo|wed.| ||BROMOKETAL |||1 kg.||1 |2,4 Dichl|oroAceteo|phenone|0.546 kg.|| |||||||2 |1,2 Penta|ndiol||0.326 kg.|| ||||||||||||| ||||||3 ||Cychlohexane|||0.100 kg.|| ||||||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||||||



Case No.	24 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
and Date
HQ File Number	HQRNORM REVIW00001636AM25
RA File Number	092404000606 AM17

UDIN00399699AM25

Licence No and 0910065115/31/05/2017 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.1/82-ALC4/2018 dated 01/05/2018 against advance authorization No.0910064564dated 09/01/2017 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

advance authorization No.0910064564dated 09/01/2017 , 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.
GCLE(7-Phenyl<br>Acetamideo-3-<br>Chloromethyl Cephalosporanic Acid<br>Para-Methoxy Benzyl Ester)	<br> <br>1 kg	1	Penicillin G Potassium First<br>Crystal	1.61 kg.
		2	Acetone	1.971 kg.
		3	Isopropyl Alcohol	0.66 kg.
		4	Methylene Chloride (MDC)	3.29 kg.
		5	2 Mercapto Benzo Thiazole<br>(MBT)	0.511 kg.
		6	Methanol	1.971 kg.

Case No.	25 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001635AM25
RA File Number	092404000316 AM17
Licence No and	0910065116/31/05/2017

UDIN00399699AM25

Date

Norms Committee Decision:

Export Product		Qty.	Sl. No.	Import Items	Qty.
					allowed.
GCLE(7-Phenyl	Acetamideo-3-	<br>1 kg	1	Penicillin G Potassium First	1.61 kg.
Chloromethyl Cephalosporanic Acid				Crystal
Para-Methoxy Benzyl	Ester)
			2	Acetone	1.971 kg.
			3	Isopropyl Alcohol	0.66 kg.
			4	Methylene Chloride (MDC)	3.29 kg.
			5	2 Mercapto Benzo Thiazole	0.511 kg.
				(MBT)
			6	Methanol	1.971 kg.

Case No.	Case No.	26 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Mi Nb d D		NC/ 3/ MEET/ Jl/ 202425/ 7 d 06/08/2024
eetng umer a	ate	u an
HQ Fil Nb		HQRNORM REVIW00001634AM25
e umer
RA Fil Nb		092404000480 AM18
e umer
Li N d D		0910066143/12/04/2018
cence o an a	e
Norms Committee	Decision:

UDIN00399699AM25

|HQRNORM REVIW00001634AM25| |e umer||| |RA Fil Nb||092404000480 AM18| |e umer||| |Li N d D||0910066143/12/04/2018| |cence o an a|e|| |Norms Committee|Decision:|| |||| ||||

UDIN00399699AM25

Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
GCLE(7-PHENYL ACETAMIDEO-<br>3CHLORO METHYL<br>CEPHALOSPORANIC ACID PARA<br>METHOXY<br>BENZYL ESTER)	1 kg.	1<br> <br> <br>	PENICILLIN G<br>POTASSIUM FIRST<br>CRYSTAL	1.61 kg.
		2<br>	ACETONE	1.971 kg.
		3<br>	ISOPROPYL ALCOHOL	0.66 kg.
		4<br> <br>	METHYLENE CHLORIDE<br>(MDC)	3.29 kg.
		5<br> <br>	2 MERCAPTO BENZO<br>THIAZOLE(MBT)	0.511 kg.
		6<br>	METHANOL	1.971 kg.

Case No.	27 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001518AM25
RA File Number	092404000128 AM19

UDIN00399699AM25

Licence No and 0910066351/19/06/2018 Date Norms Committee Decision:

UDIN00399699AM25

Licence No and 0910066351/19/06/2018 Date Norms Committee Decision:

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

Export Product	Qty.	Sl. No.<br>	Import Items	Qty. allowed.
PANTOPRAZOLE BASE	1 kg.	1<br>	MALTOL	0.80 kg.

Case No.	28 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	PALADIN PAINTS & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001511AM25
RA File Number	039504000456 AM19
Licence No and<br>Date	0310823254/24/08/2018
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>Chemical reaction indicating molecular weight of both reactant & products indicating<br>Stoichiometric material balance on molar basis.<br>1.<br>The percentage of yield of the reaction<br>2.

Chemical reaction indicating molecular weight of both reactant & products indicating Stoichiometric material balance on molar basis.

Case No.	29 / NC/3/MEET/Jul/202425/7
Case Status	Case Rejected
Party Name	TATA CHEMICALS LIMITED

UDIN00399699AM25

cating Stoichiometric material balance on molar basis.**

Case No.	29 / NC/3/MEET/Jul/202425/7
Case Status	Case Rejected
Party Name	TATA CHEMICALS LIMITED

UDIN00399699AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	018205001646AM19
RA File Number	039504000901 AM19
Licence No and<br>Date	0310825645/13/12/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that Norms Committee-3 in its<br>Meeting No. NC/3/MEET/Aug/202122/7 dated 13/08/2021 has already decided to transfer the case to<br>Norms Committee-6as the export product – Fossence (Oligofructose/FOS) Poweder P 90/Liquid L95<br>comes under Food category. Therefore, Committee decided toclosethe case.

Case No.	30 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00002022AM25
RA File Number	052304000507 AM19
Licence No and<br>Date	0510409676/15/02/2019
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>Copy of Drug Manufacturing Licence (DML) showing approved composition.<br>1.<br>Copy of Advance Authorisation to show actual export and import quantity, if amended in the<br>licence.<br>2.

of Drug Manufacturing Licence (DML) showing approved composition.** 1. Copy of Advance Authorisation to show actual export and import quantity, if amended in the licence. 2.||

Case No.	31 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	REFLUX PHARMACEUTICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001943AM25
RA File Number	039504000931 AM20
Licence No and	0310833815/01/01/2020

25 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

UDIN00399699AM25

Date

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:-

Copy of technical literature in support of molar excess and percentage yield.

Case No.	32 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	AQUILA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001956AM25
RA File Number	039404000879 AM20
Licence No and<br>Date	0310834406/22/01/2020
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 item in meetingNo. NC/3/MEET/Mar/202324/25dated11/03/2024against advance<br>authorizationNo.0310830783dated02/08/2019,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. Import Items<br>Qty. allowed.<br>1<br>2,3 Dimethyl 1 Butene<br>1.19 kg.<br>7-Acetyl-1,1,3,4,4,6-Hexamethyl<br>1,2,3,4-Tetrahydro Naphthalene<br>1 kg.<br>2<br>PARACYMENE<br>1.03 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 33 / NC/3/MEET/Jul/202425/7

UDIN00399699AM25

Naphthalene 1 kg. 2 PARACYMENE 1.03 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 33 / NC/3/MEET/Jul/202425/7

UDIN00399699AM25

Case Status	Case Approved
Party Name	ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00006628AM24
RA File Number	092404000024 AM21
Licence No and<br>Date	0910068681/28/04/2020
Norms Committee Decision:<br>The representatiove of the firm attended personal hearing thorugh Video Concerence and explained their<br>case. The Committee heard the explanation of the firmand after due deliberation,it was decided to fix the<br>norms based on Production/Consumption Data provided by the firmas per details given below or as<br>applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Ethyl(3R,4S,5S)4,5-Epoxy-3-(1-<br>ethylpropoxy)cyclohex-1-ene-1-<br>carboxylate/<br>5000 kg.<br>2<br>Sodium Azide<br>913 kg.<br>3<br>Acetonitrile<br>3244 kg.<br>4<br>Dimethyl Formamide<br>5872 kg.<br>Oseltamivir Phosphate<br>1468 kg.<br>5<br>Isopropyl alcohol<br>4404 kg.<br>Note: The above norms are for regularization and closure purposes only.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	34 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved

UDIN00399699AM25

es only.** RA concerned may take further necessary action as per above decision of NC.||

Case No.	34 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved

UDIN00399699AM25

Party Name	Party Name	Party Name	Party Name	BROOKS LABORATORIES LIMITED	BROOKS LABORATORIES LIMITED	BROOKS LABORATORIES LIMITED	BROOKS LABORATORIES LIMITED	BROOKS LABORATORIES LIMITED	BROOKS LABORATORIES LIMITED	BROOKS LABORATORIES LIMITED	BROOKS LABORATORIES LIMITED	BROOKS LABORATORIES LIMITED
Meeting Number and Date				NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number				HQRNORM REVIW00001377AM25
RA File Number				302404000010 AM21
Licence No and Date				3010105213/02/06/2020
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 item in meetingNo. 14/82-ALC4/2018dated14/02/2019against advance authorizationNo.2210015917<br>dated12/06/2018,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

ct/import item in meetingNo. 14/82-ALC4/2018dated14/02/2019against advance authorizationNo.2210015917 dated12/06/2018,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 Injection USP1000 mg.Each vial contains Sterile Meropenem Trihydrate USP equ to AnhydrousMeropenem1000mg(SterileSodiumCarbonateUSPequtoSodium90.2mg 1 Number 1 MEROPENEM WITH SODIUM CARBONATE USP 0.690 gm/500 mg vial Meropenem Injection 500 mg USPEach vial contains Sterile Meropenem Trihydrate USP equ to AnhydrousMeropenem500mg(SterileSodiumCarbonateUSPequtoSodium90.2mg 1 Number 2 MEROPENEM WITH SODIUM CARBONATE USP 1.380 gm/1 gm vial RA concerned may take further necessary action as per above decision of NC.|||||||||||||| |proucmpor e dated12/06/2018|||m n meengo. -ae agans avance auorzaono. it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

ion as per above decision of NC.|||||||||||||| |proucmpor e dated12/06/2018|||m n meengo. -ae agans avance auorzaono. it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or||||||||||| | applied by the fir||| m, whichever is less:-||||||||||| ||||||||||||||| ||||||||||||||| ||||||||||||||ed.| ||Export Pro||duct|||||Qty.|Sl.|Import Items||Qty.|| ||||||||||No.|||allow|| ||||||||||||||| ||M I||i USP1000 Eh il i Sil M|||||1|1|MEROPENEM|| 0690| 0 al| |eropenem njecton mg.ac va contans tere eropenem Trihydrate USP equ to AnhydrousMeropenem1000mg(SterileSodiumCarbonateUSPequtoSodium90.2mg Number WITH SODIUM CARBONATE USP . gm/50 mg vi Meropenem Injection 500 mg USPEach vial contains Sterile Meropenem Trihydrate USP equ to AnhydrousMeropenem500mg(SterileSodiumCarbonateUSPequtoSodium90.2mg 1 Number 2 MEROPENEM WITH SODIUM CARBONATE USP 1.380 gm/1 gm vi RA concerned may take further necessary action as per above decision of NC.|eropenem njecton mg.ac va contans tere eropenem Trihydrate USP equ to AnhydrousMeropenem1000mg(SterileSodiumCarbonateUSPequtoSodium90.2mg||||||| Number|| WITH SODIUM CARBONATE USP|| . gm/50 mg vi|| ||Meropenem Injection 500 mg USPEach vial contains Sterile Meropenem Trihydrate USP equ to AnhydrousMeropenem500mg(SterileSodiumCarbonateUSPequtoSodium90.2mg|||||||1 Number|2|MEROPENEM WITH SODIUM|| 1.380 gm/1 i| al|

ntains Sterile Meropenem Trihydrate USP equ to AnhydrousMeropenem500mg(SterileSodiumCarbonateUSPequtoSodium90.2mg|||||||1 Number|2|MEROPENEM WITH SODIUM|| 1.380 gm/1 i| al| |||nyrouseropenemmgereoumaron|||eequo|um.|mg||| C U| ARBONATE SP|gm v|| ||||||||||||||| |||concerned may take further necessary action as per|||above decisio|n of NC.|||||||| ||||||||||||||| ||||||||||||||| |Cas||e No.|35 / NC/3/MEET/Jul/202425/7||||||||||| |Cas||e Status|Case Approved||||||||||| |Par||ty Name|KusuMa PharMa||||||||||| |Me and||eting Number Date|NC/ 3/ MEET/ Jul/ 202425/ 7 and 06||/08/2024||||||||| |HQ||File Number|HQRNORM REVIW00001447AM2||5||||||||| |RA||File Number|039404000115 AM21||||||||||| |Lic Dat||ence No and|||||||||||| ||| e|0310836572/08/06/2020||||||||||| |Nor||ms Committee Decision:||||||||||||

Case No.	35 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001447AM25
RA File Number	039404000115 AM21
Licence No and<br>Date	0310836572/08/06/2020
Norms Committee Decision:

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7 and 06/08/2024| |HQ File Number|HQRNORM REVIW00001447AM25| |RA File Number|039404000115 AM21| |Licence No and Date|0310836572/08/06/2020| |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 item in meeting No.NC/3/MEET/Sep/202223/8dated 23/09/2022 against advance authorization No.0311008529dated 13/11/2021 , 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.<br>allowed.
SACCHARIN<br>POWDER<br>(PURE/AR)<br>(DENTAL GRADE)<br>(Not less than 98% purity)	<br>1 kg.	1<br>	SODIUM SACCHARIN	1.38 kg.

Case No.	36 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	REFLUX PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001944AM25
RA File Number	NA
Licence No and<br>Date	0311001445/03/02/2021
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and as per the advise of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Copy of technical literature in support of molar excess and percentage yield.

Case No.	37 / NC/3/MEET/Jul/202425/7
Case Status	Case Rejected

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rm:- Copy of technical literature in support of molar excess and percentage yield.||

Case No.	37 / NC/3/MEET/Jul/202425/7
Case Status	Case Rejected

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Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001998AM25
RA File Number	09AA04004523 AM21
Licence No and<br>Date	0911000350/15/02/2021
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.	38 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	BHAGWATI INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00219420AM22
RA File Number	08AA04033013 AM22
Licence No and<br>Date	0811002934/21/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Ethyl Alcohol<br>0.878 kg.<br>Chloral Anhydrous<br>1 kg.<br>2<br>Caustic Soda<br>0.20 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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Ethyl Alcohol 0.878 kg. Chloral Anhydrous 1 kg. 2 Caustic Soda 0.20 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	Case No.	39 / NC/3/MEET/Jul/202425/7	39 / NC/3/MEET/Jul/202425/7	39 / NC/3/MEET/Jul/202425/7	39 / NC/3/MEET/Jul/202425/7	39 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number		NC/ 3/ MEET/ Jl/ 202425/ 7 d 06/08/2024
and Date		u an
HQ File Number		HQRNORM REVIW00001995AM25
RA File Number		09AA04016734 AM22
Licence No and		0911001888/22/11/2021
Date

Norms Committee		Decision:
The Committee		considered the case as per agenda and taking cue from the earlier decision for same export
<br>product/import<br>authorizationN		<br>item in meetingNo.NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance<br>0910051360dated 21/02/2012it was decided to fix ad-hoc norms under Para 407 of
<br>HBP Vol I as p		., .<br>r details given below or as applied by the firm whichever is less:-
	.			,


	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	AA		1 k	1<br>	4 2 A 1	446 k
	RCTOPMINE HCL<br>(for Veterneryuse)		g.	<br>	S MINO HYDROXY ETHYL<br>PHENOL HCL	0.

Export Product*|||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||AA|||1 k|1 |4 2 A 1|446 k| ||RCTOPMINE HCL (for Veterneryuse)|||g.| |S MINO HYDROXY ETHYL PHENOL HCL|0. g.| ||||||2 |4 HYDROXY BENZALDEHYDE|0.70 kg.| ||||||||| ||||||||| ||||||||| ||||||||| |RA concerned m||ay take further necessary action as per above decision of NC.|||||| ||||||||| ||||||||| ||||||||| ||||||||| |Case No.||40 / NC/3/MEET/Jul/202425/7|||||| |Case Status||Case Deferred|||||| |Party Name||GLOBAL CALCIUM PRIVATE LIMITED|||||| |Mi Nb|||||||| |eetng umer and Date||NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024|||||| |HQ File Number||HQRNORM APPLY 00299344AM22|||||| |RA File Number||07AA04038998 AM22|||||| |Licence No and|||||||| | Date||071100|2737/28/12/2021||||| ||||||||| |Norms Committee Decision|||:||||| ||||||||| |The representatiove of |||the firm attended personal hearing thorugh Video Concerence and explain their ||||| |case. The Committee|||heard the explanation of the firmand after due deliberation it was directed to firm||||| |||||||||

nded personal hearing thorugh Video Concerence and explain their ||||| |case. The Committee|||heard the explanation of the firmand after due deliberation it was directed to firm||||| |||||||||

Case No.	40 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00299344AM22
RA File Number	07AA04038998 AM22
Licence No and<br>Date	0711002737/28/12/2021
Norms Committee Decision:
The representatiove of the firm attended personal hearing thorugh Video Concerence and explain their
case. The Committee heard the explanation of the firmand after due deliberation it was directed to firm

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to furnish the following information/documents for further consideration:-

Complete balanced chemical reaction, indicating molecular weight or reactant(s) and product/s with overall yield of the reaction with justification.
Production of the export item viz-à-viz consumption of raw materials for the specific export which is in question. (Not all the products of the company) for the last three years duly certified by Chartered Accountant.
End use of export item(s) with copy of norms, if the same is fixed in the past.

on. (Not all the products of the company) for the last three years duly certified by Chartered Accountant.**

End use of export item(s) with copy of norms, if the same is fixed in the past.

Case No.	Case No.	41 / NC/3/MEET/Jul/202425/7	41 / NC/3/MEET/Jul/202425/7	41 / NC/3/MEET/Jul/202425/7	41 / NC/3/MEET/Jul/202425/7	41 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00380949AM22
RA File Number		34AX04000157 AM22
Licence No and<br>Date		3411001935/09/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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>Erythromycin Thiocyanate<br>(on 100% activity basis )<br>1.865 kg.A<br>2<br>Hydroxylamine Hydrochloride<br>0.540 kg.<br>3<br>Acetone<br>3.44 kg.<br>4<br>IPA<br>1.58 kg.<br>5<br>Platinum Oxide<br>1.00 gm.<br>AZITHROMYCIN<br>MONOHYDRATE<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	AZITHROMYCIN<br>MONOHYDRATE		1 kg.	1<br> <br>	Erythromycin Thiocyanate<br>(on 100% activity basis )	1.865 kg.A
				2<br>	Hydroxylamine Hydrochloride	0.540 kg.
				3<br>	Acetone	3.44 kg.
				4<br>	IPA	1.58 kg.
				5<br>	Platinum Oxide	1.00 gm.

in Thiocyanate (on 100% activity basis )|1.865 kg.A| |||||2 |Hydroxylamine Hydrochloride|0.540 kg.| |||||3 |Acetone|3.44 kg.| |||||4 |IPA|1.58 kg.| |||||5 |Platinum Oxide|1.00 gm.|

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	6	Triethylamine	0.30 kg.
	7	Methylene Chloride	3.16 kg.
	8	Activated Carbon	0.020 kg.

Case No.	42 / NC/3/MEET/Jul/202425/7
Case Status	Case Rejected
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00386056AM22
RA File Number	08AX04000650 AM22
Licence No and<br>Date	0811004377/14/03/2022
Norms Committee Decision:
The firmhas informed that they have surrendered their above license to RA. Therefore, the Committee
decided toclosethe application of the firm.

Case No.	43 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00000197AM23
RA File Number	09AX04000016 AM23
Licence No and<br>Date	0911002850/12/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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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.
AMLODIPINE BASE	1 kg.	1<br>	Phthalic anhydride	0.870 kg.
		2<br>	Monoethanolamine	0.356 kg.
		3<br>	Toluene	2.40 kg.
		4<br>	Ethyl 4-chloroacetoacetate	0.993 kg.
		5<br>	Acetic Acid	4.40 kg.
		6<br>	Ortho ChloroBenzaldehyde	0.775 kg.
		7<br>	Methyl Aceto Acetate	1.40 kg.
		8<br>	Methanol	1.25 kg.

Case No.	44 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00008588AM24
RA File Number	52AX04000039 AM23
Licence No and Date	5211002485/13/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>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.
5-NITROSO-2,4,6-	1 kg.	1	MALONONITRILE	0.571 kg.
TRIAMINOPYRIMIDINE(5-
NITROSO-2,4,6-<br>TRIAMINOPYRIMIDINE)		2	GUANIDINE HCL	0.826 kg.
		3	N,N DIMETHYL FORMAMIDE 99.	<br>3.465 kg.
			5% (Tech. Spec. Liquid)

NITRILE||0.571 kg.| |TRIAMINOPYRIMIDINE(5-|||||| |NITROSO-2,4,6- TRIAMINOPYRIMIDINE)||2|GUANIDINE HCL||0.826 kg.| |||3|N,N DIMETHYL FORMAMIDE 99.|| 3.465 kg.| ||||5% (Tech. Spec. Liquid)|||

Case No.<br>45 / NC/3/MEET/Jul/202425/7
Case Status<br>Case Approved
Party Name<br>JODAS EXPOIM PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number<br>HQRNORM APPLY 00000912AM23
RA File Number<br>09AX04000058 AM23
Licence No and Date<br>0911003033/20/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and	taking cue		from the earlier decision for same export
product/import item in meetingNo.NC/3/MEET/Jan/202324/21 dated 24/01/2024				against advance
authorizationNo.0911006014 dated 17/10/2023, 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.
Colistimethate sodium powder for<br>340000	1	ColistimethateSodium			26.687 kg.
preparation of solution for<br>Numbers
inhalation1000000 Units(Each vial
contains: Colistimethate
sodium 1000000 U (corresponds to
approximately 80 mg))

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on for Numbers||||||| |inhalation1000000 Units(Each vial||||||| |contains: Colistimethate||||||| |sodium 1000000 U (corresponds to||||||| |approximately 80 mg))|||||||

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R					e decision of NC.
	A concer	ned may take further necessary action		as per abov


Ca	se No.		46 / NC/3/MEET/Jul/20	2425/7
Ca	se Status		Case Approved
Pa	rty Name		METROPOLITAN EX	IMCHEM PR	IVATE LIMITED
M	eeting Nu	mber and Date	NC/ 3/ MEET/ Jul/ 202	425/ 7 and 06	/08/2024
H	Q File Nu	mber	HQRNORM APPLY 0	0000920AM2	3
R	A File Nu	mber	03AX04000550 AM23
Li	cence No	and Date	0311014915/22/05/202	2
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. allowed.<br>1<br>SAYTEX CP 2000<br>TETRABROMOBISPHENOL A<br>TBBPA<br>0.683 kg.<br>TETRABROMOBISPHENOL A<br>BIS<br>(DIBROMOMETHYL<br>PROPYL ETHER<br>1 kg.<br>2<br>METHALLYL CHLORIDE<br>0.227 kg.<br>RA concerned may take further necessary action as per above decision of NC.	rms Com<br>he Com<br>f HBP V	mittee Decision:<br>mittee considered the case as per agen<br>ol.

LYL CHLORIDE 0.227 kg. RA concerned may take further necessary action as per above decision of NC.|rms Com he Com f HBP V|mittee Decision: mittee considered the case as per agen ol. I as per details given below or as a||||da and it wa plied by the||s decided to fix ad-hoc norms und firm, whichever is less:-||er Para 4.07| |||||||||||| ||Export|Product||Qty.|S N|l. o. |Import I|tems|Qt|y. allowed.| |||||||||||| ||TETRA BIS PROPY|BROMOBISPHENOL A (DIBROMOMETHYL L ETHER|| 1 kg.||1 |SAYTE TETRAB TBBPA|X CP 2000 ROMOBISPHENOL A||0.683 kg.| |||||||||||| ||||||2 ||METHALLYL CHLORIDE||0.227 kg.|| ||||||||||||



Case No.	47 / NC/3/MEET/Jul/202425/7

Case Status	Case Deferred

Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
and Date

HQ File Number	HQRNORM APPLY 00000980AM23

RA File Number	03AX04000822 AM23

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LIMITED| |Meeting Number |NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024| |and Date|| ||| |HQ File Number|HQRNORM APPLY 00000980AM23| ||| |RA File Number|03AX04000822 AM23|

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Licence No and Date

0311014992/25/05/2022

Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Chemical reaction indicating molecular weight of both reactant and the products with yield of the reaction. 1. Stoichiometric material balance on a molar basis. 2. Concentration of the ammonia in aqueous solution and accordingly, calculation of requirement of both the chemicals. 3.

Case No.	48 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00001090AM23
RA File Number	09AX04000132 AM23
Licence No and<br>Date	0911003083/31/05/2022

| |Meeting Number and Date|NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024| |HQ File Number|HQRNORM APPLY 00001090AM23| |RA File Number|09AX04000132 AM23| |Licence No and Date|0911003083/31/05/2022| |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:- How many moles of each reactant is used to manufactured export product. 1. Provide Stoichiometric balance on molar basis to arrive at the quantity of raw material. 2. Percentage yield on molar basis at each stage of reaction. 3.||

Case No.	49 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00005924AM23
RA File Number	03AX04001050 AM23

37 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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Licence No and 0311015297/07/06/2022 Date Norms Committee Decision:

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

Committee Decision:

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

Lic<br>Dat	ence No and<br>e	0311015297/07/06/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-	ms Committee Decision:
Sl.<br>No.<br>Export Product<br>Qty.<br>Import Items<br>Qty.<br>allowed.
	Sl.<br>No.<br>Export Product<br>Qty.<br>Import Items<br>Qty.<br>allowed.

	1<br>Clobetas	ol Propionate Foam 0.05percent<br>200000<br>36.295 kg.<br>CLOBETASOL<br>PROPIONATE<br>USP
	<br>50gm((	<br>Net. wt. of Net. wt. of Clobetasol<br>Numbers<br> <br>(MICRONIZED)
	Propion	ate USP (Micronized) is5.00 Kgs)
	2<br>Clobetas	ol<br>Propionate<br>Foam<br>0.05percent<br>200000
	100gm((	<br> <br>Net. wt.

lobetasol Numbers (MICRONIZED)||||||| ||Propion|ate USP (Micronized) is5.00 Kgs)||||||| ||2 Clobetas|ol Propionate Foam 0.05percent 200000||||||| ||100gm((| Net. wt. of Clobetasol Propionate USP ||||||| ||(Microni|zed) is 10.00 Kgs.)) Numbers||||||| ||3 Clobetasol Propionate Cream USP 0.05percent (Pack Size 15gm)((Net Weight of Clobetasol Propionate USP (Micronized) 0.15 Kgs)) 200000 Numbers 4 Clobetasol Propionate Cream USP 0.05percent (Pack size 30gm)((Net Weight of Clobetasol Propionate USP 200000 Numbers|||||||| || (Micronized) 0.300 Kgs)) |||||||| ||Clobetasol Propionate Cream USP 0.05percent (Pack size 45 gm)(( Net Wei of Clobetasol Propionate USP (Micronized) 1.125 Kgs))||ght 5000 Numb| ers||||| |||||||||| ||6 Clobetasol Propionate Cream USP 0.05percent (Pack size 60gm)((Net Weight of Clobetasol Propionate USP (Micronized) 1.500 Kgs)) 50000 Numbers|||||||| ||7 Clobetasol Propionate Ointment USP 0.05percent (Pack size 15gm)((Net Weight of Clobetasol Propionate USP 50000 Numbers|||||||| ||(Microni|zed) 0.375 Kgs))||||||| ||||||||||

38 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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e USP 50000 Numbers|||||||| ||(Microni|zed) 0.375 Kgs))||||||| ||||||||||

38 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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8	Clobetasol Propionate Ointment USP	50000
	0.05percent (Pack size 30gm)((Net Weight of	Numbers
	Clobetasol Propionate USP
	(Micronized) 0.750 Kgs))
9	Clobetasol Propionate Ointment USP	40000
	0.05percent (Pack size 45gm)((Net Weight of	Numbers
	Clobetasol Propionate USP
	(Micronized) 0.900 Kgs))
10	Clobetasol Propionate Ointment USP	20000
	0.05percent (Pack size 60gm)((Net Weight of	Numbers
	Clobetasol Propionate USP
	(Micronized) 0.600 Kgs))
11	Clobetasol Propionate Spray 0.05percent	40000
	(Pack size 59ml)((Net Weight of Clobetasol	Numbers
	Propionate USP (Micronized)
	1.180 Kgs))
12	Clobetasol Propionate Spray 0.05percent	40000
	(Pack size 125ml)((Net Weight of Clobetasol	Numbers
	Propionate USP (Micronized)
	2.500 Kgs))
13	Clobetasol Prop. Top Sol USP, 0.05percent	50000
	25ml((Net Weight of Clobetasol Propionate	Numbers
	USP (Micronized) 0.625
	Kgs))
14	Clobetasol Prop. Top Sol USP, 0.05percent	<br>60000
	50ml((Net Weight of Clobetasol Propionate	<br>Numbers
	USP (Micronized) 1.50 Kgs))
15	Clobetasol<br>Pro<br>Shampoo,<br>0.05<br>percent	<br>60000
	118ml((Net Weight of Clobetasol Propionate	<br>Numbers
	USP (Micronized) 3.54 Kgs))
16	Clobetasol Propionate Foam 0.05percent	50000
	100gm (Emulsion Formulation)(( Net. wt.

ercent| 60000| ||118ml((Net Weight of Clobetasol Propionate| Numbers| ||USP (Micronized) 3.54 Kgs))|| |16|Clobetasol Propionate Foam 0.05percent|50000| ||100gm (Emulsion Formulation)(( Net. wt. of|Numbers| ||Clobetasol Propionate USP|| ||(Micronized) is 2.50 Kgs.))||

39 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

UDIN00399699AM25

17 Clobetasol Propionate Foam 0.05percent 50000 50gm (Emulsion Formulation)(( Net. wt. of Numbers Clobetasol Propionate USP

(Micronized) is 1.250 Kgs.))

Case No.	50 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00001347AM23
RA File Number	05AX04000669 AM23
Licence No and<br>Date	0511013173/13/06/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>To give balance chemical reaction indicating molecular weight of all the reactants and product<br>with stage wise yield of the reaction.<br>1.<br>To indicate where Alumino Silicate Catalyst, Denatured Ethyl alcohol and methanol are used<br>in the chemical reaction giving their application/use.<br>2.<br>Calculation of the requirement of all the chemicals with justification of low yield.<br>3.

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

Case No.	51 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00006007AM23
RA File Number	03AX04001989 AM23
Licence No and Date	0311016055/04/07/2022

40 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

UDIN00399699AM25

Norms Committee Decision:

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

Export Product<br>	Qty.	Sl. No.	Import Items	Qty. allowed.
Momate AZ NASAL SPRAY 150<br>MD /Mometasone Furoate &<br>Azelastine HCL Nasal Spray<br>(150MD)((Net Wt. of<br>Azelastine<br>Hydrochloride<br>BP<br>5250 Grams))<br> <br>	250000<br>Numbers	1	Azelastine Hydrochloride<br>BP	5355 grams
Mometasone Furoate & Azelastine<br>Hydrochloride Nasal Spray<br>(75MD)(Momat Rino Advance 75<br>MD/MOMATE AZ<br>NASAL SPRAY 75<br>MD/(GLENSPRAY ACTIVE 75<br>NS Pack size : 75 MD bottle (Net<br>Wt. of Azelastine Hydrochloride<br>BP 2100 Grams))<br> <br>	<br>200000<br>Numbers	2	Azelastine Hydrochloride<br>BP	2142 grams

Case No.	52 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00007068AM24
RA File Number	05AX04001017 AM23
Licence No and<br>Date	0511013648/07/07/2022
Norms Committee Decision:

UDIN00399699AM25

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

idered the request of firm for fixation of ad-hoc norms and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.
PBA - (4-CHLORO 2-FLUORO 3-<br>METHOXY PHENYL) BORONIC<br>ACID	<br>1 kg.	1	2-Fluorophenol	0.83 kg.
		2	Toluene (Bulk)	0.12 kg.
		3	Lithium Metal	0.100 kg.
		4	Monoglyme<br>(1, 2 Dimethoxyethane)	0.80 kg.
		5	Mixed Hexanes	0.29 kg.
		6	Trimethyl borate	0.79 kg.

Case No.	53 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00001895AM23
RA File Number	34AX04000273 AM23
Licence No and<br>Date	3411002508/07/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

UDIN00399699AM25

product/import item in meeting No.NC/3/MEET/Jun/202122/2 dated 02/07/2021 against advance authorization No.3411000551dated 11/05/2021 , 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:-

advance authorization No.3411000551dated 11/05/2021 , 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	Export Product			Qty.	Sl.	Import Items	Qty.
						No.		allowed.
DI	METHYL	AMINO		PROPYL	<br>1 kg.	1	1-BROMO-3-CHLORO PROPANE	0.72 kg.
CHLORIDE		HYDROCHLORIDE
65%	<br>SOLUTION		IN	WATER
(DMPC- 65%)

Case No.	Case No.	54 / NC/3/MEET/Jul/202425/7	54 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ	File Number	HQRNORM APPLY 00001959AM23
RA File Number		03AX04002151 AM23
Licence No and Date		0311016241/11/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix				ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product	Qty.<br>Sl. No.	Import Items	Qty. allowed.
	RIVAROXABAN EP	1<br>1 kg.	4 4 AMINOPHENYL	0.713 kg.
			MORPHOLINE 3 ONE
		2	S N 2 3 EPOXYPROPYL	Item not shown	in the
			PHTHALIMIDE	process/reaction.	Hence
				not allowed.

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1 kg.|4 4 AMINOPHENYL|0.713 kg.||| ||||MORPHOLINE 3 ONE|||| |||2|S N 2 3 EPOXYPROPYL|Item not shown|in the|| ||||PHTHALIMIDE|process/reaction.|Hence|| |||||not allowed.|||

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3 5 CHLOROTHIOPHENE 2 Both are not the same CARBOXYLIC ACID OR 2 items. Hence not allowed OXIRAN 2 YL METHYL ISOINDOLINE 1 3 DIONE

Case No.	55 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00001963AM23
RA File Number	05AX04001045 AM23
Licence No and Date	0511013693/11/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Jun/202425/5 dated 14/06/2024against advance<br>authorizationNo.0511004178 dated 18/08/2021, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Ropivacaine<br>Hydrochloride<br>Anhydrous(API)<br>1 kg.<br>1<br>S)-2',6' Pipecoloxylidide OR<br>(S)-N-(2,6-dimethy phenyl-2-<br>piperidinecarboxamide)<br>0.923 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 56 / NC/3/MEET/Jul/202425/7

UDIN00399699AM25

hy phenyl-2- piperidinecarboxamide) 0.923 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 56 / NC/3/MEET/Jul/202425/7

UDIN00399699AM25

Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00001993AM23
RA File Number	34AX04000353 AM23
Licence No and<br>Date	3411002522/12/07/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master-Batch Formula showing the net content of inputs in export item.

Case No.	57 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00000597AM24
RA File Number	03AX04002093 AM23
Licence No and<br>Date	0311016291/12/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Apr/202425/2dated 30/04/2024against advance<br>authorizationNo.0311024234 dated 05/06/2023, 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. E.D.T.A. DI SODIUM(PURE/AR) 1 kg. 1 EDTA ACID 0.80 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00399699AM25

Case No.	58 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00007416AM24
RA File Number	34AX04000357 AM23
Licence No and<br>Date	3411002528/13/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>NITRIC ACID 68%<br>0.675 kg. .<br>2<br>TOLUENE<br>0.661 kg.<br>3<br>SULPHURIC ACID 98%<br>Deleted, procured from<br>indigenous source<br>ORTHO NITRO TOLUENE<br>1 kg.<br>4<br>SODA ASH<br>Deleted, procured from<br>indigenous source<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	59 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024

UDIN00399699AM25

9 / NC/3/MEET/Jul/202425/7| |---|---| |Case Status|Case Deferred| |Party Name|AMI ORGANICS LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024|

UDIN00399699AM25

HQ File Number	HQRNORM APPLY 00002011AM23
RA File Number	52AX04001578 AM23
Licence No and<br>Date	5211002817/13/07/2022
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:-
Details of items Methylene chloride and Methanol in the process and justify the high<br>1.
requirement of these two.
Yield of the reaction and giving calculation for the requirement of all the chemicals.<br>2.
Current Production/Consumption data duty endorsed by CA.<br>3.

Details of items Methylene chloride and Methanol in the process and justify the high requirement of these two.

2.|| |Current Production/Consumption data duty endorsed by CA. 3.||

Details of items Methylene chloride and Methanol in the process and justify the high requirement of these two.

Case No.<br>60 / NC/3/MEET/Jul/202425/7
Case Status<br>Case Approved
Party Name<br>AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number<br>HQRNORM APPLY 00002017AM23
RA File Number<br>09AX04000301 AM23
Licence No and Date<br>0911003338/13/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue	from the earlier decision for same export
product/import item in meetingNo.NC/3/MEET/Jun/202425/6dated 01/07/2024against advance
authorizationNo.0911004646 dated 08/03/2023, it was decided	to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>4-(2-(2-(6,6-dimethylbicyclo<br>[3.1.1]<br>1 kg.	DIHYDRONOPOL	0.66 kg.
heptan-2-yl)ethoxy)ethyl)
2<br>morpholine(intermediate)	TOLUENE	1.915 kg.
3	SODAMIDE	0.19 kg.
4	METHANOL	0.56 kg.

UDIN00399699AM25

r>[3.1.1] 1 kg.|DIHYDRONOPOL|0.66 kg.|| |heptan-2-yl)ethoxy)ethyl)|||| |2 morpholine(intermediate)|TOLUENE|1.915 kg.|| |3|SODAMIDE|0.19 kg.|| |4|METHANOL|0.56 kg.||

UDIN00399699AM25



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



Case No.			61 / NC/3/MEET/Jul/202425/7
Case Status			Case Approved
Party Name			AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date			NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number			H	QRNORM APPLY 00002018AM23
RA File Number			0	9AX04000333 AM23
Licence No and Date			0	911003339/13/07/2022
Norms Committee Decision:
The Committee consider				d the case as per agenda and taking cue from the earlier decision for same export
<br>product/import item in				<br>meetingNo.NC/3/MEET/Jun/202425/6dated 01/07/2024against advance
<br>authorizationNo.091100				<br>4646 dated 08/03/2023it 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<br>Export Product<br>Qty.<br>4-(2-(2-(6,6-dimethylbicyclo<br>[3.1.1]<br>heptan-2-yl)ethoxy)ethyl)<br>morpholine(intermediate)<br>1 kg.<br>RA concerned may take further necessary action as per						<br>the firm, whichever is less:-
	Export Product				Qty.	Sl. No.	Import Items	**Qty.

(intermediate) 1 kg. RA concerned may take further necessary action as per||||||||| the firm, whichever is less:-|||| ||Export Product||||||Qty.||Sl. No.|Import Items||Qty. allowed.| ||4-(2-(2-(6,6-dimethylbic heptan-2-yl)ethoxy)ethy||||yclo l)|[3.1.1]| 1|kg.|1|DIHYDRONOPOL||0.66 kg.| || morpholine(intermediate|||| )||||2|TOLUENE||1.915 kg.| ||||||||||3|SODAMIDE||0.19 kg.| |||||||||||||| ||||||||||4|METHANOL||0.56 kg.| ||concerned may take furt||||her nece|||||||| |||||||ssar action||as er|above decision of NC|||| |||||||y||p|.|||| |||||||||||||| |||||||||||||| |||||||||||||| |Cas|e No.|62 / NC/3/M|||EET/Jul/|202425/7||||||| |Cas|e Status|Case Deferr|||ed|||||||| |Party Name||AURORE LIFE SCIENCES PRIVATE LIMITED|||||||||||

Case No.	62 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED

UDIN00399699AM25

Me<br>and	eting Number<br>Date	NC/ 3/ MEE	T/ Jul/ 20	2425/ 7 and 0	6/08/2024
HQ	File Number	HQRNORM	APPLY	00002019AM	23

RA	File Number	09AX04000	338 AM2	3
Lic<br>Dat	ence No and<br>e	0911003340	/13/07/20	22
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.	ms Committee Decision:<br>e case is under consider		ation an
				d TE was re	quested to expedite his comments.

tion and TE was requested to expedite his comments.**|ms Committee Decision: e case is under consider||ation an|||| |||||d TE was re|quested to expedite his comments.|| ||||||||

Case No.	Case No.	63 / NC/3/MEET/Jul/202425/7	63 / NC/3/MEET/Jul/202425/7	63 / NC/3/MEET/Jul/202425/7	63 / NC/3/MEET/Jul/202425/7	63 / NC/3/MEET/Jul/202425/7	63 / NC/3/MEET/Jul/202425/7	63 / NC/3/MEET/Jul/202425/7	63 / NC/3/MEET/Jul/202425/7	63 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		ALEOR DERMACEUTICALS LIMITED

Meeting Number<br>		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
and Date

HQ File Number		HQRNORM APPLY 00002067AM23

RA File Number		34AX04000361 AM23
Licence No and<br>		3411002535/15/07/2022
Date

Norms Committee		Decision:
The Committee<br>product/import it		considered the case as per agenda and taking cue from the earlier decision for same export<br>em in meetingNo.NC/3/MEET/Jun/202425/5dated 14/06/2024against advance authorization
No.3410046549 dated 13/11/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ointment(Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1 % - 15 gm 1 Number 1 Nystatin USP 238.65 mg. Ointment(Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1 % - 30 gm 1 Number 2 Nystatin USP 477.30 mg. Ointment(Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 60 gm 1 Number 3 Nystatin USP 954.61 mg. Cream(Nystatin and Triamcinolone Acetonide Cream USP, 1,00,000 UNITS / GM; 0.1% - 15 gm 1 Number 4 Nystatin USP 238.65 mg||||||||||| ||Export Product|||||Qty.|**Sl. No. **|Import Items||Qty. allowed.| |||||||||||| ||Ointment(Nystatin and ||Triamci |nolone Acet |onide | 1 Number|1|Nystatin USP||238.65 mg.| ||Ointment USP, 1,00,000 U||NITS / G|M; 0.1 % - 15|gm|||||| ||Ointment(Nystatin and Ointment USP, 1,00,000 U||Triamci NITS / G| || ||||| |||||nolone Acet M; 0.1 % - 30|onide gm| 1 Number|2|Nystatin USP||477.30 mg.| ||Ointment(Nystatin and Ointment USP, 1,00,000 U||Triamci NITS / G|||||||| |||||nolone Acet M; 0.1% - 60|onide gm| 1 Number|3|Nystatin USP||954.61 mg.| |||||||||||| ||Cream(Nystatin and Tria USP, 1,00,000 UNITS / G||mcinolone M;

Triamci NITS / G|||||||| |||||nolone Acet M; 0.1% - 60|onide gm| 1 Number|3|Nystatin USP||954.61 mg.| |||||||||||| ||Cream(Nystatin and Tria USP, 1,00,000 UNITS / G||mcinolone M; 0.1% -|Acetonide C |ream| 1 Number|4|Nystatin USP||238.65 mg| |||||15 gm||||||| ||||||||||||

UDIN00399699AM25

Cream(Nystatin and Triamcinolone Acetonide Cream	<br>1 Number	5	Nystatin USP	477.30 mg.
USP, 1,00,000 UNITS / GM; 0.1% - 30 gm
Cream(Nystatin and Triamcinolone Acetonide Cream	<br>1 Number	6	Nystatin USP	954.61 mg
USP, 1,00,000 UNITS / GM; 0.1% - 60 gm

Case No.	Case No.	64 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number an	d Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00002087AM23
RA File Number		09AX04000341 AM23

Licence No and Da	te	0911003356/15/07/2022

Norms Committee	Decision:
The Committee	considered the case as per agenda and it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.Import Items<br>**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. 1 6-Amino Penicillanic Acid 199.464 mg. 2 D-(-)-4-hydroxyphenylglycine methyl ester 172.25 mg. Amoxicillin and Clavulanate Potassium Tablets 375 mg [300+75 mg](Each tablet contains 300 mg Amoxicillin astrihydrate and 75 mg Clavulanic Acid as 1 Number|||||||| ||Export Product |||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Amoxicillin and Clavulanate Potassium Tablets 375 mg [300+75 mg](Each tablet contains 300 mg Amoxicillin astrihydrate and 75 mg Clavulanic Acid as |||1 Number|1 |6-Amino Penicillanic Acid|199.464 mg.| ||||||2 |D-(-)-4-hydroxyphenylglycine methyl ester|172.25 mg.| ||||||||| ||Clavulanate Potassium.)||||3 |Diluted Clavulanate Potassium (1:1)|182.264 mg.| ||Amoxicillin and Clavulanate|||1 Number|4 |6-Amino Penicillanic Acid|132.976 mg.| ||Potassium Ta|blets 250 mg|||||| || [200+50 mg]| (Each tablet|||||| || contains 200| mg Amoxicillin|||5 |D-(-)-4-hydroxyphenylglycine |114.834 mg.| ||astrihydrate a|nd 50 mg||||methyl ester|| |||||||||

UDIN00399699AM25

r>(Each tablet|||||| || contains 200| mg Amoxicillin|||5 |D-(-)-4-hydroxyphenylglycine |114.834 mg.| ||astrihydrate a|nd 50 mg||||methyl ester|| |||||||||

UDIN00399699AM25

Clavulanic Acid as<br>Clavulanate Potassium.)<br>6<br>Diluted Clavulanate Potassium<br>(1:1)<br>121.509 mg.<br>7<br>6-Amino Penicillanic Acid<br>66.488 mg.<br>8<br>D-(-)-4-hydroxyphenylglycine<br>methyl ester<br>57.417 mg.<br>Amoxicillin and Clavulanate<br>Potassium Tablets 125 mg<br>[100+25 mg](Each tablet<br>contains 100 mg Amoxicillin<br>astrihydrate and 25 mg<br>Clavulanic Acid as<br>Clavulanate Potassium.)<br>1 Number<br>9<br>Diluted Clavulanate Potassium<br>(1:1)<br>60.755 mg.<br>10<br>6-Amino Penicillanic Acid<br>33.244 mg.<br>11<br>D-(-)-4-hydroxyphenylglycine<br>methyl ester<br>28.708 mg.<br>Amoxicillin and Clavulanate<br>Potassium Tablets 62.5 mg<br>[50+12.50](Each tablet<br>contains 50 mg Amoxicillin<br>astrihydrate and 12.5 mg<br>Clavulanic Acid as<br>Clavulanate Potassium.)<br>1 Number<br>12<br>Diluted Clavulanate Potassium<br>(1:1)<br>30.377 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Clavulanic Acid as<br>Clavulanate Potassium.)		6<br> <br>(	Diluted Clavulanate Potassium<br>1:1)	121.509 mg.
	Amoxicillin and Clavulanate<br>Potassium Tablets 125 mg<br>[100+25 mg](Each tablet<br>contains 100 mg Amoxicillin<br>astrihydrate and 25 mg<br>Clavulanic Acid as<br>Clavulanate Potassium.)	1 Number	7<br>	6-Amino Penicillanic Acid	66.488 mg.

ablets 125 mg [100+25 mg](Each tablet contains 100 mg Amoxicillin astrihydrate and 25 mg Clavulanic Acid as Clavulanate Potassium.)|1 Number|7 |6-Amino Penicillanic Acid|66.488 mg.| ||||8 |D-(-)-4-hydroxyphenylglycine methyl ester|57.417 mg.| ||||9 (|Diluted Clavulanate Potassium 1:1)|60.755 mg.| ||Amoxicillin and Clavulanate Potassium Tablets 62.5 mg [50+12.50](Each tablet contains 50 mg Amoxicillin astrihydrate and 12.5 mg Clavulanic Acid as Clavulanate Potassium.)|1 Number|10 |6-Amino Penicillanic Acid|33.244 mg.| ||||11 |D-(-)-4-hydroxyphenylglycine methyl ester|28.708 mg.| ||||12 (|Diluted Clavulanate Potassium 1:1)|30.377 mg.|

Case No.	Case No.	65 / NC/3/MEET/Jul/202425/7	65 / NC/3/MEET/Jul/202425/7	65 / NC/3/MEET/Jul/202425/7	65 / NC/3/MEET/Jul/202425/7	65 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00002187AM23
RA File Number		09AX04000313 AM23
Licence No and Date		0911003379/21/07/2022
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>Qty.<br>Export Product<br>Qty.<br>Sl. No.Import Items
	Export Product<br>		Qty.	Sl. No.	Import Items	Qty.

applied by the firm, whichever is less:- Qty. Export Product Qty. Sl. No.Import Items||||||| ||Export Product ||Qty.|Sl. No.|Import Items|Qty.|

UDIN00399699AM25

					allowed.
(1S,4R)-4-[(2-AMINO-6-CHLORO-5-	1	kg.	1	VINCELACTAM	0.92 kg.
FORMAMIDO-4-
PYRIMIDINYL)AMINO)-2-<br>CYCLOPENTENE-1-			2	N 2 AMINO 4 6 DICHLORO 5<br>PYRIMDINYL FORMAMIDE	0.764 kg.
METHANOL
			3	SODIUM BORO HYDRIDE	0.226 kg.
			4	L TARTARIC ACID	0.519 kg.
			5	D TARTARIC ACID	0.76 kg.

Case No.<br>66 / NC/3/MEET/Jul/202425/7
Case Status<br>Case Deferred
Party Name<br>GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number<br>HQRNORM APPLY 00002221AM23
RA File Number<br>07AX04000559 AM23
Licence No and<br>Date<br>0711004755/23/07/2022
Norms Committee Decision:
The representatiove of the firm attended personal hearing thorugh Video Concerence and explain their
case. The Committee heard the explanation of the firmand after due deliberation it was directed to firm
to furnish the following information/documents for further consideration:-
Complete balanced chemical reaction, indicating molecular weight or reactant(s) and product/s<br>I.
with overall yield of the reaction with justification.
Production of the export item viz-à-viz consumption of raw materials for the specific export<br>II.
**which is in question.

I.| |with overall yield of the reaction with justification.| |Production of the export item viz-à-viz consumption of raw materials for the specific export II.| |which is in question. (not all the products of the company) for the last three years duly certified| |by Chartered Accountant.| |End use of export item(s) with copy of norms, if the same is fixed in the past. III.|

I. Complete balanced chemical reaction, indicating molecular weight or reactant(s) and product/s with overall yield of the reaction with justification.
II. Production of the export item viz-à-viz consumption of raw materials for the specific export which is in question. (not all the products of the company) for the last three years duly certified by Chartered Accountant.

UDIN00399699AM25

Case No.	67 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002279AM23
RA File Number	31AX04000122 AM23
Licence No and Date	3111001586/26/07/2022
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. 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. METFORMIN HYDROCHLORIDE DIRECT COMPRESSIBLE GRANULES 83.33% W/W WHITE GRANULESPOWDER 1 kg. 1 DICYANDIAMIDE (DCDA) WHITE POWDER 0.465 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	68 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002317AM23
RA File Number	09AX04000364 AM23
Licence No and Date	0911003412/28/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-<br>hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:-

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Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
LiHMDS<br>1.0M	IN	<br>1 kg.	1	LITHIUM METAL 98PCT MIN	0.10 kg.
TETRAHYDROFURAN(CLEAR
YELLOW TO BROWN<br>LIQUID)	COLOR		2	HEXAMETHYLDISILAZANE	0.2367 kg.
			3	TETRAHYDROFURAN	0.712 kg.
			4	ISOPRENE	0.0508 kg.

|1|LITHIUM METAL 98PCT MIN|0.10 kg.| |TETRAHYDROFURAN(CLEAR|||||| |YELLOW TO BROWN LIQUID)|COLOR||2|HEXAMETHYLDISILAZANE|0.2367 kg.| ||||3|TETRAHYDROFURAN|0.712 kg.| ||||4|ISOPRENE|0.0508 kg.|

Case No.		69 / NC/3/MEET/Jul/202425/7
Case Status		Case Deferred
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00002358AM23
RA File Number		34AX04000398 AM23
Licence No and<br>Date		3411002586/29/07/2022
Norms Committee	Decision:
The committee	considered the request of firm for fixation of ad-hoc norms and as per the advise of the
TE, it was decided to call for following information/documents from the firm:-
Copy of Master-Batch Formula showing net content of inputs in the export item.

Case No.	70 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	METROPOLITAN EXIMCHEM PRIVATE LIMITED

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ntent of inputs in the export item.**|||

Case No.	70 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	METROPOLITAN EXIMCHEM PRIVATE LIMITED

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Me	eting Number and Date	NC	/ 3/ MEET/ Jul/	/ 3/ MEET/ Jul/	202425/ 7	202425/ 7	and 06/08/2024	and 06/08/2024
HQ	File Number	HQ	RNORM APPL		Y 000024		81AM23
RA	File Number	03A	X04002332 AM		23
Lic	ence No and Date	031	1016872/04/08/		2022
No<br>T<br>of	rms Committee Decision:<br>he Committee considered the<br>HBP Vol. I as per details gi		case as per ag<br>ven below or a		enda an<br>s applied		d it was decided to fix ad-hoc norms un<br>by the firm, whichever is less:-		der Para 4.07

	Export Product			Qty.	Sl.<br>No.<br>	Im	port Items		Qty. allowed.
	TETRABROMOBISPHEN<br>BIS<br>(DIBROMOMET<br>PROPYL ETHER		OL A<br>HYL	<br> <br>1 kg.	1<br> <br> <br>	S<br>T<br>T	AYTEX CP 2000<br>ETRABROMOBISPHENOL A<br>BBPA		0.683 kg.

					2<br>	METHALLYL CHLORIDE		0.227 kg.

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

ETRABROMOBISPHENOL A BBPA||0.683 kg.| ||||||||||| ||||||2 |METHALLYL CHLORIDE||0.227 kg.|| ||||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||||




Case No.		71 / NC/3/	MEET/Jul/202425/7

Case Status		Case Defer	red

Party Name		ALEMBIC	PHARMACEUTICALS LIMITED

Meeting Number<br>		NC/ 3/ ME	ET/ Jul/ 202425/ 7 and 06/08/2024
and Date

HQ File Number		HQRNORM APPLY 00002474AM23
RA File Number		34AX04000434 AM23
Licence No and<br>Date		3411002610/04/08/2022
No<br>T<br>T<br>Co	rms Committee Decision:<br>e committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the
	<br>E, it was decided to call for following inform<br>py of Master-Batch Formula showing net			<br>ation/docume	<br>nts from	<br>the firm:-
				content of in	puts, ce	rtified by Quality Cont	rol Incharge.

UDIN00399699AM25

r-Batch Formula showing net**||| ation/docume| nts from| the firm:-|| |||||content of in|puts, ce|rtified by Quality Cont|rol Incharge.| |||||||||

UDIN00399699AM25


Cas	N	72 / NC/3/MEET/Jl/202425/7
	e o.	u
Cas	e Status	Case Deferred
Par	ty Name	JODAS EXPOIM PRIVATE LIM	ITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and	06/08/2024
HQ	File Number	HQRNORM REVIW00006414A	M24
RA	File Number	09AX04000207 AM23
Lic<br>Dat	ence No and<br>e	0911003443/05/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br>before Norms Committee to explain its case along with relevant documents from the firm.	rms Committee Decision:<br>

Case No.	Case No.	73 / NC/3/MEET/Jul/202425/7	73 / NC/3/MEET/Jul/202425/7	73 / NC/3/MEET/Jul/202425/7	73 / NC/3/MEET/Jul/202425/7	73 / NC/3/MEET/Jul/202425/7
C Stt		C Dfd
ase aus		ase eerre
Part Name		SUDEEP PHARMA PRIVATE LIMITED
y
Meetin Number
g<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024

HQ File Number		HQRNORM APPLY 00002560AM23
RA File Number		34AX04000414 AM23

Licence No and
<br>Date		3411002630/10/08/2022

Norms Committee		Decision:

HQ File Number||HQRNORM APPLY 00002560AM23||||| |RA File Number||34AX04000414 AM23||||| |||||||| |Licence No and||||||| | Date||3411002630/10/08/2022||||| |||||||| |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:- Provide Stoichiometric balance between import and export on molar basis. 1. Percentage yield of reaction. 2. Percentage purity of export product. 3.||||||| || Percentage purity of export pro 3.||duct.|||| |||||||| |||||||| |Cas|e No.|74 / NC/3/MEET/Jul/202|425/7|||| |Cas|e Status|Case Approved||||| |Party Name||ALCHEMIE FINECHEM PRIVATE LIMITED|||||

Case No.	74 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	ALCHEMIE FINECHEM PRIVATE LIMITED

56 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

UDIN00399699AM25

---| |Case Status|Case Approved| |Party Name|ALCHEMIE FINECHEM PRIVATE LIMITED|

56 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

UDIN00399699AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002553AM23
RA File Number	03AX04002069 AM23
Licence No and<br>Date	0311017059/10/08/2022
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. allowed.<br>1<br>META TOLUIDINE<br>0.834 kg.<br>MONO<br>METHYL<br>META<br>TOLUIDINE<br>1 kg.<br>2<br>DENATURED ETHYL ALCOHOL<br>0.360 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	75 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002645AM23
RA File Number	03AX04002727 AM23
Licence No and<br>Date	0311017254/16/08/2022
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	76 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved

UDIN00399699AM25

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

Case No.	76 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved

UDIN00399699AM25

Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002758AM23
RA File Number	08AX04000605 AM23
Licence No and Date	0811005824/24/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Magnesium Sulfate In Water for<br>Injection (0.325m Eq Mg++/mL)<br>40mg/mL2g Total (Each<br>50mLContains)-NET667.092KGS<br>1 Number<br>1<br>MEGNESIUM SULFATE<br>HEPTAHYDRATE USP<br>2.00 gm.<br>Magnesium Sulfate In Water for<br>Injection (0.325 mEq Mg++/mL) 40<br>mg/mL 4g Total (Each 100 mL<br>Contains)-NET 257.908KGS<br>1 Number<br>2<br>MEGNESIUM SULFATE<br>HEPTAHYDRATE USP<br>4.00 gm.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	77 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002801AM23
RA File Number	09AX04000470 AM23
Licence No and<br>Date	0911003541/26/08/2022
Norms Committee Decision:

3/ MEET/ Jul/ 202425/ 7 and 06/08/2024| |HQ File Number|HQRNORM APPLY 00002801AM23| |RA File Number|09AX04000470 AM23| |Licence No and Date|0911003541/26/08/2022| |Norms Committee Decision:||

UDIN00399699AM25

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

Case No.	78 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002813AM23
RA File Number	07AX04000768 AM23
Licence No and<br>Date	0711005110/26/08/2022
Norms Committee Decision:<br>The representative of the firm attended personal hearing thorugh Video Concerence and explain their<br>case. The Committee heard the explanation of the firmand after due deliberation it was directed to firm<br>to furnish the following information/documents for further consideration:-<br>Complete balanced chemical reaction, indicating molecular weight or reactant(s) and product/s<br>with overall yield of the reaction with justification.<br>I.<br>Production of the export item viz-à-viz consumption of raw materials for the specific export<br>which is in question. (Not all the products of the company) for the last three years duly certified<br>by Chartered Accountant.<br>II.<br>End use of export item(s) with copy of norms, if the same is fixed in the past.<br>III.

I. Complete balanced chemical reaction, indicating molecular weight or reactant(s) and product/s with overall yield of the reaction with justification.

me is fixed in the past.** III.||

I. Complete balanced chemical reaction, indicating molecular weight or reactant(s) and product/s with overall yield of the reaction with justification.
II. Production of the export item viz-à-viz consumption of raw materials for the specific export which is in question. (Not all the products of the company) for the last three years duly certified by Chartered Accountant.

Case No.	79 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	GODAVARI BIOREFINERIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002842AM23
RA File Number	03AX04002739 AM23
Licence No and<br>Date	0311017558/29/08/2022
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:-

59 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

UDIN00399699AM25

Certificate of Analysis (CoA) of export item indicating moisture content in it. 2. Justification of quantity required for Denatured Ethyl Alcohol.

-09-2024 16:00:43.

UDIN00399699AM25

Certificate of Analysis (CoA) of export item indicating moisture content in it. 2. Justification of quantity required for Denatured Ethyl Alcohol.

Case No.	80 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002857AM23
RA File Number	09AX04000483 AM23
Licence No and<br>Date	0911003562/30/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>4-chloro-7H-pyrolo[2,3-d]pyrimidine<br>1.00 kg.<br>Tofacitnab citrate<br>1 kg.<br>2<br>(3R,4R)-1-Benzyl-N,4-Dimethyl<br>piperidin-3-amine dihydrochloride<br>1.72 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	81 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002871AM23

UDIN00399699AM25

UDIN00399699AM25

RA File Number

08AX04000919 AM23

Licence No and Date

0811005862/01/09/2022

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Nystatin Cream, 100000 units/gm, 15gm(Each gram Contains: 100,000 USP Nystatin Units in an aqueous, cream base. 85000 Numbers 1 Nystatin USP(Nystatin Micronized USDMF GRADE) 20.466 kg. Nystatin Cream, 100000 units/gm, 30gm(Each gram Contains: 100,000 USP Nystatin Units in anaqueous, cream base. 528750 Numbers 2 Nystatin USP(Nystatin Micronized USDMF GRADE) 259.708 kg. RA concerned may take further necessary action as per above decision of NC.

Case No.	82 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	HI-PURITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002877AM23
RA File Number	03AX04002948 AM23
Licence No and<br>Date	0311017592/01/09/2022
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

48 AM23| |Licence No and Date|0311017592/01/09/2022| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07||

UDIN00399699AM25

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.
Dichlorophene<br>	1 kg.	1<br>	Para ChloroPhenol	1.006 kg.

Case No.	83 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002919AM23
RA File Number	34AX04000543 AM23
Licence No and<br>Date	3411002729/02/09/2022
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	84 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00002944AM23
RA File Number	07AX04000812 AM23
Licence No and<br>Date	0711005159/05/09/2022
Norms Committee Decision:<br>The representatiove of the firm attended personal hearing thorugh Video Concerence and explain their<br>case. The Committee heard the explanation of the firmand after due deliberation it was directed to firm

UDIN00399699AM25

to furnish the following information/documents for further consideration:-

ommittee heard the explanation of the firmand after due deliberation it was directed to firm||

UDIN00399699AM25

to furnish the following information/documents for further consideration:-

I. Complete balanced chemical reaction, indicating molecular weight or reactant(s) and product/s with overall yield of the reaction with justification.
II. Production of the export item viz-à-viz consumption of raw materials for the specific export which is in question. (Not all the products of the company) for the last three years duly certified by Chartered Accountant.
III. End use of export item(s) with copy of norms, if the same is fixed in the past.

Case No.	85 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	SUDEEP NUTRITION PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00003021AM23
RA File Number	34AX04000522 AM23
Licence No and<br>Date	3411002756/09/09/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>FUMARIC ACID ENCAPSULATED 80%<br>1 MT<br>1<br>Fumaric Acid<br>0.80 MT<br>FUMARIC ACID ENCAPSULATED 85%<br>1 MT<br>2<br>Fumaric Acid<br>0.85 MT<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 86 / NC/3/MEET/Jul/202425/7

FUMARIC ACID ENCAPSULATED 85% 1 MT 2 Fumaric Acid 0.85 MT RA concerned may take further necessary action as per above decision of NC.||

Case No. 86 / NC/3/MEET/Jul/202425/7

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Case Status	Case Deferred
Party Name	INTIGREAT CONSULTING SERVICES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00003056AM23
RA File Number	03AX04002543 AM23
Licence No and<br>Date	0311017790/12/09/2022
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	87 / NC/3/MEET/Jul/202425/7
Case Status	Case Approved
Party Name	SUDEEP NUTRITION PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00003092AM23
RA File Number	34AX04000422 AM23
Licence No and<br>Date	3411002775/13/09/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Sorbic Acid Encapsulated 85% with Vegetable<br>Fat<br>1 MT<br>1<br>Sorbic Acid<br>0.85 MT<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	88 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred

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br>0.85 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	88 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred

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Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00003118AM23
RA File Number	09AX04000498 AM23
Licence No and<br>Date	0911003623/14/09/2022
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	Case No.	89 / NC/3/MEET/Jul/202425/7	89 / NC/3/MEET/Jul/202425/7	89 / NC/3/MEET/Jul/202425/7	89 / NC/3/MEET/Jul/202425/7	89 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00003266AM23
RA File Number		08AX04001009 AM23
Licence No and Date		0811006072/21/09/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Opipramol Dihydrochloride Tablets<br>50 MG (OPIPRAMOL HEUMANN<br>50 MG FILMTABLETTEN) (Each<br>film coatedtablet contains:<br>Opipramol Dihydrochloride 50 mg<br>Excipients.

*Qty.** allowed. Opipramol Dihydrochloride Tablets 50 MG (OPIPRAMOL HEUMANN 50 MG FILMTABLETTEN) (Each film coatedtablet contains: Opipramol Dihydrochloride 50 mg Excipients. q.s.Colors: Titanium Dioxide and Yellow Oxide of Iron. 1 Number 1 Opipramol Dihydrochloride 51 mg. Opipramol Dihydrochloride Tablets 100 MG (OPIPRAMOL HEUMANN 100 MG FILMTABLETTEN)(Each film coatedtablet contains: Opipramol Dihydrochloride 100 mg 1 Number 2 Opipramol Dihydrochloride 102 mg.||||||| ||Export Product ||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Opipramol Dihydrochloride Tablets 50 MG (OPIPRAMOL HEUMANN 50 MG FILMTABLETTEN) (Each film coatedtablet contains: Opipramol Dihydrochloride 50 mg Excipients. q.s.Colors: Titanium Dioxide and Yellow Oxide of Iron. || 1 Number|1 |Opipramol Dihydrochloride|51 mg.| ||Opipramol Dihydrochloride Tablets 100 MG (OPIPRAMOL HEUMANN 100 MG FILMTABLETTEN)(Each film coatedtablet contains: Opipramol Dihydrochloride 100 mg || 1 Number|2 |Opipramol Dihydrochloride|102 mg.|

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Excipients. q.s.Colors: Titanium Dioxide and Yellow Oxide of Iron.

ramol Dihydrochloride 100 mg || 1 Number|2 |Opipramol Dihydrochloride|102 mg.|

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Excipients. q.s.Colors: Titanium Dioxide and Yellow Oxide of Iron.

Case No.	90 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00003251AM23
RA File Number	34AX04000590 AM23
Licence No and<br>Date	3411002800/21/09/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master Batch Formula<br>1.

Case No.	91 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00006256AM24
RA File Number	08AX04000971 AM23
Licence No and<br>Date	0811006083/22/09/2022
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

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971 AM23| |Licence No and Date|0811006083/22/09/2022| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

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Case No.	92 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	KAVALIFE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00003326AM23
RA File Number	07AX04000884 AM23
Licence No and<br>Date	0711005312/23/09/2022
Norms Committee Decision:<br>The firm was called for Personal Hearing on 08/08/2024 through Video Conference, but the firm could not<br>appear before Norms Committee. Itwas decided to grant one more opportunity to the firm forPersonal<br>Hearingwith relevant documents/information.

Case No.	93 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00003339AM23
RA File Number	03AX04003267 AM23
Licence No and<br>Date	0311018114/24/09/2022
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	94 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00003389AM23
RA File Number	08AX04001054 AM23
Licence No and	0811006114/26/09/2022

67 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

UDIN00399699AM25

Date

Norms Committee Decision:

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

Case No.	95 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00003395AM23
RA File Number	34AX04000620 AM23
Licence No and<br>Date	3411002830/27/09/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master Batch Formula<br>1.

Case No.	96 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred
Party Name	VINYL PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001983AM25
RA File Number	05AX04002721 AM23
Licence No and<br>Date	0511016406/15/12/2022
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No. 97 / NC/3/MEET/Jul/202425/7

68 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

deration and TE was requested to expedite his comments.**||

Case No. 97 / NC/3/MEET/Jul/202425/7

68 This document has been digitally signed by Raman Kumar, Deputy DGFT on 18-09-2024 16:00:43.

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Case Status	Case Rejected
Party Name	B G P HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM APPLY 00005000AM23
RA File Number	34AX04000827 AM23
Licence No and<br>Date	3411003121/15/12/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it has been observed that Ion<br>Exchange Resin is not a raw material for manufacturing of export item. Hence the committee has decided to<br>rejectthe application of the firm.

Case No.	Case No.	98 / NC/3/MEET/Jul/202425/7	98 / NC/3/MEET/Jul/202425/7	98 / NC/3/MEET/Jul/202425/7	98 / NC/3/MEET/Jul/202425/7	98 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		SAVA HEALTHCARE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00006536AM23
RA File Number		31AX04000353 AM23
Licence No and<br>Date		3111002045/23/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Scoralite DC 90 MD 3017.60 kg. 2 Niacinamide 71.00 kg. 3 Ascorbic Acid, Granular 425.95 kg. 4 Copper Gluconate 50.76 kg. 5 Ferrous Fumarate 378.00 kg. Pregnency Multivitamin Tablet(Pack Size 2 x 30 Quantity Total No. of Tablets 6960000 Nos) 6960000 Numbers||||||| ||Export Product ||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Pregnency Multivitamin Tablet(Pack Size 2 x 30 Quantity Total No. of Tablets 6960000 Nos) ||6960000 Numbers|1 |Scoralite DC 90 MD|3017.60 kg.| |||||2 |Niacinamide|71.00 kg.| |||||3 |Ascorbic Acid, Granular|425.95 kg.| |||||4 |Copper Gluconate|50.76 kg.| |||||5 |Ferrous Fumarate|378.00 kg.|

Case No.	Case No.	98 / NC/3/MEET/Jul/202425/7	98 / NC/3/MEET/Jul/202425/7	98 / NC/3/MEET/Jul/202425/7	98 / NC/3/MEET/Jul/202425/7	98 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		SAVA HEALTHCARE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM APPLY 00006536AM23
RA File Number		31AX04000353 AM23
Licence No and<br>Date		3111002045/23/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

|Licence No and Date||3111002045/23/02/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Scoralite DC 90 MD 3017.60 kg. 2 Niacinamide 71.00 kg. 3 Ascorbic Acid, Granular 425.95 kg. 4 Copper Gluconate 50.76 kg. 5 Ferrous Fumarate 378.00 kg. Pregnency Multivitamin Tablet(Pack Size 2 x 30 Quantity Total No. of Tablets 6960000 Nos) 6960000 Numbers||||||| ||Export Product ||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Pregnency Multivitamin Tablet(Pack Size 2 x 30 Quantity Total No. of Tablets 6960000 Nos) ||6960000 Numbers|1 |Scoralite DC 90 MD|3017.60 kg.| |||||2 |Niacinamide|71.00 kg.| |||||3 |Ascorbic Acid, Granular|425.95 kg.| |||||4 |Copper Gluconate|50.76 kg.| |||||5 |Ferrous Fumarate|378.00 kg.|

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017.60 kg.| |||||2 |Niacinamide|71.00 kg.| |||||3 |Ascorbic Acid, Granular|425.95 kg.| |||||4 |Copper Gluconate|50.76 kg.| |||||5 |Ferrous Fumarate|378.00 kg.|

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	6<br>	Magnesium Oxide	294.26 kg.
	7<br>	BETA TAB 20% S	28.40 kg.
	8<br>	Folic acid	3.90 kg.
	9<br>	Pyridoxine Hydrochloride	35.50 kg.
	10<br>	Dry Vitamin E 50%	145.97 kg.
Pregnency Multivitamin Folic 5 Tablet(Pack<br>Size 2 x 30 Quantity Total No.

.| ||||8 |Folic acid|3.90 kg.| ||||9 |Pyridoxine Hydrochloride|35.50 kg.| ||||10 |Dry Vitamin E 50%|145.97 kg.| ||Pregnency Multivitamin Folic 5 Tablet(Pack Size 2 x 30 Quantity Total No. of Tablets 2400000 Nos) |2400000 Numbers|11 |Scoralite DC 90 MD|1040.55 kg.| ||||12 |Niacinamide|24.48 kg.| ||||13 |Ascorbic Acid, Granular|146.88 kg.| ||||14 |Copper Gluconate|17.50 kg.| ||||15 |Ferrous Fumarate|130.34 kg.| ||||16 |Magnesium Oxide|101.47 kg.| ||||17 |BETA TAB 20% S|9.80 kg.| ||||18 |Folic acid|1.35 kg.| ||||19 |Pyridoxine Hydrochloride|12.24 kg.| ||||20 |Dry Vitamin E 50%|50.34 kg.|

Case No.	99 / NC/3/MEET/Jul/202425/7
Case Status	Case Deferred

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Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number	HQRNORM REVIW00001706AM25
RA File Number	03AX04001312 AM24
Licence No and<br>Date	0311025237/07/07/2023
Norms Committee Decision:<br>The firm was called for Personal Hearing on 08/08/2024 through Video Conference, but the firm could not<br>appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal<br>Hearingwith relevant documents/information.

o Conference, but the firm could not appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal Hearingwith relevant documents/information.||

Case No.	Case No.	100 / NC/3/MEET/Jul/202425/7	100 / NC/3/MEET/Jul/202425/7	100 / NC/3/MEET/Jul/202425/7	100 / NC/3/MEET/Jul/202425/7	100 / NC/3/MEET/Jul/202425/7
Case Status		Case Approved
Party Name		SUPRIYA LIFESCIENCE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jul/ 202425/ 7 and 06/08/2024
HQ File Number		HQRNORM REVIW00001325AM25
RA File Number		03AX04003085 AM24
Licence No and<br>Date		0311028054/19/10/2023
Norms Committee Decision:<br>The Committee considered the request of the firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>1<br>RIBOFLAVIN<br>(VITAMIN B2)<br>1.30 kg.<br>2<br>PYRIDINE<br>2.00 kg.<br>3<br>ACETONITRILE<br>1.73 kg.<br>RIBOFLAVIN SODIUM PHOSPHATE<br>HYDRATE EP 11.2<br>1 kg.<br>4<br>PHOSPHORUS<br>OXYCHLORIDE<br>2.00 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	RIBOFLAVIN SODIUM PHOSPHATE<br>HYDRATE EP 11.2		1 kg.	1<br> <br>	RIBOFLAVIN<br>(VITAMIN B2)	1.30 kg.
				2<br>	PYRIDINE	2.00 kg.
				3<br>	ACETONITRILE	1.73 kg.
				4<br> <br>	PHOSPHORUS<br>OXYCHLORIDE	2.00 kg.

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Note:

I. Above ad-hoc norms are valid only for export to DSM Nutritional Product AG, Switzerland under Contract Manufacturing Agreement between DSM, Switzerland and M/s Supriya Lifescience Limited.
II. No fresh Advance Authorisation on above norms will be considered except for those already taken before 06/06/2024 and further Advance Authorisation to be considered based on revised yields and consumption data.
III. Above norms are for EP11.2 only and not for any other Pharmaceutical specification like EP/BP/USP etc.
IV. RA concerned may take further necessary action as per above decision of Norms Committee and conditions attached with the Norms.

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