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/Mar/202425/18 DATED: 17/03/2025

Minutes of the Norms Committee 3 Meeting No. NC/3/MEET/Mar/202425/18 dated 17/03/2025, under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of the Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

The following members were present in the meeting:-

S.No.	Name and Designation	Department
1	Shri Dinesh Narain Mathur, Technical Expert	Consultant (Pharma)
2	Shri Shaish Kumar, Technical Expert	Consultant (Chemical)
3	Shri Nand Lal, Technical Expert	Consultant (Chemical)
In attendance:
1	Shri Raman Kumar, Deputy DGFT	DGFT (HQ)
2	Shri Uttam Dey Sarkar, ASO	DGFT (HQ)

The Norms Committee has taken decisions only with respect to technical aspect/ wastage norms While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure, including those in notifications, public notices and policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularisation of the case

RAs shall ensure compliance with SION, General Notes and Chapter Notes wherever applicable.

er provisions under FTP/HBP for issuance of Advance Authorization and regularisation of the case

RAs shall ensure compliance with SION, General Notes and Chapter Notes wherever applicable.

RAs shall also ensure that authorization is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard, full compliance with the provisions of Para 4.12 of FTP, Para 4.16, Para 4.21, and Para 4.51 of HBP shall be made.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00000291AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for fixation of ad-hoc norms to enable them to<br>obtain Advance Authorization from concerned RA and it was decided to fix ad-hoc norms as per details<br>given below or as applied by the firm, whichever is less:- (para 4.06)<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Terpineol<br>1 kg.<br>1<br>Gum Terpentine Oil containing Alpha<br>Pinene 82.5%<br>1.95 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	2 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	ADSILA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00002270AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda, and it has been observed that the firm has added the<br>weight of shell in the potency of Soft Gelatin Capsule, which is not certified by Drug Manufacturing<br>License and not in convention.

agenda, and it has been observed that the firm has added the weight of shell in the potency of Soft Gelatin Capsule, which is not certified by Drug Manufacturing License and not in convention. Further,other issues related to the content of the shell are to be provided. Therefore, it was decided to contact the firm to attend a personal hearing before the Norms Committee to explain its case, along with purchase orders and other relevant details.||

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Case No.	3 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	TROIKAA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00002512AM25
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 to enable them to obtain<br>Advance Authorization from concerned RA and it was decided to fix ad-hoc norms as per details given<br>below or as applied by the firm, whichever is less:- (para 4.06)<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Propofol<br>210.00 mg.<br>2<br>E 80 (Egg Lecithin)<br>240.00 mg.<br>3<br>Sodium Oleate B<br>6.00 mg.<br>4<br>Purified Soyabean Oil 700<br>2000.00 mg.<br>Drug Formulations Injections<br>(ampoules / vials above 10<br>ML) (Propofol Injection) (20<br>ml.

br>240.00 mg. 3 Sodium Oleate B 6.00 mg. 4 Purified Soyabean Oil 700 2000.00 mg. Drug Formulations Injections (ampoules / vials above 10 ML) (Propofol Injection) (20 ml. Injection) 1 Number 5 Rubber stopper Relevant, as per Packing Policy and General Notes. RA concerned may take further necessary action as per above decision of NC.||

Case No.	4 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	VINDHYA ORGANICS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00002820AM25
RA File Number	NA
Licence No and Date	NA
Norms Committee Decision:

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The Committee considered the request of firm for fixation of ad-hoc norms to enable them to obtain Advance Authorization from concerned RA and it was decided to fix ad-hoc norms as per details given below or as applied by the firm, whichever is less:- (para 4.06)

c norms to enable them to obtain Advance Authorization from concerned RA and it was decided to fix ad-hoc norms as per details given below or as applied by the firm, whichever is less:- (para 4.06)

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
(1S,4R)-4-(2-AMINO-6-<br>CHLORO-9H-PURIN-YL)-2-<br>CYCLOPENTANE-1-<br>METHANOL(AFC-2FB) (or)<br>AbacavirSulfate (ABC) I (SA)	<br>1 kg.	1	2-AZABICYCLO (2.2.1)HEPT-5-<br>EN-3-ONE ( VINCELACTAM)	1.75 kg.
		2	N-(2-AMINO-4, 6-DICHLORO-5-<br>PYRIMIDINYL) FORMAMIDE	1.07 kg.
		3	SODIUM BOROHYDRIDE<br>POWDER	0.44 kg.
		4	D(-) TARTARIC ACID	0.088 kg.
		5	L + TARTARIC ACID	1.54 kg.
		6	ISO PROPYL ALCOHOL	2.24 kg.
		7	TRIETHYL ORTHOFORMATE<br>(TEOF)	1.16 kg.

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

Case No.	5 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	ANUPAM RASAYAN INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	018205000924AM10
RA File Number	522404000031 AM10
Licence No and<br>Date	5210029505/27/01/2010
Norms Committee Decision:

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

I. Complete technical details as per Annexure to Appendix 4E for chemical products.

s and as per the advice of the TE, it was decided to call for following information/documents from the firm:-

I. Complete technical details as per Annexure to Appendix 4E for chemical products.
II. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
III. Material balance for entire process.

Case No.	6 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	VIJAYASRI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	018305000961AM12
RA File Number	092404000478 AM12
Licence No and<br>Date	0910051240/13/02/2012
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that the application of the firm<br>was transferred by NC-4 and no such attachment of the application is available on the portal. Therefore, it<br>was decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>I.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise<br>percentage yields on molar basis.<br>II.<br>Material balance for entire process.<br>III.<br>It is also decided to send a letter to RA to upload copy of licence, applications and other details on the portal.

ields on molar basis. II. Material balance for entire process. III. It is also decided to send a letter to RA to upload copy of licence, applications and other details on the portal.||

Case No.	Case No.	7 / NC/3/MEET/Mar/202425/18	7 / NC/3/MEET/Mar/202425/18	7 / NC/3/MEET/Mar/202425/18	7 / NC/3/MEET/Mar/202425/18	7 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00009259AM24
RA File Number		039504000262 AM13
Licence No and Date		0310705888/22/08/2012
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>Sl.<br>Qty.<br>Export Product<br>Qty.<br>Import Items
	Export Product		Qty.	Sl.	Import Items	Qty.

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Export Product||Qty.|Sl.|Import Items|Qty.|

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No.<br>allowed.<br>1<br>4-CHLOROBENZYL<br>CYANIDE 99%<br>0.78 kg.<br>4-AMINO-2-CHLORO-ALPHA<br>(4-CHLOROPHENYL)<br>5-METHYL<br>BENZENE<br>ACETO<br>NITRILE<br>1 kg.<br>2<br>4-CHLORO-2 NITRO<br>TOLUENE 99%<br>0.68 kg.<br>RA concerned may take further necessary action as per above decision of NC.			No.		allowed.
	4-AMINO-2-CHLORO-ALPHA<br>(4-CHLOROPHENYL)<br>5-METHYL<br>BENZENE<br>ACETO<br>NITRILE	<br>1 kg.	1	4-CHLOROBENZYL<br>CYANIDE 99%	0.78 kg.
			2	4-CHLORO-2 NITRO<br>TOLUENE 99%	0.68 kg.

Case No.	8 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	SWEMED DIAGNOSTICS
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	018305000077AM15
RA File Number	072404000426 AM14
Licence No and<br>Date	0710102252/20/02/2014
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that the application of the firm<br>was transferred by NC-4 and no such attachment of the application is available on Portal. Therefore, it<br>was decided that the firm may be advised to submit complete application alongwith relevant documents to<br>enable to consider the request of the firm.<br>It is also decided to send a letter to RA to upload copy of licence, applications and other details on the portal.

ngwith relevant documents to enable to consider the request of the firm. It is also decided to send a letter to RA to upload copy of licence, applications and other details on the portal.||

Case No.	9 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	NECTAR LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001482AM25
RA File Number	222404000083 AM14
Licence No and<br>Date	2210015019/15/07/2014
Norms Committee Decision:<br>The representative of the firm attended personal hearing through Video Conference and explain their<br>case. The Committee heard the explanation of the firm and after due deliberation it was directed to<br>firm to furnish the following information/documents for further consideration:-

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Copy of Certificate of Analysis (CoA) of export item for the relevant period of 2014-2015.

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Copy of Certificate of Analysis (CoA) of export item for the relevant period of 2014-2015.

Case No.	10 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	UNIJULES LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	018305000700AM15
RA File Number	039504000413 AM15
Licence No and<br>Date	0310787952/12/08/2014
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix 4E.<br>I.<br>Copy of Drug Manufacturing License (DML) showing approved composition of each export item.<br>II.<br>Master-Batch Formula for each export item showing net content of each input.<br>III.

br>I. Copy of Drug Manufacturing License (DML) showing approved composition of each export item. II. Master-Batch Formula for each export item showing net content of each input. III.||

Case No.	11 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001409AM25
RA File Number	039404000525 AM17
Licence No and<br>Date	0310807975/22/09/2016
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage yield of reaction on molar basis.<br>1.<br>If yield is less than 80% justification for the same.<br>2.<br>Quantity and value of by-product obtained.<br>3.<br>Certificate of Analysis (CoA) of export item with percentage purity and impurity profile.<br>4.<br>Production/Consumption data for licensing period duly certified by authorized Auditor of the firm.<br>5.

Case No.	12 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001645AM25

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/ 18 and 17/03/2025| |HQ File Number|HQRNORM REVIW00001645AM25|

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RA File Number	092404000590 AM17
Licence No and Date	0910065113/31/05/2017
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>PENICILLIN G<br>POTASSIUM FIRST<br>CRYSTAL<br>1.375 kg.<br>2<br>ACETONE<br>1.971 kg.<br>3<br>ISOPROPYL ALCOHOL<br>0.66 kg.<br>4<br>METHYLENE<br>CHLORIDE(MDC)<br>3.29 kg.<br>5<br>2 MERCAPTO BENZO<br>THIAZOLE(MBT)<br>0.511 kg.<br>GCLE(7-PHENYL ACETAMIDEO-<br>3-CHLOROMETHYL-<br>CEPHALOSPORANIC ACID PARA-<br>METHOXY BENZYL ESTER)<br>1 kg.<br>6<br>METHANOL<br>1.971 kg.<br>RA concerned may take further necessary action as per above decision of NC.

RA File Number

092404000590 AM17

Licence No and Date

0910065113/31/05/2017

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 PENICILLIN G POTASSIUM FIRST CRYSTAL 1.375 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.

O- 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.||

Case No.	13 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00002136AM25
RA File Number	052304000266 AM18
Licence No and<br>Date	0510404285/13/10/2017
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.
IOPAMIDOL (612.34mg/ml)<br>Injection. 300mgI/ml. 30ml Vial.<br>IMPORT & EXPORT TO BE<br>GOVERNED AS PER<br>P/C 9 DATED 30.06.2003	<br>1 Number	1	IOPAMIDOL USP.<br>IMPORT & EXPORT TO<br>BE GOVERNED AS PER<br>P/C 9 DATED 30.06.2003	19.289 gm.
IOPAMIDOL (612.34mg/ml)<br>Injection. 300mgI/ml. 50ml Vial.<br>IMPORT & EXPORT TO BE<br>GOVERNED AS PER<br>P/C 9 DATED 30.06.2003	<br>1 Number	2	IOPAMIDOL USP.<br>IMPORT & EXPORT TO<br>BE GOVERNED AS PER<br>P/C 9 DATED 30.06.2003	32.148 gm.
IOPAMIDOL (612.34mg/ml)<br>Injection. 300mgI/ml. 100ml<br>Vial.

/C 9 DATED 30.06.2003| 1 Number|2|IOPAMIDOL USP. IMPORT & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003|32.148 gm.| ||IOPAMIDOL (612.34mg/ml) Injection. 300mgI/ml. 100ml Vial. IMPORT & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003|1 Number|3|IOPAMIDOL USP. IMPORT & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003|64.296 gm.| ||IOPAMIDOL (755.22mg/ml) Injection. 370mgI/ml. 30ml Vial. IMPORT & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003| 1 Number|4|IOPAMIDOL USP. IMPORT & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003|23.789 gm.| ||IOPAMIDOL (755.22mg/ml) Injection. 370mgI/ml. 50ml Vial. IMPORT & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003| 1 Number|5|IOPAMIDOL USP. IMPORT & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003|39.65 gm.| ||IOPAMIDOL (755.22mg/ml) Injection. 370mgI/ml. 100ml Vial. IMPORT & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003|1 Number|6|IOPAMIDOL USP. IMPORT & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003|79.30 gm.|

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T TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003|79.30 gm.|

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IOPAMIDOL (755.22mg/ml)<br>Injection. 370mgI/ml. 200ml<br>Vial. IMPORT & EXPORT TO<br>BE GOVERNED AS PER<br>P/C 9 DATED 30.06.2003<br>1 Number<br>7<br>IOPAMIDOL USP.<br>IMPORT & EXPORT TO<br>BE GOVERNED AS PER<br>P/C 9 DATED 30.06.2003<br>158.60 gm.<br>RA concerned may take further necessary action as per above decision of NC.	IOPAMIDOL (755.22mg/ml)<br>Injection. 370mgI/ml. 200ml<br>Vial. IMPORT & EXPORT TO<br>BE GOVERNED AS PER<br>P/C 9 DATED 30.06.2003	1 Number	7	IOPAMIDOL USP.<br>IMPORT & EXPORT TO<br>BE GOVERNED AS PER<br>P/C 9 DATED 30.06.2003	158.60 gm.

Case No.	Case No.	14 / NC/3/MEET/Mar/202425/18	14 / NC/3/MEET/Mar/202425/18	14 / NC/3/MEET/Mar/202425/18	14 / NC/3/MEET/Mar/202425/18	14 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		CIPLA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00002128AM25
RA File Number		039404000726 AM18
Licence No and<br>Date		0310817755/13/12/2017

and Date||NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025||||| |HQ File Number||HQRNORM REVIW00002128AM25||||| |RA File Number||039404000726 AM18||||| |Licence No and Date||0310817755/13/12/2017||||| |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.4/82-ALC4/2018 dated 19/06/2018 against advance authorization No.0310817755 dated 13/12/2017 , 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 Ipratropium Bromide 4.00 mg. 4 63mcl AEROSOL VALVES 7 19ml Plasma Coated ALUMINIUM CAN 10 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 20mcg / Ipravent 20mcg Inhaler (200MD) (Ipramar 20mcg Inhaler / INFLUMIX 20 MCG (200MD) with 63mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48mm Actuator HFA 227 Gas 21.30 gms) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

r>with 63mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48mm Actuator HFA 227 Gas 21.30 gms) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ipratropium Pressurised Inhalation 20mcg / Ipravent 20mcg Inhaler (200MD) (Ipramar 20mcg Inhaler / INFLUMIX 20 MCG (200MD) with 63mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48mm Actuator HFA 227 Gas 21.30 gms)||1 kg.|1|Ipratropium Bromide|4.00 mg.| |||||4|63mcl AEROSOL VALVES|Relevant, as per Packing Policy and General Notes.| |||||7|19ml Plasma Coated ALUMINIUM CAN|| |||||10|0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS||

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|13 Heptafluropropane P227 Gas (HFA-227) 21.12 mg. 2 Ipratropium Bromide 8.00 mg. 5 63mcl AEROSOL VALVES 8 19ml Plasma Coated ALUMINIUM CAN 11 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 40mcg / Ipravent 40mcg Inhaler (200MD) Ipramar 40mcg Inhaler(with 63mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48mm Actuator HFA 227 Gas 21.25 gms) 1 kg. 14 Heptafluropropane P227 Gas 21.12 mg. 3 Ipratropium Bromide 4.00 mg. 6 63mcl AEROSOL VALVES 9 19ml Plasma Coated ALUMINIUM CAN 12 0.58 mm OD ACTUATORS WITH DUST COVERS /

		13	Heptafluropropane P227<br>Gas (HFA-227)	21.12 mg.
Ipratropium Pressurised<br>Inhalation 40mcg / Ipravent<br>40mcg Inhaler (200MD)<br>Ipramar 40mcg Inhaler(with<br>63mcl Aerosol<br>Valve, 19ml Plasma Coated<br>Aluminium Can with 0.48mm<br>Actuator HFA 227 Gas 21.25<br>gms)	1 kg.	2	Ipratropium Bromide	8.00 mg.
		5	63mcl AEROSOL<br>VALVES	Relevant, as per<br>Packing Policy and<br>General Notes.
		8	19ml Plasma Coated<br>ALUMINIUM CAN
		11	0.48 mm OD<br>ACTUATORS WITH<br>DUST COVERS / CAPS
		14	Heptafluropropane P227<br>Gas	21.12 mg.
Ipratropium Bromide 20mcg<br>and Salbutamol Sulphate<br>100mcg Inhaler (200MD)<br>DUOLIN INHALER<br>(200MD) (with<br>63mcl Aerosol Valve, 19ml<br>Plasma coated Aluminium<br>Can with 0.58mm Actuator<br>HFA 227 Gas 21.10 gms)	1 kg.	3	Ipratropium Bromide	4.00 mg.
		6	63mcl AEROSOL<br>VALVES	Relevant, as per<br>Packing Policy and<br>General Notes.

ma coated Aluminium Can with 0.58mm Actuator HFA 227 Gas 21.10 gms)|1 kg.|3|Ipratropium Bromide|4.00 mg.| ||||6|63mcl AEROSOL VALVES|Relevant, as per Packing Policy and General Notes.| ||||9|19ml Plasma Coated ALUMINIUM CAN|| ||||12|0.58 mm OD ACTUATORS WITH DUST COVERS / CAPS|| ||||15|Heptafluropropane P227 Gas|21.12 mg.|

Case No.	15 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001412AM25
RA File Number	039404000762 AM18
Licence No and<br>Date	0310818348/09/01/2018
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage yield of reaction on molar basis.<br>I.<br>If yield is less than 80% justification for the same.<br>II.<br>Quantity and value of by-product obtained.<br>III.<br>Certificate of Analysis (CoA) of export item with percentage purity and impurity profile.<br>IV.<br>Production/Consumption data for licensing period duly certified by authorized Auditor of the firm.<br>V.

e of Analysis (CoA) of export item with percentage purity and impurity profile. IV. Production/Consumption data for licensing period duly certified by authorized Auditor of the firm. V.||

Case No.	Case No.	16 / NC/3/MEET/Mar/202425/18	16 / NC/3/MEET/Mar/202425/18	16 / NC/3/MEET/Mar/202425/18	16 / NC/3/MEET/Mar/202425/18	16 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00001639AM25
RA File Number		092404000511 AM18
Licence No and Date		0910066144/12/04/2018
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>PENICILLIN G<br>POTASSIUM FIRST<br>CRYSTAL<br>1.375 kg.<br>2<br>ACETONE<br>1.971 kg.<br>3<br>ISOPROPYL ALCOHOL<br>0.66 kg.<br>4<br>METHYLENE<br>CHLORIDE(MDC)<br>3.29 kg.<br>GCLE(7-PHENYL ACETAMIDEO-<br>3-CHLOROMETHYL-<br>CEPHALOSPORANIC ACID PARA-<br>METHOXY BENZYL ESTER)<br>1 kg.
	Export Product		Qty.	Sl.<br>No.	Import Items	**Qty.

29 kg. GCLE(7-PHENYL ACETAMIDEO- 3-CHLOROMETHYL- CEPHALOSPORANIC ACID PARA- METHOXY BENZYL ESTER) 1 kg.||||||| ||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|1.375 kg.| |||||2|ACETONE|1.971 kg.| |||||3|ISOPROPYL ALCOHOL|0.66 kg.| |||||4|METHYLENE CHLORIDE(MDC)|3.29 kg.|

Case No.	Case No.	16 / NC/3/MEET/Mar/202425/18	16 / NC/3/MEET/Mar/202425/18	16 / NC/3/MEET/Mar/202425/18	16 / NC/3/MEET/Mar/202425/18	16 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00001639AM25
RA File Number		092404000511 AM18
Licence No and Date		0910066144/12/04/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 PENICILLIN G POTASSIUM FIRST CRYSTAL 1.375 kg. 2 ACETONE 1.971 kg. 3 ISOPROPYL ALCOHOL 0.66 kg. 4 METHYLENE CHLORIDE(MDC) 3.29 kg. GCLE(7-PHENYL ACETAMIDEO- 3-CHLOROMETHYL- CEPHALOSPORANIC ACID PARA- METHOXY BENZYL ESTER) 1 kg.||||||| ||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|1.375 kg.| |||||2|ACETONE|1.971 kg.| |||||3|ISOPROPYL ALCOHOL|0.66 kg.| |||||4|METHYLENE CHLORIDE(MDC)|3.29 kg.|

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	5	2 MERCAPTO BENZO	0.511 kg.
		THIAZOLE(MBT)
	6	METHANOL	1.971 kg.

tally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0** 12 43 .

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	5	2 MERCAPTO BENZO	0.511 kg.
		THIAZOLE(MBT)
	6	METHANOL	1.971 kg.

Case No.	Case No.	17 / NC/3/MEET/Mar/202425/18	17 / NC/3/MEET/Mar/202425/18	17 / NC/3/MEET/Mar/202425/18	17 / NC/3/MEET/Mar/202425/18	17 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00001641AM25
RA File Number		092404000608 AM18
Licence No and Date		0910066145/12/04/2018
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>PENICILLIN G<br>POTASSIUM FIRST<br>CRYSTAL<br>1.375 kg.<br>2<br>ACETONE<br>1.971 kg.<br>3<br>ISOPROPYL ALCOHOL<br>0.66 kg.<br>4<br>METHYLENE<br>CHLORIDE(MDC)<br>3.29 kg.<br>5<br>2 -MERCAPTO BENZO<br>THIAZOLE (MBT)<br>0.511 kg.<br>GCLE(7-PHENYL ACETAMIDEO-<br>3-CHLOROMETHYL-<br>CEPHALOSPORANIC ACID PARA-<br>METHOXY BENZYL ESTER)<br>1 kg.<br>6<br>METHANOL<br>1.971 kg.
	Export Product		Qty.	Sl.<br>No.	Import Items	**Qty.

IDEO- 3-CHLOROMETHYL- CEPHALOSPORANIC ACID PARA- METHOXY BENZYL ESTER) 1 kg. 6 METHANOL 1.971 kg.||||||| ||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|1.375 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.|

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Case No.	18 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001640AM25
RA File Number	092404000649 AM18
Licence No and Date	0910066322/11/06/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 PENICILLIN G POTASSIUM FIRST CRYSTAL 1.375 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.||

Case No. 19 / NC/3/MEET/Mar/202425/18

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Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001643AM25
RA File Number	092404000623 AM18
Licence No and Date	0910066323/11/06/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 PENICILLIN G POTASSIUM FIRST CRYSTAL 1.375 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.||

Case No.	20 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001642AM25
RA File Number	092404000137 AM19
Licence No and Date	0910066398/28/06/2018

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Norms Committee Decision:

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

Export Product	Qty.	Sl.<br>No.	Import Items	Qty. allowed.
GCLE(7-PHENYL ACETAMIDEO-<br>3-CHLOROMETHYL-<br>CEPHALOSPORANIC ACID PARA-<br>METHOXY BENZYL ESTER)	1 kg.	1	PENICILLIN G<br>POTASSIUM FIRST<br>CRYSTAL	1.375 kg.
		2	ACETONE	1.971 kg.
		3	ISOPROPYL ALCOHOL	0.66 kg.
		4	METHYLENE<br>CHLORIDE(MDC)	3.29 kg.
		5	2 -MERCAPTO BENZO<br>THIAZOLE (MBT)	0.511 kg.
		6	METHANOL	1.971 kg.

Case No.	21 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001644AM25
RA File Number	092404000065 AM19
Licence No and Date	0910066425/06/07/2018
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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s given below or as applied by the firm, whichever is less:-||

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Export Product	Qty.	Sl.<br>No.	Import Items	Qty. allowed.
GCLE(7-PHENYL ACETAMIDEO-<br>3-CHLOROMETHYL-<br>CEPHALOSPORANIC ACID<br>PARA-METHOXY BENZYL<br>ESTER)	1 kg.	1	PENICILLIN G<br>POTASSIUM FIRST<br>CRYSTAL	1.375 kg.
		2	ACETONE	1.971 kg.
		3	ISOPROPYL ALCOHOL	0.66 kg.
		4	METHYLENE<br>CHLORIDE(MDC)	3.29 kg.
		5	2 -MERCAPTO BENZO<br>THIAZOLE (MBT)	0.511 kg.
		6	METHANOL	1.971 kg.

TAL|1.375 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.|

Case No.	22 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001454AM25
RA File Number	039404000390 AM19
Licence No and<br>Date	0310822723/31/07/2018
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage yield of reaction on molar basis.<br>I.<br>If yield is less than 80% justification for the same.<br>II.<br>Quantity and value of by-product obtained.<br>III.<br>Certificate of Analysis (CoA) of export item with percentage purity and impurity profile.<br>IV.<br>Why export product No. 1 is call as natural when it is made synthetically.<br>V.

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VI. Production/Consumption data for licensing period duly certified by authorized Auditor of the firm.

gned by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0** 17 43 .

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VI. Production/Consumption data for licensing period duly certified by authorized Auditor of the firm.

Case No.	23 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	SHUBHLAXMI INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00002134AM25
RA File Number	082404000267 AM19
Licence No and<br>Date	0810144119/20/12/2018
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete and balanced chemical reactions, showing molecular weight and percentage yield on molar<br>basis.<br>I.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>II.

Case No.	24 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001411AM25
RA File Number	039404000052 AM20
Licence No and<br>Date	0310828561/24/04/2019

| |Meeting Number and Date|NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025| |HQ File Number|HQRNORM REVIW00001411AM25| |RA File Number|039404000052 AM20| |Licence No and Date|0310828561/24/04/2019| |Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Percentage yield of reaction on molar basis. I. If yield is less than 80% justification for the same. II. Quantity and value of by-product obtained. III. Certificate of Analysis (CoA) of export item with percentage purity and impurity profile. IV. Complete technical details as per Annexure to Appendix-4E for chemical products. V. Production/Consumption data for licensing period duly certified by authorized Auditor of the firm. VI.||

Case No.	25 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025

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| |Meeting Number|NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025|

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and Date
HQ File Number	018205000499AM20
RA File Number	039404000373 AM20
Licence No and<br>Date	0310830887/07/08/2019
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Exact chemical name of import and export items.<br>I.<br>Certificate of Analysis (CoA) of import from foreign supplier indicating weight wise percentage<br>composition<br>II.<br>Certificate of Analysis (CoA) of export item.<br>III.<br>Complete technical details as per Annexure to Appendix-4E for chemical products.<br>IV.<br>Production/Consumption data for licensing period duly certified by authorized Auditor of the firm.<br>V.

omplete technical details as per Annexure to Appendix-4E for chemical products. IV. Production/Consumption data for licensing period duly certified by authorized Auditor of the firm. V.||

Case No.	26 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001456AM25
RA File Number	039404000462 AM20
Licence No and<br>Date	0310831524/13/09/2019
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage yield of reaction on molar basis.<br>I.<br>If yield is less than 80% justification for the same.<br>II.<br>Quantity and value of by-product obtained.<br>III.<br>Certificate of Analysis (CoA) of export item with percentage purity and impurity profile.<br>IV.<br>Why export product No. 1 is call as natural when it is made synthetically.<br>V.<br>Complete technical details as per Annexure to Appendix-4E for chemical products.<br>VI.<br>Production/Consumption data for licensing period duly certified by authorized Auditor of the firm.<br>VII.

Case No.	27 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00002103AM25
RA File Number	039404000526 AM20

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Licence No and Date 0310832396/23/10/2019

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:-

Licence No and Date	0310832396/23/10/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ashoxy 5% (100ML VIAL)(Oxytetracycline Hydrochloride Injection 50mg) 1 Number 1 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 10% (100 ML VIAL) (Oxytetracycline Injection 100mg) 1 Number 2 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 20% LA (100 ML VIAL) (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg ) 1 Number 3 PROPYLENE GLYCOL 18.00 gm/Vial Ashiver 1% (100 ML VIAL) (Ivermectin 10 Mg Injection) 1 Number 4 PROPYLENE GLYCOL 104.00 gm/Vial Ashiver 1% (50 ML VIAL) (Ivermectin 10 Mg Injection) 1 Number 5 PROPYLENE GLYCOL 52.00 gm/Vial Ashiver Forte (100 ML VIAL) (Ivermectin 10mg and Clorsulon 100mg Injection) 1 Number 6 PROPYLENE GLYCOL 101.92 gm/Vial Ashienro 10% (100 ML VIAL)(Enrofloxacin Injection 100mg) 1 Number 7 PROPYLENE GLYCOL 10.40 gm/Vial Ashityl 20% (100 ML VIAL)(Tylosin Tartrate injection eq to Tylosin 200mg) 1 Number 8 PROPYLENE GLYCOL 20.80 gm/Vial||

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00mg) 1 Number 8 PROPYLENE GLYCOL 20.80 gm/Vial||

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Case No.	28 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00009300AM24
RA File Number	052404000670 AM20
Licence No and<br>Date	0510413367/17/01/2020
Norms Committee Decision:<br>The Committee considered the 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>Terpineol<br>1 kg.<br>1<br>Gum Terpentine Oil containing Alpha<br>Pinene 82.5%<br>1.95 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Qty. allowed. Terpineol 1 kg. 1 Gum Terpentine Oil containing Alpha Pinene 82.5% 1.95 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	29 / NC/3/MEET/Mar/202425/18	29 / NC/3/MEET/Mar/202425/18	29 / NC/3/MEET/Mar/202425/18	29 / NC/3/MEET/Mar/202425/18	29 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00009301AM24
RA File Number		052404000729 AM20
Licence No and<br>Date		0510413656/19/02/2020
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>Terpineol<br>1 kg.<br>1<br>Gum Terpentine Oil containing Alpha<br>Pinene 82.5%<br>1.95 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Terpineol		1 kg.	1	Gum Terpentine Oil containing Alpha<br>Pinene 82.5%	1.95 kg.

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Gum Terpentine Oil containing Alpha Pinene 82.5%|1.95 kg.|

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Case No.	30 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00009299AM24
RA File Number	052404000071 AM21
Licence No and<br>Date	0510414288/29/05/2020
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>Terpineol<br>1 kg.<br>1<br>Gum Terpentine Oil containing Alpha<br>Pinene 82.5%<br>1.95 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Qty. allowed. Terpineol 1 kg. 1 Gum Terpentine Oil containing Alpha Pinene 82.5% 1.95 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	31 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	SAVLA CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00002129AM25
RA File Number	039504000192 AM21
Licence No and<br>Date	0310837078/08/07/2020
Norms Committee Decision:<br>The committee considered the request of firm for reviewof ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Certificate of Analysis (CoA) of import item indicating percentage purity.<br>1.<br>Copies of the Bill of Entry indicating percentage purity.<br>2.

Case No.	32 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED

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Meeting Number NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025 and Date HQ File Number HQRNORM REVIW00001452AM25 RA File Number 039404000218 AM21 Licence No and 0310837120/09/07/2020 Date Norms Committee Decision:

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

I. Percentage yield of reaction on molar basis.

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

I. Percentage yield of reaction on molar basis.
II. If yield is less than 80% justification for the same.
III. Quantity and value of by-product obtained.
IV. Certificate of Analysis (CoA) of export item with percentage purity and impurity profile.
V. Why export product No. 1 is call as natural when it is made synthetically.
VI. Complete technical details as per Annexure to Appendix-4E for chemical products.
VII. Production/Consumption data for licensing period duly certified by authorized Auditor of the firm.

Case No.	33 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001216AM25
RA File Number	072404000145 AM21
Licence No and<br>Date	0710116940/28/08/2020
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meeting No.NC/3/MEET/Oct/202223/11 dated 31/10/2022 against<br>advance authorization No.0711002507 dated 02/12/2021 , it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. ZINC GLUCONATE - POWDER 1 kg. 1 ZINC GLUCONATE - GRANULAR 1.005 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	Case No.	34 / NC/3/MEET/Mar/202425/18	34 / NC/3/MEET/Mar/202425/18	34 / NC/3/MEET/Mar/202425/18	34 / NC/3/MEET/Mar/202425/18	34 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00002102AM25
RA File Number		039404000571 AM21
Licence No and<br>Date		0310839148/27/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial 1 Number 1 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial 1 Number 2 PROPYLENE GLYCOL 39.52 gm/vial Ashoxy 10% (Oxytetracycline Injection 100mg) 100ml vial 1 Number 3 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 50ml vial 1 Number 4 PROPYLENE GLYCOL 35.256 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial 1 Number 5 PROPYLENE GLYCOL 18.00 gm/Vial Ashiver 1% (Ivermectin 10 Mg Injection) 100ml vial 1 Number 6 PROPYLENE GLYCOL 104.00 gm/Vial Ashiver 1% (Ivermectin 10 Mg Injection) 50ml vial 1 Number 7 PROPYLENE GLYCOL 52.00 gm/Vial Ashiver Forte (Ivermectin 10mg 1 Number 8 PROPYLENE GLYCOL 101.92 gm/Vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

7 PROPYLENE GLYCOL 52.00 gm/Vial Ashiver Forte (Ivermectin 10mg 1 Number 8 PROPYLENE GLYCOL 101.92 gm/Vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial||1 Number|1|PROPYLENE GLYCOL|79.04 gm/Vial| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial|| 1 Number|2|PROPYLENE GLYCOL|39.52 gm/vial| ||Ashoxy 10% (Oxytetracycline Injection 100mg) 100ml vial|| 1 Number|3|PROPYLENE GLYCOL|70.512 gm/Vial| ||Ashoxy 10% (Oxytetracycline Injection 100mg) 50ml vial|| 1 Number|4|PROPYLENE GLYCOL|35.256 gm/Vial| ||Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial|| 1 Number|5|PROPYLENE GLYCOL|18.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection) 100ml vial|| 1 Number|6|PROPYLENE GLYCOL|104.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection) 50ml vial|| 1 Number|7|PROPYLENE GLYCOL|52.00 gm/Vial| ||Ashiver Forte (Ivermectin 10mg||1 Number|8|PROPYLENE GLYCOL|101.92 gm/Vial|

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(Ivermectin 10mg||1 Number|8|PROPYLENE GLYCOL|101.92 gm/Vial|

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and Clorsulon 100mg Injection)<br>100ml vial<br>Ashienro<br>10%<br>(Enrofloxacin<br>Injection 100mg) 100ml vial<br>1 Number<br>9<br>PROPYLENE GLYCOL<br>10.40 gm/Vial<br>Ashityl 20% (Tylosin Tartrate<br>injection eq to Tylosin 200mg)<br>100ml vial<br>1 Number<br>10<br>PROPYLENE GLYCOL<br>20.80 gm/Vial<br>RA concerned may take further necessary action as per above decision of NC.	and Clorsulon 100mg Injection)<br>100ml vial
	Ashienro<br>10%<br>(Enrofloxacin<br>Injection 100mg) 100ml vial	<br>1 Number	9	PROPYLENE GLYCOL	10.40 gm/Vial
	Ashityl 20% (Tylosin Tartrate<br>injection eq to Tylosin 200mg)<br>100ml vial	<br> <br>1 Number	10	PROPYLENE GLYCOL	20.80 gm/Vial

Case No.	Case No.	35 / NC/3/MEET/Mar/202425/18	35 / NC/3/MEET/Mar/202425/18	35 / NC/3/MEET/Mar/202425/18	35 / NC/3/MEET/Mar/202425/18	35 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00002101AM25
RA File Number		03AA04011100 AM22
Licence No and<br>Date		0311003600/06/05/2021
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.

|Licence No and Date||0311003600/06/05/2021||||| |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. Ashoxy 5PCT (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial Ashoxy 5PCT (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial 1 Number 2 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 5PCT (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial 1 Number 3 PROPYLENE GLYCOL 197.60 gm/Vial Ashoxy 5PCT (Oxytetracycline Hydrochloride Injection 50mg) 500ml 1 Number 4 PROPYLENE GLYCOL 395.20 gm/Vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ashoxy 5PCT (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial||1 Number|1|PROPYLENE GLYCOL|39.52 gm/Vial| ||Ashoxy 5PCT (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial|| 1 Number|2|PROPYLENE GLYCOL|79.04 gm/Vial| ||Ashoxy 5PCT (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial|| 1 Number|3|PROPYLENE GLYCOL|197.60 gm/Vial| ||Ashoxy 5PCT (Oxytetracycline Hydrochloride Injection 50mg) 500ml|| 1 Number|4|PROPYLENE GLYCOL|395.20 gm/Vial|

50ml vial|| 1 Number|3|PROPYLENE GLYCOL|197.60 gm/Vial| ||Ashoxy 5PCT (Oxytetracycline Hydrochloride Injection 50mg) 500ml|| 1 Number|4|PROPYLENE GLYCOL|395.20 gm/Vial|

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vial
Ashoxy<br>10PCT<br>(Oxytetracycline<br>Injection 100mg) 50ml vial	<br>1 Number	5	PROPYLENE GLYCOL	35.256 gm/Vial
Ashoxy<br>10PCT<br>(Oxytetracycline<br>Injection 100mg) 100ml vial	<br>1 Number	6	PROPYLENE GLYCOL	70.512 gm/Vial
Ashoxy<br>10PCT<br>(Oxytetracycline<br>Injection 100mg) 250ml vial	<br>1 Number	7	PROPYLENE GLYCOL	176.28 gm/Vial
PAN Ashoxy 3PCT (Oxytetracycline<br>Injection 30mg) 100ml vial	<br>1 Number	8	PROPYLENE GLYCOL	70.512 gm/Vial
Ashoxy 20PCT LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200mg) 50ml vial	<br> <br>1 Number	9	PROPYLENE GLYCOL	9.00 gm/Vial
Ashoxy 20PCT LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200mg) 100ml vial	<br> <br>1 Number	10	PROPYLENE GLYCOL	18.00 gm/Vial
Ashoxy 20PCT LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200mg) 250ml vial	<br> <br>1 Number	11	PROPYLENE GLYCOL	45.00 gm/Vial
Ashiver 1PCT (Ivermectin 10 Mg<br>Injection) 50ml vial((Ivermectin 10<br>Mg Injection) 50ml vial	<br> <br>1 Number	12	PROPYLENE GLYCOL	52.00 gm/Vial
Ashiver 1PCT (Ivermectin 10 Mg<br>Injection) 100ml vial	<br>1 Number	13	PROPYLENE GLYCOL	104.00 gm/Vial

vermectin 10 Mg Injection) 50ml vial| 1 Number|12|PROPYLENE GLYCOL|52.00 gm/Vial| ||Ashiver 1PCT (Ivermectin 10 Mg Injection) 100ml vial| 1 Number|13|PROPYLENE GLYCOL|104.00 gm/Vial| ||Ashiver 1PCT (Ivermectin 10 Mg Injection) 250ml vial| 1 Number|14|PROPYLENE GLYCOL|260.00 gm/Vial| ||Ashiver 1PCT (Ivermectin 10 Mg Injection) 500ml vial| 1 Number|15|PROPYLENE GLYCOL|520.00 gm/Vial| ||Ashiver Forte (Ivermectin 10mg and Clorsulon 100mg Injection) 100ml vial| 1 Number|16|PROPYLENE GLYCOL|101.92 gm/Vial|

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Ashienro<br>10PCT<br>(Enrofloxacin<br>Injection 100mg) 50ml vial<br>1 Number<br>17<br>PROPYLENE GLYCOL<br>5.20 gm/Vial<br>Ashienro<br>10PCT<br>(Enrofloxacin<br>Injection 100mg) 100ml vial<br>1 Number<br>18<br>PROPYLENE GLYCOL<br>10.40 gm/Vial<br>Ashienro<br>10pct<br>(Enrofloxacin<br>Injection 100mg) 250ml vial<br>1 Number<br>19<br>PROPYLENE GLYCOL<br>26.00gm/Vial<br>Ashityl<br>20pct<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 200mg) 100ml<br>vial<br>1 Number<br>20<br>PROPYLENE GLYCOL<br>20.80 gm/Vial<br>Ashityl<br>5PCT<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 50mg) 50ml<br>vial<br>1 Number<br>21<br>PROPYLENE GLYCOL<br>10.40 gm/Vial<br>RA concerned may take further necessary action as per above decision of NC.	Ashienro<br>10PCT<br>(Enrofloxacin<br>Injection 100mg) 50ml vial	<br>1 Number	17	PROPYLENE GLYCOL	5.20 gm/Vial

Ashienro<br>10PCT<br>(Enrofloxacin<br>Injection 100mg) 50ml vial	<br>1 Number	17	PROPYLENE GLYCOL	5.20 gm/Vial
Ashienro<br>10PCT<br>(Enrofloxacin<br>Injection 100mg) 100ml vial	<br>1 Number	18	PROPYLENE GLYCOL	10.40 gm/Vial
Ashienro<br>10pct<br>(Enrofloxacin<br>Injection 100mg) 250ml vial	<br>1 Number	19	PROPYLENE GLYCOL	26.00gm/Vial
Ashityl<br>20pct<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 200mg) 100ml<br>vial	<br> <br>1 Number	20	PROPYLENE GLYCOL	20.80 gm/Vial
Ashityl<br>5PCT<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 50mg) 50ml<br>vial	<br> <br>1 Number	21	PROPYLENE GLYCOL	10.40 gm/Vial

Case No.	Case No.	36 / NC/3/MEET/Mar/202425/18	36 / NC/3/MEET/Mar/202425/18	36 / NC/3/MEET/Mar/202425/18	36 / NC/3/MEET/Mar/202425/18	36 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00003011AM25
RA File Number		03AA04065031 AM22
Licence No and<br>Date		0311006216/17/08/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

eview of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert- butoxycarbonyl)amino)-2-methylpentanoic acid 279.6 kg. 2 L-Valine 170.0 kg. Sacubitril/ Valsartan 500 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Sacubitril/ Valsartan||500 kg.|1|2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert- butoxycarbonyl)amino)-2-methylpentanoic acid|279.6 kg.| |||||2|L-Valine|170.0 kg.|

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3 4-Bromomethyl-2-Cyanobiphenyl 220.0 kg.

Case No.	Case No.	37 / NC/3/MEET/Mar/202425/18	37 / NC/3/MEET/Mar/202425/18	37 / NC/3/MEET/Mar/202425/18	37 / NC/3/MEET/Mar/202425/18	37 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00002096AM25
RA File Number		03AA040112749 AM22
Licence No and<br>Date		0311008637/17/11/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>**Sl.

red the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. TYLOSIN TARTRATE POWDER 100PCT-100GMSACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100PCT) 1 Number 1 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100PCT-500GMSACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100PCT) 1 Number 2 TYLOSIN TARTRATE 505 gm. TYLOSIN TARTRATE POWDER 100PCT-1KG JAR (EACHGRAM CONTAINS TYLOSIN TARTRATE 100PCT 1 Nimner 3 TYLOSIN TARTRATE 1010 gm. TYLOSIN TARTRATE POWDER 99PCT -100GMSACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99PCT) 1 Number 4 TYLOSIN TARTRATE 100 gm.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||TYLOSIN TARTRATE POWDER 100PCT-100GMSACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100PCT)||1 Number|1|TYLOSIN TARTRATE|101 gm.| ||TYLOSIN TARTRATE POWDER 100PCT-500GMSACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100PCT)||1 Number|2|TYLOSIN TARTRATE|505 gm.| ||TYLOSIN TARTRATE POWDER 100PCT-1KG JAR (EACHGRAM CONTAINS TYLOSIN TARTRATE 100PCT||1 Nimner|3|TYLOSIN TARTRATE|1010 gm.| ||TYLOSIN TARTRATE POWDER 99PCT -100GMSACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99PCT)||1 Number|4|TYLOSIN TARTRATE|100 gm.|

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LOSIN TARTRATE 99PCT)||1 Number|4|TYLOSIN TARTRATE|100 gm.|

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TYLOSIN TARTRATE POWDER<br>99PCT -500GMSACHET (EACH<br>GRAM CONTAINS TYLOSIN<br>TARTRATE 99PCT)	1 Number	5	TYLOSIN TARTRATE	500 gm.
TYLOSIN TARTRATE POWDER<br>99PCT -1KG JAR (EACHGRAM<br>CONTAINS TYLOSIN TARTRATE<br>99PCT	1 Number	6	TYLOSIN TARTRATE	1000 gm.
TYLOSIN TARTRATE POWDER<br>20PCT-5GM (EACHGRAM CONTAINS<br>TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 20PCT)	<br>1 Number	7	TYLOSIN TARTRATE	gm.<br>1756.
TYLOSIN TARTRATE POWDER<br>20PCT -100GM (EACHGRAM<br>CONTAINS TYLOSIN TARTRATE EQ.<br>TO TYLOSIN 20PCT)	<br>1 Number	8	TYLOSIN TARTRATE	23.513 gm.
TYLOSIN TARTRATE POWDER<br>20PCT -500GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE EQ.<br>TO TYLOSIN 20PCT)	<br>1 Number	9	TYLOSIN TARTRATE	117.564 gm.
TYLOSIN TARTRATE POWDER<br>20PCT -1KG JAR (EACHGRAM<br>CONTAINS TYLOSIN TARTRATE EQ.<br>TO TYLOSIN 20PCT)	<br>1 Number	10	TYLOSIN TARTRATE	235.128 gm.
TYLOSIN BOLUS 200MG(TYLOSIN<br>BOLUS<br>200MG<br>(EACH<br>BOLUS<br>CONTAINS TYLOSIN 200MG)	<br> <br>1 Number	11	TYLOSIN TARTRATE	204.00 gm.
TYLOSIN INJECTION 5PCT-30<br>ML(TYLOSIN INJECTION 5PCT-30<br>ML (EACH ML CONTAINS TYLOSIN<br>TARTRATE EQ. TO TYLOSIN BASE<br>50MG)	<br>1 Number	12	TYLOSIN TARTRATE	1.833 gm.
TYLOSIN INJECTION 5PCT-50 ML<br>(EACH ML CONTAINS TYLOSIN	1 Number	13	TYLOSIN TARTRATE	3.056 gm.

INS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG)| 1 Number|12|TYLOSIN TARTRATE|1.833 gm.| ||TYLOSIN INJECTION 5PCT-50 ML (EACH ML CONTAINS TYLOSIN|1 Number|13|TYLOSIN TARTRATE|3.056 gm.|

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TARTRATE EQ. TO TYLOSIN BASE
50MG)
TYLOSIN INJECTION 5PCT-100 ML	1 Number	14	TYLOSIN TARTRATE	6.111 gm.
(EACH ML CONTAINS TYLOSIN
TARTRATE EQ. TO TYLOSIN BASE
50MG)
TYLOSIN TARTRATE INJECTION	1 Number	15	TYLOSIN TARTRATE	7.333 gm.
20PCT-30 ML (EACH MLCONTAINS
TYLOSIN TARTRATE EQ. TO
TYLOSIN 200MG)
TYLOSIN TARTRATE INJECTION	1 Number	16	TYLOSIN TARTRATE	12.222 gm.
20PCT-50 ML (EACH ML
CONTAINS TYLOSIN TARTRATE EQ.
TO TYLOSIN 200MG)
TYLOSIN TARTRATE INJECTION	1 Number	17	TYLOSIN TARTRATE	24.444 gm.
20PCT-100 ML (EACH ML
CONTAINS TYLOSIN TARTRATE EQ.
TO TYLOSIN 200MG)

TRATE EQ.||||| |TO TYLOSIN 200MG)||||| |TYLOSIN TARTRATE INJECTION|1 Number|17|TYLOSIN TARTRATE|24.444 gm.| |20PCT-100 ML (EACH ML||||| |CONTAINS TYLOSIN TARTRATE EQ.||||| |TO TYLOSIN 200MG)|||||

Case No.	Case No.	38 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00002091AM25
RA File Number		03AA040123869 AM22
Licence No and<br>Date		0311009212/06/12/2021
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		Qty.	Sl. No.	Import Items	Qty. allowed.

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

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Ashoxy 5% (Oxytetracycline Hydrochloride<br>Injection50mg) 50ml vial	1 Number	1	PROPYLENE GYCOL	39.52 gm/Vial
Ashoxy 5% (Oxytetracycline Hydrochloride<br>Injection50mg) 100ml vial	1 Number	2	PROPYLENE GYCOL	79.04 gm/Vial
Ashoxy 5% (Oxytetracycline Hydrochloride<br>Injection50mg) 250ml vial	1 Number	3	PROPYLENE GYCOL	197.60 gm/Vial
Ashoxy 5% (Oxytetracycline Hydrochloride<br>Injection50mg) 500ml vial	1 Number	4	PROPYLENE GYCOL	395.20 gm/Vial
Ashoxy 10% (Oxytetracycline Injection<br>100mg) 50ml vial	1 Number	5	PROPYLENE GYCOL	35.256 gm/Vial
Ashoxy 10% (Oxytetracycline Injection<br>100mg) 100ml vial	1 Number	6	PROPYLENE GYCOL	70.512 gm/Vial
Ashoxy 10% (Oxytetracycline Injection<br>100mg) 250ml vial	1 Number	7	PROPYLENE GYCOL	176.28 gm/Vial
PAN Ashoxy 3% (Oxytetracycline Injection<br>30mg) 100ml vial	1 Number	8	PROPYLENE GYCOL	70.512 gm/Vial
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline<br>200mg) 50ml vial	<br>1 Number	9	PROPYLENE GYCOL	9.00 gm/Vial
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate Injection eq Oxytetracycline<br>200mg) 100ml vial	1 Number	10	PROPYLENE GYCOL	18.00 gm/Vial
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline<br>200mg) 250ml vial	<br>1 Number	11	PROPYLENE GYCOL	45.00 gm/Vial

vial|1 Number|10|PROPYLENE GYCOL|18.00 gm/Vial| ||Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 250ml vial| 1 Number|11|PROPYLENE GYCOL|45.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection) 50ml vial| 1 Number|12|PROPYLENE GYCOL|52.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection)|1 Number|13|PROPYLENE GYCOL|52.00 gm./Vial|

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	50ml vial


	Ashiver 1% (Iv<br>100ml vial	ermectin 10 Mg Injection)	<br>1 Number	14	PROPYLENE GYCOL	104.00 gm/Vial

	Ahi 1% (I	ti 10 M Iti)	1 Nb	15	PROPYLENE GYCOL	26000 /Vil
	sver ve<br>250ml vial	mecn g njecon	umer			. gma
Ashiver 1% (Ivermectin 10 Mg Injection)<br>500ml vial<br>1 Number<br>16<br>PROPYLENE GYCOL<br>520.00 gm/Vial<br>Ashiver Forte (Ivermectin 10mg and<br>Clorsulon100mgInjection) 100ml vial<br>1 Number<br>17<br>PROPYLENE GYCOL<br>101.92 gm/Vial<br>Ashiver Forte (Ivermectin 10mg and<br>Clorsulon100mgInjection) 100ml vial<br>1 Number<br>18<br>PROPYLENE GYCOL<br>101.92 gm/Vial<br>Ashienro 10 % (Enrofloxacin Injection<br>100mg) 50ml vial<br>1 Number<br>19<br>PROPYLENE GYCOL<br>5.20 gm/Vial<br>Ashienro 10% (Enrofloxacin Injection<br>100mg) 100ml vial<br>1 Number<br>20<br>PROPYLENE GYCOL<br>10.40 gm/Vial<br>Ashienro 10% (Enrofloxacin Injection<br>100mg) 250ml vial<br>1 Number<br>21<br>P

l Ashienro 10% (Enrofloxacin Injection 100mg) 100ml vial 1 Number 20 PROPYLENE GYCOL 10.40 gm/Vial Ashienro 10% (Enrofloxacin Injection 100mg) 250ml vial 1 Number 21 PROPYLENE GYCOL 26.00 gm/Vial Ashityl 20% (Tylosin Tartrate injection eq to Tylosin200mg) 100ml vial 1 Number 22 PROPYLENE GYCOL 20.80 gm/Vial Ashityl 5% (Tylosin Tartrate injection eq to Tylosin50mg)50ml vial 1 Number 23 PROPYLENE GYCOL 10.40 gm/Vial RA d tk fth ti b dii f NC|Ashiver 1% (Ivermectin 10 Mg Injection) 500ml vial||||||1 Number||16||PROPYLENE GYCOL||520.00 gm/Vial| ||Ashiver Forte (Ivermectin 10mg and Clorsulon100mgInjection) 100ml vial||||||1 Number||17||PROPYLENE GYCOL||101.92 gm/Vial| || C|Ashiver Forte (Ivermectin 10mg and lorsulon100mgInjection) 100ml vi|||| al|1 N|umber||18|PROPYLENE GYCOL||101.92 gm/Vial| ||||||||||||||| || 1|Ashienro 10 % (Enrofloxacin Injec 00mg) 50ml vial||||tion|1 N|umber||19|PROPYLENE GYCOL||5.20 gm/Vial| ||||||||||||||| || 1|Ashienro 10% (Enrofloxacin Injecti 00mg) 100ml vial||||on|1 N||||||| |||||||||umber||20|PROPYLENE GYCOL||10.40 gm/Vial| || 1|Ashienro 10% (Enrofloxacin Injecti 00mg) 250ml vial||||on|1 N|umber||21|PROPYLENE GYCOL||26.00 gm/Vial| ||||||||||||||| || T|Ashityl 20% (Tylosin Tartrate inject ylosin200mg) 100ml vial||||ion eq to|1 N|umber||22|PROPYLENE GYCOL||20.80 gm/Vial| ||Ashityl 5% (Tylosin Tartrate injection eq to Tylosin50mg)50ml vial||||||||||||| ||||||||1 N|umber|23||PROPYLENE GYCOL||10.40 gm/Vial|

l||||ion eq to|1 N|umber||22|PROPYLENE GYCOL||20.80 gm/Vial| ||Ashityl 5% (Tylosin Tartrate injection eq to Tylosin50mg)50ml vial||||||||||||| ||||||||1 N|umber|23||PROPYLENE GYCOL||10.40 gm/Vial| |concerne may ae urer necessary acon as per aove ecson o .|||||||||||||| ||||||||||||||| ||||||||||||||| |Case No.|||||39 / NC/3/MEET/Mar/202425/18||||||||| |Case Status|||||Case Approved||||||||| |Party Name|||||SAINOR LABORATORIES PRIVATE LIMITED||||||||| |Meeting Number and Date|||||NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025||||||||| ||||||||||||||| |HQ File Number|||||HQRNORM REVIW00002222AM25||||||||| ||||||||||||||| |RA File Number|||||09AX04000389 AM22||||||||| ||||||||||||||| |Licence No and Date|||||0911002926/29/04/2022||||||||| ||||||||||||||| |||||||||||||||

Case No.	39 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00002222AM25
RA File Number	09AX04000389 AM22
Licence No and Date	0911002926/29/04/2022

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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	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
LiHMDS	<br>1.0M	IN	<br>1 Litre	1	LITHIUM METAL 98 % MIN	0.01 kg
TETRAHYDROFURAN
(CLEAR	YELLOW	TO		2	HEXAMETHYL DISILAZANE	0.2367 kg.
BROWN	COLOR LIQUID)
				3	TETRAHYDROFURAN	0.712 kg
				4	ISOPRENE	0.0508 kg

Case No.	40 / NC/3/MEET/Mar/202425/18	40 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number and	Date NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00002223AM25
RA File Number	09AX04000388 AM22
Licence No and Date	0911002925/29/04/2022
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	Qty.	Sl. No.	Import Items	**Qty.

iew of ad-hoc norms and on||the basis of|| |information provided by the firm, it was decided to revise ad-hoc norms as under:-||||||| |Export Product|Qty.||Sl. No.|Import Items|Qty. allowed.|| |LiHMDS|1.0M IN 1 Litre||1|LITHIUM METAL 98 % MIN|0.01 kg|| |TETRAHYDROFURAN||||||| |(CLEAR YELLOW TO|||2|HEXAMETHYL DISILAZANE|0.2367 kg.|| |BROWN COLOR LIQUID)||||||| ||||3|TETRAHYDROFURAN|0.712 kg|| ||||4|ISOPRENE|0.0508 kg|| |RA concerned may|take further necessary action as per above decision of NC.||||||

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Case No.	41 / NC/3/MEET/Mar/202425/18	41 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number and	Date NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00002226AM25
RA File Number	09AX04000372 AM22
Licence No and Date	0911002924/29/04/2022
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	Qty.	Sl. No.	Import Items	**Qty.

Case No.	42 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001406AM25
RA File Number	03AX04000821 AM23
Licence No and<br>Date	0311015467/13/06/2022
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the
TE, it was decided to call for following information/documents from the firm:-
Percentage yield of reaction on molar basis.<br>I.
If yield is less than 80% justification for the same.<br>II.
Quantity and value of by-product obtained.<br>III.
Certificate of Analysis (CoA) of export item with percentage purity and impurity profile.<br>IV.

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ort item with percentage purity and impurity profile. IV.||

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V. Why export product No. 1 is call as natural when it is made synthetically. VI. Complete technical details as per Annexure to Appendix-4E for chemical products. VII. Production/Consumption data for licensing period duly certified by authorized Auditor of the firm.

Case No.	43 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00001455AM25
RA File Number	03AX04002522 AM23
Licence No and<br>Date	0311017151/12/08/2022
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms and on the basis
of information	provided by the firm and it has been observed by the committee that item of export
appears to be perfumery compoundcomes under para 4.11(b) of FTP, 2023, and the said para states that
“For export of	perfumes, perfumery compounds and various feed ingredients containing vitamins, no
authorisation shall be issued by Regional Authority under para 4.07 of HBP and applicants shall be
required to apply under para 4.06 of HBP to the Norms Committee”.
Accordingly, it was decided that a clarification in this regard may be obtained from the firm as well as RA.

ants shall be|| |required to apply under para 4.06 of HBP to the Norms Committee”.|| |Accordingly, it was decided that a clarification in this regard may be obtained from the firm as well as RA.||

Case No.<br>44 / NC/3/MEET/Mar/202425/18
Case Status<br>Case Deferred
Party Name<br>ASSOCIATED DYESTUFF PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number<br>HQRNORM REVIW00001845AM25
RA File Number<br>08AX04001207 AM23
Licence No and<br>Date<br>0811006504/22/11/2022
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the
TE, it was decided to call for following information/documents from the firm:-
Chemistry starting from Acetanilide to formation of end product giving molecular weight of all the<br>1.
reactant and product.
Yield of reaction and reason for low yield, if any.<br>2.
End use of Export product<br>3.

Case No.	45 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved

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NC/3/MEET/Mar/202425/18| |---|---| |Case Status|Case Approved|

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Party Name	AMI ORGANICS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00006136AM24
RA File Number	52AX04001711 AM23
Licence No and Date	5211003710/07/12/2022
Norms Committee Decision:<br>The representative of the firm attended personal hearing through Video Conference and explains their<br>case. The Committee heard the explanation of the firm and after due deliberation it was decided to fix the<br>norms 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>Triphenylphosphine<br>1.237 kg.<br>2<br>Tert-Butyl((1S)-2-hydroxy-1-<br>methylethyl)carbamate<br>(DARO-IV)<br>0.826 kg.<br>3<br>(S)-4-(1-(2-aminopropyl)-1H-<br>pyrazol-3-yl)-2-chlorobenzonitrile<br>(DARO-V)<br>0.001 kg.<br>4<br>2-chloro-4-(1H-pyrazol-3-<br>yl)benzonitrile (DARO-III)<br>0.963 kg.<br>4-{1-[(2S)-2-Aminopropyl]-1-H-<br>Pyrazole-3-yl}-2-<br>Chlorobenzonitrile<br>1 kg.<br>5<br>Diisopropyl azodicarboxylate<br>(DIAD)<br>1.034 kg.<br>RA concerned may take further necessary action as per above decision of NC.

-H- Pyrazole-3-yl}-2- Chlorobenzonitrile 1 kg. 5 Diisopropyl azodicarboxylate (DIAD) 1.034 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	46 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00000068AM24
RA File Number	09AX04001155 AM23
Licence No and<br>Date	0911004801/10/04/2023
Norms Committee Decision:

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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:-

s less:-
Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Tetanus Antitoxin I.H.S / B.P	1,00,000	1	Tetanus Antitoxin 2500 I.U / ml	69.3 Liter
1500 IU / ML Plus [overage of	Vials
150 IU in addition] in PFS / vials /
Ampoule) [733333 Vials]

anus Antitoxin I.H.S / B.P|1,00,000|1|Tetanus Antitoxin 2500 I.U / ml|69.3 Liter| |1500 IU / ML Plus [overage of|Vials|||| |150 IU in addition] in PFS / vials /||||| |Ampoule) [733333 Vials]|||||

Case No.<br>47 / NC/3/MEET/Mar/202425/18	Case No.<br>47 / NC/3/MEET/Mar/202425/18
Case Status<br>Case Approved
Party Name<br>NEULAND LABORATORIES LTD.
Meeting Number and Date<br>NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number<br>HQRNORM REVIW00003637AM25
RA File Number<br>09AX04000067 AM24
Licence No and Date<br>0911004910/28/04/2023
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-
hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever
is less:-
Export Product	Qty.	Sl.	Import Items	Qty.
		No.		allowed.
Benzyl	1 kg.	1	ENFUMAFUNGIN	2.086 kg.
(1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR) -3-
hydrazineyl-2-hydroxy-1,6a,8,10a-tetramethyl-8-
((R)-3-methylbutan. (-2-yl)- 1, 3, 4, 6, 6a, 7, 8, 9,
10, 10a,10b,11,12,12a-tetradecahydro-2H-1,4a-
(methanooxymethano) chrysene-7-carboxylate
(Drug Intermediate of Ibrexafungerp Citrate))
RA concerned may take further necessary action as per above decision			of NC.

Case No. 48 / NC/3/MEET/Mar/202425/18

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sary action as per above decision|||of NC.|||

Case No. 48 / NC/3/MEET/Mar/202425/18

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Case Status<br>Case Approved
Party Name<br>NEULAND LABORATORIES LTD.
Meeting Number and Date<br>NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number<br>HQRNORM REVIW00003635AM25
RA File Number<br>09AX04000052 AM24
Licence No and Date<br>0911004957/03/05/2023
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-
hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever
is less:-
Export Product	Qty.	Sl.	Import Items	Qty.
		No.		allowed.
Benzyl	1 kg.	1	ENFUMAFUNGIN	2.086 kg.
(1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR) -3-
hydrazineyl-2-hydroxy-1,6a,8,10a-tetramethyl-8-
((R)-3-methylbutan. (-2-yl)- 1, 3, 4, 6, 6a, 7, 8, 9,
10, 10a,10b,11,12,12a-tetradecahydro-2H-1,4a-
(methanooxymethano) chrysene-7-carboxylate
(Drug Intermediate of Ibrexafungerp Citrate))
RA concerned may take further necessary action as per above decision			of NC.

1,4a-|||||| |(methanooxymethano) chrysene-7-carboxylate|||||| |(Drug Intermediate of Ibrexafungerp Citrate))|||||| |RA concerned may take further necessary action as per above decision|||of NC.|||

Case No.	Case No.	49 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		NEULAND LABORATORIES LTD.
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00003638AM25
RA File Number		09AX04000149 AM24
Licence No and Date		0911005088/22/05/2023
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-
hoc norms under Para 4.07		of HBP Vol. I as per details given below or as applied by the firm, whichever
is less:-
	Export Product	Qty.	Sl.	Import Items	Qty.
			No.		allowed.
	Benzyl	1 kg.	1	ENFUMAFUNGIN	2.086 kg.
	(1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR) -3-

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hydrazineyl-2-hydroxy-1,6a,8,10a-tetramethyl-8((R)-3-methylbutan. (-2-yl)- 1, 3, 4, 6, 6a, 7, 8, 9, 10, 10a,10b,11,12,12a-tetradecahydro-2H-1,4a(methanooxymethano) chrysene-7-carboxylate (Drug Intermediate of Ibrexafungerp Citrate))

ramethyl-8((R)-3-methylbutan. (-2-yl)- 1, 3, 4, 6, 6a, 7, 8, 9, 10, 10a,10b,11,12,12a-tetradecahydro-2H-1,4a(methanooxymethano) chrysene-7-carboxylate (Drug Intermediate of Ibrexafungerp Citrate))

Case No.	50 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00003640AM25
RA File Number	09AX04000170 AM24
Licence No and Date	0911005122/26/05/2023
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:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>Benzyl<br>(1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR) -3-<br>hydrazineyl-2-hydroxy-1,6a,8,10a-tetramethyl-8-<br>((R)-3-methylbutan. (-2-yl)- 1, 3, 4, 6, 6a, 7, 8, 9,<br>10, 10a,10b,11,12,12a-tetradecahydro-2H-1,4a-<br>(methanooxymethano) chrysene-7-carboxylate<br>(Drug Intermediate of Ibrexafungerp Citrate))<br>1 kg.<br>1<br>ENFUMAFUNGIN<br>2.086 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No.	51 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00001348AM24
RA File Number	08AX04000333 AM24
Licence No and Date	0811008323/06/06/2023
Norms Committee Decision:

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s less:-
Export Product	Qty.	Sl.	Import Items	Qty. allowed.
		No.
NORELGESTROMIN AND	1 Patch	1	NORELGESTROMIN USP	5.8475 mg/ Patch
ETHINYL ESTRADIOL
TRANSDERMAL SYSTEM<br>150/35 MCG PER DAY((EACH		2	ETHINYL ESTRADIOL USP	0.6625 mg/ Patch
15.75 CM2 PATCH CONTAINS:
NORELGESTROMIN USP 4.678
MG TO PROVIDE
NORELGESTROMIN 150
MCG/DAY & ETHINYL
ESTRADIOL USP 0.53 MG TO
PROVIDE ETHINYL
ESTRADIOL 35 MCG/DAY))

ONTAINS:||||| |NORELGESTROMIN USP 4.678||||| |MG TO PROVIDE||||| |NORELGESTROMIN 150||||| |MCG/DAY & ETHINYL||||| |ESTRADIOL USP 0.53 MG TO||||| |PROVIDE ETHINYL||||| |ESTRADIOL 35 MCG/DAY))|||||

Case No.	52 / NC/3/MEET/Mar/202425/18
Case Status	Case Rejected
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00002105AM25
RA File Number	07AX04000371 AM24
Licence No and<br>Date	0711008304/19/06/2023
Norms Committee Decision:
The Committee	considered the request of firm for review of ad-hoc norms and it was observed that the
firm has not provided any technical justification / information for enhancement. Hence, it was decided to
reject the case maintaining the status quo.

Case No.	53 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00002092AM25
RA File Number	03AX04001845 AM24

This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 40 43 .

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This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 40 43 .

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Licence No and<br>Date	Licence No and<br>Date	0311025665/24/07/2023	0311025665/24/07/2023	0311025665/24/07/2023	0311025665/24/07/2023	0311025665/24/07/2023
Norms Committee		Decision:

The Committee<br>hoc norms unde<br>		considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-<br>r Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever
is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Ashoxy<br>5%<br>(Oxytetracycline<br>Hydrochloride Injection 50mg) 50ml<br>vial<br>1 Number<br>1<br>PROPYLENE GLYCOL<br>39.52 gm/Vial<br>Ashoxy<br>5%<br>(Oxytetracycline<br> <br>1 Number<br>2<br>PROPYLENE GLYCOL<br>79.04 gm/Vial
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

OL 39.52 gm/Vial Ashoxy 5% (Oxytetracycline 1 Number 2 PROPYLENE GLYCOL 79.04 gm/Vial||||||||||||| ||Export Product||||Qty.||Sl. No.||Import Items||Qty. allowed.|| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial|||| 1 Number||1||PROPYLENE GLYCOL||39.52 gm/Vial|| ||Ashoxy 5% (Oxytetracycline |||| 1 Number||2||PROPYLENE GLYCOL||79.04 gm/Vial|| ||Hydrochloride Injection 50mg) 100ml il|||||||||||| ||va|||||||||||| |||||||||||||| ||Ashoxy 5% (O |||xytetracycline | 1 Number||3||PROPYLENE GLYCOL||197.60 gm/Vial|| ||Hydrochloride Injection |||50mg) 250ml||||||||| ||vial|||||||||||| |||||||||||||| |||||||||||||| ||Ashoxy 5% (O |||xytetracycline | 1 Number||4||PROPYLENE GLYCOL||395.20 gm/Vial|| ||Hydrochloride Injection 50mg) 500ml vial|||||||||||| ||A I|shoxy 10% (Oxytetracycline njection 100mg) 50ml vial||| 1 Number||5||PROPYLENE GLYCOL||35.256 gm/Vial|| ||A I|shoxy 10% (Oxytetracycline njection 100mg) 100ml vial||| 1 N|umber||6||PROPYLENE GLYCOL|7|0.512 gm/Vial| ||A I|||||||||||| |||shoxy 10% (Oxytetracycline njection 100mg) 250ml vial||| 1 N|umber||7||PROPYLENE GLYCOL|1|76.28 gm/Vial| ||P I|AN Ashoxy 3% (Oxytetracycline njection 30mg) 100ml vial||| 1 N|umber||8||PROPYLENE GLYCOL|7|0.512 gm/Vial| |||||||||||||| ||A D O|shoxy 20% LA (Oxytetracycline ihydrate Injection eq xytetracycline 200mg) 50ml vial||| 1 N|umber|||||||

N|umber||8||PROPYLENE GLYCOL|7|0.512 gm/Vial| |||||||||||||| ||A D O|shoxy 20% LA (Oxytetracycline ihydrate Injection eq xytetracycline 200mg) 50ml vial||| 1 N|umber||||||| |||||||||9||PROPYLENE GLYCOL||9.00 gm/Vial| |||||||||||||| ||A|shoxy 20% LA (Oxytetracycline||| 1 N|umber||10||PROPYLENE GLYCOL|1|8.00 gm/Vial|

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Dihydrate Injection eqOxytetracycline<br>200mg) 100ml vial
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200mg) 250ml vial	<br> <br>1 Number	11	PROPYLENE GLYCOL	45.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 10ml viaL	<br>1 Number	12	PROPYLENE GLYCOL	10.40 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 50ml vial	<br>1 Number	13	PROPYLENE GLYCOL	52.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 100ml vial	<br>1 Number	14	PROPYLENE GLYCOL	104.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 250ml vial	<br>1 Number	15	PROPYLENE GLYCOL	260.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 500ml vial	<br>1 Number	16	PROPYLENE GLYCOL	520.00 gm/Vial
Ashiver Forte (Ivermectin 10mg and<br>Clorsulon 100mg Injection) 50ml viaL	<br>1 Number	17	PROPYLENE GLYCOL	50.96 gm/Vial
Ashiver Forte (Ivermectin 10mg and<br>Clorsulon 100mg Injection) 100ml<br>vial	<br> <br>1 Number	18	PROPYLENE GLYCOL	101.92 gm/Vial

ction) 50ml viaL| 1 Number|17|PROPYLENE GLYCOL|50.96 gm/Vial| ||Ashiver Forte (Ivermectin 10mg and Clorsulon 100mg Injection) 100ml vial| 1 Number|18|PROPYLENE GLYCOL|101.92 gm/Vial| ||Ashienro 10% (Enrofloxacin Injection 100mg) 50ml vial| 1 Number|19|PROPYLENE GLYCOL|5.20 gm/Vial| ||Ashienro 10% (Enrofloxacin Injection 100mg) 100ml vial| 1 Number|20|PROPYLENE GLYCOL|10.40 gm/Vial| ||Ashienro 10% (Enrofloxacin Injection 100mg) 250ml vial| 1 Number|21|PROPYLENE GLYCOL|26.00 gm/Vial| ||Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial| 1 Number|22|PROPYLENE GLYCOL|20.80 gm/Vial|

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Ashityl<br>20%<br>(Tylosin<br>Tartrate	<br>1 Number	23	PROPYLENE GLYCOL	20.80 gm/Vial
injection eq to Tylosin 200mg) 100ml
vial
Ashityl<br>20%<br>(Tylosin<br>Tartrate	<br>1 Number	24	PROPYLENE GLYCOL	20.80 gm/Vial
injection eq to Tylosin 200mg) 100ml
vial
Ashityl 5% (Tylosin Tartrate injection	<br>1 Number	25	PROPYLENE GLYCOL	10.40 gm/Vial
eq to Tylosin 50mg) 50ml vial
Ashital 10% (Closantel 10% Inj)	<br>1 Number	26	PROPYLENE GLYCOL	55.12 gm/Vial
100ml vial

ate injection| 1 Number|25|PROPYLENE GLYCOL|10.40 gm/Vial| |eq to Tylosin 50mg) 50ml vial||||| |Ashital 10% (Closantel 10% Inj)| 1 Number|26|PROPYLENE GLYCOL|55.12 gm/Vial| |100ml vial|||||

	Ashityl<br>20%<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 200mg) 100ml<br>vial	Ashityl<br>20%<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 200mg) 100ml<br>vial	Ashityl<br>20%<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 200mg) 100ml<br>vial	Ashityl<br>20%<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 200mg) 100ml<br>vial	<br> <br>1 Number	<br> <br>1 Number	23	PROPYLENE GLYCOL	20.80 gm/Vial


	Ashityl<br>20%<br>(Tylo			sin<br>Tartrate	<br>1 Number		24	PROPYLENE GLYCOL	20.80 gm/Vial
	injection eq to Tylosin<br>			200mg) 100ml
	vial


	Ashityl 5% (Tylosin Ta			rtrate injection	<br>1 Number		25	PROPYLENE GLYCOL	10.40 gm/Vial
	eq to Tylosin 50mg) 50			ml vial


Ashital 10% (Closantel 10% Inj)<br>100ml vial<br>1 Number<br>26<br>PROPYLENE GLYCOL<br>55.12 gm/Vial<br>RA concerned may take further necessary action as per above decision of NC.	Ashital 10% (Closantel 10% Inj)<br>100ml vial				<br>1 Number		26	PROPYLENE GLYCOL	55.12 gm/Vial
		A concerned may take further necessary action as per above decision of NC.


Cas		e No.	54 / NC/3/MEET/Mar/20242			5/18
Cas		e Status	Case Approved

erned may take further necessary action as per above decision of NC.||||||||||| |||||||||||||| |||||||||||||| |Cas||e No.|54 / NC/3/MEET/Mar/20242||||5/18|||||| |Cas||e Status|Case Approved|||||||||| |Par||ty Name|ASHISH LIFE SCIENCE PR||||IVATE LI||MITED|||| |Me and||eting Number Date|NC/ 3/ MEET/ Mar/ 202425/||||18 and 17||/03/2025|||| |HQ||File Number|HQRNORM REVIW000020||||97AM25|||||| |RA||File Number|03AX04001847 AM24|||||||||| |Lic Dat||ence No and e|0311025741/25/07/2023|||||||||| |||||||||||||| |Norms Committee Decision: The Committee considered the request of firm for fixation hoc norms under Para 4.07 of HBP Vol. I as per details giv is less:- Export Product Qty. Sl. No. TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATEEQ. TO TYLOSIN BASE 50MG) 1 Number 2||ms Committee Decision: e Committee considered the request of c norms under Para 4.07 of HBP Vol. I less:-|||||firm for f as per det|||||| ||||||||||ixation ails giv|of ad-hoc norms and it was dec en below or as applied by the fi||ided to fix ad- rm, whichever| |||||||||||||| ||E|xport Product|||||Qty.||Sl. No.|Import Items||Qty. allowed.| |||||||||||||| ||T B 2|YLOSIN BOLUS 200MG (EACH OLUS CONTAINS TYLOSIN 00MG)|||| 1 N|umber||1|TYLOSIN TARTRATE||204.00 gm.| |||||||||||||| ||TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATEEQ.

OLUS 200MG (EACH OLUS CONTAINS TYLOSIN 00MG)|||| 1 N|umber||1|TYLOSIN TARTRATE||204.00 gm.| |||||||||||||| ||TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATEEQ. TO TYLOSIN BASE 50MG)|||||||||||| |||||||1 Number||2||TYLOSIN TARTRATE|3.056 gm.|| |||||||||||||| ||TYLOSIN INJECTION|||5%-100 ML||1 Number||3||TYLOSIN TARTRATE|6.111 gm.|| ||||||||||||||

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(EACH ML CONTAINS TYLOSIN<br>TARTRATE EQ. TO TYLOSIN BASE<br>50MG)
TYLOSIN TARTRATE INJECTION<br>20%-50 ML (EACH MLCONTAINS<br>TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 200MG)	1 Number	4	TYLOSIN TARTRATE	12.222 gm.
TYLOSIN TARTRATE INJECTION<br>20%-100 ML (EACH MLCONTAINS<br>TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 200MG	1 Number	5	TYLOSIN TARTRATE	24.444 gm.
TYLOSIN TARTRATE POWDER<br>100%-100GM SACHET (EACH<br>GRAM CONTAINS TYLOSIN<br>TARTRATE 100%)	1 Number	6	TYLOSIN TARTRATE	101 gm.
TYLOSIN TARTRATE POWDER<br>100% -500GM SACHET(EACH<br>GRAM CONTAINS TYLOSIN<br>TARTRATE 100%)	1 Number	7	TYLOSIN TARTRATE	505 gm.
TYLOSIN TARTRATE POWDER<br>100% -1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>100%)	<br>1 Number	8	TYLOSIN TARTRATE	1010 gm.
TYLOSIN TARTRATE POWDER<br>20%-5GM (EACH GRAM<br>CONTAINSTYLOSIN TARTRATE<br>EQ. TO TYLOSIN 20%)	1 Number	9	TYLOSIN TARTRATE	1.1756 gm.
TYLOSIN TARTRATE POWDER<br>20% -100GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>EQ.

br>20%-5GM (EACH GRAM CONTAINSTYLOSIN TARTRATE EQ. TO TYLOSIN 20%)|1 Number|9|TYLOSIN TARTRATE|1.1756 gm.| ||TYLOSIN TARTRATE POWDER 20% -100GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%)| 1 Number|10|TYLOSIN TARTRATE|23.513 gm.| ||TYLOSIN TARTRATE POWDER 20% -500GM (EACH GRAM CONTAINS TYLOSIN TARTRATE| 1 Number|11|TYLOSIN TARTRATE|117.564 gm.|

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EQ. TO TYLOSIN 20%)
TYLOSIN TARTRATE POWDER	1 Number	12	TYLOSIN TARTRATE	235.128 gm.
20% -1KG JAR (EACH GRAM
CONTAINS TYLOSIN TARTRATE
EQ. TO TYLOSIN 20%)
TYLOSIN TARTRATE POWDER	1 Number	13	TYLOSIN TARTRATE	100 gm.
99% -100GM SACHET(EACH
GRAM CONTAINS TYLOSIN
TARTRATE 99%)
TYLOSIN TARTRATE POWDER	1 Number	14	TYLOSIN TARTRATE	500 gm.
99% -500GM SACHET(EACH
GRAM CONTAINS TYLOSIN
TARTRATE 99%)
TYLOSIN TARTRATE POWDER	1Number	15	TYLOSIN TARTRATE	1000 gm
99% -1KG JAR (EACH GRAM
CONTAINS TYLOSIN TARTRATE
99%)

ET(EACH||||| |GRAM CONTAINS TYLOSIN||||| |TARTRATE 99%)||||| |TYLOSIN TARTRATE POWDER|1Number|15|TYLOSIN TARTRATE|1000 gm| |99% -1KG JAR (EACH GRAM||||| |CONTAINS TYLOSIN TARTRATE||||| |99%)|||||

Case No.	Case No.	55 / NC/3/MEET/Mar/202425/18	55 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM REVIW00002098AM25
RA File Number		03AX04001846 AM24
Licence No and<br>Date		0311025742/25/07/2023
Norms Committee Decision:
The Committee considered the request of firm for				fixation	of ad-hoc norms and it was decided to fix ad-
hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever
is less:-
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	TYLOSIN BOLUS 200MG (EACH		1 Number	1	TYLOSIN TARTRATE	204.00 gm.

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IN BOLUS 200MG (EACH||1 Number|1|TYLOSIN TARTRATE|204.00 gm.||

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B<br>2	OLUS<br>CONTAINS<br>TYLOSIN<br>00MG)
T<br>(<br>T<br>	YLOSIN INJECTION 5%-50 ML<br>EACH ML CONTAINS TYLOSIN<br>ARTRATE EQ. TO TYLOSIN<br>BASE 50MG)	1 N	umber	2	TYLOSIN TARTRATE	3.056 gm.

T<br>(<br>T<br>B	YLOSIN INJECTION 5%-100 ML<br>EACH ML CONTAINS TYLOSIN<br>ARTRATE<br>EQ.<br>TO<br>TYLOSIN<br>ASE 50MG)	<br>1 N	umber	3	TYLOSIN TARTRATE	6.111 gm.


T<br>2<br>T<br>T	YLOSIN TARTRATE INJECTION<br>0%-50 ML (EACH ML CONTAINS<br>YLOSIN TARTRATE EQ. TO<br>YLOSIN 200MG)	1 N	umber	4	TYLOSIN TARTRATE	12.222 gm.

TYLOSIN TARTRATE INJECTION<br>20%-100 ML (EACH ML<br>CONTAINS TYLOSIN TARTRATE<br>EQ.

CONTAINS YLOSIN TARTRATE EQ. TO YLOSIN 200MG)||1 N|umber||4||TYLOSIN TARTRATE||12.222 gm.| ||||||||||||| ||TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG|YLOSIN TARTRATE INJECTION 0%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE||1 N|umber||||||| ||||||||5||TYLOSIN TARTRATE||24.444 gm.| ||||||||||||| ||TYLOSIN TARTRATE POWDER |||1 Number||6||TYLOSIN TARTRATE||101 gm.|| ||100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN||||||||||| || TARTRATE 10|| 0%)||||||||| ||||||||||||| ||||||||||||| ||TYLOSIN TAR 100% -500GM ||TRATE POWDER SACHET (EACH |1 Number||7||TYLOSIN TARTRATE||505 gm.|| ||GRAM CONT TARTRATE 10||INS TYLOSIN 0%)||||||||| ||||||||||||| ||TYLOSIN TAR||TRATE POWDER|1 Number||8||TYLOSIN TARTRATE||1010 gm.|| ||100% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%)||||||||||| ||TYLOSIN TARTRATE POWDER 20%-5GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%)|||1 Number||9||TYLOSIN TARTRATE||1.1756 gm.|| |||||||||||||

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%)|||1 Number||9||TYLOSIN TARTRATE||1.1756 gm.|| |||||||||||||

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TYLOSIN TARTRATE POWDER<br>20% -100GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN 20%)<br>1 Number<br>10<br>TYLOSIN TARTRATE<br>23.513 gm.<br>TYLOSIN TARTRATE POWDER<br>20% -500GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN 20%)<br>1 Number<br>11<br>TYLOSIN TARTRATE<br>117.564 gm.<br>TYLOSIN TARTRATE POWDER<br>20% -1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN 20%)<br>1 Number<br>12<br>TYLOSIN TARTRATE<br>235.128 gm.<br>TYLOSIN TARTRATE POWDER<br>99% -100GM SACHET (EACH<br>GRAM CONTAINS TYLOSIN<br>TARTRATE 99%)<br>1 Number<br>13<br>TYLOSIN TARTRATE<br>100 gm.<br>TYLOSIN TARTRATE POWDER<br>99% -500GM SACHET (EACH<br>GRAM CONTAINS TYLOSIN<br>TARTRATE 99%)<br>1 Number<br>14<br>TYLOSIN TARTRATE<br>500 gm.<br>TYLOSIN TARTRATE POWDER<br>99% -1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>99%)<br>1 Number<br>15<br>TYLOSIN TARTRATE<br>1000 gm.<br>RA concerned may take further necessary action as per above decision of NC.	TYLOSIN TARTRATE POWDER<br>20% -100GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN 20%)	<br>1 Number	10	TYLOSIN TARTRATE	23.513 gm.
	TYLOSIN TARTRATE POWDER<br>20% -500GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN 20%)	<br>1 Number	11	TYLOSIN TARTRATE	117.564 gm.
	TYLOSIN TARTRATE POWDER<br>20% -1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>EQ.

M (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%)| 1 Number|11|TYLOSIN TARTRATE|117.564 gm.| ||TYLOSIN TARTRATE POWDER 20% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%)| 1 Number|12|TYLOSIN TARTRATE|235.128 gm.| ||TYLOSIN TARTRATE POWDER 99% -100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%)|1 Number|13|TYLOSIN TARTRATE|100 gm.| ||TYLOSIN TARTRATE POWDER 99% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%)|1 Number|14|TYLOSIN TARTRATE|500 gm.| ||TYLOSIN TARTRATE POWDER 99% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%)| 1 Number|15|TYLOSIN TARTRATE|1000 gm.|

Case No.	56 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM REVIW00002093AM25
RA File Number	03AX04002632 AM24
Licence No and<br>Date	0311027028/12/09/2023
Norms Committee Decision:

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nd Date|0311027028/12/09/2023| |Norms Committee Decision:||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 47 43 .

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The Committee<br>		considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-<br>
hoc norms unde<br>		r 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.
	Ashoxy<br>5%<br>(Oxytetracycline<br>Hydrochloride Injection 50mg) 50ml<br>vial		<br> <br>1 Number	1	PROPYLENE GLYCOL	39.52 gm/Vial
	Ashoxy<br>5%<br>(Oxytetracycline<br>Hydrochloride Injection 50mg) 100ml<br>vial		<br> <br>1 Number	2	PROPYLENE GLYCOL	79.04 gm/Vial

	Ashoxy<br>5%<br>(Oxytetracycline		<br>1 Number	3	PROPYLENE GLYCOL	197.60 gm/Vial
	Hydrochloride I<br>	njection 50mg) 250ml
	vial


	Ashoxy<br>5%<br>Hydrochloride I	<br>(Oxytetracycline<br>njection 50mg) 500ml	<br> <br>1 Number	4	PROPYLENE GLYCOL	395.20 gm/Vial
	vial


	Ashoxy<br>10%<br>Injection 100mg	<br>(Oxytetracycline<br>) 50ml vial	<br>1 Number	5	PROPYLENE GLYCOL	35.256 gm/Vial

	Ashoxy<br>10%<br>(Oxytetracycline<br>Injection 100mg) 100ml vial		<br>1 Number	6	PROPYLENE GLYCOL	70.512 gm/Vial
	Ashoxy<br>10%<br>(Oxytetracycline<br>Injection 100mg) 250ml vial		<br>1 Number	7	PROPYLENE GLYCOL	176.28 gm/Vial

e Injection 100mg) 100ml vial||| 1 Number|6|PROPYLENE GLYCOL|70.512 gm/Vial| ||Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial||| 1 Number|7|PROPYLENE GLYCOL|176.28 gm/Vial| ||PAN Ashoxy 3% (Oxytetracycline Injection 30mg) 100ml vial||| 1 Number|8|PROPYLENE GLYCOL|70.512 gm/Vial| ||Ah 20% LA Ottli||| 1 Nb|9|PROPYLENE GLYCOL|900 /Vil| ||soxy (xyeracycne Dihdrate Injection e||| umer|||. gma| ||y Oxytetracycline 200mg|| q ) 50ml vial||||| ||||||||| ||||| |||| ||Ashoxy 20% LA ( Dihydrate Injec Oli 200||xytetracycline tion eq 100l il| 1 Number|10|PROPYLENE GLYCOL|18.00 gm/Vial| ||xytetracycne mg||) m va||||| |||||||||

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Ashoxy 20% LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200mg) 250ml vial	<br> <br>1 Number	11	PROPYLENE GLYCOL	45.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 10ml viaL	<br>1 Number	12	PROPYLENE GLYCOL	10.40 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 50ml vial	<br>1 Number	13	PROPYLENE GLYCOL	52.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 100ml vial	<br>1 Number	14	PROPYLENE GLYCOL	104.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 250ml vial	<br>1 Number	15	PROPYLENE GLYCOL	260.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 500ml vial	<br>1 Number	16	PROPYLENE GLYCOL	520.00 gm/Vial

1% (Ivermectin 10 Mg Injection) 250ml vial| 1 Number|15|PROPYLENE GLYCOL|260.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection) 500ml vial| 1 Number|16|PROPYLENE GLYCOL|520.00 gm/Vial| ||Ashiver Forte (Ivermectin 10mg and Clorsulon 100mg Injection) 50ml viaL| 1 Number|17|PROPYLENE GLYCOL|50.96 gm/Vial| ||Ashiver Forte (Ivermectin 10mg and Clorsulon 100mg Injection) 100ml vial| 1 Number|18|PROPYLENE GLYCOL|101.92 gm/Vial| ||Ashienro 10% (Enrofloxacin Injection 100mg) 50ml vial| 1 Number|19|PROPYLENE GLYCOL|5.20 gm/Vial| ||Ashienro 10% (Enrofloxacin Injection 100mg) 100ml vial| 1 Number|20|PROPYLENE GLYCOL|10.40 gm/Vial| ||Ashienro 10% (Enrofloxacin Injection 100mg) 250ml vial| 1 Number|21|PROPYLENE GLYCOL|26.00 gm/Vial| ||Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial| 1 Number|22|PROPYLENE GLYCOL|20.80 gm.Vial| ||Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml| 1 Number|23|PROPYLENE GLYCOL|20.80 gm/Vial|

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This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 49 43 .

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vial
Ashityl<br>20%<br>(Tylosin<br>Tartrate	<br>1 Number	24	PROPYLENE GLYCOL	20.80 gm/Vial
injection eq to Tylosin 200mg) 100ml
vial
Ashityl 5% (Tylosin Tartrate injection	<br>1 Number	25	PROPYLENE GLYCOL	10.40 gm/Vial
eq to Tylosin 50mg) 50ml vial
Ashital 10% (Closantel 10% Inj)	<br>1 Number	26	PROPYLENE GLYCOL	55.12 gm/Vial
100ml vial

	vial	vial	vial	vial	vial
	<br> <br> <br>					<br>
	Ashityl<br>20%<br>		(Tylosin<br>Tartrate<br>			<br> <br>1 Number		24	PROPYLENE GLYCOL	20.80 gm/Vial
	injection eq to T<br>il		ylosin 200mg) 100ml
	va
	Ashityl 5% (Tyl		osin Tartrate injection			<br>1 Number		25	PROPYLENE GLYCOL	10.40 gm/Vial
	eq to Tylosin 50		mg) 50ml vial


	Ashital 10% (<br>100ml vial		Closantel 10% Inj)			<br>1 Number		26	PROPYLENE GLYCOL	55.12 gm/Vial
RA concerned may take further necessary action as per above decision of NC.

Cas		e No.	57 / NC/	3/MEET/Ma	r/202425/18
Cas		e Status	Case Ap	proved
Par
		y Name	ASHIS	LIFE SCIE	NCE PRIV		TE LIMITED
Me<br>and		eting Number<br>Date	NC/ 3/ M	EET/ Mar/	202425/ 18 a		nd 17/03/2025
HQ		File Number	HQRNO	RM REVIW	00002094A		M25

|||||||||| |||y Name|ASHIS|LIFE SCIE|NCE PRIV||TE LIMITED||||| |Me and||eting Number Date|NC/ 3/ M|EET/ Mar/|202425/ 18 a||nd 17/03/2025||||| |HQ||File Number|HQRNO|RM REVIW|00002094A||M25||||| |RA||File Number|03AX04002741 AM24||||||||| |Licence No and D|||0311027160/15/09/2023||||||||| |ate|||||||||||| ||||||||||||| |Norms Committee|||ecision:||||||||| |The Committee|||considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-||||||||| |hoc norms unde|||r Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever||||||||| |is less:-|||||||||||| ||E Pd|||||||Sl N|I I|lld|| ||xport rouc|||||Qty.||. o.|mport tems|Qty. aowe.|| ||Ashoxy 5%|| (Oxytetracycline||| 1 Number||1|PROPYLENE GLYCOL|39.52 gm/Vial|| ||Hydrochloride Injection 50mg) 50ml vial||||||||||| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial||||| 1 Number||2|PROPYLENE GLYCOL|79.04 gm/Vial|| |||ydrochloride Injection ial||50mg) 100m|l||||||| ||A H v|shoxy 5% (O ydrochloride Injection ial||xytetracyclin 50mg) 250m|e l| 1 Numb|er|3|PROPYLENE GLYCOL||197.60 gm/Vial| |||||||||||||

r>ial||50mg) 100m|l||||||| ||A H v|shoxy 5% (O ydrochloride Injection ial||xytetracyclin 50mg) 250m|e l| 1 Numb|er|3|PROPYLENE GLYCOL||197.60 gm/Vial| |||||||||||||

	vial	vial	vial	vial	vial
	<br> <br> <br>					<br>
	Ashityl<br>20%<br>		(Tylosin<br>Tartrate<br>			<br> <br>1 Number		24	PROPYLENE GLYCOL	20.80 gm/Vial
	injection eq to T<br>il		ylosin 200mg) 100ml
	va
	Ashityl 5% (Tyl		osin Tartrate injection			<br>1 Number		25	PROPYLENE GLYCOL	10.40 gm/Vial
	eq to Tylosin 50		mg) 50ml vial


	Ashital 10% (<br>100ml vial		Closantel 10% Inj)			<br>1 Number		26	PROPYLENE GLYCOL	55.12 gm/Vial
RA concerned may take further necessary action as per above decision of NC.

Cas		e No.	57 / NC/	3/MEET/Ma	r/202425/18
Cas		e Status	Case Ap	proved
Par
		y Name	ASHIS	LIFE SCIE	NCE PRIV		TE LIMITED
Me<br>and		eting Number<br>Date	NC/ 3/ M	EET/ Mar/	202425/ 18 a		nd 17/03/2025
HQ		File Number	HQRNO	RM REVIW	00002094A		M25
RA		File Number	03AX04002741 AM24
Licence No and<br>D			0311027160/15/09/2023
ate

Norms Committee			ecision:
The Committee			considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-
hoc norms unde			r Para 4.07 of HBP Vol.

|||| |Norms Committee|||ecision:||||||||| |The Committee|||considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-||||||||| |hoc norms unde|||r Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever||||||||| |is less:-|||||||||||| ||E Pd|||||||Sl N|I I|lld|| ||xport rouc|||||Qty.||. o.|mport tems|Qty. aowe.|| ||Ashoxy 5%|| (Oxytetracycline||| 1 Number||1|PROPYLENE GLYCOL|39.52 gm/Vial|| ||Hydrochloride Injection 50mg) 50ml vial||||||||||| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial||||| 1 Number||2|PROPYLENE GLYCOL|79.04 gm/Vial|| |||ydrochloride Injection ial||50mg) 100m|l||||||| ||A H v|shoxy 5% (O ydrochloride Injection ial||xytetracyclin 50mg) 250m|e l| 1 Numb|er|3|PROPYLENE GLYCOL||197.60 gm/Vial| |||||||||||||

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br>1 Numb|er|3|PROPYLENE GLYCOL||197.60 gm/Vial| |||||||||||||

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Ashoxy<br>5%<br>(Oxytetracycline<br>Hydrochloride Injection 50mg) 500ml	Ashoxy<br>5%<br>(Oxytetracycline<br>Hydrochloride Injection 50mg) 500ml	Ashoxy<br>5%<br>(Oxytetracycline<br>Hydrochloride Injection 50mg) 500ml	Ashoxy<br>5%<br>(Oxytetracycline<br>Hydrochloride Injection 50mg) 500ml	Ashoxy<br>5%<br>(Oxytetracycline<br>Hydrochloride Injection 50mg) 500ml	<br> <br>1 Number	<br> <br>1 Number	4	PROPYLENE GLYCOL	395.20 gm/Vial	395.20 gm/Vial
<br>vial

Ah<br>10		<br>(Ottli			<br>1 Nb		5	PROPYLENE GLYCOL	35256 /Vil
soxy<br> <br>Injection 100mg		<br>xyeracycne<br>) 50ml vial			<br>umer				. gma


Ashoxy<br>10%<br>		<br>(Oxytetracycline<br>			<br>1 Number		6	PROPYLENE GLYCOL	70.512 gm/Vial
Injection 100mg		) 100ml vial

Ashoxy<br>10%		<br>(Oxytetracycline			<br>1 Number		7	PROPYLENE GLYCOL	176.28 gm/Vial
<br> <br>Injection 100mg) 250ml vial
PAN Ashoxy 3% (Oxytetracycline<br>Injection 30mg) 100ml vial					<br>1 Number		8	PROPYLENE GLYCOL	70.512 gm/Vial

A<br>D<br>O	shoxy 20% LA (O		xytetracyclin	e	<br>1 Numb	er	9	PROPYLENE GLYCOL		9.00 gm/Vial
	ihydrate<br>Injecti<br>xytetracycline 200mg)		on<br>e<br>50ml vial	q

2 gm/Vial|| ||||||||||||| ||A D O|shoxy 20% LA (O||xytetracyclin|e| 1 Numb|er|9|PROPYLENE GLYCOL||9.00 gm/Vial| |||ihydrate Injecti xytetracycline 200mg)||on e 50ml vial|q||||||| ||Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial||||| |||||| ||||||| 1 Number||10|PROPYLENE GLYCOL|18.00 gm/Vial|| ||||||||||||| ||||||||||||| ||Ashox 20%||LA (Oxtetraccline||| 1 Number||11|PROPYLENE GLYCOL|4500 m/Vial|| ||y Dihydrate||yy Injection eq||| ||||. g|| || Oxytetracycline|| 200mg) 250ml vial||||||||| ||||||||||||| ||||||| |||||| ||Ashiver 1% Iti 10l||Ivermectin 10 Mg iL||| 1 Number||12|PROPYLENE GLYCOL|10.40 gm/Vial|| ||njecon) m||a||||||||| ||Ashiver 1%||(Ivermectin 10 Mg||| 1 Number||13|PROPYLENE GLYCOL|52.00 gm/Vial|| ||Injection) 50ml vial||||||||||| ||Ashiver 1% (Ivermectin 10 Mg Injection) 100ml vial||||| 1 Number||14|PROPYLENE GLYCOL|104.00 gm/Vial|| ||Ashiver 1% (Ivermectin 10 Mg Injection) 250ml vial||||| 1 Number||15|PROPYLENE GLYCOL|260.00 gm/Vial|| ||||||||||||| ||||||||||||| ||Ashiver 1% ||(Ivermectin 10 Mg ||| 1 Number||16|PROPYLENE GLYCOL|520.00 gm/Vial|| ||Injection) 500ml||vial||||||||| |||||||||||||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 51 43 .

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0.00 gm/Vial|| ||Injection) 500ml||vial||||||||| |||||||||||||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 51 43 .

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Ashiver Forte (	Ivermectin 10mg and	<br>1 Number	17	PROPYLENE GLYCOL	50.96 gm/Vial
Clorsulon 100<br>	mg Injection) 50ml
viaL

Ashiver Forte (	Ivermectin 10mg and	<br>1 Number	18	PROPYLENE GLYCOL	101.92 gm/Vial
Clorsulon 100mg Injection) 100ml<br>vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 50ml vial		<br>1 Number	19	PROPYLENE GLYCOL	5.20 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 100ml vial		<br>1 Number	20	PROPYLENE GLYCOL	10.40 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 250ml vial		<br>1 Number	21	PROPYLENE GLYCOL	26.00 gm/Vial


Ashityl<br>20%	(Tylosin<br>Tartrate	<br>1 Number	22	PROPYLENE GLYCOL	20.80 gm/Vial
<br>injection eq to T	<br>ylosin 200mg) 100ml
vial

Ashitl<br>20%	(Tlosin<br>Tartrate	<br>1 Number	23	PROPYLENE GLYCOL	2080 m/Vial
y<br> <br>injection eq to T	y<br> <br>ylosin 200mg) 100ml	<br> <br>			.

||||| ||vial|||||||||| |||||||||||| ||Ashitl 20%|(Tlosin Tartrate|| 1 Number||23||PROPYLENE GLYCOL||2080 m/Vial| ||y injection eq to T|y ylosin 200mg) 100ml|| ||||||. g| || vial|||||||||| |||||||||||| || | || ||||||| |R|Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial||| 1 Number||24||PROPYLENE GLYCOL||20.80 gm/Vial| ||Ashityl 5% (Tylosin Tartrate injection eq to Tylosin 50mg) 50ml vial||| 1 Number||25||PROPYLENE GLYCOL||10.40 gm/Vial| ||Ashital 10% (Closantel 10% Inj)||| 1 Number||26||PROPYLENE GLYCOL||55.12 gm/Vial| || 100ml vial||| ||||||| |||||||||||| ||A concerned may take furthe||r necessar||y action as||per above decision of NC.|||| |||||||||||| |C|ase No|58 / NC/3/ME|ET/Mar/20||425/18|||||| ||.|||||||||| |C|ase Status|Case Approved||||||||| |P|arty Name|AARTI INDUSTRIES LTD||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025||||||||| |||||||||||| |HQFile Number||HQRNORM APPLY 00006252AM24|||||||||

Case No.	58 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	AARTI INDUSTRIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQFile Number	HQRNORM APPLY 00006252AM24

This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 52 43 .

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18 and 17/03/2025| |HQFile Number|HQRNORM APPLY 00006252AM24|

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RA File Number	RA File Number	03AX04003081 AM24	03AX04003081 AM24	03AX04003081 AM24	03AX04003081 AM24	03AX04003081 AM24
Licence No and<br>Date		0311027889/14/10/2023
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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>1<br>META DICHLORO BENZENE<br>1.23 kg.<br>2<br>POTTASSIUM FLUORIDE (KF)<br>0.91 kg.<br>2,4 DIFLUORO NITRO BENZENE<br>(2,4 DFNB)<br>1 kg.<br>3<br>SULFOLANE ANHYDROUS<br>0.10 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	2,4 DIFLUORO NITRO BENZENE<br>(2,4 DFNB)		1 kg.	1	META DICHLORO BENZENE	1.23 kg.
				2	POTTASSIUM FLUORIDE (KF)	0.91 kg.
				3	SULFOLANE ANHYDROUS	0.10 kg.
				per above decision of NC.

||2,4 DIFLUORO NITRO BENZENE (2,4 DFNB)||1 kg.|1|META DICHLORO BENZENE|1.23 kg.| |||||2|POTTASSIUM FLUORIDE (KF)|0.91 kg.| |||||3|SULFOLANE ANHYDROUS|0.10 kg.| |||||per above decision of NC.|||

Case No.	59 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006295AM24
RA File Number	03AX04003186 AM24
Licence No and<br>Date	0311027939/17/10/2023
Norms Committee Decision:<br>Committee considered the request of firm for fixation of ad-hoc norms and on the basis of information<br>provided by the firm and it has been observed by the committee that item of export appears to be<br>perfumery compound comes under para 4.11(b) of FTP, 2023, and the said para<br>states that “For export of perfumes, perfumery compounds and various feed ingredients containing<br>vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP and applicants<br>shall be required to apply under para 4.06 of HBP to the Norms Committee”.<br>Accordingly, it was decided that a clarification in this regard may be obtained from the firm as well as RA.

Case No.	60 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	VIDACARE MEDICA PRIVATE LIMITED

This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 53 43 .

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This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 53 43 .

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Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006329AM24
RA File Number	03AX04003293 AM24
Licence No and<br>Date	0311028015/18/10/2023
Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Nov/202425/10 dated 22/11/2024 against advance authorization No. 0311031320 dated 19/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006329AM24
RA File Number	03AX04003293 AM24
Licence No and<br>Date	0311028015/18/10/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same expor<br>product/import item in meeting No. NC/3/MEET/Nov/202425/10 dated 22/11/2024 against advanc<br>authorization No. 0311031320 dated 19/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of HB<br>Vol.

t/import item in meeting No. NC/3/MEET/Nov/202425/10 dated 22/11/2024 against advanc authorization No. 0311031320 dated 19/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of HB Vol. I as per details given below or as applied by the firm, whichever is less:-|||||| |Export Product||Qty.|Sl. No.|Import Item|Qty. allowed| |TETRACYCLLINE HCL CAPSULE BP 250 MG EACH CAPSULE CONTAINS TETRACYCLLINE HCL BP 250MG 200000 X 10 X 10 C)||1 Number|1|TETRACYCLINE HCL BP/USP/EP|255 mg.| |DEVITHRO 500 TABLETS ERYTHROMYCIN STEARATE TABLETS BP 500 MG EACH FILM COATED TABLET CONTAINS ERYTHROMYCIN STEARATE BP ( 693.789 MG) EQ. TO ERYTHROMYCIN BP 500 MG 35000 X 10 X 10 T)|| 1 Number|2|ERYTHROMYCIN STEARATE BP/USP/EP|510 mg.| |DEVITHRO 250 TABLETS ERYTHROMYCIN STEARATE TABLETS BP 250 MG EACH FILM COATED TABLET CONTAINS ERYTHROMYCIN STEARATE BP (346.89 MG) EQ. TO ERYTHROMYCIN BP 250 MG 45310 X 10 X 10 T)||1 Number|3|ERYTHROMYCIN STEARATE BP/USP/EP|255 mg.| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	61 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	SWISS PARENTERALS LIMITED

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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. Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial 1 Number 2 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial 1 Number 3 PROPYLENE GLYCOL 197.60 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 500ml vial 1 Number 4 PROPYLENE GLYCOL 395.20 gm/Vial Ashoxy 10% (Oxytetracycline 1 Number 5 PROPYLENE GLYCOL 35.256 gm/Vial||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial|| 1 Number|1|PROPYLENE GLYCOL|39.52 gm/Vial| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial|| 1 Number|2|PROPYLENE GLYCOL|79.04 gm/Vial| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial|| 1 Number|3|PROPYLENE GLYCOL|197.60 gm/Vial| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 500ml vial|| 1 Number|4|PROPYLENE GLYCOL|395.20 gm/Vial| ||Ashoxy 10% (Oxytetracycline||1 Number|5|PROPYLENE GLYCOL|35.256 gm/Vial|

xytetracycline Hydrochloride Injection 50mg) 500ml vial|| 1 Number|4|PROPYLENE GLYCOL|395.20 gm/Vial| ||Ashoxy 10% (Oxytetracycline||1 Number|5|PROPYLENE GLYCOL|35.256 gm/Vial|

This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 66 43 .

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Injection 100mg) 50ml vial
Ashoxy<br>10%<br>(Oxytetracycline<br>Injection 100mg) 100ml vial	<br>1 Number	6	PROPYLENE GLYCOL	70.512 gm/Vial
Ashoxy<br>10%<br>(Oxytetracycline<br>Injection 100mg) 250ml vial	<br>1 Number	7	PROPYLENE GLYCOL	176.28 gm/Vial
PAN Ashoxy 3% (Oxytetracycline<br>Injection 30mg) 100ml vial	<br>1 Number	8	PROPYLENE GLYCOL	70.512 gm/Vial
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200mg) 50ml vial	<br> <br>1 Number	9	PROPYLENE GLYCOL	9.00 gm/Vial
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200mg) 100ml vial	<br> <br>1 Number	10	PROPYLENE GLYCOL	18.00 gm/Vial
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200mg) 250ml vial	<br> <br>1 Number	11	PROPYLENE GLYCOL	45.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 10ml viaL	<br>1 Number	12	PROPYLENE GLYCOL	10.40 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 50ml vial	<br>1 Number	13	PROPYLENE GLYCOL	52.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 100ml vial	<br>1 Number	14	PROPYLENE GLYCOL	104.00 gm/Vial

r 1% (Ivermectin 10 Mg Injection) 50ml vial| 1 Number|13|PROPYLENE GLYCOL|52.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection) 100ml vial| 1 Number|14|PROPYLENE GLYCOL|104.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection) 250ml vial| 1 Number|15|PROPYLENE GLYCOL|260.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection) 500ml vial| 1 Number|16|PROPYLENE GLYCOL|520.00 gm/Vial| ||Ashiver Forte (Ivermectin 10mg and Clorsulon 100mg Injection) 50ml viaL| 1 Number|17|PROPYLENE GLYCOL|50.96 gm/Vial|

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|Ashiver Forte (Ivermectin 10mg and Clorsulon 100mg Injection) 100ml vial 1 Number 18 PROPYLENE GLYCOL 101.92 gm/Vial Ashienro 10% (Enrofloxacin Injection 100mg) 50ml vial 1 Number 19 PROPYLENE GLYCOL 5.20 gm/Vial Ashienro 10% (Enrofloxacin Injection 100mg) 100ml vial 1 Number 20 PROPYLENE GLYCOL 10.40 gm/Vial Ashienro 10% (Enrofloxacin Injection 100mg) 250ml vial 1 Number 21 PROPYLENE GLYCOL 26.00 gm/Vial Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial 1 Number 22 PROPYLENE GLYCOL 20.80 gm/Vial Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial 1 Number 23 PROPYLENE GLYCOL 20.80 gm/Vial Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial 1 Number 24 PROPYLENE GLYCOL 20.80 gm/Vial

Ashiver Forte (Ivermectin 10mg and<br>Clorsulon 100mg Injection) 100ml<br>vial	<br> <br>1 Number	18	PROPYLENE GLYCOL	101.92 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 50ml vial	<br>1 Number	19	PROPYLENE GLYCOL	5.20 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 100ml vial	<br>1 Number	20	PROPYLENE GLYCOL	10.40 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 250ml vial	<br>1 Number	21	PROPYLENE GLYCOL	26.00 gm/Vial
Ashityl<br>20%<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 200mg) 100ml<br>vial	<br> <br>1 Number	22	PROPYLENE GLYCOL	20.80 gm/Vial
Ashityl<br>20%<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 200mg) 100ml<br>vial	<br> <br>1 Number	23	PROPYLENE GLYCOL	20.80 gm/Vial
Ashityl<br>20%<br>(Tylosin<br>Tartrate<br>injection eq to Tylosin 200mg) 100ml<br>vial	<br> <br>1 Number	24	PROPYLENE GLYCOL	20.80 gm/Vial
Ashityl 5% (Tylosin Tartrate injection<br>eq to Tylosin 50mg) 50ml vial	<br>1 Number	25	PROPYLENE GLYCOL	10.40 gm/Vial

sin 200mg) 100ml vial| 1 Number|24|PROPYLENE GLYCOL|20.80 gm/Vial| ||Ashityl 5% (Tylosin Tartrate injection eq to Tylosin 50mg) 50ml vial| 1 Number|25|PROPYLENE GLYCOL|10.40 gm/Vial| ||Ashital 10% (Closantel 10% Inj) 100ml vial| 1 Number|26|PROPYLENE GLYCOL|55.12 gm/Vial|

Case No.	77 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006591AM24
RA File Number	03AX04003361 AM24
Licence No and	0311028403/02/11/2023

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Date

Norms Committee Decision:

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:-

Date	Date
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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>TYLOSIN BOLUS 200MG(TYLOSIN BOLUS<br>200MG<br>(EACH<br>BOLUS<br>CONTAINS<br>TYLOSIN 200MG)<br>1 Number<br>1<br>TYLOSIN TARTRATE<br>204.00 gm.<br>TYLOSIN INJECTION 5%-50 ML (TYLOSIN<br>INJECTION 5%-50 ML (EACH ML<br>CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN BASE 50MG)<br>1 Number<br>2<br>TYLOSIN TARTRATE<br>3.056 gm.<br>TYLOSIN INJECTION 5%-100 ML<br>(TYLOSIN INJECTION 5%-100 ML (EACH<br>ML CONTAINS TYLOSIN TARTRATE EQ.<br>TO TYLOSIN BASE 50MG)<br>1 Number<br>3<br>TYLOSIN TARTRATE<br>6.111 gm.<br>TYLOSIN TARTRATE INJECTION 20%-50<br>ML(TYLOSIN TARTRATE INJECTION<br>20%-50 ML (EACH ML CONTAINS<br>TYLOSIN TARTRATE EQ. TO TYLOSIN<br>200MG)<br>1 Number<br>4<br>TYLOSIN TARTRATE<br>12.222 gm.<br>TYLOSIN TARTRATE INJECTION 20%-100<br>ML(TYLOSIN TARTRATE INJECTION<br>20%-100 ML (EACH ML<br>CONTAINS TYLOSIN TARTRATE EQ.

TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 5 TYLOSIN TARTRATE 24.444 gm. TYLOSIN TARTRATE POWDER 100%- 100GM SACHET(TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 6 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100% - 500GM SACHET(TYLOSIN TARTRATE 1 Number 7 TYLOSIN TARTRATE 505 gm.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||TYLOSIN BOLUS 200MG(TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG)|| 1 Number|1|TYLOSIN TARTRATE|204.00 gm.| ||TYLOSIN INJECTION 5%-50 ML (TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG)|| 1 Number|2|TYLOSIN TARTRATE|3.056 gm.| ||TYLOSIN INJECTION 5%-100 ML (TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG)||1 Number|3|TYLOSIN TARTRATE|6.111 gm.| ||TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG)||1 Number|4|TYLOSIN TARTRATE|12.222 gm.| ||TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ.

ARTRATE EQ. TO TYLOSIN 200MG)||1 Number|4|TYLOSIN TARTRATE|12.222 gm.| ||TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG)|| 1 Number|5|TYLOSIN TARTRATE|24.444 gm.| ||TYLOSIN TARTRATE POWDER 100%- 100GM SACHET(TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%)|| 1 Number|6|TYLOSIN TARTRATE|101 gm.| ||TYLOSIN TARTRATE POWDER 100% - 500GM SACHET(TYLOSIN TARTRATE||1 Number|7|TYLOSIN TARTRATE|505 gm.|

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POWDER 100% -500GM SACHET<br>(EACH<br>GRAM<br>CONTAINS<br>TYLOSIN<br>TARTRATE 100%)
TYLOSIN TARTRATE POWDER 100% -<br>1KG JAR(TYLOSIN TARTRATE POWDER<br>100% -1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE 100%)	1 Number	8	TYLOSIN TARTRATE	1010 gm.
TYLOSIN TARTRATE POWDER 20%-5GM<br>(TYLOSIN TARTRATE POWDER 20%-5GM<br>(EACH GRAM CONTAINS<br>TYLOSIN TARTRATE EQ. TO TYLOSIN<br>20%)	<br>1 Number	9	TYLOSIN TARTRATE	1.1756 gm.
TYLOSIN TARTRATE POWDER 20% -<br>100GM (TYLOSIN TARTRATE POWDER<br>20% -100GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 20%)	<br>1 Number	10	TYLOSIN TARTRATE	23.513 gm.
TYLOSIN TARTRATE POWDER 20% -<br>500GM (TYLOSIN TARTRATE POWDER<br>20% -500GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE EQ.

ARTRATE EQ. TO TYLOSIN 20%)| 1 Number|10|TYLOSIN TARTRATE|23.513 gm.| ||TYLOSIN TARTRATE POWDER 20% - 500GM (TYLOSIN TARTRATE POWDER 20% -500GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%)| 1 Number|11|TYLOSIN TARTRATE|117.564 gm.| ||TYLOSIN TARTRATE POWDER 20% -1KG JAR (TYLOSIN TARTRATE POWDER 20% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%)| 1 Number|12|TYLOSIN TARTRATE|235.128 gm.| ||TYLOSIN TARTRATE POWDER 99% - 100GM SACHET(TYLOSIN TARTRATE POWDER 99% -100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%)| 1 Number|13|TYLOSIN TARTRATE|100 gm.| ||TYLOSIN TARTRATE POWDER 99% -|1 Number|14|TYLOSIN TARTRATE|500 gm.|

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500GM SACHET(TYLOSIN TARTRATE<br>POWDER 99% -500GM SACHET (EACH<br>GRAM CONTAINS TYLOSIN TARTRATE<br>99%)<br>TYLOSIN TARTRATE POWDER 99% -1KG<br>JAR(TYLOSIN TARTRATE POWDER 99% -<br>1KG JAR (EACH GRAM CONTAINS<br>TYLOSIN TARTRATE 99%)<br>1 Number<br>15<br>TYLOSIN TARTRATE<br>1000 gm<br>RA concerned may take further necessary action as per above decision of NC.	500GM SACHET(TYLOSIN TARTRATE<br>POWDER 99% -500GM SACHET (EACH<br>GRAM CONTAINS TYLOSIN TARTRATE<br>99%)
	TYLOSIN TARTRATE POWDER 99% -1KG<br>JAR(TYLOSIN TARTRATE POWDER 99% -<br>1KG JAR (EACH GRAM CONTAINS<br>TYLOSIN TARTRATE 99%)	1 Number	15	TYLOSIN TARTRATE	1000 gm

||| |---|---|---|---|---|---| ||TYLOSIN TARTRATE POWDER 99% -1KG JAR(TYLOSIN TARTRATE POWDER 99% - 1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%)|1 Number|15|TYLOSIN TARTRATE|1000 gm|

Case No.	Case No.	78 / NC/3/MEET/Mar/202425/18	78 / NC/3/MEET/Mar/202425/18	78 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM APPLY 00006592AM24
RA File Number		03AX04003362 AM24
Licence No and<br>Date		0311028404/02/11/2023
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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>TYLOSIN BOLUS 200MG(TYLOSIN BOLUS<br>200MG<br>(EACH<br>BOLUS<br>CONTAINS<br>TYLOSIN 200MG)<br>1 Number<br>1<br>TYLOSIN TARTRATE<br>204.00 gm.<br>TYLOSIN INJECTION 5%-50 ML (TYLOSIN<br>INJECTION 5%-50 ML (EACH ML<br>CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN BASE 50MG)<br>1 Number<br>2<br>TYLOSIN TARTRATE<br>3.056 gm.<br>TYLOSIN INJECTION 5%-100 ML<br>(TYLOSIN INJECTION 5%-100 ML (EACH<br>ML CONTAINS TYLOSIN TARTRATE EQ.<br>TO TYLOSIN BASE 50MG)<br>1 Number<br>3<br>TYLOSIN TARTRATE<br>6.111 gm.
	Export Product		Qty.	**Sl.

100 ML (TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||TYLOSIN BOLUS 200MG(TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG)|| 1 Number|1|TYLOSIN TARTRATE|204.00 gm.| ||TYLOSIN INJECTION 5%-50 ML (TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG)|| 1 Number|2|TYLOSIN TARTRATE|3.056 gm.| ||TYLOSIN INJECTION 5%-100 ML (TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG)||1 Number|3|TYLOSIN TARTRATE|6.111 gm.|

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	TYLOSIN TARTRATE INJECTION 20%-50<br>ML(TYLOSIN TARTRATE INJECTION<br>20%-50 ML (EACH ML CONTAINS<br>TYLOSIN TARTRATE EQ. TO TYLOSIN<br>200MG)	1 Number	4	TYLOSIN TARTRATE	12.222 gm.
	TYLOSIN TARTRATE INJECTION 20%-100<br>ML(TYLOSIN TARTRATE INJECTION<br>20%-100 ML (EACH ML<br>CONTAINS TYLOSIN TARTRATE EQ.

200MG)|1 Number|4|TYLOSIN TARTRATE|12.222 gm.| |---|---|---|---|---|---| ||TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG)| 1 Number|5|TYLOSIN TARTRATE|24.444 gm.| ||TYLOSIN TARTRATE POWDER 100%- 100GM SACHET(TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%)| 1 Number|6|TYLOSIN TARTRATE|101 gm.| ||TYLOSIN TARTRATE POWDER 100% - 500GM SACHET(TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%)| 1 Number|7|TYLOSIN TARTRATE|505 gm.| ||TYLOSIN TARTRATE POWDER 100% - 1KG JAR(TYLOSIN TARTRATE POWDER 100% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%)|1 Number|8|TYLOSIN TARTRATE|1010 gm.| ||TYLOSIN TARTRATE POWDER 20%-5GM (TYLOSIN TARTRATE POWDER 20%-5GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%)| 1 Number|9|TYLOSIN TARTRATE|1.1756 gm.| ||TYLOSIN TARTRATE POWDER 20% - 100GM (TYLOSIN TARTRATE POWDER 20% -100GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%)| 1 Number|10|TYLOSIN TARTRATE|23.513 gm.|

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This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0 72 43 .

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TYLOSIN TARTRATE POWDER 20% -<br>500GM (TYLOSIN TARTRATE POWDER<br>20% -500GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 20%)<br>1 Number<br>11<br>TYLOSIN TARTRATE<br>117.564 gm.<br>TYLOSIN TARTRATE POWDER 20% -1KG<br>JAR (TYLOSIN TARTRATE POWDER 20%<br>-1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 20%)<br>1 Number<br>12<br>TYLOSIN TARTRATE<br>235.128 gm.<br>TYLOSIN TARTRATE POWDER 99% -<br>100GM SACHET(TYLOSIN TARTRATE<br>POWDER 99% -100GM SACHET<br>(EACH<br>GRAM<br>CONTAINS<br>TYLOSIN<br>TARTRATE 99%)<br>1 Number<br>13<br>TYLOSIN TARTRATE<br>100 gm.<br>TYLOSIN TARTRATE POWDER 99% -<br>500GM SACHET(TYLOSIN TARTRATE<br>POWDER 99% -500GM SACHET (EACH<br>GRAM CONTAINS TYLOSIN TARTRATE<br>99%)<br>1 Number<br>14<br>TYLOSIN TARTRATE<br>500 gm.<br>TYLOSIN TARTRATE POWDER 99% -1KG<br>JAR(TYLOSIN TARTRATE POWDER 99% -<br>1KG JAR (EACH GRAM CONTAINS<br>TYLOSIN TARTRATE 99%)<br>1 Number<br>15<br>TYLOSIN TARTRATE<br>1000 gm.<br>RA concerned may take further necessary action as per above decision of NC.	TYLOSIN TARTRATE POWDER 20% -<br>500GM (TYLOSIN TARTRATE POWDER<br>20% -500GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 20%)	<br>1 Number	11	TYLOSIN TARTRATE	117.564 gm.
	TYLOSIN TARTRATE POWDER 20% -1KG<br>JAR (TYLOSIN TARTRATE POWDER 20%<br>-1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE EQ.

| 1 Number|11|TYLOSIN TARTRATE|117.564 gm.| |---|---|---|---|---|---| ||TYLOSIN TARTRATE POWDER 20% -1KG JAR (TYLOSIN TARTRATE POWDER 20% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%)| 1 Number|12|TYLOSIN TARTRATE|235.128 gm.| ||TYLOSIN TARTRATE POWDER 99% - 100GM SACHET(TYLOSIN TARTRATE POWDER 99% -100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%)| 1 Number|13|TYLOSIN TARTRATE|100 gm.| ||TYLOSIN TARTRATE POWDER 99% - 500GM SACHET(TYLOSIN TARTRATE POWDER 99% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%)|1 Number|14|TYLOSIN TARTRATE|500 gm.| ||TYLOSIN TARTRATE POWDER 99% -1KG JAR(TYLOSIN TARTRATE POWDER 99% - 1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%)|1 Number|15|TYLOSIN TARTRATE|1000 gm.|

Case No.	79 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006599AM24
RA File Number	03AX04003360 AM24
Licence No and<br>Date	0311028414/02/11/2023
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-

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

an Kumar, Deputy DGFT on 15-04-2025 10:27:0** 73 43 .

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

|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. TYLOSIN BOLUS 200MG(TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ.

TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 5 TYLOSIN TARTRATE 24.444 gm. TYLOSIN TARTRATE POWDER 100%- 100GM SACHET (TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 6 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100% - 500GM SACHET(TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm.|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. TYLOSIN BOLUS 200MG(TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ.

br>TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 5 TYLOSIN TARTRATE 24.444 gm. TYLOSIN TARTRATE POWDER 100%- 100GM SACHET (TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 6 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100% - 500GM SACHET(TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm.|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. TYLOSIN BOLUS 200MG(TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ.

ACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 5 TYLOSIN TARTRATE 24.444 gm. TYLOSIN TARTRATE POWDER 100%- 100GM SACHET (TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 6 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100% - 500GM SACHET(TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm.|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.

gm.|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. TYLOSIN BOLUS 200MG(TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 5 TYLOSIN TARTRATE 24.444 gm. TYLOSIN TARTRATE POWDER 100%- 100GM SACHET (TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 6 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100% - 500GM SACHET(TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm.|hoc norms under Para 4.07 of HBP Vol.

GM SACHET(TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm.|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. TYLOSIN BOLUS 200MG(TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ.

TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 5 TYLOSIN TARTRATE 24.444 gm. TYLOSIN TARTRATE POWDER 100%- 100GM SACHET (TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 6 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100% - 500GM SACHET(TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm.|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. TYLOSIN BOLUS 200MG(TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ.

br>TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 5 TYLOSIN TARTRATE 24.444 gm. TYLOSIN TARTRATE POWDER 100%- 100GM SACHET (TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 6 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100% - 500GM SACHET(TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm.| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||TYLOSIN BOLUS 200MG(TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG)| 1 Number|1|TYLOSIN TARTRATE|204.00 gm.| ||TYLOSIN INJECTION 5%-50 ML (TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG)| 1 Number|2|TYLOSIN TARTRATE|3.056 gm.| ||TYLOSIN INJECTION 5%-100 ML (TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG)|1 Number|3|TYLOSIN TARTRATE|6.111 gm.| ||TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ.

ARTRATE EQ. TO TYLOSIN BASE 50MG)|1 Number|3|TYLOSIN TARTRATE|6.111 gm.| ||TYLOSIN TARTRATE INJECTION 20%-50 ML(TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG)|1 Number|4|TYLOSIN TARTRATE|12.222 gm.| ||TYLOSIN TARTRATE INJECTION 20%-100 ML(TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG)| 1 Number|5|TYLOSIN TARTRATE|24.444 gm.| ||TYLOSIN TARTRATE POWDER 100%- 100GM SACHET (TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%)| 1 Number|6|TYLOSIN TARTRATE|101 gm.| ||TYLOSIN TARTRATE POWDER 100% - 500GM SACHET(TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%)| 1 Number|7|TYLOSIN TARTRATE|505 gm.|

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TYLOSIN TARTRATE POWDER 100% -<br>1KG JAR(TYLOSIN TARTRATE POWDER<br>100% -1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE 100%)	1 Number	8	TYLOSIN TARTRATE	1010 gm.
TYLOSIN TARTRATE POWDER 20%-5GM<br>(TYLOSIN TARTRATE POWDER 20%-5GM<br>(EACH GRAM CONTAINS<br>TYLOSIN TARTRATE EQ. TO TYLOSIN<br>20%)	<br>1 Number	9	TYLOSIN TARTRATE	1.1756 gm.
TYLOSIN TARTRATE POWDER 20% -<br>100GM (TYLOSIN TARTRATE POWDER<br>20% -100GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 20%)	<br>1 Number	10	TYLOSIN TARTRATE	23.513 gm.
TYLOSIN TARTRATE POWDER 20% -<br>500GM (TYLOSIN TARTRATE POWDER<br>20% -500GM (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 20%)	<br>1 Number	11	TYLOSIN TARTRATE	117.564 gm.
TYLOSIN TARTRATE POWDER 20% -1KG<br>JAR (TYLOSIN TARTRATE POWDER 20%<br>-1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 20%)	<br>1 Number	12	TYLOSIN TARTRATE	235.128 gm.
TYLOSIN TARTRATE POWDER 99% -<br>100GM SACHET(TYLOSIN TARTRATE<br>POWDER 99% -100GM SACHET<br>(EACH<br>GRAM<br>CONTAINS<br>TYLOSIN<br>TARTRATE 99%)	<br>1 Number	13	TYLOSIN TARTRATE	100 gm.
TYLOSIN TARTRATE POWDER 99% -<br>500GM SACHET(TYLOSIN TARTRATE<br>POWDER 99% -500GM SACHET (EACH<br>GRAM CONTAINS TYLOSIN TARTRATE<br>99%)	1 Number	14	TYLOSIN TARTRATE	500 gm.

TARTRATE|100 gm.| ||TYLOSIN TARTRATE POWDER 99% - 500GM SACHET(TYLOSIN TARTRATE POWDER 99% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%)|1 Number|14|TYLOSIN TARTRATE|500 gm.|

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TYLOSIN TARTRATE POWDER 99% -1KG<br>JAR(TYLOSIN TARTRATE POWDER 99% -<br>1KG JAR (EACH GRAM CONTAINS<br>TYLOSIN TARTRATE 99%)<br>1 Number<br>15<br>TYLOSIN TARTRATE<br>1000 gm.<br>RA concerned may take further necessary action as per above decision of NC.	TYLOSIN TARTRATE POWDER 99% -1KG<br>JAR(TYLOSIN TARTRATE POWDER 99% -<br>1KG JAR (EACH GRAM CONTAINS<br>TYLOSIN TARTRATE 99%)	1 Number	15	TYLOSIN TARTRATE	1000 gm.

Case No.	Case No.	80 / NC/3/MEET/Mar/202425/18	80 / NC/3/MEET/Mar/202425/18	80 / NC/3/MEET/Mar/202425/18	80 / NC/3/MEET/Mar/202425/18	80 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM APPLY 00006633AM24
RA File Number		03AX04003515 AM24
Licence No and<br>Date		0311028487/04/11/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Acetic Acid (Glacial) 609000 kg. N Propyl Acetate 1000000 kg. 2 N-Propanol 605000 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||N Propyl Acetate||1000000 kg.|1|Acetic Acid (Glacial)|609000 kg.| |||||2|N-Propanol|605000 kg.| |||||action as per above decision of NC.|||

Case No.	81 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006646AM24
RA File Number	34AX04000591 AM24
Licence No and<br>Date	3411004295/06/11/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No.NC/3/MEET/Jan/202425/2 dated 28/01/2025 against advance<br>authorization No.3411003627 dated 26/04/2023 , it was decided to fix ad-hoc norms under Para 4.07 of

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

been digitally signed by Raman Kumar, Deputy DGFT on 15-04-2025 10:27:0** 76 43 .

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

|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 Clomipramine Hydrochloride USP 25.50 mg. 2 Microcrystalline Cellulose (Avicel PH 301) 148.80 mg. 3 Pregelatinized starch (Starch 1500 LM) 39.60 mg. 4 Colloidal silicon dioxide (Aerosil 200 Pharma) 2.20 mg. CLOMIPRAMINE HCL CAP USP 25 MG 1 Number 5 Magnesium Stearate (Vegetable Source) 4.40 mg. 6 Clomipramine Hydrochloride USP 51.00 mg. 7 Microcrystalline Cellulose (Avicel PH 301) 210.70 mg. 8 Pregelatinized starch (Starch 1500 LM) 59.40 mg. 9 Colloidal silicon dioxide (Aerosil 200 Pharma) 3.30 mg. CLOMIPRAMINE HCL CAP USP 50 MG 1 Number 10 Magnesium Stearate (Vegetable Source) 6.60 mg. 11 Clomipramine Hydrochloride USP 76.50 mg. Microcrystalline Cellulose CLOMIPRAMINE HCL CAP USP 75 MG 1 Number 12 205.45 mg.|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.

MG 1 Number 12 205.45 mg.|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 Clomipramine Hydrochloride USP 25.50 mg. 2 Microcrystalline Cellulose (Avicel PH 301) 148.80 mg. 3 Pregelatinized starch (Starch 1500 LM) 39.60 mg. 4 Colloidal silicon dioxide (Aerosil 200 Pharma) 2.20 mg. CLOMIPRAMINE HCL CAP USP 25 MG 1 Number 5 Magnesium Stearate (Vegetable Source) 4.40 mg. 6 Clomipramine Hydrochloride USP 51.00 mg. 7 Microcrystalline Cellulose (Avicel PH 301) 210.70 mg. 8 Pregelatinized starch (Starch 1500 LM) 59.40 mg. 9 Colloidal silicon dioxide (Aerosil 200 Pharma) 3.30 mg. CLOMIPRAMINE HCL CAP USP 50 MG 1 Number 10 Magnesium Stearate (Vegetable Source) 6.60 mg. 11 Clomipramine Hydrochloride USP 76.50 mg. Microcrystalline Cellulose CLOMIPRAMINE HCL CAP USP 75 MG 1 Number 12 205.45 mg.|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.

MG 1 Number 12 205.45 mg.|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 Clomipramine Hydrochloride USP 25.50 mg. 2 Microcrystalline Cellulose (Avicel PH 301) 148.80 mg. 3 Pregelatinized starch (Starch 1500 LM) 39.60 mg. 4 Colloidal silicon dioxide (Aerosil 200 Pharma) 2.20 mg. CLOMIPRAMINE HCL CAP USP 25 MG 1 Number 5 Magnesium Stearate (Vegetable Source) 4.40 mg. 6 Clomipramine Hydrochloride USP 51.00 mg. 7 Microcrystalline Cellulose (Avicel PH 301) 210.70 mg. 8 Pregelatinized starch (Starch 1500 LM) 59.40 mg. 9 Colloidal silicon dioxide (Aerosil 200 Pharma) 3.30 mg. CLOMIPRAMINE HCL CAP USP 50 MG 1 Number 10 Magnesium Stearate (Vegetable Source) 6.60 mg. 11 Clomipramine Hydrochloride USP 76.50 mg. Microcrystalline Cellulose CLOMIPRAMINE HCL CAP USP 75 MG 1 Number 12 205.45 mg.| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|**Qty.

.50 mg. Microcrystalline Cellulose CLOMIPRAMINE HCL CAP USP 75 MG 1 Number 12 205.45 mg.| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||CLOMIPRAMINE HCL CAP USP 25 MG|1 Number|1|Clomipramine Hydrochloride USP|25.50 mg.| ||||2|Microcrystalline Cellulose (Avicel PH 301)|148.80 mg.| ||||3|Pregelatinized starch (Starch 1500 LM)|39.60 mg.| ||||4|Colloidal silicon dioxide (Aerosil 200 Pharma)|2.20 mg.| ||||5|Magnesium Stearate (Vegetable Source)|4.40 mg.| ||CLOMIPRAMINE HCL CAP USP 50 MG|1 Number|6|Clomipramine Hydrochloride USP|51.00 mg.| ||||7|Microcrystalline Cellulose (Avicel PH 301)|210.70 mg.| ||||8|Pregelatinized starch (Starch 1500 LM)|59.40 mg.| ||||9|Colloidal silicon dioxide (Aerosil 200 Pharma)|3.30 mg.| ||||10|Magnesium Stearate (Vegetable Source)|6.60 mg.| ||CLOMIPRAMINE HCL CAP USP 75 MG|1 Number|11|Clomipramine Hydrochloride USP|76.50 mg.| ||||12|Microcrystalline Cellulose|205.45 mg.|

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e USP|76.50 mg.| ||||12|Microcrystalline Cellulose|205.45 mg.|

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	(Avicel PH 301)
13	Pregelatinized starch<br>(Starch 1500 LM)	63.90 mg.
14	Colloidal silicon dioxide<br>(Aerosil 200 Pharma)	3.55 mg.
15	Magnesium Stearate<br>(Vegetable Source)	7.10 mg.

Case No.	82 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	RALLIS INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006775AM24
RA File Number	03AX04003377 AM24
Licence No and<br>Date	0311028623/09/11/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Yield for first stage of reaction.<br>1.<br>Justification of low yield of 48% in second stage.<br>2.<br>Quantity of DMSO as solvent and recovery thereof.<br>3.<br>Balanced chemical reaction withy stichometric balance on molar basis.<br>4.

Justification of low yield of 48% in second stage. 2. Quantity of DMSO as solvent and recovery thereof. 3. Balanced chemical reaction withy stichometric balance on molar basis. 4.||

Case No.	83 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006801AM24
RA File Number	52AX04000234 AM24
Licence No and<br>Date	5211006397/10/11/2023
Norms Committee Decision:

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

Case No.	Case No.	84 / NC/3/MEET/Mar/202425/18	84 / NC/3/MEET/Mar/202425/18	84 / NC/3/MEET/Mar/202425/18	84 / NC/3/MEET/Mar/202425/18	84 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM APPLY 00006807AM24
RA File Number		34AX04000624 AM24
Licence No and<br>Date		3411004346/10/11/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Jan/202425/15 dated 28/01/2025 against advance<br>authorization No.3411003627 dated 26/04/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Clomipramine Hydrochloride USP 25.50 mg. 2 Microcrystalline Cellulose (Avicel PH 301) 148.80 mg. 3 Pregelatinized starch (Starch 1500 LM) 39.60 mg. 4 Colloidal silicon dioxide (Aerosil 200 Pharma) 2.20 mg. CLOMIPRAMINE HCL CAP USP 25 MG 1 Number 5 Magnesium Stearate (Vegetable Source) 4.40 mg. 6 Clomipramine Hydrochloride USP 51.00 mg. Microcrystalline Cellulose CLOMIPRAMINE HCL CAP USP 50 MG 1 Number 7 210.70 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CLOMIPRAMINE HCL CAP USP 25 MG||1 Number|1|Clomipramine Hydrochloride USP|25.50 mg.| |||||2|Microcrystalline Cellulose (Avicel PH 301)|148.80 mg.| |||||3|Pregelatinized starch (Starch 1500 LM)|39.60 mg.| |||||4|Colloidal silicon dioxide (Aerosil 200 Pharma)|2.20 mg.| |||||5|Magnesium Stearate (Vegetable Source)|4.40 mg.| ||CLOMIPRAMINE HCL CAP USP 50 MG||1 Number|6|Clomipramine Hydrochloride USP|51.00 mg.| |||||7|Microcrystalline Cellulose|210.70 mg.|

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e USP|51.00 mg.| |||||7|Microcrystalline Cellulose|210.70 mg.|

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			(Avicel PH 301)
		8	Pregelatinized starch<br>(Starch 1500 LM)	59.40 mg.
		9	Colloidal silicon dioxide<br>(Aerosil 200 Pharma)	3.30 mg.
		10	Magnesium Stearate<br>(Vegetable Source)	6.60 mg.
CLOMIPRAMINE HCL CAP<br>USP 75 MG	1 Number	11	Clomipramine Hydrochloride USP	76.50 mg.
		12	Microcrystalline Cellulose<br>(Avicel PH 301)	205.45 mg.
		13	Pregelatinized starch<br>(Starch 1500 LM)	63.90 mg.
		14	Colloidal silicon dioxide<br>(Aerosil 200 Pharma)	3.55 mg.
		15	Magnesium Stearate<br>(Vegetable Source)	7.10 mg.

05.45 mg.| ||||13|Pregelatinized starch (Starch 1500 LM)|63.90 mg.| ||||14|Colloidal silicon dioxide (Aerosil 200 Pharma)|3.55 mg.| ||||15|Magnesium Stearate (Vegetable Source)|7.10 mg.|

Case No.	85 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006837AM24
RA File Number	09AX04000734 AM24
Licence No and<br>Date	0911006227/14/11/2023
Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Vonoprazan Fumarate	1 kg.	1	2-FLUORO<br>ACETOPHENONE	0.860 kg.
		2	Pyridine 3 sulfonyl chloride	0.856 kg.
		3	Tetrahydrofuran	3.29 kg.
		4	Methylene Di Chloride	3.80 kg.
		5	Sodium Borohydrate	0.22 kg.
		6	Potassium Carbonate	0.66 kg.
		7	Di Methyl sulfoxide	1.00 kg.

nyl chloride|0.856 kg.| |||3|Tetrahydrofuran|3.29 kg.| |||4|Methylene Di Chloride|3.80 kg.| |||5|Sodium Borohydrate|0.22 kg.| |||6|Potassium Carbonate|0.66 kg.| |||7|Di Methyl sulfoxide|1.00 kg.|

Case No.	Case No.	86 / NC/3/MEET/Mar/202425/18	86 / NC/3/MEET/Mar/202425/18	86 / NC/3/MEET/Mar/202425/18	86 / NC/3/MEET/Mar/202425/18	86 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM APPLY 00006838AM24
RA File Number		09AX04000733 AM24
Licence No and<br>Date		0911006228/14/11/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

Case No.	Case No.	86 / NC/3/MEET/Mar/202425/18	86 / NC/3/MEET/Mar/202425/18	86 / NC/3/MEET/Mar/202425/18	86 / NC/3/MEET/Mar/202425/18	86 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM APPLY 00006838AM24
RA File Number		09AX04000733 AM24
Licence No and<br>Date		0911006228/14/11/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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ct**||Qty.|Sl. No.|Import Items|Qty. allowed.|

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1	Methanol	2.00 kg.
2	(S)-(+)-1,2-PROPANEDIOL	0.20 kg.
3	n-Heptane	2.00 kg.
4	Lithium Metal	0.124 kg.
5	Methylene Di Chloride	3.00 kg.
6	Acetonitrile	2.10 kg.
7	TETRA HYDRO FURAN<br>(THF)	2.50 kg.
8	SODIUM BOROHYDRIDE	0.20 kg.

Case No.	87 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006896AM24
RA File Number	08AX04001535 AM24
Licence No and<br>Date	0811009983/17/11/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|08AX04001535 AM24| |Licence No and Date|0811009983/17/11/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	88 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006966AM24
RA File Number	08AX04001564 AM24
Licence No and<br>Date	0811010011/22/11/2023

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Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Feb/202324/23 dated 19/02/2024 against advance authorization No.0810145144 dated 01/05/2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Indoline	1 kg.	1	O CHLOROBENZYL CYANIDE	2.20 kg.
		2	TOLUENE	1.00 kg.

Case No.	89 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	MEONE HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00006991AM24
RA File Number	04AX04000678 AM24
Licence No and<br>Date	0411006454/22/11/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Jan/202425/23 dated 28/01/2025 against advance<br>authorization No.0411005383 dated 10/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<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. FOSCARNET SODIUM INJECTION 250 ML (24mg/ml which contain 88.33% strength of import item) 1 Number 1 Foscarnet Sodium API (Foscarnet Sodium Hexahydrate EP 8.0 6.30 gm. RA concerned may take further necessary action as per above decision of NC.||

Case No.	90 / NC/3/MEET/Mar/202425/18
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00007038AM24
RA File Number	07AX04001334 AM24
Licence No and<br>Date	0711009791/24/11/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Jan/202425/15 dated 28/01/2025 against advance<br>authorization No.0711006773 dated 16/03/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<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. Calcium Dobesilate Monohydrate BP/ Calcium Dobesilate Monohydrate Eur.Ph / Calcium Dobesilate 1 kg. 1 Hydroquinone 0.631 kg. Etamsylate / Etamsylate EP 1 kg. 2 Hydroquinone 0.527 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	91 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00007039AM24
RA File Number	07AX04001335 AM24
Licence No and<br>Date	0711009794/24/11/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>A balance chemical reaction indicting molecular weight of reactants and products with yield of the<br>reaction.<br>1.<br>Difference between import and export based on end use.<br>2.

Case No.	92 / NC/3/MEET/Mar/202425/18
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number	HQRNORM APPLY 00007114AM24
RA File Number	07AX04001360 AM24
Licence No and<br>Date	0711009823/30/11/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	Case No.	93 / NC/3/MEET/Mar/202425/18	93 / NC/3/MEET/Mar/202425/18	93 / NC/3/MEET/Mar/202425/18	93 / NC/3/MEET/Mar/202425/18	93 / NC/3/MEET/Mar/202425/18
Case Status		Case Approved
Party Name		VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 18 and 17/03/2025
HQ File Number		HQRNORM APPLY 00007141AM24
RA File Number		03AX04003919 AM24
Licence No and<br>Date		0311029038/01/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Assurity Plus SPOT ON (For Small Cat ) (Pack size 0.4ml x 6 pipettes), (Each ml contains: Imidacloprid 100mg, Net Weight = 480 Grams) 2000 Numbers 1 Assurity Plus SPOT ON (For Large Cat) (Pack size 0.8ml x 6 pipettes),(Each ml contains: Imidacloprid 100mg, Net Weight = 960 Grams) 2000 Numbers 2 Assurity Plus SPOT ON (For Small Dog) (Pack size 0.4ml x 6 Pipettes),(Each ml contains: Imidacloprid 100mg, Net Weight = 480 Grams) 2000 Number 3 Assurity Plus SPOT ON (For Medium Dog) (Pack size 1ml x 6 Pipettes),(Each ml contains: Imidacloprid 100mg , Net Weight = 1200 Grams) 2000 Numbers 4 Assurity Plus SPOT ON (For Large Dog) (Pack size 2.5ml x 6 Pipettes),(Each ml contains: Imidacloprid 100mg , Net Weight = 3000 Grams) 2000 Numbers 5 Imidacloprid 60.064 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

es),(Each ml contains: Imidacloprid 100mg , Net Weight = 3000 Grams) 2000 Numbers 5 Imidacloprid 60.064 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Assurity Plus SPOT ON (For Small Cat ) (Pack size 0.4ml x 6 pipettes), (Each ml contains: Imidacloprid 100mg, Net Weight = 480 Grams)||2000 Numbers|1|Imidacloprid|60.064 kg.| ||Assurity Plus SPOT ON (For Large Cat) (Pack size 0.8ml x 6 pipettes),(Each ml contains: Imidacloprid 100mg, Net Weight = 960 Grams)|| 2000 Numbers|2||| ||Assurity Plus SPOT ON (For Small Dog) (Pack size 0.4ml x 6 Pipettes),(Each ml contains: Imidacloprid 100mg, Net Weight = 480 Grams)||2000 Number|3||| ||Assurity Plus SPOT ON (For Medium Dog) (Pack size 1ml x 6 Pipettes),(Each ml contains: Imidacloprid 100mg , Net Weight = 1200 Grams)||2000 Numbers|4||| ||Assurity Plus SPOT ON (For Large Dog) (Pack size 2.5ml x 6 Pipettes),(Each ml contains: Imidacloprid 100mg , Net Weight = 3000 Grams)||2000 Numbers|5|||

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cloprid 100mg , Net Weight = 3000 Grams)||2000 Numbers|5|||

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Assurity Plus SPOT ON (For Extra Large Dog)<br>(Pack size 4ml x 6 Pipettes),(Each ml contains:<br>Imidacloprid 100mg , Net Weight = 7200 Grams)	3000<br>Numbers	6
Banflea Plus SPOT ON (For Small Cat) (Pack size<br>0.4ml x 6 Pipettes)(Each ml contains:<br>Imidacloprid 91mg, Net Weight = 218.40 Grams)	<br>1000<br>Numbers	7
Banflea Plus SPOT ON (For Large Cat) (Pack size<br>0.8ml x 6 Pipettes),(Each ml contains:<br>Imidacloprid 91mg, Net Weight = 436.80 Grams)	<br>1000<br>Numbers	8
Banflea Plus SPOT ON (For Small Dog) (Pack<br>size 0.4ml x 6 Pipettes)(Each ml contains:<br>Imidacloprid 91mg, Net Weight = 262.08 Grams)	1200<br>Numbers	9
Banflea Plus Spot on for Dog (For Medium Dog)<br>(Pack size 1ml x 6 Pipettes),(Each ml contains:<br>Imidacloprid 91mg, Net Weight = 546.00 Grams)	1000<br>Numbers	10
Banflea Plus SPOT ON (For Large Dog)

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