IN FORCE Advance Authorisation

DGFT Minutes

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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/Oct/202324/15 DATED: 13/10/2023

Please Note

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

Meeting No. NC/3/MEET/Oct/202324/15 dated 13/10/2023 of Norms Committee - III for the year 2023-24 was held on 13/10/2023 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

cations for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	T SONGZALIAN,Deputy DGFT	DGFT(HQ)
2	UTTAM SARKAR,Assistant Section Officer	DGFT(HQ)
3	NAND Lal,Technical Consultant	DPIIT
4	SHAISH KUMAR,Technical Consultant	DGFT
5	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT
6	Nand Lal,Technical Consultant	DGFT

This document has been digitally signed by T SONGZALIAN, Deputy DGFT on 22-11-2023 13:03:42.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	CYKLO PHARMA CHEM PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00003200AM24
RA File Number	032404000318 AM04
Licence No and<br>Date	0310204913/29/05/2003
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Molar Weight of each input and output item of each stage.<br>i.<br>Percentage yield on molar basis for each step.<br>ii.<br>CA certified Production/Consumption data.<br>iii.<br>Sample of Shipping Bills and Bill of Entry of the export products along with statement of Input-output<br>as per export documents of the said authorization.<br>iv.

Case No.	2 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00006470AM23
RA File Number	052404000420 AM14
Licence No and<br>Date	0510378413/05/02/2014
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call the firm for attending before Norms Committee to explain its case.||Personal Hearing|

Case No.	3 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00003812AM23
RA File Number	342404000295 AM15
Licence No and<br>Date	3410040965/16/02/2015

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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.

Qty.	Sl. No.	Import Items	Qty. allowed.
1 kg.	1	Sorbic Acid	1.429 kg.
	2	Vitride	3.045 kg.

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

Case No.	4 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00006437AM23
RA File Number	052404000073 AM16
Licence No and<br>Date	0510394342/25/05/2015
Norms Committee Decision:<br> The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	Case No.	5 / NC/3/MEET/Oct/202324/15	5 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00004115AM23
RA File Number		039404001044 AM16
Licence No and<br>Date		0310803171/09/03/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under.<br>**Sl.

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. Sl. No. Export Product Quantity|||| ||Export Product||Quantity|

Case No.	Case No.	5 / NC/3/MEET/Oct/202324/15	5 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00004115AM23
RA File Number		039404001044 AM16
Licence No and<br>Date		0310803171/09/03/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under.<br>Sl. No.<br>Export Product<br>Quantity
	Export Product		Quantity

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1	NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM USP	15	GM	1	Number
	TUBE
2	NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM USP	30	GM	1	Number
	TUBE
3	NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM USP	60	GM	1	Number
	TUBE

Sl. No.	Import Items	Quantity allowed.
1	Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
2	Relevant Excipients	Net content in the export product plus 2% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

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

Case No.	Case No.	6 / NC/3/MEET/Oct/202324/15	6 / NC/3/MEET/Oct/202324/15	6 / NC/3/MEET/Oct/202324/15	6 / NC/3/MEET/Oct/202324/15	6 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00001869AM23
RA File Number		052404000399 AM17
Licence No and<br>Date		0510400599/02/12/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items<br>	Qty. allowed.

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CARVACROL 27,500 kg 1 DIPENTENE 1,94,128 kg.

Note: The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms.

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

he above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms.**

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

Case No.	7 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00001867AM23
RA File Number	052404000008 AM18
Licence No and<br>Date	0510402246/18/04/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CARVACROL<br>59,300 kg.<br>1<br>DIPENTENE<br>3,95,727 kg.<br>Note: The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by<br>RA on above norms.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	8 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00001870AM23
RA File Number	052404000297 AM18
Licence No and	0510404439/31/10/2017

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Date

Norms Committee Decision:

/ 15 and 13/10/2023| |HQ File Number|HQRNORM REVIW00001870AM23| |RA File Number|052404000297 AM18| |Licence No and|0510404439/31/10/2017|

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Date

Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
CARVACROL	71,400 kg	1	DIPENTENE	1,41,700 kg.

Note: The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms.

Case No.	9 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00002756AM23
RA File Number	522404000085 AM18
Licence No and<br>Date	5210042570/20/03/2018
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	10 / NC/3/MEET/Oct/202324/15	10 / NC/3/MEET/Oct/202324/15	10 / NC/3/MEET/Oct/202324/15	10 / NC/3/MEET/Oct/202324/15	10 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00006188AM23
RA File Number		092404000168 AM19
Licence No and<br>Date		0910066418/04/07/2018
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

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1	Cefepime Hydrochloride<br>(Non-sterile)	1.2428 gm
2	L - Arginine	0.702 gm
3	Acetone	1.8975 gm
4	Isopropyl Alcohol	0.9488 gm
5	Methanol	2.9812 gm

umber|1|Cefepime Hydrochloride (Non-sterile)|1.2428 gm| |---|---|---|---|---|---| ||||2|L - Arginine|0.702 gm| ||||3|Acetone|1.8975 gm| ||||4|Isopropyl Alcohol|0.9488 gm| ||||5|Methanol|2.9812 gm| ||Cefepime for Injection 2000mg (50ml Vial) (Each vial contains Sterile mixture of Cefepime Hydrochloride and L-Arginine equivalent to anhydrous Cefepime 2000 mg)|1 Number|1|Cefepime Hydrochloride (Non-sterile)|2.4856 gm| ||||2|L - Arginine|1.404 gm| ||||3|Acetone|3.795 gm| ||||4|Isopropyl Alcohol|1.8976 gm| ||||5|Methanol|5.962 gm|

Case No.	11 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00001184AM23
RA File Number	092404000181 AM19
Licence No and<br>Date	0910066442/11/07/2018
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-

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Import Quantity for each export item not matching with DML in electronic format. Hard copy of Advance Authorisation may be called from the firm.

from the firm:-||

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Import Quantity for each export item not matching with DML in electronic format. Hard copy of Advance Authorisation may be called from the firm.

Case No.	12 / NC/3/MEET/Oct/202324/15
Case Status	Case Rejected
Party Name	CROPNOSYS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00005535AM23
RA File Number	039404000527 AM19
Licence No and<br>Date	0310823957/24/09/2018
Norms Committee Decision:<br>Dr. Vijendra H. Pardeshi, Sr. Group Leader of the firm had attended the Personal Hearing and explained<br>firm’s case. The Committee heard the explanation of the representative of the firm and after due<br>deliberation, the committee rejected the request as found no ground as the export obligation period has<br>already been expired.

Case No.	Case No.	13 / NC/3/MEET/Oct/202324/15	13 / NC/3/MEET/Oct/202324/15	13 / NC/3/MEET/Oct/202324/15	13 / NC/3/MEET/Oct/202324/15	13 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number and<br>Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00006120AM23
RA File Number		092404000345 AM19
Licence No and Date		0910066762/25/10/2018
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 of HBP<br>Vol.

|| |Licence No and Date||0910066762/25/10/2018||||| |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 6-APA 325.00 mg. 2 Methanol 18.717 mg. 3 Methyl d-(-)-4-hydroxy- phenylglycinate OR D-(-)-4- hydroxyphenylglycine methyl ester [PHPG Ester] 281.86 mg. AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 625 MG. (Each film coated Tablet contains: Amoxicillin Trihydrate equivalent to Anhydrous Amoxicillin 500 mg an Clavulanate Potassium equivalent to Clavulanic Acid 125 mg. 1 Number||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 625 MG. (Each film coated Tablet contains: Amoxicillin Trihydrate equivalent to Anhydrous Amoxicillin 500 mg an Clavulanate Potassium equivalent to Clavulanic Acid 125 mg.||1 Number|1|6-APA|325.00 mg.| |||||2|Methanol|18.717 mg.| |||||3|Methyl d-(-)-4-hydroxy- phenylglycinate OR D-(-)-4- hydroxyphenylglycine methyl ester [PHPG Ester]|281.86 mg.|

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PA|325.00 mg.| |||||2|Methanol|18.717 mg.| |||||3|Methyl d-(-)-4-hydroxy- phenylglycinate OR D-(-)-4- hydroxyphenylglycine methyl ester [PHPG Ester]|281.86 mg.|

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4<br>Penicillin<br>G<br>Amidase<br>(Particle size 250 - 500<br>micron, Creamish to Brown<br>regularly shaped beads)<br>1.00 mg.<br>5<br>Potassium<br>Clavulanate<br>diluted with Microcrystalline<br>Cellulose (1:1) / Clavulanate<br>Potassium +Avicel [in Acitve<br>Base]<br>297.825 mg.<br>RA concerned may take further necessary action as per above decision of NC.			4	Penicillin<br>G<br>Amidase<br>(Particle size 250 - 500<br>micron, Creamish to Brown<br>regularly shaped beads)	1.00 mg.
			5	Potassium<br>Clavulanate<br>diluted with Microcrystalline<br>Cellulose (1:1) / Clavulanate<br>Potassium +Avicel [in Acitve<br>Base]	297.825 mg.

Case No.	Case No.	14 / NC/3/MEET/Oct/202324/15	14 / NC/3/MEET/Oct/202324/15	14 / NC/3/MEET/Oct/202324/15	14 / NC/3/MEET/Oct/202324/15	14 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00006118AM23
RA File Number		092404000386 AM19
Licence No and<br>Date		0910066874/20/11/2018
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 of HBP<br>Vol.

|Licence No and Date||0910066874/20/11/2018||||| |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 6-APA 581.77 mg. 2 Methanol 32.755 mg. 3 Methyl d-(-)-4-hydroxy- phenylglycinate OR D-(-)-4- hydroxyphenylglycine methyl ester [PHPG Ester] 502.40 mg. 4 Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads) 2.00 mg AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 1000 MG (Each film coated Tablet contains: Amoxicillin Trihydrate equivalent to Anhydrous Amoxicillin 875 mg and Clavulanate Potassium equivalent to Clavulanic Acid 125 mg)||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 1000 MG (Each film coated Tablet contains: Amoxicillin Trihydrate equivalent to Anhydrous Amoxicillin 875 mg and Clavulanate Potassium equivalent to Clavulanic Acid 125 mg)|||1 |6-APA|581.77 mg.| |||||2 |Methanol|32.755 mg.| |||||3 |Methyl d-(-)-4-hydroxy- phenylglycinate OR D-(-)-4- hydroxyphenylglycine methyl ester [PHPG Ester]| 502.40 mg.| |||||4|Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads)| 2.00 mg|

br>hydroxyphenylglycine methyl ester [PHPG Ester]| 502.40 mg.| |||||4|Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads)| 2.00 mg|

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	5	Potassium Clavulanate diluted with	<br>303.773 mg
		Microcrystalline Cellulose (1:1) /
		Clavulanate Potassium +Avicel [in
		Acitve Base]

Case No.	15 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00003496AM23
RA File Number	522404000068 AM19
Licence No and<br>Date	5210042870/18/12/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/May/202324/2 dated 12/05/2023against advance<br>authorizationNo. 5211002273 dated 30/03/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Acetyl Salicylic Acid (For<br>Industrial Use)<br>1.56 kg.<br>4-HYDROXY COUMARIN<br>(by Acetyl Salicylic Acid route)<br>1 kg.<br>2<br>Ethyl Aceto Acetate<br>1.147 kg.<br>RA concerned may take further necessary action as per above decision of NC

1.56 kg. 4-HYDROXY COUMARIN (by Acetyl Salicylic Acid route) 1 kg. 2 Ethyl Aceto Acetate 1.147 kg. RA concerned may take further necessary action as per above decision of NC||

Case No.	16 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00004154AM23
RA File Number	039404000526 AM20
Licence No and<br>Date	0310832396/23/10/2019

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Norms Committee Decision:

The firm was called for personal hearing for explanation of their case. The committed heard the explanation of the firm and after due deliberation the committee has directed to the firm to appear again before Norms Committee with all relevant documents, so that a decision could be taken.

Case No.	17 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	LACTOSE (INDIA) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00002116AM23
RA File Number	039504001033 AM20
Licence No and<br>Date	0310834414/23/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	Case No.	18 / NC/3/MEET/Oct/202324/15	18 / NC/3/MEET/Oct/202324/15	18 / NC/3/MEET/Oct/202324/15	18 / NC/3/MEET/Oct/202324/15	18 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		018205001136AM20
RA File Number		052404000749 AM20
Licence No and<br>Date		0510413850/12/03/2020
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 of HBP<br>Vol.

|Licence No and Date||0510413850/12/03/2020||||| |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 7(Alpha)-(2-Hydroxy-3,3-Dimethyl-2- Butyl)-6, 14-Endo-Ethano-6, 7, 8, 14- Tetrahydronorthebaine 1.955 kg. 2 Cyclopropyl methanol 1.60 kg. 3 Mehtane Sulfonyl Chloride 2.50 kg. Buprenorphine Hydrochloride (Bulk Drug/ Pharmacopeal Grade) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Buprenorphine Hydrochloride (Bulk Drug/ Pharmacopeal Grade)||1 kg.|1|7(Alpha)-(2-Hydroxy-3,3-Dimethyl-2- Butyl)-6, 14-Endo-Ethano-6, 7, 8, 14- Tetrahydronorthebaine|1.955 kg.| |||||2|Cyclopropyl methanol|1.60 kg.| |||||3|Mehtane Sulfonyl Chloride|2.50 kg.|

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3-Dimethyl-2- Butyl)-6, 14-Endo-Ethano-6, 7, 8, 14- Tetrahydronorthebaine|1.955 kg.| |||||2|Cyclopropyl methanol|1.60 kg.| |||||3|Mehtane Sulfonyl Chloride|2.50 kg.|

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4	Lithium Bromide	2.00 kg.
5	Thiophenol	2.50 kg.
6	Dimethyl Formamide	4.00 kg.
7	Triethyl Amine	4.80 kg.
8	Toluene	20.50 kg.
9	Methanol	5.50 kg.
10	Activated Carbon / Eno Carbon	0.200 kg.
11	Acetone	4.50 kg.

Case No.	Case No.	19 / NC/3/MEET/Oct/202324/15	19 / NC/3/MEET/Oct/202324/15	19 / NC/3/MEET/Oct/202324/15	19 / NC/3/MEET/Oct/202324/15	19 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		AMI ORGANICS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00003586AM23
RA File Number		522404000007 AM21
Licence No and Date		5210043401/22/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jul/202324/9 dated 28/07/2023against advance authorization<br>**No.

e case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo. NC/3/MEET/Jul/202324/9 dated 28/07/2023against advance authorization No. 5211002485 dated 13/05/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 MALONONITRILE 0.571 kg. 2 GUANIDINE HCL 0.826 kg. 5-NITROSO-2,4,6- TRIAMINOPYRIMIDINE 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||5-NITROSO-2,4,6- TRIAMINOPYRIMIDINE||1 kg.|1|MALONONITRILE|0.571 kg.| |||||2|GUANIDINE HCL|0.826 kg.|

Case No.	Case No.	19 / NC/3/MEET/Oct/202324/15	19 / NC/3/MEET/Oct/202324/15	19 / NC/3/MEET/Oct/202324/15	19 / NC/3/MEET/Oct/202324/15	19 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		AMI ORGANICS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00003586AM23
RA File Number		522404000007 AM21
Licence No and Date		5210043401/22/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jul/202324/9 dated 28/07/2023against advance authorization<br>**No.

UDIN00370709AM24

	3	N,N DIMETHYL FORMAMIDE 99. 5%	0.632 kg.
		(Tech. Spec. Liquid)

Case No.	20 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00005662AM23
RA File Number	342404000171 AM21
Licence No and<br>Date	3410046407/18/09/2020
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<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. ESLICARBAZEPINE ACETATE 1 kg. 1 10-METHOXY IMINOSTILBENE 1.506 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	21 / NC/3/MEET/Oct/202324/15	21 / NC/3/MEET/Oct/202324/15	21 / NC/3/MEET/Oct/202324/15	21 / NC/3/MEET/Oct/202324/15	21 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00000568AM23
RA File Number		052404000295 AM21
Licence No and<br>Date		0510415273/21/09/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. 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.	21 / NC/3/MEET/Oct/202324/15	21 / NC/3/MEET/Oct/202324/15	21 / NC/3/MEET/Oct/202324/15	21 / NC/3/MEET/Oct/202324/15	21 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00000568AM23
RA File Number		052404000295 AM21
Licence No and<br>Date		0510415273/21/09/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00370709AM24

Meropenem for Injection	1	kg.	1	(4R,<br>5S,<br>6S)-3-[[(3S,	5S)-5-	0.8278	kg.
				(Dimethylcarbamoyl)

ems**|Qty. allowed.|

UDIN00370709AM24

Meropenem for Injection	1	kg.	1	(4R,<br>5S,<br>6S)-3-[[(3S,	5S)-5-	0.8278	kg.
				(Dimethylcarbamoyl)

Case No.	22 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	AVA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00004365AM23
RA File Number	03AA04020902 AM21
Licence No and<br>Date	0311001331/28/01/2021
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>i.<br>Meaning of DTPA Ferric Sodium 13% with complete calculations based on chemistry of reaction.<br>ii.

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

ased on chemistry of reaction.** ii.||

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

Case No.	Case No.	23 / NC/3/MEET/Oct/202324/15	23 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00002205AM23
RA File Number		03AA04021752 AM21
Licence No and<br>Date		0311001487/04/02/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under.<br>Sl. No.<br>Export Product<br>Quantity<br>AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 625 MG ([The<br>Relevant Bulk Drug content in the export product is Amoxcillin Trihydrate 40000 Kgs<br>1<br>1 Number
	Export Product		Quantity
	AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 625 MG ([The<br>Relevant Bulk Drug content in the export product is Amoxcillin Trihydrate 40000 Kgs		<br>1 Number

Export Product||Quantity| ||AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 625 MG ([The Relevant Bulk Drug content in the export product is Amoxcillin Trihydrate 40000 Kgs|| 1 Number|

Case No.	Case No.	23 / NC/3/MEET/Oct/202324/15	23 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00002205AM23
RA File Number		03AA04021752 AM21
Licence No and<br>Date		0311001487/04/02/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under.<br>Sl. No.<br>Export Product<br>Quantity<br>AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 625 MG ([The<br>Relevant Bulk Drug content in the export product is Amoxcillin Trihydrate 40000 Kgs<br>1<br>1 Number
	Export Product		Quantity
	AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 625 MG ([The<br>Relevant Bulk Drug content in the export product is Amoxcillin Trihydrate 40000 Kgs		<br>1 Number

UDIN00370709AM24

and Clavulanate Potasssium +Avicel 10000 KgA])

Import Items	Quantity allowed.
Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
Relevant Excipients	Net content in the export product plus 2% wastage.
Relevant Packaging Material	Relevant as per Packing Policy

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

Case No.	Case No.	24 / NC/3/MEET/Oct/202324/15	24 / NC/3/MEET/Oct/202324/15	24 / NC/3/MEET/Oct/202324/15	24 / NC/3/MEET/Oct/202324/15	24 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00003798AM23
RA File Number		03AA04029725 AM21
Licence No and<br>Date		0311002554/16/03/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Alpha Pinene<br>1.813 kg.<br>MYSORNAOL AB18019<br>(Perfumery Compound)<br>1 kg<br>2<br>Sec butanol<br>0.425 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	MYSORNAOL AB18019<br>(Perfumery Compound)		1 kg	1	Alpha Pinene	1.813 kg.
				2	Sec butanol	0.425 kg.

UDIN00370709AM24

duct**||Qty.|Sl. No.|Import Items|Qty.| ||MYSORNAOL AB18019 (Perfumery Compound)||1 kg|1|Alpha Pinene|1.813 kg.| |||||2|Sec butanol|0.425 kg.| ||||||||

UDIN00370709AM24

Case No.	25 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00002912AM23
RA File Number	05AA04041798 AM21
Licence No and<br>Date	0511001982/01/04/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Chloramphenicol Hemisuccinate (Anti Bacterial)<br>1 kg.<br>1<br>Chloramphenicol<br>1.16 kg.<br>RA concerned may take further necessary action as per above decision of NC.

br>Qty. allowed. Chloramphenicol Hemisuccinate (Anti Bacterial) 1 kg. 1 Chloramphenicol 1.16 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	26 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00029824AM22
RA File Number	03AA04003827 AM22
Licence No and<br>Date	0311003447/30/04/2021
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl. No.<br>Export Product<br>Quantity<br>1<br>Medical Ointments/Creams(Clotrimazole 1 Percentage Cream 1/2 OZ 14 Gm Tube Total<br>Net Wt. 500.01Kg, Cetostearyl Alcohol 50 Kg, Octyldodecanol 67.50Kg, Cetyl Esters 15<br>Kg, Sorbitan Mono 10 Kg, Polysorbate 60 NF 7.5 Kg, Clotrimazole USP 5.13 Kg, Benzyl<br>Alcohol NF 5kg)<br>1 Number

UDIN00370709AM24

ohol 50 Kg, Octyldodecanol 67.50Kg, Cetyl Esters 15 Kg, Sorbitan Mono 10 Kg, Polysorbate 60 NF 7.5 Kg, Clotrimazole USP 5.13 Kg, Benzyl Alcohol NF 5kg) 1 Number||

UDIN00370709AM24

2	Medical Ointments/Creams(Clotrimazole 1 Percentage Cream 1 OZ 28 Gm Tube Total	1 Number
	Net Wt. 3300.02Kg, Cetostearyl Alcohol 330 Kg, Octyldodecanol 445.50Kg, Cetyl Esters
	99 Kg, Sorbitan Mono 66 Kg, Polysorbate 60 NF 49.50 Kg, Clotrimazole USP 33.84Kg,
	Benzyl Alcohol NF 33 kg)
3	Medical Ointments/Creams(Clotrimazole 1 Percentage Cream 45 Gm Tube with 1	1 Number
	Applicator Total Net Wt. 7219.49Kg, Cetostearyl Alcol 721.95Kg, Octyldo 974.63Kg,
	Cetyl Esters 216.58Kg, Sorbitan 144.39Kg, Polysorbate 108.29Kg, Clotri 74.04Kg,
	Benzyl 72.20Kg, Plas App 160433 Nos)
4	Medical Ointments/Creams(Clotrimazole 1 Percentage Cream 45 Gm Tube with 7	1 Number
	Applicator Total Net Wt. 692.33Kg, Cetostearyl Alcol 69.23Kg, Octyldo 93.46Kg, Cetyl
	Esters 20.77Kg, Sorbitan 13.85Kg, Polysorbate 10.39Kg, Clotri 7.10Kg, Benzyl 6.92Kg,
	Plas App 15385 Nos)
Sl. No.	Import Items<br>Quantity allowed.
1	Relevant Bulk Drugs<br>Net content in the export product plus 2% wastage.
2	Relevant Excipients<br>Net content in the export product plus 2% wastage.
3	Relevant Packaging Material<br>Relevant as per Packing Policy

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

kaging Material Relevant as per Packing Policy||

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

Case No.	27 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00001514AM23
RA File Number	03AA04011100 AM22
Licence No and<br>Date	0311003600/06/05/2021
Norms Committee Decision:<br>Shri Manuel Nazareth, GM and Shri Versing Shinde, Plant Head of the firm had attended the Personal<br>Hearing and explained firm’s case. The Committee heard the explanation of Representatives of the firm and

UDIN00370709AM24

after personal hearing the committee has directed to the firm to appear again within one month before Norms Committee with all relevant documents, so that a decision could be taken.

N00370709AM24

after personal hearing the committee has directed to the firm to appear again within one month before Norms Committee with all relevant documents, so that a decision could be taken.

Case No.	28 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00003538AM23
RA File Number	03AA04007907 AM22
Licence No and<br>Date	0311003867/17/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance authorization<br>No. 0310838453 dated 24/09/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>PHENOL<br>1.15 kg.<br>2<br>XYLENE<br>0.50 kg.<br>3<br>MAGNESIUM TURNINGS<br>0.148 kg.<br>4<br>PARAFORMALDEHYDE<br>0.9177 kg.<br>COUMARIN<br>1 kg.<br>5<br>ACETIC ANHYDRIDE<br>0.7356 kg.<br>RA concerned may take further necessary action as per above decision of NC.

NGS 0.148 kg. 4 PARAFORMALDEHYDE 0.9177 kg. COUMARIN 1 kg. 5 ACETIC ANHYDRIDE 0.7356 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	29 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	U. K. AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00005651AM23
RA File Number	03AA04019445 AM22
Licence No and	0311004281/03/06/2021

UDIN00370709AM24

Date

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.
BENZYL PROPIONATE	1 kg.	1	PROPIONIC ACID	0.53 kg.

Case No.	30 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00002621AM23
RA File Number	30AA04004647 AM22
Licence No and<br>Date	3011000736/12/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

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 KETOPROFEN 1 kg. 1 3 1 CYANOETHYL BENZOIC ACID 0.90 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	31 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00004186AM23
RA File Number	03AA04019330 AM22
Licence No and<br>Date	0311004745/19/06/2021

UDIN00370709AM24

|Nor T V RA|ms Committee Decision: he Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP ol. I as per details given below or as applied by the firm, whichever is less:-|ms Committee Decision: he Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP ol. I as per details given below or as applied by the firm, whichever is less:-|ms Committee Decision: he Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP ol. I as per details given below or as applied by the firm, whichever is less:-|ms Committee Decision: he Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP ol.

iven below or as applied by the firm, whichever is less:-|ms Committee Decision: he Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP ol. I as per details given below or as applied by the firm, whichever is less:-|ms Committee Decision: he Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP ol. I as per details given below or as applied by the firm, whichever is less:-| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||MEROPENEM FOR INJECTION (MEROPENEM BUFFERED STERILE) [Containing NLT 84% Sterile Meropenem]|1 kg.|1|MEROPENEM NON STERILE MEROPENEM TRIHYDRATE NON STERILE| 0.8968 kg.| ||||2|Packing Material|Relevant, as per Packing Policy| ||concerned may take further necessary action as per above decision of NC.|||||

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:-

on:

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:-

Case No.	32 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	ORGANIC INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00129686AM22
RA File Number	06AA04003603 AM22
Licence No and<br>Date	0611000533/02/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toNorms Committee-6.

Case No.	Case No.	33 / NC/3/MEET/Oct/202324/15	33 / NC/3/MEET/Oct/202324/15	33 / NC/3/MEET/Oct/202324/15	33 / NC/3/MEET/Oct/202324/15	33 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		SAURAV CHEMICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00135125AM22
RA File Number		30AA04009718 AM22
Licence No and Date		3011000867/09/07/2021
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00370709AM24

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

UDIN00370709AM24

1	L PROLINAMIDE	0.768 kg
2	3 AMINO 1 ADAMANTANOL	0.769 kg
3	IMIDAZOLE	0.464 kg
4	METHYL ETHYL KETONE 2 BUTANONE	1.00 kg
5	CYCLOHEXANE	0.50 kg
6	POTASSIUM CARBONATE	0.74 kg
7	ACETONE	0.80 kg

Case No.	34 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	VARTIKA CHEMICALS AND PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00002099AM23
RA File Number	NA
Licence No and<br>Date	1311000462/22/07/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	35 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00148419AM22
RA File Number	31AA04021097 AM22
Licence No and<br>Date	3111000476/27/07/2021
Norms Committee Decision:

3/ MEET/ Oct/ 202324/ 15 and 13/10/2023| |HQ File Number|HQRNORM APPLY 00148419AM22| |RA File Number|31AA04021097 AM22| |Licence No and Date|3111000476/27/07/2021| |Norms Committee Decision:||

UDIN00370709AM24

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

Copy of DML with complete composition of export items.

Case No.	36 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00150875AM22
RA File Number	05AA04055660 AM22
Licence No and<br>Date	0511003910/30/07/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	37 / NC/3/MEET/Oct/202324/15	37 / NC/3/MEET/Oct/202324/15	37 / NC/3/MEET/Oct/202324/15	37 / NC/3/MEET/Oct/202324/15	37 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		MEGHMANI NOVOTECH PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00160149AM22
RA File Number		08AA04019584 AM22
Licence No and<br>Date		0811002298/11/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed<br>1<br>Biphenyl<br>1.389 kg.<br>2<br>Paraformaldehyde<br>1.0 kg.<br>3<br>Zinc Chloride Anhydrous<br>1.0 kg.<br>BCMB<br>(Bis Chloro Methyl Biphenyl)<br>1 kg<br>4<br>Methanol<br>0.889 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

kg. 3 Zinc Chloride Anhydrous 1.0 kg. BCMB (Bis Chloro Methyl Biphenyl) 1 kg 4 Methanol 0.889 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed| ||BCMB (Bis Chloro Methyl Biphenyl)||1 kg|1|Biphenyl|1.389 kg.| |||||2|Paraformaldehyde|1.0 kg.| |||||3|Zinc Chloride Anhydrous|1.0 kg.| |||||4|Methanol|0.889 kg.|

Case No.	Case No.	37 / NC/3/MEET/Oct/202324/15	37 / NC/3/MEET/Oct/202324/15	37 / NC/3/MEET/Oct/202324/15	37 / NC/3/MEET/Oct/202324/15	37 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		MEGHMANI NOVOTECH PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00160149AM22
RA File Number		08AA04019584 AM22
Licence No and<br>Date		0811002298/11/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed<br>1<br>Biphenyl<br>1.389 kg.<br>2<br>Paraformaldehyde<br>1.0 kg.<br>3<br>Zinc Chloride Anhydrous<br>1.0 kg.<br>BCMB<br>(Bis Chloro Methyl Biphenyl)<br>1 kg<br>4<br>Methanol<br>0.889 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

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Case No.	38 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00165403AM22
RA File Number	05AA04062260 AM22
Licence No and<br>Date	0511004178/18/08/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	39 / NC/3/MEET/Oct/202324/15	39 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00003533AM23
RA File Number		03AA04055267 AM22
Licence No and<br>Date		0311006418/25/08/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>**Sl. No.

est 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:- Sl. No. Export Product Quantity 1 Medical Creams/ Ointments(Clotrimazole 1 Percentage Cream 1/2 OZ 14 Gm Tube Tot Wt: 773.50 Kg (Net Cont: Ceto 77.35 Kg, Oct 104.42 Kg, Cetyl 23.21Kg, Sorbitan 15.47Kg, Polysorbate 11.60Kg, Clotrimazole 7.93 Kg, Benzyl 7.74Kg)) 1 Number 2 Medical Creams/ Ointments(Clotrimazole 1 Percentage Cream 45 Gm Tube with 1 Applicator Tot Wt: 7120.31 Kg (Net Cont: Ceto 712.03 Kg, Oct 961.24Kg, Cetyl 213.61Kg, Sorbitan 142.41Kg, Polysorbate 106.80Kg, Clotrimazole 73.02 Kg, Benzyl 71.20Kg, App 158229 Nos)) 1 Number Medical Creams/ Ointments(Clotrimazole 1 Percentage Cream 45 Gm Tube with 7 Applicator Tot Wt: 791.19 Kg (Net Cont: Ceto 79.12 Kg, Oct 106.81Kg, Cetyl 3 Number|||| ||Export Product||Quantity| ||Medical Creams/ Ointments(Clotrimazole 1 Percentage Cream 1/2 OZ 14 Gm Tube Tot Wt: 773.50 Kg (Net Cont: Ceto 77.35 Kg, Oct 104.42 Kg, Cetyl 23.21Kg, Sorbitan 15.47Kg, Polysorbate 11.60Kg, Clotrimazole 7.93 Kg, Benzyl 7.74Kg))||1 Number| ||Medical Creams/ Ointments(Clotrimazole 1 Percentage Cream 45 Gm Tube with 1 Applicator Tot Wt: 7120.31 Kg (Net Cont: Ceto 712.03 Kg, Oct 961.24Kg, Cetyl 213.61Kg, Sorbitan 142.41Kg, Polysorbate 106.80Kg, Clotrimazole 73.02 Kg, Benzyl 71.20Kg, App 158229 Nos))||1 Number|

pplicator Tot Wt: 7120.31 Kg (Net Cont: Ceto 712.03 Kg, Oct 961.24Kg, Cetyl 213.61Kg, Sorbitan 142.41Kg, Polysorbate 106.80Kg, Clotrimazole 73.02 Kg, Benzyl 71.20Kg, App 158229 Nos))||1 Number| ||Medical Creams/ Ointments(Clotrimazole 1 Percentage Cream 45 Gm Tube with 7 Applicator Tot Wt: 791.19 Kg (Net Cont: Ceto 79.12 Kg, Oct 106.81Kg, Cetyl||Number|

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23.74Kg, Sorbitan 15.82Kg, Polysorbate 11.87Kg, Clotrimazole 8.11 Kg, Benzyl 7.91Kg, App 17582 Nos))

Import Items	Quantity allowed.
Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
Relevant Excipients	Net content in the export product plus 2% wastage.
Relevant Packaging Material	Relevant as per Packing Policy

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

Case No.	Case No.	40 / NC/3/MEET/Oct/202324/15	40 / NC/3/MEET/Oct/202324/15	40 / NC/3/MEET/Oct/202324/15	40 / NC/3/MEET/Oct/202324/15	40 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00177562AM22
RA File Number		08AA04023793 AM22
Licence No and<br>Date		0811002515/06/09/2021
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 of HBP<br>Vol.

|Licence No and Date||0811002515/06/09/2021||||| |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. 1 OSELTAMIVIR PHOSPHATE USP 512.34 mg. 2 NEOSORB P100T-SORBITOL 11162.16 mg 3 XANTHAN GUM, XANTRUAL 180 195.00 mg. OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION 6MG/ML, 60ML((ACTIVE INGREDIENT: OSELTAMIVIR PHOSPHATE USP - NET WT. 1854.000 KGS.)) 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION 6MG/ML, 60ML((ACTIVE INGREDIENT: OSELTAMIVIR PHOSPHATE USP - NET WT. 1854.000 KGS.))|| 1 Number|1|OSELTAMIVIR PHOSPHATE USP|512.34 mg.| |||||2|NEOSORB P100T-SORBITOL|11162.16 mg| |||||3|XANTHAN GUM, XANTRUAL 180|195.00 mg.|

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==> picture [464 x 249] intentionally omitted <==

----- Start of picture text ----- 4 MONOSODIUM CITRATE D 695.00 mg. 5 SODIUM SACCHARIN, 13.00 mg. DIHYDRATE, POWDER, USP 6 ETHYL ALCOHOL 200 PROOF 1558.00 mg. 7 TITANIUM DIOXIDE USP 195.00 mg. 8 BOTTLE: AMBER GLASS 100 Relevant as per ML Packing Policy 9 CLOSURE: VISTOP CRC 28 Relevant as per Packing Policy ----- End of picture text -----

M DIOXIDE USP 195.00 mg. 8 BOTTLE: AMBER GLASS 100 Relevant as per ML Packing Policy 9 CLOSURE: VISTOP CRC 28 Relevant as per Packing Policy ----- End of picture text -----

Case No.	41 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00181385AM22
RA File Number	08AA04024263 AM22
Licence No and<br>Date	0811002550/10/09/2021
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Meropenem for injection 1 Gm<br>(Each vial contains Meropenem<br>1000 mg on Anhydrous basis)<br>1 Vial<br>1<br>Meropenem with Sodium Carbonate<br>USP<br>1.29 gm.<br>RA concerned may take further necessary action as per above decision of NC.

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g on Anhydrous basis) 1 Vial 1 Meropenem with Sodium Carbonate USP 1.29 gm. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	42 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00192148AM22
RA File Number	03AA04091496 AM22
Licence No and<br>Date	0311007180/23/09/2021
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Molar Weight of each input and output item of each stage.<br>i.<br>Percentage yield on molar basis for each step.<br>ii.<br>CA certified Production/Consumption data.<br>iii.<br>Sample of Shipping Bills and Bill of Entry of the export products along with statement of Input-output as per<br>export documents of the said authorization.<br>iv.

ion data.** iii. Sample of Shipping Bills and Bill of Entry of the export products along with statement of Input-output as per export documents of the said authorization. iv.||

Case No.	Case No.	43 / NC/3/MEET/Oct/202324/15	43 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00195497AM22
RA File Number		03AA040105795 AM22
Licence No and<br>Date		0311007265/27/09/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl. No. Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Clobetasol Propionate Cream 0.05 Percentage 15 Gm tube<br>Tot Wt. 1500 Kgs (Net Cont: Clobetasol 0.78 Kg, Arlacel 67.50 Kgs, White Wax 15 Kgs,<br>Empty Tubes: 100000 Nos))<br>1 Number<br>2<br>Medical Creams & Ointments(Clobetasol Propionate Cream 0.05 Percentage 30 Gm tube<br>Tot Wt. 2000.01Kgs (Net Cont: Clobetasol 1.04 Kg, Arlacel 90 Kgs, White Wax 20 Kgs,<br>Empty Tubes: 66667 Nos))<br>1 Number
	Export Product		Quantity
	Medical Creams & Ointments(Clobetasol Propionate Cream 0.05 Percentage 15 Gm tube<br>Tot Wt.

0 Kgs, White Wax 20 Kgs, Empty Tubes: 66667 Nos)) 1 Number|||| ||Export Product||Quantity| ||Medical Creams & Ointments(Clobetasol Propionate Cream 0.05 Percentage 15 Gm tube Tot Wt. 1500 Kgs (Net Cont: Clobetasol 0.78 Kg, Arlacel 67.50 Kgs, White Wax 15 Kgs, Empty Tubes: 100000 Nos))||1 Number| ||Medical Creams & Ointments(Clobetasol Propionate Cream 0.05 Percentage 30 Gm tube Tot Wt. 2000.01Kgs (Net Cont: Clobetasol 1.04 Kg, Arlacel 90 Kgs, White Wax 20 Kgs, Empty Tubes: 66667 Nos))||1 Number|

UDIN00370709AM24

3	Medical Creams & Ointments(Clobetasol Propionate Cream 0.05 Percentage 45 Gm tube	Number
	Tot Wt. 1500.03Kgs (Net Cont: Clobetasol 0.78 Kg, Arlacel 67.50 Kgs, White Wax 15
	Kgs, Empty Tubes: 33334 Nos))
4	Medical Creams & Ointments(Clobetasol Propionate Cream 0.05 Percentage 60 Gm tube	1 Number
	Tot Wt. 2999.88Kgs (Net Cont: Clobetasol 1.56 Kg, Arlacel 135 Kgs, White Wax 30 Kgs,
	Empty Tubes: 49998 Nos))

Import Items	Quantity allowed.
Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
Relevant Excipients	Net content in the export product plus 2% wastage.
Relevant Packaging Material	Relevant as per Packing Policy

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

Case No.	Case No.	44 / NC/3/MEET/Oct/202324/15	44 / NC/3/MEET/Oct/202324/15	44 / NC/3/MEET/Oct/202324/15	44 / NC/3/MEET/Oct/202324/15	44 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		HONOUR LAB LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00197140AM22
RA File Number		09AA04015351 AM22
Licence No and<br>Date		0911001652/29/09/2021
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>5 -(2-fluoropheny 1)-1H-pyrrole-3 -<br>carbaldehyde (FPC)<br>0.757 kg.<br>VONOPRAZAN FUMARATE<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items<br>	Qty. allowed.
	VONOPRAZAN FUMARATE		1 kg.	1	5 -(2-fluoropheny 1)-1H-pyrrole-3 -<br>carbaldehyde (FPC)<br>	0.757 kg.

g.||||||| ||Export Product||Qty.|Sl. No.|Import Items |Qty. allowed.| ||VONOPRAZAN FUMARATE||1 kg.|1|5 -(2-fluoropheny 1)-1H-pyrrole-3 - carbaldehyde (FPC) |0.757 kg.|

Case No.	Case No.	44 / NC/3/MEET/Oct/202324/15	44 / NC/3/MEET/Oct/202324/15	44 / NC/3/MEET/Oct/202324/15	44 / NC/3/MEET/Oct/202324/15	44 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		HONOUR LAB LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00197140AM22
RA File Number		09AA04015351 AM22
Licence No and<br>Date		0911001652/29/09/2021
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>5 -(2-fluoropheny 1)-1H-pyrrole-3 -<br>carbaldehyde (FPC)<br>0.757 kg.<br>VONOPRAZAN FUMARATE<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items<br>	Qty. allowed.
	VONOPRAZAN FUMARATE		1 kg.	1	5 -(2-fluoropheny 1)-1H-pyrrole-3 -<br>carbaldehyde (FPC)<br>	0.757 kg.

UDIN00370709AM24

uct**||Qty.|Sl. No.|Import Items |Qty. allowed.| ||VONOPRAZAN FUMARATE||1 kg.|1|5 -(2-fluoropheny 1)-1H-pyrrole-3 - carbaldehyde (FPC) |0.757 kg.|

UDIN00370709AM24

2<br>5-(2-Fluorophenyl)-l-(pyridin-3-<br>ylsulfonyl)-lH-pyrrole-3- carbaldehyde.<br>(VNF-I)<br>Not required.<br>3<br>Pyridine-3-sulfonyl chloride<br>0.856 kg.<br>RA concerned may take further necessary action as per above decision of NC			2	5-(2-Fluorophenyl)-l-(pyridin-3-<br>ylsulfonyl)-lH-pyrrole-3- carbaldehyde.<br>(VNF-I)	<br>Not required.
			3	Pyridine-3-sulfonyl chloride	0.856 kg.

Case No.	45 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00210670AM22
RA File Number	56AA04005794 AM22
Licence No and<br>Date	5611000556/12/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Soya Lecithin Liquid<br>1 MT<br>1<br>Crude Soya Lecithin<br>1.01 MT<br> RA concerned may take further necessary action as per above decision of NC.

** Import Items Qty. allowed. Soya Lecithin Liquid 1 MT 1 Crude Soya Lecithin 1.01 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	46 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	AMARA LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00211472AM22
RA File Number	09AA04016055 AM22
Licence No and<br>Date	0911001711/13/10/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

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Case No.	47 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00001209AM23
RA File Number	08AA04033169 AM22
Licence No and<br>Date	0811002929/20/10/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>MITOXANTRONE CONCENTRATE FOR<br>SOLUTION FOR INFUSION 2MG/ML,<br>5ML VIAL(EACH ML CONTAINS:<br>MITOXANTRONE HYDROCHLORIDE<br>PH. EUR. EQ. TO MITOXANTRONE 2<br>MG)<br>1 Number<br>1<br>MITOXANTRONE<br>HYDROCHLORIDE<br>EP / BP / IP / USP / PH.

OR INFUSION 2MG/ML, 5ML VIAL(EACH ML CONTAINS: MITOXANTRONE HYDROCHLORIDE PH. EUR. EQ. TO MITOXANTRONE 2 MG) 1 Number 1 MITOXANTRONE HYDROCHLORIDE EP / BP / IP / USP / PH. EUR. (WATER + Residual Solvent NLT 3.56 %) 13.27 mg MITOXANTRONE CONCENTRATE FOR SOLUTION FOR INFUISON 2MG/ML, 10 ML VIAL(EACH ML CONTAINS: MITOXANTRONE HYDROCHLORIDE PH. EUR. EQ. TO MITOXANTRONE 2 MG) 1 Number 2 MITOXANTRONE HYDROCHLORIDE EP / BP / IP / USP / PH. EUR. (WATER + Residual Solvent NLT 3.56 %) 26.54 mg MITOXANTRONE CONCENTRATE FOR SOLUTION FOR INFUSION 2MG/ML, 15 ML VIAL(EACH ML CONTAINS: MITOXANTRONE HYDROCHLORIDE PH. EUR. EQ. TO MITOXANTRONE 2 MG [IN WHICH ACTIVE INGREDIENT MITOXANTRONE HCL USED IS 134.000 GRAMS]) 1 Number 3 MITOXANTRONE HYDROCHLORIDE EP / BP / IP / USP / PH. EUR. (WATER + Residual Solvent NLT 3.56 %) 38.01 mg RA concerned may take further necessary action as per above decision of NC||

Case No.	48 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED

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r necessary action as per above decision of NC||

Case No.	48 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED

UDIN00370709AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00220585AM22
RA File Number	05AA04090983 AM22
Licence No and<br>Date	0511005557/21/10/2021
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Stepwise complete and balanced chemical reaction with molar weight and percentage yields on molar<br>basis for each step.<br>1.<br>Past-Production-consumption data for three years.<br>2.

Case No.	49 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	BHAGWATI INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00219420AM22
RA File Number	08AA04033013 AM22
Licence No and<br>Date	0811002934/21/10/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE

APPLY 00219420AM22| |RA File Number|08AA04033013 AM22| |Licence No and Date|0811002934/21/10/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE||

Case No.	50 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00220583AM22
RA File Number	05AA04091027 AM22
Licence No and<br>Date	0511005556/21/10/2021
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Stepwise complete and balanced chemical reaction with molar weight and percentage yields on molar<br>basis for each step.<br>i.

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ii. Past-Production-consumption data for three years.

Case No.	51 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00221594AM22
RA File Number	08AA04033661 AM22
Licence No and<br>Date	0811002958/22/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>VINORELBINE CONCENTRATE<br>FOR SOLUTION FOR INFUSION<br>10MG/ML, 1ML VIAL(EACH ML<br>CONTAINS: VINORELBINE<br>TARTRATE PH.EUR EQ. TO<br>VINORELBINE 10 MG)<br>1 Number<br>1<br>VINORELBINE TARTRATE<br>EP / BP / IP / USP / PH. EUR<br>(Water content 2.3 %)<br>14.33 mg<br>VINORELBINE CONCENTRATE<br>FOR SOLUTION FOR INFUSION<br>10MG/ML, 5ML VIAL(EACH ML<br>CONTAINS: VINORELBINE<br>TARTRATE PH.EUR EQ. TO<br>VINORELBINE 10 MG [IN WHICH<br>ACTIVE INGREDIENT<br>VINORELBINE TARTRATE<br>USED IS 843.000 GRAMS])<br>1 Number<br>2<br>VINORELBINE TARTRATE<br>EP / BP / IP / USP / PH. EUR<br>(Water content 2.3 %)<br>71.66 mg<br>RA concerned may take further necessary action as per above decision of NC

RAMS]) 1 Number 2 VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR (Water content 2.3 %) 71.66 mg RA concerned may take further necessary action as per above decision of NC||

Case No.	52 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00227461AM22

UDIN00370709AM24

RA File Number	RA File Number	03AA04097792 AM22	03AA04097792 AM22	03AA04097792 AM22	03AA04097792 AM22	03AA04097792 AM22
Licence No and<br>Date		0311007966/27/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>[(R)-9-(2-PHOSPHONYL<br>METHOXYPROPYL) ADENINE]<br>0.769 kg.<br>2<br>MDC<br>1.363 kg.<br>3<br>IPA<br>1.363 kg.<br>4<br>CYCLOHEXANE<br>3.40 kg.<br>5<br>N-METHYL-2-PYRROLIDONE?<br>1.4478 kg.<br>TENOFOVIR<br>DISOPROXIL<br>FUMARATE<br>1 kg.<br>6<br>CHLOROMETHYL<br>ISOPROPYL<br>CARBONATE<br>1.3527 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

kg. 6 CHLOROMETHYL ISOPROPYL CARBONATE 1.3527 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||TENOFOVIR DISOPROXIL FUMARATE|| 1 kg.|1|[(R)-9-(2-PHOSPHONYL METHOXYPROPYL) ADENINE]|0.769 kg.| |||||2|MDC|1.363 kg.| |||||3|IPA|1.363 kg.| |||||4|CYCLOHEXANE|3.40 kg.| |||||5|N-METHYL-2-PYRROLIDONE?|1.4478 kg.| |||||6|CHLOROMETHYL ISOPROPYL CARBONATE| 1.3527 kg.| |||||action as per above decision of NC.|||

Case No.	53 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00006964AM23
RA File Number	09AA04016788 AM22
Licence No and<br>Date	0911001796/29/10/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-

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

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Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Calcium and Colecalciferol Tablets<br>500mg/400 IU(D-CALSOR 500mg/400<br>IU)(Calcium and Colecalciferol Tablets<br>500mg/400 IU(D-CALSOR 500mg/400<br>IU))<br>1 Number<br>1<br>Colecalciferol<br>concentrate<br>(powder form)] (Dry Vitamin<br>D3 100 SD/S )<br>4.73 mg<br>Calcium and Colecalciferol Tablets<br>500mg/800 IU(D-CALSOR 500mg/800<br>IU)(Calcium and Colecalciferol Tablets<br>500mg/800 IU(D-CALSOR 500mg/800<br>IU))<br>1 Number<br>2<br>Colecalciferol<br>concentrate<br>(powder form)] (Dry Vitamin<br>D3 100 SD/S )<br>9.56 mg<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Calcium and Colecalciferol Tablets<br>500mg/400 IU(D-CALSOR 500mg/400<br>IU)(Calcium and Colecalciferol Tablets<br>500mg/400 IU(D-CALSOR 500mg/400<br>IU))	<br> <br> <br>1 Number	1	Colecalciferol<br>concentrate<br>(powder form)] (Dry Vitamin<br>D3 100 SD/S )	<br> <br>4.73 mg
	Calcium and Colecalciferol Tablets<br>500mg/800 IU(D-CALSOR 500mg/800<br>IU)(Calcium and Colecalciferol Tablets<br>500mg/800 IU(D-CALSOR 500mg/800<br>IU))	<br> <br> <br>1 Number	2	Colecalciferol<br>concentrate<br>(powder form)] (Dry Vitamin<br>D3 100 SD/S )	<br> <br>9.56 mg

Case No.	54 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00239769AM22
RA File Number	09AA04001389 AM22
Licence No and<br>Date	0911001808/02/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technology<br>for obtaining their comments.

Case No.	55 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00003766AM23
RA File Number	03AA040116810 AM22
Licence No and Date	0311008170/02/11/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00370709AM24

ixation 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:-||

UDIN00370709AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
2,5-DIMERCAPTO-1,3,4-<br>THIADIAZOLE(YALUB DMTD)	1 kg.	1	HYDRAZINE HYDRATE<br>(Max. 80% purity)	0.4125 kg.
		2	CAUSTIC SODA	0.266 kg.
		3	CARBON DISULPHIDE	0.048 kg.

Case No.	56 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00253270AM22
RA File Number	05AA04099135 AM22
Licence No and<br>Date	0511006147/15/11/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00253270AM22| |RA File Number|05AA04099135 AM22| |Licence No and Date|0511006147/15/11/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	57 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00255868AM22
RA File Number	03AA040112749 AM22
Licence No and<br>Date	0311008637/17/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	58 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED

UDIN00370709AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00255297AM22
RA File Number	34AA04009240 AM22
Licence No and<br>Date	3411001409/17/11/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00255297AM22| |RA File Number|34AA04009240 AM22| |Licence No and Date|3411001409/17/11/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	59 / NC/3/MEET/Oct/202324/15	59 / NC/3/MEET/Oct/202324/15	59 / NC/3/MEET/Oct/202324/15	59 / NC/3/MEET/Oct/202324/15	59 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00262432AM22
RA File Number		05AA04098038 AM22
Licence No and<br>Date		0511006369/23/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Nov/202223/12 dated 18/11/2022against advance<br>authorizationNo.0511011349 dated 24/03/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2-Deoxy-2,-difluoro-D-ribofuranose-3,5-<br>dibenzoate-1-methanesulphonate (T-8).<br>5.40 gram<br>Gemcitabine Hydrochloride USP<br>1 gram<br>2<br>N Acetylcytosine<br>2.92 gram<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

1 gram 2 N Acetylcytosine 2.92 gram RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Gemcitabine Hydrochloride USP||1 gram|1|2-Deoxy-2,-difluoro-D-ribofuranose-3,5- dibenzoate-1-methanesulphonate (T-8).|5.40 gram| |||||2|N Acetylcytosine|2.92 gram| |||||as per above decision of NC.|||

Case No.	60 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00266181AM22
RA File Number	08AA04035102 AM22
Licence No and<br>Date	0811003242/26/11/2021

UDIN00370709AM24

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Aug/202324/11 dated 22/08/2023 against advance authorization No.0811002696 dated 27/09/2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
TOPOTECAN INJECTION 1<br>MG/ML, 1 ML VIAL (EACH ML<br>CONTAINS TOPOTECAN<br>HYDROCHLORIDE EQ. TO<br>TOPOTECAN 1MG)	1 Number	1	TOPOTECAN HYDROCHLORIDE<br>(Water and Residual solvents content not<br>less than 9.0% in the API)	<br>1.313 mg.
TOPOTECAN INJECTION 1<br>MG/ML, 4 ML VIAL (EACH ML<br>CONTAINS TOPOTECAN<br>HYDROCHLORIDE EQ. TO<br>TOPOTECAN 1 MG)	1 Number	2	TOPOTECAN HYDROCHLORIDE<br>(Water and Residual solvents content not<br>less than 9.0% in the API)	<br>5.16 mg.
TOPOTECAN HYDROCHLORIDE<br>FOR INJECTION 4MG/VIAL (5ML<br>VIAL) (EACH VIAL CONTAINS<br>TOPOTECAN HYDROCHLORIDE<br>EQ. TO TOPOTECAN 4 MG [IN<br>WHICH ACTIVE INGREDIENT<br>TOPOTECAN HYDROCHLORIDE<br>USED IS 71.000 GRAMS])	1 Number	3	TOPOTECAN HYDROCHLORIDE<br>(Water and Residual solvents content not<br>less than 9.0% in the API)	<br>5.16 mg.

Case No.	61 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00276162AM22
RA File Number	03AA040123869 AM22
Licence No and<br>Date	0311009212/06/12/2021
Norms Committee Decision:<br>Shri Manuel Nazareth, GM and Shri Versing Shinde, Plant Head of the firm had attended the Personal<br>Hearing and explained firm’s case. The Committee heard the explanation of Representatives of the firm and<br>after personal hearing the committee has directed to the firm to appear again within one month before

UDIN00370709AM24

Norms Committee with all relevant documents, so that a decision could be taken.

hearing the committee has directed to the firm to appear again within one month before||

UDIN00370709AM24

Norms Committee with all relevant documents, so that a decision could be taken.

Case No.	62 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00283764AM22
RA File Number	09AA04017426 AM22
Licence No and Date	0911001978/13/12/2021
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Ethyl-3-amino-1-4-<br>cyanotetrahydro-2H-pyran-3-yl)-<br>1H-Pyrazole-4-carboxylate<br>(Racemic ECPC)<br>5.120 kg.<br>2<br>2-Fluoro-4-Iodo-6-Methoxy<br>Pyridine (IFMP)<br>2.267 kg.<br>1-[(3R,4S)-4-Cyanotetrahydropyran-3-<br>yl]-3-[(2-fluoro-6-methoxy-4-pyridyl)<br>amino]pyrazole-4-carboxamide((L-<br>005251026-Form-I))<br>1 kg.<br>3<br>4,5-bis(Diphenylphosphino)-9,9-<br>dimethylxanthane (Xantphos)<br>0.153 kg.<br>RA concerned may take further necessary action as per above decision of NC.

005251026-Form-I)) 1 kg. 3 4,5-bis(Diphenylphosphino)-9,9- dimethylxanthane (Xantphos) 0.153 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	63 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM REVIW00006199AM23
RA File Number	09AX04000002 AM22
Licence No and<br>Date	0911002041/13/12/2021
Norms Committee Decision:<br>.

UDIN00370709AM24

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.
AMOXYCILLIN<br>AND<br>CLAVULANATE<br>POTASSIUM<br>TABLETS 1000 MG (each film<br>coated Tablet contains: amoxicillin<br>Trihydrate<br>Equivalent<br>to<br>Amoxicillin 875 mg, Clavulanate<br>Potassium equivalent to Clavulanic<br>Acid 125 mg.	<br> <br> <br> <br> <br> <br> <br>1 Number	1	6-Amino penicillanic acid (6-APA)	581.77 mg.
		2	D-(-)-4-hydroxyphenylglycine methyl<br>ester [PHPG Ester]	502.40 mg.
		3	Penicillin G Amidase	2.00 mg.
		4	Diluted Clavulanate Potassium (1:1) /<br>Potassium Clavulanate Diluted with<br>Microcrystalline Cellulose (1:1)	303.773 mg.

ster [PHPG Ester]|502.40 mg.| |||3|Penicillin G Amidase|2.00 mg.| |||4|Diluted Clavulanate Potassium (1:1) / Potassium Clavulanate Diluted with Microcrystalline Cellulose (1:1)|303.773 mg.|

Case No.	Case No.	64 / NC/3/MEET/Oct/202324/15	64 / NC/3/MEET/Oct/202324/15	64 / NC/3/MEET/Oct/202324/15	64 / NC/3/MEET/Oct/202324/15	64 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00285202AM22
RA File Number		09AA04017427 AM22
Licence No and Date		0911002053/14/12/2021
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>4,5-bis(Diphenylphosphino)-9,9-<br>dimethylxanthane (Xantphos)<br>0.153 kg.<br>2<br>Ethyl-3-amino-1-4-<br>cyanotetrahydro-2H-pyran-3-yl)-<br>1H-Pyrazole-4-carboxylate<br>(Racemic ECPC)<br>5.120 kg.<br>1-[(3R,4S)-4-Cyanotetrahydropyran-3-yl]-3-<br>[(2-fluoro-6-methoxy-4-pyridyl)<br>amino]pyrazole-4-carboxamide ((L-<br>005251026-Form-I))<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

rahydropyran-3-yl]-3- [(2-fluoro-6-methoxy-4-pyridyl) amino]pyrazole-4-carboxamide ((L- 005251026-Form-I)) 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||1-[(3R,4S)-4-Cyanotetrahydropyran-3-yl]-3- [(2-fluoro-6-methoxy-4-pyridyl) amino]pyrazole-4-carboxamide ((L- 005251026-Form-I))||1 kg.|1|4,5-bis(Diphenylphosphino)-9,9- dimethylxanthane (Xantphos)|0.153 kg.| |||||2|Ethyl-3-amino-1-4- cyanotetrahydro-2H-pyran-3-yl)- 1H-Pyrazole-4-carboxylate (Racemic ECPC)|5.120 kg.|

UDIN00370709AM24

	3	2-Fluoro-4-Iodo-6-Methoxy	2.267 kg.
		Pyridine (IFMP)

Case No.	65 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00287478AM22
RA File Number	03AA040122138 AM22
Licence No and<br>Date	0311009510/16/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call the firm for attending before Norms Committee to explain its case.||Personal Hearing|

Case No.	Case No.	66 / NC/3/MEET/Oct/202324/15	66 / NC/3/MEET/Oct/202324/15	66 / NC/3/MEET/Oct/202324/15	66 / NC/3/MEET/Oct/202324/15	66 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		INFICHEM PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00291201AM22
RA File Number		52AX04000002 AM22
Licence No and<br>Date		5211001739/20/12/2021
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>FLUORENE<br>1.18 kg.<br>2,7-DICHLORO-9H-FLUORENE (DCF)<br>1 kg.<br>2<br>DIMETHYL<br>FORMAMIDE<br>(DMF)<br>1.10 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	2,7-DICHLORO-9H-FLUORENE (DCF)		1 kg.	1	FLUORENE	1.18 kg.
				2	DIMETHYL<br>FORMAMIDE<br>(DMF)	<br>1.10 kg.

UDIN00370709AM24

**Sl. No. **|Import Items|Qty. allowed.| ||2,7-DICHLORO-9H-FLUORENE (DCF)||1 kg.|1|FLUORENE|1.18 kg.| |||||2|DIMETHYL FORMAMIDE (DMF)| 1.10 kg.| ||||||||

UDIN00370709AM24

Case No.	67 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00291474AM22
RA File Number	08AX04000083 AM22
Licence No and<br>Date	0811003487/20/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance<br>authorizationNo. 0811001969 dated 12/07/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Q PARIN 1000 IU/ML (HEPARIN<br>SODIUM INJECTION USP/BP 5000<br>IU)<br>1 Number<br>1<br>HEPARIN SODIUM BP<br>(580 MEGA)<br>(Potency 156.3 IU/mg)<br>175.944 mg.<br>Q PARIN 5000 IU/ML (HEPARIN<br>SODIUM INJECTION USP/BP 25000<br>IU)<br>1 Number<br>2<br>HEPARIN SODIUM BP<br>(580 MEGA)<br>(Potency 156.3 IU/mg)<br>35.189 mg<br>RA concerned may take further necessary action as per above decision of NC.

CTION USP/BP 25000 IU) 1 Number 2 HEPARIN SODIUM BP (580 MEGA) (Potency 156.3 IU/mg) 35.189 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	68 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00291533AM22
RA File Number	34AX04000052 AM22
Licence No and<br>Date	3411001560/20/12/2021
Norms Committee Decision:

UDIN00370709AM24

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:-

|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.

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 Temazepam USP 7.65 mg 2 Lactose monohydrate (Spherolac 100) 169.13 mg 3 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 4 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 5 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 7.5 mg (Temazepam Caps Usp 7.5 mg (net content of active ingredients = 22.50 kgs)) 1 Number 6 Magnesium Stearate 2.00 mg 7 Temazepam USP 15.30 mg 8 Lactose monohydrate (Spherolac 100) 161.63 mg 9 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 10 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 11 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 15 mg (Temazepam Caps Usp 15 mg (net content of active ingredients = 135.00 kgs)) 1 Number 12 Magnesium Stearate 2.00 mg 13 Temazepam USP 22.95 mg 14 Lactose monohydrate (Spherolac 100) 154.13 mg 15 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 16 Microcrystalline Cellulose (Avicel PH200) 42.47 mg Temazepam Caps Usp 22.5 mg (Temazepam Caps Usp 22.5 mg (net content of active ingredients = 67.500 kgs)) 1 Number|The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

Caps Usp 22.5 mg (net content of active ingredients = 67.500 kgs)) 1 Number|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 Temazepam USP 7.65 mg 2 Lactose monohydrate (Spherolac 100) 169.13 mg 3 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 4 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 5 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 7.5 mg (Temazepam Caps Usp 7.5 mg (net content of active ingredients = 22.50 kgs)) 1 Number 6 Magnesium Stearate 2.00 mg 7 Temazepam USP 15.30 mg 8 Lactose monohydrate (Spherolac 100) 161.63 mg 9 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 10 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 11 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 15 mg (Temazepam Caps Usp 15 mg (net content of active ingredients = 135.00 kgs)) 1 Number 12 Magnesium Stearate 2.00 mg 13 Temazepam USP 22.95 mg 14 Lactose monohydrate (Spherolac 100) 154.13 mg 15 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 16 Microcrystalline Cellulose (Avicel PH200) 42.47 mg Temazepam Caps Usp 22.5 mg (Temazepam Caps Usp 22.5 mg (net content of active ingredients = 67.500 kgs)) 1 Number|The Committee considered the case as per ag

00) 42.47 mg Temazepam Caps Usp 22.5 mg (Temazepam Caps Usp 22.5 mg (net content of active ingredients = 67.500 kgs)) 1 Number|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 Temazepam USP 7.65 mg 2 Lactose monohydrate (Spherolac 100) 169.13 mg 3 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 4 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 5 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 7.5 mg (Temazepam Caps Usp 7.5 mg (net content of active ingredients = 22.50 kgs)) 1 Number 6 Magnesium Stearate 2.00 mg 7 Temazepam USP 15.30 mg 8 Lactose monohydrate (Spherolac 100) 161.63 mg 9 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 10 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 11 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 15 mg (Temazepam Caps Usp 15 mg (net content of active ingredients = 135.00 kgs)) 1 Number 12 Magnesium Stearate 2.00 mg 13 Temazepam USP 22.95 mg 14 Lactose monohydrate (Spherolac 100) 154.13 mg 15 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 16 Microcrystalline Cellulose (Avicel PH200) 42.47 mg Temazepam Caps Usp 22.5 mg (Temazepam Caps Usp 22.5 mg (net content of active ingredients =

Ac-Di-Sol) 6.90 mg 16 Microcrystalline Cellulose (Avicel PH200) 42.47 mg Temazepam Caps Usp 22.5 mg (Temazepam Caps Usp 22.5 mg (net content of active ingredients = 67.500 kgs)) 1 Number|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 Temazepam USP 7.65 mg 2 Lactose monohydrate (Spherolac 100) 169.13 mg 3 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 4 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 5 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 7.5 mg (Temazepam Caps Usp 7.5 mg (net content of active ingredients = 22.50 kgs)) 1 Number 6 Magnesium Stearate 2.00 mg 7 Temazepam USP 15.30 mg 8 Lactose monohydrate (Spherolac 100) 161.63 mg 9 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 10 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 11 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 15 mg (Temazepam Caps Usp 15 mg (net content of active ingredients = 135.00 kgs)) 1 Number 12 Magnesium Stearate 2.00 mg 13 Temazepam USP 22.95 mg 14 Lactose monohydrate (Spherolac 100) 154.13 mg 15 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 16 Microcrystalline Cellulose (Avicel PH200) 42.47 mg Temazepam Caps Usp 22.5 m

onohydrate (Spherolac 100) 154.13 mg 15 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 16 Microcrystalline Cellulose (Avicel PH200) 42.47 mg Temazepam Caps Usp 22.5 mg (Temazepam Caps Usp 22.5 mg (net content of active ingredients = 67.500 kgs)) 1 Number|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 Temazepam USP 7.65 mg 2 Lactose monohydrate (Spherolac 100) 169.13 mg 3 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 4 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 5 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 7.5 mg (Temazepam Caps Usp 7.5 mg (net content of active ingredients = 22.50 kgs)) 1 Number 6 Magnesium Stearate 2.00 mg 7 Temazepam USP 15.30 mg 8 Lactose monohydrate (Spherolac 100) 161.63 mg 9 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 10 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 11 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 15 mg (Temazepam Caps Usp 15 mg (net content of active ingredients = 135.00 kgs)) 1 Number 12 Magnesium Stearate 2.00 mg 13 Temazepam USP 22.95 mg 14 Lactose monohydrate (Spherolac 100) 154.13 mg 15 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 16 Microcrystalline Cellulos

tearate 2.00 mg 13 Temazepam USP 22.95 mg 14 Lactose monohydrate (Spherolac 100) 154.13 mg 15 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 16 Microcrystalline Cellulose (Avicel PH200) 42.47 mg Temazepam Caps Usp 22.5 mg (Temazepam Caps Usp 22.5 mg (net content of active ingredients = 67.500 kgs)) 1 Number|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 Temazepam USP 7.65 mg 2 Lactose monohydrate (Spherolac 100) 169.13 mg 3 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 4 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 5 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 7.5 mg (Temazepam Caps Usp 7.5 mg (net content of active ingredients = 22.50 kgs)) 1 Number 6 Magnesium Stearate 2.00 mg 7 Temazepam USP 15.30 mg 8 Lactose monohydrate (Spherolac 100) 161.63 mg 9 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 10 Microcrystalline Cellulose (Avicel PH200) 42.47 mg 11 Sodium Lauryl Sulfate 2.00 mg Temazepam Caps Usp 15 mg (Temazepam Caps Usp 15 mg (net content of active ingredients = 135.00 kgs)) 1 Number 12 Magnesium Stearate 2.00 mg 13 Temazepam USP 22.95 mg 14 Lactose monohydrate (Spherolac 100) 154.13 mg 15 Croscar

of active ingredients = 135.00 kgs)) 1 Number 12 Magnesium Stearate 2.00 mg 13 Temazepam USP 22.95 mg 14 Lactose monohydrate (Spherolac 100) 154.13 mg 15 Croscarmellose Sodium (Ac-Di-Sol) 6.90 mg 16 Microcrystalline Cellulose (Avicel PH200) 42.47 mg Temazepam Caps Usp 22.5 mg (Temazepam Caps Usp 22.5 mg (net content of active ingredients = 67.500 kgs)) 1 Number| |---|---|---|---|---|---| ||Export Product|Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Temazepam Caps Usp 7.5 mg (Temazepam Caps Usp 7.5 mg (net content of active ingredients = 22.50 kgs))| 1 Number|1|Temazepam USP|7.65 mg| ||||2|Lactose monohydrate (Spherolac 100)|169.13 mg| ||||3|Croscarmellose Sodium (Ac-Di-Sol)|6.90 mg| ||||4|Microcrystalline Cellulose (Avicel PH200)|42.47 mg| ||||5|Sodium Lauryl Sulfate|2.00 mg| ||||6|Magnesium Stearate|2.00 mg| ||Temazepam Caps Usp 15 mg (Temazepam Caps Usp 15 mg (net content of active ingredients = 135.00 kgs))| 1 Number|7|Temazepam USP|15.30 mg| ||||8|Lactose monohydrate (Spherolac 100)|161.63 mg| ||||9|Croscarmellose Sodium (Ac-Di-Sol)|6.90 mg| ||||10|Microcrystalline Cellulose (Avicel PH200)|42.47 mg| ||||11|Sodium Lauryl Sulfate|2.00 mg| ||||12|Magnesium Stearate|2.00 mg| ||Temazepam Caps Usp 22.5 mg (Temazepam Caps Usp 22.5 mg (net content of active ingredients = 67.500 kgs))| 1 Number|13|Temazepam USP|22.95 mg| ||||14|Lactose monohydrate (Spherolac 100)|154.13 mg|

br>22.5 mg (Temazepam Caps Usp 22.5 mg (net content of active ingredients = 67.500 kgs))| 1 Number|13|Temazepam USP|22.95 mg| ||||14|Lactose monohydrate (Spherolac 100)|154.13 mg| ||||15|Croscarmellose Sodium (Ac-Di-Sol)|6.90 mg| ||||16|Microcrystalline Cellulose (Avicel PH200)|42.47 mg|

UDIN00370709AM24

		17	Sodium Lauryl Sulfate	2.00 mg
		18	Magnesium Stearate	2.00 mg
Temazepam Caps Usp 30 mg (Temazepam<br>Caps Usp 30 mg<br>(net content of active ingredients = 270.00<br>kgs))	<br> <br>1 Number	19	Temazepam USP	30.60 mg
		20	Lactose monohydrate (Spherolac 100)	146.63 mg
		21	Croscarmellose Sodium (Ac-Di-Sol)	6.90 mg
		22	Microcrystalline Cellulose (Avicel<br>PH200)	42.47 mg
		23	Sodium Lauryl Sulfate	2.00 mg
		24	Magnesium Stearate	2.00 mg

146.63 mg| ||||21|Croscarmellose Sodium (Ac-Di-Sol)|6.90 mg| ||||22|Microcrystalline Cellulose (Avicel PH200)|42.47 mg| ||||23|Sodium Lauryl Sulfate|2.00 mg| ||||24|Magnesium Stearate|2.00 mg|

Case No.	Case No.	69 / NC/3/MEET/Oct/202324/15	69 / NC/3/MEET/Oct/202324/15	69 / NC/3/MEET/Oct/202324/15	69 / NC/3/MEET/Oct/202324/15	69 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00298292AM22
RA File Number		08AX04000091 AM22
Licence No and<br>Date		0811003537/27/12/2021
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>BUSPIRONE HYDROCHLORIDE<br>TABLETS USP 5 MG (EACH UNCOATED<br>TABLET CONTAINS: BUSPIRONE<br>HYDROCHLORIDE USP 5 MG)<br>29000000<br>Numbers<br>1<br>BUSPIRONE HYDROCHLORID E<br>EP / BP / IP / USP / PH. EUR.<br>147.90 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	BUSPIRONE HYDROCHLORIDE<br>TABLETS USP 5 MG (EACH UNCOATED<br>TABLET CONTAINS: BUSPIRONE<br>HYDROCHLORIDE USP 5 MG)		29000000<br>Numbers	1	BUSPIRONE HYDROCHLORID E<br>EP / BP / IP / USP / PH. EUR.	147.90 kg

UDIN00370709AM24

SP 5 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 5 MG)||29000000 Numbers|1|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|147.90 kg|

UDIN00370709AM24

|BUSPIRONE HYDROCHLORIDE TABLETS USP 7.5 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 7.5 MG) 15000000 Numbers 2 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 114.75 kg BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 10 MG) 8000000 Numbers 3 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 81.60 kg BUSPIRONE HYDROCHLORIDE TABLETS USP 15 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 15 MG) 5000000 Numbers 4 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 76.50 kg BUSPIRONE HYDROCHLORIDE TABLETS USP 30 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 30 MG [IN WHICH ACTIVE INGREDIENT BUSPIRONE HYDROCHLORIDE USED IS 484.500 KGS.]) 2400000 Numbers 5 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 73.44 kg RA concerned may take further necessary action as per above decision of NC.|BUSPIRONE HYDROCHLORIDE TABLETS USP 7.5 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 7.5 MG)| 15000000 Numbers|2|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH.

|BUSPIRONE HYDROCHLORIDE TABLETS USP 7.5 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 7.5 MG)| 15000000 Numbers|2|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|114.75 kg| |---|---|---|---|---|---| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 10 MG)|8000000 Numbers|3|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|81.60 kg| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 15 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 15 MG)|5000000 Numbers|4|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|76.50 kg| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 30 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 30 MG [IN WHICH ACTIVE INGREDIENT BUSPIRONE HYDROCHLORIDE USED IS 484.500 KGS.])|2400000 Numbers|5|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|73.44 kg|

Case No.	Case No.	70 / NC/3/MEET/Oct/202324/15	70 / NC/3/MEET/Oct/202324/15	70 / NC/3/MEET/Oct/202324/15	70 / NC/3/MEET/Oct/202324/15	70 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM REVIW00006967AM23
RA File Number		09AX04000070 AM22
Licence No and<br>Date		0911002189/28/12/2021

and Date||NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023||||| |HQ File Number||HQRNORM REVIW00006967AM23||||| |RA File Number||09AX04000070 AM22||||| |Licence No and Date||0911002189/28/12/2021||||| |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. Calcium and Colecalciferol Tablets 500mg/400 IU(D-CALSOR 500mg/400 IU)(Calcium and Colecalciferol Tablets 1 Number 1 Colecalciferol concentrate (powder form)] (Dry Vitamin D3 100 SD/S ) 4.73 mg||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Calcium and Colecalciferol Tablets 500mg/400 IU(D-CALSOR 500mg/400 IU)(Calcium and Colecalciferol Tablets||1 Number|1|Colecalciferol concentrate (powder form)] (Dry Vitamin D3 100 SD/S )| 4.73 mg|

UDIN00370709AM24

IU(D-CALSOR 500mg/400 IU)(Calcium and Colecalciferol Tablets||1 Number|1|Colecalciferol concentrate (powder form)] (Dry Vitamin D3 100 SD/S )| 4.73 mg|

UDIN00370709AM24

500mg/400 IU(D-CALSOR 500mg/400<br>IU))<br>Calcium and Colecalciferol Tablets<br>500mg/800 IU(D-CALSOR 500mg/800<br>IU)(Calcium and Colecalciferol Tablets<br>500mg/800 IU(D-CALSOR 500mg/800<br>IU))<br>1 Number<br>2<br>Colecalciferol<br>concentrate<br>(powder form)] (Dry Vitamin<br>D3 100 SD/S )<br>9.56 mg<br>RA concerned may take further necessary action as per above decision of NC.	500mg/400 IU(D-CALSOR 500mg/400<br>IU))
	Calcium and Colecalciferol Tablets<br>500mg/800 IU(D-CALSOR 500mg/800<br>IU)(Calcium and Colecalciferol Tablets<br>500mg/800 IU(D-CALSOR 500mg/800<br>IU))	1 Number	2	Colecalciferol<br>concentrate<br>(powder form)] (Dry Vitamin<br>D3 100 SD/S )	<br> <br>9.56 mg

Case No.	71 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00299344AM22
RA File Number	07AA04038998 AM22
Licence No and<br>Date	0711002737/28/12/2021
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was observed that the firm<br>has still not furnished the following documents/information.

mmittee Decision: The committee considered the request of firm for review/fixation of ad-hoc norms and it was observed that the firm has still not furnished the following documents/information. Therefore, the committee decided to call for the same from the firm:- Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis. 1. Sample of Shipping Bills and Bill of Entry of the export products along with statement of Input-output as per export documents of the said authorization 2.||

Case No.	72 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00310736AM22
RA File Number	05AX04000472 AM22
Licence No and<br>Date	0511007713/07/01/2022
Norms Committee Decision:

UDIN00370709AM24

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

i. Stepwise complete and balanced chemical reaction with molar weight and percentage yields on molar basis for each step.
ii. Past-Production-consumption data for three years

firm:-

i. Stepwise complete and balanced chemical reaction with molar weight and percentage yields on molar basis for each step.
ii. Past-Production-consumption data for three years

Case No.	73 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00310737AM22
RA File Number	05AX04000473 AM22
Licence No and<br>Date	0511007715/07/01/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Stepwise complete and balanced chemical reaction with molar weight and percentage yields on molar<br>basis for each step.<br>i.<br>Past-Production-consumption data for three years.<br>ii.

Case No.	74 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00317040AM22
RA File Number	08AX04000199 AM22
Licence No and<br>Date	0811003776/13/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and observed that the Master Batch Formula for export item 1 to 4<br>are not given separately and details given so far are confusing, therefore, it was decided to call the firm for attending<br>Personal Hearing<br>before Norms Committee to explain its case.

are not given separately and details given so far are confusing, therefore, it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case.||

Case No.	75 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD

UDIN00370709AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00326841AM22
RA File Number	09AA04016329 AM22
Licence No and<br>Date	0911002348/21/01/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	76 / NC/3/MEET/Oct/202324/15	76 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00329136AM22
RA File Number		03AX04000717 AM22
Licence No and<br>Date		0311010813/24/01/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>**Sl. No.

est 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:- Sl. No. Export Product Quantity 1 Medical Creams & Ointments(Bacitracin Zinc Ointment 0.5 OZ /14 GM Tube Tot Wt: 399Kgs ( Net Cont: Bacitracin 3.38 Kgs)) 1 Number 2 Medical Creams & Ointments(Bacitracin Zinc Ointment 1 OZ / 28 GM Tube Tot Wt: 5598.79Kgs ( Net Cont: Bacitracin 47.37Kgs)) 1 Number 3 Medical Creams & Ointments(Double Antibiotic Ointment 0.5 OZ / 14 GM Tube Tot Wt: 199.78Kgs ( Net Cont: Bacitracin 1.69Kgs, Polymixin 0.37Kgs)) 1 Number 4 Medical Creams & Ointments(Double Antibiotic Ointment 1 OZ / 28 GM tube Tot Wt: 1604.26Kgs ( Net Cont: Bacitracin 13.57Kgs, Polymixin 2.94Kgs)) 1 Number 5 Medical Creams & Ointments(Triple Antibiotic Ointment W/ Pramoxine HCL 0.2 OZ / 14 GM Tube Tot Wt: 2918.86Kgs ( Net Cont: Baci 24.69Kgs, Poly 5.34Kgs, Neo 20.43Kgs, Pramo 29.77Kgs)) 1 Number 6 Medical Creams & Ointments(Triple Antibiotic Ointment 1 OZ / 28 Gm Tube Tot Wt: 1641Kgs ( Net Cont: Baci 10.51Kgs, Poly 1.39Kgs, Neo 11.48Kgs)) 1 Number 7 Medical Creams & Ointments(Triple MS Antibiotic Ointment 1 OZ / 28 Gm Tube Tot Wt: 1090.04Kgs ( Net Cont: Baci 9.22Kgs, Poly 2Kgs, Neo 7.63Kgs)) 1 Number|||| ||Export Product||Quantity| ||Medical Creams & Ointments(Bacitracin Zinc Ointment 0.5 OZ /14 GM Tube Tot Wt: 399Kgs ( Net Cont: Bacitracin 3.38 Kgs))||1 Number|

o 7.63Kgs)) 1 Number|||| ||Export Product||Quantity| ||Medical Creams & Ointments(Bacitracin Zinc Ointment 0.5 OZ /14 GM Tube Tot Wt: 399Kgs ( Net Cont: Bacitracin 3.38 Kgs))||1 Number| ||Medical Creams & Ointments(Bacitracin Zinc Ointment 1 OZ / 28 GM Tube Tot Wt: 5598.79Kgs ( Net Cont: Bacitracin 47.37Kgs))||1 Number| ||Medical Creams & Ointments(Double Antibiotic Ointment 0.5 OZ / 14 GM Tube Tot Wt: 199.78Kgs ( Net Cont: Bacitracin 1.69Kgs, Polymixin 0.37Kgs))||1 Number| ||Medical Creams & Ointments(Double Antibiotic Ointment 1 OZ / 28 GM tube Tot Wt: 1604.26Kgs ( Net Cont: Bacitracin 13.57Kgs, Polymixin 2.94Kgs))||1 Number| ||Medical Creams & Ointments(Triple Antibiotic Ointment W/ Pramoxine HCL 0.2 OZ / 14 GM Tube Tot Wt: 2918.86Kgs ( Net Cont: Baci 24.69Kgs, Poly 5.34Kgs, Neo 20.43Kgs, Pramo 29.77Kgs))||1 Number| ||Medical Creams & Ointments(Triple Antibiotic Ointment 1 OZ / 28 Gm Tube Tot Wt: 1641Kgs ( Net Cont: Baci 10.51Kgs, Poly 1.39Kgs, Neo 11.48Kgs))||1 Number| ||Medical Creams & Ointments(Triple MS Antibiotic Ointment 1 OZ / 28 Gm Tube Tot Wt: 1090.04Kgs ( Net Cont: Baci 9.22Kgs, Poly 2Kgs, Neo 7.63Kgs))||1 Number|

UDIN00370709AM24

|1 Number| ||Medical Creams & Ointments(Triple MS Antibiotic Ointment 1 OZ / 28 Gm Tube Tot Wt: 1090.04Kgs ( Net Cont: Baci 9.22Kgs, Poly 2Kgs, Neo 7.63Kgs))||1 Number|

UDIN00370709AM24

8	Medical Creams & Ointments(Triple MS Antibiotic Ointment 0.5 OZ / 14 Gm TubeTot Wt: 518Kgs ( Net Cont:	1 Number
	Baci 4.38Kgs, Poly 0.95Kgs, Neo 3.62Kgs))
9	Medical Creams & Ointments(Triple MS Antibiotic Ointment 2 OZ / 56 Gm Tube Tot Wt: 392Kgs ( Net Cont: Baci	<br>1 Number
	3.32Kgs, Poly 0.72Kgs, Neo 2.74Kgs))
10	Medical Creams & Ointments(Triple Antibiotic Ointment W/ Pramoxine HCL 1 OZ / 28 GM Tube Tot Wt: 448Kgs	1 Number
	( Net Cont: Baci 3.79Kgs, Poly 0.82Kgs, Neo 3.14Kgs, Pramo 4.57Kgs))
11	Medical Creams & Ointments(Triple Antibiotic Ointment W/ Pramoxine HCL 2 OZ / 56 GM Tube Tot Wt:	1 Number
	10286.19Kgs ( Net Cont: Baci 87.02Kgs, Poly 18.82Kgs, Neo 71.98Kgs, Pramo 104.92Kgs))

Sl. No.	Import Items	Quantity allowed.
1	Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
2	Relevant Excipients	Net content in the export product plus 2% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

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

Case No.	Case No.	77 / NC/3/MEET/Oct/202324/15	77 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00331260AM22
RA File Number		03AX04000915 AM22
Licence No and<br>Date		0311010867/25/01/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl. No. Export Product<br>Quantity
	Export Product		Quantity

UDIN00370709AM24

1	Medical Creams & Ointments(FLUOCINONIDE TOPICAL SOLUTION 0.05% 60 ML Tot	1 Number
	Wt: 8675.80Kgs (Net Cont: Fluocin 4.75Kgs, Ethyl 2601.08Kgs, Iso 563.93Kgs, Bottle
	152207Nos, Cap 152207Nos, Needle 152207Nos))

Import Items	Quantity allowed.
Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
Relevant Excipients	Net content in the export product plus 2% wastage.
Relevant Packaging Material	Relevant as per Packing Policy

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

Case No.	Case No.	78 / NC/3/MEET/Oct/202324/15	78 / NC/3/MEET/Oct/202324/15	78 / NC/3/MEET/Oct/202324/15	78 / NC/3/MEET/Oct/202324/15	78 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00332964AM22
RA File Number		09AX04000151 AM22
Licence No and Date		0911002396/27/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed<br>1<br>2-Fluoro-6-methoxy pyridine (FMP)<br>3.23 kg.<br>1-[(3R,4S)-4-Cyanotetrahydropyran-3-<br>yl]-3-[(2-fluoro-6-methoxy-4-pyridyl)<br>amino]pyrazole-4-carboxamide<br>((L- 005251026-Form-I))<br>1 kg<br>2<br>4,5-bis(Diphenylphosphino)-9,9-<br>dimethylxanthane (Xantphos)<br>0.153 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

xamide ((L- 005251026-Form-I)) 1 kg 2 4,5-bis(Diphenylphosphino)-9,9- dimethylxanthane (Xantphos) 0.153 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed| ||1-[(3R,4S)-4-Cyanotetrahydropyran-3- yl]-3-[(2-fluoro-6-methoxy-4-pyridyl) amino]pyrazole-4-carboxamide ((L- 005251026-Form-I))||1 kg|1|2-Fluoro-6-methoxy pyridine (FMP)|3.23 kg.| |||||2|4,5-bis(Diphenylphosphino)-9,9- dimethylxanthane (Xantphos)|0.153 kg.| ||||||||

UDIN00370709AM24

Case No.	Case No.	79 / NC/3/MEET/Oct/202324/15	79 / NC/3/MEET/Oct/202324/15	79 / NC/3/MEET/Oct/202324/15	79 / NC/3/MEET/Oct/202324/15	79 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		ASTEC LIFESCIENCES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00343395AM22
RA File Number		03AX04001061 AM22
Licence No and Date		0311011086/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<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 2 FLURO ANILINE 0.66 kg. 2 ETHYL CHLOROFORMATE 0.55 kg. PDSH (PDSH Technical) 1 kg. 3 DI METHYL FORMAMIDE Deleted (not given in production/consumption data and also not a main reactant RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||PDSH (PDSH Technical)||1 kg.|1|2 FLURO ANILINE|0.66 kg.| |||||2|ETHYL CHLOROFORMATE|0.55 kg.| |||||3|DI METHYL FORMAMIDE|Deleted (not given in production/consumption data and also not a main reactant| |||||action as per above decision of NC.|||

Case No.	80 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00346268AM22
RA File Number	34AX04000204 AM22
Licence No and<br>Date	3411001767/07/02/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No. 81 / NC/3/MEET/Oct/202324/15

UDIN00370709AM24

e No and Date|3411001767/07/02/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No. 81 / NC/3/MEET/Oct/202324/15

UDIN00370709AM24

Case Status	Case Approved
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00347306AM22
RA File Number	08AX04000205 AM22
Licence No and Date	0811003993/08/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>Phenylephrine Hydrochloride<br>Injection USP, 10 mg/mL (1 mL)<br>(Phenylephrine Hydrochloride<br>Injection USP, 10 mg/mL (1 mL))<br>1 Number<br>1<br>PHENYLEPHRINEHYDROCHLORIDE<br>USP SIEGFRIED<br>11.00 mg.<br>Phenylephrine Hydrochloride<br>Injection USP, 10 mg/mL (5 mL)<br>(Phenylephrine Hydrochloride<br>Injection USP, 10 mg/mL (5 mL))<br>1 Number<br>2<br>PHENYLEPHRINEHYDROCHLORIDE<br>USP SIEGFRIED<br>55.00 mg.<br>Phenylephrine Hydrochloride<br>Injection USP, 10 mg/mL (10<br>mL) (Phenylephrine<br>Hydrochloride Injection USP, 10<br>mg/mL (10 mL))<br>1 Number<br>3<br>PHENYLEPHRINEHYDROCHLORIDE<br>USP SIEGFRIED<br>110.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.

e Injection USP, 10 mg/mL (10 mL)) 1 Number 3 PHENYLEPHRINEHYDROCHLORIDE USP SIEGFRIED 110.00 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	82 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00348248AM22
RA File Number	03AX04001105 AM22
Licence No and<br>Date	0311011230/09/02/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms

UDIN00370709AM24

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

ara 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product	Quantity
Medical Creams & Ointments(CLINDAMYCIN PHOSPHATE TOP. LOT. 1% 60ML Tot<br>Wt: 24600Kgs (Net Cont: Stearic 516.61 Kgs, Kolliwax 645.76 Kgs, Clindamycin 306.87<br>Kgs, Bottle 430500 Nos))	1 Number

Import Items	Quantity allowed.
Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
Relevant Excipients	Net content in the export product plus 2% wastage.
Relevant Packaging Material	Relevant as per Packing Policy

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

Packaging Material|Relevant as per Packing Policy|

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

Case No.	83 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00350237AM22
RA File Number	05AX04000943 AM22
Licence No and<br>Date	0511008753/10/02/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	84 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023

UDIN00370709AM24

HQ File Number	HQRNORM APPLY 00355981AM22
RA File Number	03AX04001160 AM22
Licence No and<br>Date	0311011415/15/02/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>**Sl. No.

est 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:- Sl. No. Export Product Quantity 1 Medical Creams & Ointments(Clobetasol Propionate Ointment 0.05% 15Gm Tot Wt: 2999.97 Kgs (Net Cont Clobetasol 1.55Kgs, Sorbitan 15Kgs, White Petrolatum 2833.47Kgs, Tubes 199998Nos)) 1 Number 2 Medical Creams & Ointments(Clobetasol Propionate Ointment 0.05% 30Gm Tot Wt: 999.96 Kgs (Net Cont Clobetasol 0.52Kgs, Sorbitan 5Kgs, White Petrolatum 944.46Kgs, Tubes 33332Nos)) 1 Number 3 Medical Creams & Ointments(Clobetasol Propionate Ointment 0.05% 45Gm Tot Wt: 500Kgs (Net Cont Clobetasol 0.26Kgs, Sorbitan 2.50Kgs, White Petrolatum 472.25Kgs, Tubes 11111Nos)) 1 Number 4 Medical Creams & Ointments(Clobetasol Propionate Ointment 0.05% 60Gm Tot Wt: 18499.74Kgs (Net Cont Clobetasol 9.58Kgs, Sorbitan 92.50Kgs, White Petrolatum 17473Kgs, Tubes 308329Nos)) 1 Number Sl. No. Import Items Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 2% wastage. 2 Relevant Excipients Net content in the export product plus 2% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption. RA concerned may take further necessary action as per above decision of NC.||

weight of import items (Relevant Bulk Drugs and Excipients) in export to the** RA concerned for redemption. RA concerned may take further necessary action as per above decision of NC.||

Case No. 85 / NC/3/MEET/Oct/202324/15

UDIN00370709AM24

Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00355978AM22
RA File Number	03AX04001161 AM22
Licence No and<br>Date	0311011414/15/02/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl. No. Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 15 Gm tube Tot Wt:<br>1750.01Kgs (Net Cont: Clob 0.98 Kgs, Arlacel 85.50Kgs, White Wax 18.90Kgs, Tubes<br>126000 Nos))<br>1 Number<br>2<br>Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 30 Gm tube Tot Wt:<br>5000.10 Kgs (Net Cont: Clob 2.80Kgs, Arlacel 243.01Kgs, White Wax 54Kgs, Tubes<br>180004Nos))<br>1 Number<br>3<br>Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 45 Gm tube Tot Wt:<br>4250.16 Kgs (Net Cont: Clob 2.38Kgs, Arlacel 206.56Kgs, White Wax 45.90Kgs, Tubes<br>102004Nos))<br>1 Number<br>4<br>Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 60 Gm tube Tot Wt:<br>7499.70 Kgs (Net Cont: Clob 4.20Kgs, Arlacel 364.49Kgs, White Wax 81K

90Kgs, Tubes 102004Nos)) 1 Number 4 Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 60 Gm tube Tot Wt: 7499.70 Kgs (Net Cont: Clob 4.20Kgs, Arlacel 364.49Kgs, White Wax 81Kgs, Tubes 134995Nos)) 1 Number Sl. No. Import Items Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 2% wastage. 2 Relevant Excipients Net content in the export product plus 2% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy||

UDIN00370709AM24

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

Case No.	Case No.	86 / NC/3/MEET/Oct/202324/15	86 / NC/3/MEET/Oct/202324/15	86 / NC/3/MEET/Oct/202324/15	86 / NC/3/MEET/Oct/202324/15	86 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00356333AM22
RA File Number		08AX04000425 AM22
Licence No and<br>Date		0811004071/15/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>BUSPIRONE HYDROCHLORIDE<br>TABLETS USP 5 MG (EACH UNCOATED<br>TABLET CONTAINS: BUSPIRONE<br>HYDROCHLORIDE USP 5 MG)<br>29000000<br>Numbers<br>1<br>BUSPIRONE HYDROCHLORID E<br>EP / BP / IP / USP / PH. EUR.<br>147.90 kg<br>BUSPIRONE HYDROCHLORIDE<br>TABLETS USP 7.5 MG (EACH UNCOATED<br>TABLET CONTAINS: BUSPIRONE<br>HYDROCHLORIDE USP 7.5 MG)<br>15000000<br>Numbers<br>2<br>BUSPIRONE HYDROCHLORID E<br>EP / BP / IP / USP / PH.

IRONE HYDROCHLORIDE TABLETS USP 7.5 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 7.5 MG) 15000000 Numbers 2 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 114.75 kg BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 10 MG) 8000000 Numbers 3 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 81.60 kg BUSPIRONE HYDROCHLORIDE TABLETS USP 15 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 15 MG) 5000000 Numbers 4 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 76.50 kg BUSPIRONE HYDROCHLORIDE TABLETS USP 30 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 30 MG [IN WHICH ACTIVE INGREDIENT 2400000 Numbers 5 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 73.44 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 5 MG)||29000000 Numbers|1|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|147.90 kg| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 7.5 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 7.5 MG)|| 15000000 Numbers|2|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH.

BUSPIRONE HYDROCHLORIDE TABLETS USP 7.5 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 7.5 MG)|| 15000000 Numbers|2|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|114.75 kg| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 10 MG)||8000000 Numbers|3|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|81.60 kg| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 15 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 15 MG)||5000000 Numbers|4|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|76.50 kg| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 30 MG (EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 30 MG [IN WHICH ACTIVE INGREDIENT||2400000 Numbers|5|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|73.44 kg|

UDIN00370709AM24

BUSPIRONE HYDROCHLORIDE USED IS 484.500 KGS.])

Case No.	87 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	GANGWAL HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00356909AM22
RA File Number	03AX04001205 AM22
Licence No and<br>Date	0311011422/16/02/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00356909AM22| |RA File Number|03AX04001205 AM22| |Licence No and Date|0311011422/16/02/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	88 / NC/3/MEET/Oct/202324/15	88 / NC/3/MEET/Oct/202324/15	88 / NC/3/MEET/Oct/202324/15	88 / NC/3/MEET/Oct/202324/15	88 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		MEGHMANI NOVOTECH PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00357589AM22
RA File Number		08AX04000262 AM22
Licence No and<br>Date		0811004084/16/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed<br>1<br>Biphenyl<br>1.389 kg.<br>2<br>Paraformaldehyde<br>1.0 kg.<br>3<br>Zinc Chloride Anhydrous<br>1.0 kg.<br>BCMB<br>(Bis Chloro Methyl Biphenyl)<br>1 kg<br>4<br>Methanol<br>0.889 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed
	BCMB<br>(Bis Chloro Methyl Biphenyl)		1 kg	1	Biphenyl	1.389 kg.
				2	Paraformaldehyde	1.0 kg.
				3	Zinc Chloride Anhydrous	1.0 kg.
				4	Methanol	0.889 kg.

UDIN00370709AM24

**| ||BCMB (Bis Chloro Methyl Biphenyl)||1 kg|1|Biphenyl|1.389 kg.| |||||2|Paraformaldehyde|1.0 kg.| |||||3|Zinc Chloride Anhydrous|1.0 kg.| |||||4|Methanol|0.889 kg.|

UDIN00370709AM24

Case No.	89 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00359473AM22
RA File Number	03AX04001229 AM22
Licence No and<br>Date	0311011469/18/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Sl. No. Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Clotrimazole 1 % Cream 1/2 OZ 14 Gm Tube Tot Wt: 735Kgs (Net Cont:<br>Ceto 73.50Kgs, Octy 99.23Kgs, Cetyl 22.05Kgs, Sorb 14.70Kgs, Poly 11.03Kgs, Clotri 7.54Kgs, Benzyl<br>7.35Kgs))<br>1 Number<br>2<br>Medical Creams & Ointments (Clotrimazole 1 % Cream 1 OZ 28 Gm Tube Tot Wt: 3263.40Kgs (Net<br>Cont: Ceto 326.34Kgs, Octy 440.56Kgs, Cetyl 97.90Kgs, Sorb 65.27Kgs, Poly 48.95Kgs, Clotri<br>33.47Kgs, Benzyl 32.63Kgs))<br>1 Number<br>3<br>Medical Creams & Ointments(Clotrimazole 1 % Cream 45 Gm Tube with 1 Applicator Tot Wt:<br>17800.56Kgs (Net Cont: Ceto 1780.06Kgs, Octy 2403.08Kgs, Cetyl 534.02Kgs, Sorb 356.01Kgs, Poly<br>267.01Kgs, Clotri 182.55Kgs, Benzyl 178.01Kgs, App 395568 Nos))<br>1 Number<br>**Sl.

cator Tot Wt: 17800.56Kgs (Net Cont: Ceto 1780.06Kgs, Octy 2403.08Kgs, Cetyl 534.02Kgs, Sorb 356.01Kgs, Poly 267.01Kgs, Clotri 182.55Kgs, Benzyl 178.01Kgs, App 395568 Nos)) 1 Number Sl. No. Import Items Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 2% wastage. 2 Relevant Excipients Net content in the export product plus 2% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy||

UDIN00370709AM24

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

Case No.	90 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00359728AM22
RA File Number	08AX04000474 AM22
Licence No and<br>Date	0811004112/18/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jun/202223/5 dated 08/07/2022against advance authorization<br>No.0811000632 dated 10/02/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>HEPARIN INJECTION 25000IU<br>123360 Vials 1<br>HEPARIN SODIUM IP 2018 EP<br>Mega 3378.89<br>15.21 kg.<br>HEPARIN INJECTION 5000IU<br>305316 Vials 2<br>HEPARIN SODIUM IP 2018 EP<br>Mega 1671.11<br>7.52 kg.<br>RA concerned may take further necessary action as per above decision of NC.

br>15.21 kg. HEPARIN INJECTION 5000IU 305316 Vials 2 HEPARIN SODIUM IP 2018 EP Mega 1671.11 7.52 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	91 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	DEEPAK NITRITE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00359783AM22
RA File Number	34AX04000191 AM22
Licence No and Date	3411001829/18/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00370709AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>BENZOTRIFLUORIDE<br>1.022 kg.<br>3-HYDROXY BENZOTRIFLUORIDE<br>( MHBTF)<br>1 kg.<br>2<br>TOLUENE<br>0.28 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	3-HYDROXY BENZOTRIFLUORIDE<br>( MHBTF)	1 kg.	1	BENZOTRIFLUORIDE	1.022 kg.
			2	TOLUENE	0.28 kg.

t Product**|Qty.|Sl. No.|Import Items|Qty. allowed.| |---|---|---|---|---|---| ||3-HYDROXY BENZOTRIFLUORIDE ( MHBTF)|1 kg.|1|BENZOTRIFLUORIDE|1.022 kg.| ||||2|TOLUENE|0.28 kg.|

Case No.	Case No.	92 / NC/3/MEET/Oct/202324/15	92 / NC/3/MEET/Oct/202324/15	92 / NC/3/MEET/Oct/202324/15	92 / NC/3/MEET/Oct/202324/15	92 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00367536AM22
RA File Number		08AX04000483 AM22
Licence No and<br>Date		0811004214/25/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Aug/202324/11dated22/08/2023against advance<br>authorizationNo.0811002696 dated 27/09/2021,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<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. TOPOTECAN INJECTION 1 MG/ML, 1 ML VIAL(EACH ML CONTAINS TOPOTECAN HYDROCHLORIDE EQ. TO TOPOTECAN 1MG) 1 Number 1 TOPOTECAN HYDROCHLORIDE (Water and Residual solvents content not less than 9.0% in the API) 1.313 mg TOPOTECAN INJECTION 1 MG/ML, 4 ML VIAL(EACH ML CONTAINS TOPOTECAN HYDROCHLORIDE EQ. TO TOPOTECAN 1 MG) 1 Number 2 TOPOTECAN HYDROCHLORIDE (Water and Residual solvents content not less than 9.0% in the API) 5.16 mg TOPOTECAN HYDROCHLORIDE FOR INJECTION 4MG/VIAL (5ML VIAL)(EACH VIAL CONTAINS TOPOTECAN HYDROCHLORIDE EQ. TO TOPOTECAN 4 MG [IN WHICH ACTIVE INGREDIENT TOPOTECAN HYDROCHLORIDE USED IS 71.000 1 Number 3 TOPOTECAN HYDROCHLORIDE (Water and Residual solvents content not less than 9.0% in the API) 5.16 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

1 Number 3 TOPOTECAN HYDROCHLORIDE (Water and Residual solvents content not less than 9.0% in the API) 5.16 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||TOPOTECAN INJECTION 1 MG/ML, 1 ML VIAL(EACH ML CONTAINS TOPOTECAN HYDROCHLORIDE EQ. TO TOPOTECAN 1MG)||1 Number|1|TOPOTECAN HYDROCHLORIDE (Water and Residual solvents content not less than 9.0% in the API)|1.313 mg| ||TOPOTECAN INJECTION 1 MG/ML, 4 ML VIAL(EACH ML CONTAINS TOPOTECAN HYDROCHLORIDE EQ. TO TOPOTECAN 1 MG)||1 Number|2|TOPOTECAN HYDROCHLORIDE (Water and Residual solvents content not less than 9.0% in the API)|5.16 mg| ||TOPOTECAN HYDROCHLORIDE FOR INJECTION 4MG/VIAL (5ML VIAL)(EACH VIAL CONTAINS TOPOTECAN HYDROCHLORIDE EQ. TO TOPOTECAN 4 MG [IN WHICH ACTIVE INGREDIENT TOPOTECAN HYDROCHLORIDE USED IS 71.000|| 1 Number|3|TOPOTECAN HYDROCHLORIDE (Water and Residual solvents content not less than 9.0% in the API)|5.16 mg|

UDIN00370709AM24

GRAMS])

HLORIDE USED IS 71.000|| 1 Number|3|TOPOTECAN HYDROCHLORIDE (Water and Residual solvents content not less than 9.0% in the API)|5.16 mg|

UDIN00370709AM24

GRAMS])

Case No.	Case No.	93 / NC/3/MEET/Oct/202324/15	93 / NC/3/MEET/Oct/202324/15	93 / NC/3/MEET/Oct/202324/15	93 / NC/3/MEET/Oct/202324/15	93 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00367541AM22
RA File Number		08AX04000478 AM22
Licence No and<br>Date		0811004216/25/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo.0811002528 dated 07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>METHOTREXATE INJECTION BP 25MG/ML [2ML<br>VIAL](EACH ML CONTAINS: METHOTREXATE PH.<br>EUR. 25MG)<br>1 Number Vial<br>1<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>61.87 mg/vial<br>METHOTREXATE INJECTION BP 100MG/ML [5 ML<br>VIAL](EACH ML CONTAINS: METHOTREXATE PH.<br>EUR. 100 MG)<br>1 Number Vial<br>2<br>METHOTREXATE<br>EP / BP / IP / USP / PH.

P / PH. EUR. 61.87 mg/vial METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number Vial 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. 1237.39 mg/vial METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. 306.867 mg/vial METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 5 METHOTREXATE EP / BP / IP / USP / PH. EUR. 590.57 mg/vial METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 6 METHOTREXATE EP / BP / IP / USP / PH. EUR. 1181.15 mg/vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|| 1 Number Vial|1|METHOTREXATE EP / BP / IP / USP / PH. EUR.|61.87 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG)|| 1 Number Vial|2|METHOTREXATE EP / BP / IP / USP / PH. EUR.|618.70 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG)||1 Number Vial|3|METHOTREXATE EP / BP / IP / USP / PH.

BP / IP / USP / PH. EUR.|618.70 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG)||1 Number Vial|3|METHOTREXATE EP / BP / IP / USP / PH. EUR.|1237.39 mg/vial| ||METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG)|| 1 Number Vial|4|METHOTREXATE EP / BP / IP / USP / PH. EUR.|306.867 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|| 1 Number Vial|5|METHOTREXATE EP / BP / IP / USP / PH. EUR.|590.57 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|| 1 Number Vial|6|METHOTREXATE EP / BP / IP / USP / PH. EUR.|1181.15 mg/vial|

UDIN00370709AM24

METHOTREXATE INJECTION BP 100MG/ML [50ML	1 Number Vial	7	METHOTREXATE	5737.00 mg/vial
VIAL](EACH ML CONTAINS: METHOTREXATE PH.
EUR. 100MG [IN WHICH ACTIVE INGREDIENT			EP / BP / IP / USP / PH. EUR.
METHOTREXATE USED IS 8.175 KGS.])

.00 mg/vial| |---|---|---|---|---| |VIAL](EACH ML CONTAINS: METHOTREXATE PH.||||| |EUR. 100MG [IN WHICH ACTIVE INGREDIENT|||EP / BP / IP / USP / PH. EUR.|| |METHOTREXATE USED IS 8.175 KGS.])|||||

Case No.	Case No.	94 / NC/3/MEET/Oct/202324/15	94 / NC/3/MEET/Oct/202324/15	94 / NC/3/MEET/Oct/202324/15	94 / NC/3/MEET/Oct/202324/15	94 / NC/3/MEET/Oct/202324/15
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number		HQRNORM APPLY 00367543AM22
RA File Number		08AX04000490 AM22
Licence No and<br>Date		0811004217/25/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>BUSPIRONE HYDROCHLORIDE TABLETS<br>USP 5 MG(EACH UNCOATED TABLET<br>CONTAINS: BUSPIRONE<br>HYDROCHLORIDE USP 5 MG)<br>1 Number<br>1<br>BUSPIRONE HYDROCHLORID E<br>EP / BP / IP / USP / PH. EUR.<br>5.10 mg<br>BUSPIRONE HYDROCHLORIDE TABLETS<br>USP 7.5 MG(EACH UNCOATED TABLET<br>CONTAINS: BUSPIRONE<br>HYDROCHLORIDE USP 7.5 MG)<br>1 Number<br>2<br>BUSPIRONE HYDROCHLORID E<br>EP / BP / IP / USP / PH. EUR.<br>7.65 mg<br>BUSPIRONE HYDROCHLORIDE TABLETS<br>USP 10 MG(EACH UNCOATED TABLET<br>CONTAINS: BUSPIRONE<br>HYDROCHLORIDE USP 10 MG)<br>1 Number<br>3<br>BUSPIRONE HYDROCHLORID E<br>EP / BP / IP / USP / PH.

.65 mg BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG(EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 10 MG) 1 Number 3 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 10.20 mg BUSPIRONE HYDROCHLORIDE TABLETS USP 15 MG(EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 15 MG) 1 Number 4 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 15.30 mg||||||| ||Export Product ||Qty.|Sl. No.|Import Items|Qty. allowed.| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG(EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 5 MG) ||1 Number|1|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|5.10 mg| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 7.5 MG(EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 7.5 MG) ||1 Number|2|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|7.65 mg| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG(EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 10 MG) ||1 Number|3|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|10.20 mg| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 15 MG(EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 15 MG) ||1 Number|4|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|15.30 mg|

UDIN00370709AM24

TS USP 15 MG(EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 15 MG) ||1 Number|4|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR.|15.30 mg|

UDIN00370709AM24

BUSPIRONE HYDROCHLORIDE TABLETS<br>USP 30 MG(EACH UNCOATED TABLET<br>CONTAINS: BUSPIRONE<br>HYDROCHLORIDE USP 30 MG [IN WHICH<br>ACTIVE<br>INGREDIENT<br>BUSPIRONE<br>HYDROCHLORIDE USED IS 637.500 KGS.])<br>1 Number<br>5<br>BUSPIRONE HYDROCHLORID E<br>EP / BP / IP / USP / PH. EUR.<br>30.60 mg<br>RA concerned may take further necessary action as per above decision of NC.	BUSPIRONE HYDROCHLORIDE TABLETS<br>USP 30 MG(EACH UNCOATED TABLET<br>CONTAINS: BUSPIRONE<br>HYDROCHLORIDE USP 30 MG [IN WHICH<br>ACTIVE<br>INGREDIENT<br>BUSPIRONE<br>HYDROCHLORIDE USED IS 637.500 KGS.])	<br> <br>1 Number	5	BUSPIRONE HYDROCHLORID E<br>EP / BP / IP / USP / PH. EUR.	30.60 mg

Case No.	95 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00371441AM22
RA File Number	09AX04000232 AM22
Licence No and<br>Date	0911002575/01/03/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Complete Technical details as per Appendix-4E.<br>1.<br>Material balance, showing solvents recovery.<br>2.

t was decided to call for following information/documents from the firm:- Complete Technical details as per Appendix-4E. 1. Material balance, showing solvents recovery. 2.||

Case No.	96 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	VIVIMED LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00378088AM22
RA File Number	04AX04000278 AM22
Licence No and<br>Date	0411002806/07/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 2/82-ALC4/2020 dated 10/07/2020against advance authorizationNo.<br>0910068240 dated 02/12/2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-

UDIN00370709AM24

240** dated 02/12/2019, 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:-||

UDIN00370709AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Ibuprofen Tablets USP - 800mg	1 Number Tablet	1	Ibuprofen	816 mg.
		2	Pregelatinized Starch	34.75 mg.
		3	Sodium Starch Glycolate	46.00 mg
		4	Mg Stearate - Veg Source<br>(Magnesium Stearate )	5.75 mg.

Case No.	97 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00380949AM22
RA File Number	34AX04000157 AM22
Licence No and<br>Date	3411001935/09/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call the firm for attending before Norms Committee to explain its case.||Personal Hearing|

Case No.	98 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00382075AM22
RA File Number	50AX04000031 AM22
Licence No and<br>Date	5011000413/10/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00370709AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Sunflower Lecithin Powder	1 MT	1	Sunflower Lecithin Liquid	1.40 MT

Case No.	99 / NC/3/MEET/Oct/202324/15
Case Status	Case Approved
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00386436AM22
RA File Number	03AX04001649 AM22
Licence No and<br>Date	0311012801/14/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Sodium Lactate (Hartmann's) Solution for injection, 1000ml 1 Number 1 SODIUM LACTATE ( PURASAL SP/F 50)(EP) (Sodium Lactate 50% Solution) 6.657 gm RA concerned may take further necessary action as per above decision of NC.||

Case No.	100 / NC/3/MEET/Oct/202324/15
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202324/ 15 and 13/10/2023
HQ File Number	HQRNORM APPLY 00386056AM22
RA File Number	08AX04000650 AM22
Licence No and<br>Date	0811004377/14/03/2022
Norms Committee Decision:

UDIN00370709AM24

The case is under consideration for want of comments of TE

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