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/Sep/202324/14 DATED: 27/09/2023

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/Sep/202324/14 dated 27/09/2023 of Norms Committee - III for the year 2023-24 was held on 27/09/2023 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 18-10-2023 15:44:48.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	GEM AROMATICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004772AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following<br>information/documents from the firm:-<br>Reason for applying the advance licence under para 4.06.<br>i.<br>COA report of import item ( indicating composition ) and also for export item.<br>ii.<br>A copy minutes of norms committee approved in the past for the export item, if any.<br>iii.<br>Calculation for the requirement of raw materials for the manufacturing export item.<br>iv.

Case No.	Case No.	2 / NC/3/MEET/Sep/202324/14	2 / NC/3/MEET/Sep/202324/14	2 / NC/3/MEET/Sep/202324/14	2 / NC/3/MEET/Sep/202324/14	2 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		BIO-GEN EXTRACTS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00005333AM24
RA File Number		NA
Licence No and<br>Date		NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc 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.

e as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export Product Qty. Sl. No. Import Items Qty. Natural Beta Carotene 10% CWD Powder 1 Kg 1. Beta Carotene 10% Powder ( Non dispersible in water) 1.01 Kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Natural Beta Carotene 10% CWD Powder|| 1 Kg|1.|Beta Carotene 10% Powder ( Non dispersible in water)|1.01 Kg| ||||||||

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

Case No.	3 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	BIO-GEN EXTRACTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005357AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc 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.<br>Natural<br>Beta<br>Carotene<br>20%<br>CWD<br>Powder<br>1 Kg<br>1.<br>Beta Carotene 20% Powder<br>( Non dispersible in water)<br>1.01 Kg<br>RA concerned may take further necessary action as per above decision of NC.

arotene 20% CWD Powder 1 Kg 1. Beta Carotene 20% Powder ( Non dispersible in water) 1.01 Kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	4 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005754AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 5/82-ALC4/2019 dated 02/08/2019against advance authorization<br>No.0810144980 dated 10.04.2019, 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:-

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. 5/82-ALC4/2019 dated 02/08/2019 against advance authorization No.0810144980 dated 10.04.2019 , 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:-

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Export Product

Norms recommended for OMEPRAZOLE DELAYED RELEASE CAPSULE USP 10 mg, 20 mg and 40 mg

Sl. No.	Import Items	Norms for 1 million capsule (Qty. In kg)	Norms for 1 million capsule (Qty. In kg)	Norms for 1 million capsule (Qty. In kg)
		10 mg capsule	20 mg capsule	40 mg capsule
1	OMEPRAZOLE USP	10.2 mg	20.4 mg	40.8 mg
2	HYPROMELLOSE 3 CPS 2910<br>USP	4.68 mg	9.36 mg	18.6 mg
3	HYPROMELLOSE<br>PHTHALATE NF	8.555 mg	17.110 mg	31.0 mg
4	SUGAR SPHERES NF<br>(PHARMA-SPHERES, 710-850<br>MICRON)	47.50 mg	95.0 mg	190.0 mg
5	TALC PH.E/USP/JP	4.78 mg	9.56 mg	19.12 mg
6	TRIETHYL CITRATE NF	1.285 mg	2.570 mg	4.65 mg

RA may take appropriate action as per the decision of Norms Committee.

Case No.	5 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	AQUILA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005238AM24
RA File Number	NA
Licence No and<br>Date	0310830783/null
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following<br>information/documents from the firm:-

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i. Copy of minutes approved in the past by Norms Committee.
ii. Stepwise yield and overall yield of reaction with justification of yield.
iii. Production/Consumption data for the last three years duly certified by Chartered Accountant. iv. End use of export item.

nd overall yield of reaction with justification of yield.**

iii. Production/Consumption data for the last three years duly certified by Chartered Accountant. iv. End use of export item.

Case No.	6 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004854AM24
RA File Number	039404000337 AM12
Licence No and<br>Date	0310646104/03/08/2011
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the there is no<br>justification for enhancement. Hence, it was decided torejectthe case maintaining thestatus quo.

Case No.	7 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	SATYAJIT CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005534AM24
RA File Number	NA
Licence No and<br>Date	0310786462/07/07/2014
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

umber|HQRNORM APPLY 00005534AM24| |RA File Number|NA| |Licence No and Date|0310786462/07/07/2014| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	8 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	ROYAL PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005586AM24
RA File Number	039504000958 AM15
Licence No and<br>Date	0310793866/12/02/2015
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that there is no<br>justification for enhancement. Hence, it was decided torejectthe case maintaining thestatus quo.

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Case No.	9 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004765AM24
RA File Number	039404001226 AM15
Licence No and<br>Date	0310799680/26/10/2015
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol.

5| |Licence No and Date|0310799680/26/10/2015| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less :- Export Product Qty. Sl. No. Import Items Qty. DIISOPROPYL ETHER ( Purity more than 99.05%, Moisture less than 1000 ppm) 1 MT 1 CARBOSOL TH (C-TH) ISOPROPYL ETHER - Crude (Purity not more than 93.07%, Water 0.82 %) 1.428 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	10 / NC/3/MEET/Sep/202324/14	10 / NC/3/MEET/Sep/202324/14	10 / NC/3/MEET/Sep/202324/14	10 / NC/3/MEET/Sep/202324/14	10 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM REVIW00004764AM24
RA File Number		039404000859 AM16
Licence No and<br>Date		0310802380/09/02/2016
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc 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.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

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

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DIISOPROPYL ETHER ( Purity more	<br>1 MT	1	ISOPROPYL ETHER - Crude	<br>1.428 MT
than 99.05%, Moisture less than 1000			(Purity not more than 93.07%,
ppm)			Water 0.82 %)

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

Case No.	11 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004763AM24
RA File Number	039404000374 AM17
Licence No and<br>Date	0310807578/02/09/2016
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc 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.<br>DIISOPROPYL ETHER ( Purity more<br>than 99.05%, Moisture less than 1000<br>ppm)<br>1 MT<br>1<br>ISOPROPYL ETHER - Crude<br>(Purity not more than 93.07%,<br>Water 0.82 %)<br>1.428 MT<br>RA concerned may take further necessary action as per above decision of NC.

1000 ppm) 1 MT 1 ISOPROPYL ETHER - Crude (Purity not more than 93.07%, Water 0.82 %) 1.428 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	12 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004761AM24
RA File Number	039404000800 AM17
Licence No and<br>Date	0310809684/08/12/2016
Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
DIISOPROPYL ETHER ( Purity more<br>than 99.05%, Moisture less than 1000<br>ppm)	<br> <br>1 MT	1	ISOPROPYL ETHER - Crude<br>(Purity not more than 93.07%,<br>Water 0.82 %)	<br> <br>1.428 MT

|---| |DIISOPROPYL ETHER ( Purity more than 99.05%, Moisture less than 1000 ppm)| 1 MT|1|ISOPROPYL ETHER - Crude (Purity not more than 93.07%, Water 0.82 %)| 1.428 MT|

Case No.	13 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004762AM24
RA File Number	039404000098 AM18
Licence No and<br>Date	0310813193/11/05/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc 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.<br>DIISOPROPYL ETHER ( Purity<br>more than 99.05%, Moisture less<br>than 1000 ppm)<br>1 MT<br>1<br>ISOPROPYL ETHER - Crude<br>(Purity not more than 93.07%,<br>Water 0.82 %)<br>1.428 MT<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	14 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	ROYAL PHARMA
Meeting Number	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023

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C.||

Case No.	14 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	ROYAL PHARMA
Meeting Number	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023

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and Date
HQ File Number	HQRNORM REVIW00005587AM24
RA File Number	039504000424 AM18
Licence No and<br>Date	0310815337/23/08/2017
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that there is no
justification for enhancement. Hence, it was decided torejectthe case maintaining thestatus quo.

Case No.	15 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	ROYAL PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005588AM24
RA File Number	039504000720 AM19
Licence No and<br>Date	0310824487/17/10/2018
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that there is no
justification for enhancement. Hence, it was decided torejectthe case maintaining thestatus quo.

d the request of firm for review of ad-hoc norms and it was observed that there is no|| |justification for enhancement. Hence, it was decided torejectthe case maintaining thestatus quo.||

Case No.	16 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005457AM24
RA File Number	039404000984 AM19
Licence No and<br>Date	0310827206/21/02/2019
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following
information/documents from the firm:-
COA report of the import and export items is not enclosed.<br>i.

Case No.	17 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023

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/202324/14| |---|---| |Case Status|Case Approved| |Party Name|DEEPAK NOVOCHEM TECHNOLOGIES LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023|

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HQ File Number	HQRNORM REVIW00005294AM24
RA File Number	318304000296 AM19
Licence No and<br>Date	3110067362/02/04/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance<br>authorizationNo.3111001714 dated 26/09/2022, 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.<br>1<br>OCP 50<br>1.00 MT<br>ORTHO CRESOL<br>1 MT<br>2<br>Methanol<br>0.998 MT<br>RA concerned may take further necessary action as per above decision of NC.

Qty. Sl. No. Import Items Qty. 1 OCP 50 1.00 MT ORTHO CRESOL 1 MT 2 Methanol 0.998 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	18 / NC/3/MEET/Sep/202324/14	18 / NC/3/MEET/Sep/202324/14	18 / NC/3/MEET/Sep/202324/14	18 / NC/3/MEET/Sep/202324/14	18 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		AETHER INDUSTRIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM REVIW00005368AM24
RA File Number		522104000085 AM20
Licence No and Date		5210043146/14/08/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc 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.<br>1<br>PARA CHLORO PHENOL<br>2.42 kg<br>COMPLEX<br>SUBSTANCE/MIXTURE<br>OF POLYPHENOL AE-00035, 4-(2-<br>METHOXYETHYL) PHENOL<br>1 Kg<br>2<br>TETRAHYDROFURAN<br>1.00 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	COMPLEX<br>SUBSTANCE/MIXTURE<br>OF POLYPHENOL AE-00035, 4-(2-<br>METHOXYETHYL) PHENOL		<br>1 Kg	1<br>2	PARA CHLORO PHENOL	2.42 kg
					TETRAHYDROFURAN	1.00 kg

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COMPLEX SUBSTANCE/MIXTURE OF POLYPHENOL AE-00035, 4-(2- METHOXYETHYL) PHENOL|| 1 Kg|1 2|PARA CHLORO PHENOL|2.42 kg| ||||||TETRAHYDROFURAN|1.00 kg| ||||||||

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Case No.	19 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004718AM24
RA File Number	052404000296 AM20
Licence No and<br>Date	0510411778/06/09/2019
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following<br>information/documents from the firm:-<br>Provide the readable documents such as Complete technical details as per Annexure to Appendix 4E and<br>clear chemical reaction showing molecular weight and yield.<br>i.

Case No.	20 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004716AM24
RA File Number	052404000445 AM20
Licence No and<br>Date	0510412564/21/11/2019
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following<br>information/documents from the firm:-<br>Provide the readable documents such as Complete technical details as per Annexure to Appendix 4E and clear<br>chemical reaction showing molecular weight and yield.

nts from the firm:- Provide the readable documents such as Complete technical details as per Annexure to Appendix 4E and clear chemical reaction showing molecular weight and yield.||

Case No.	21 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	SREEPATHI PHARMACEUTICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005293AM24
RA File Number	092404000502 AM20

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Licence No and Date 0910068349/09/01/2020

Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
CIPROFLOXACIN HCL / BASE	1 Kg	1	ETHYL<br>3-<br>(CYCLOPROPYLAMINO)-2-(2,4-<br>DICHLORO-5-FLUOROBENZOYL)<br>ACRYLATE	1.240 kg
		2	PIPERAZINE ANHYDROUS	0.390 kg

*|Qty.| |---|---|---|---|---| |CIPROFLOXACIN HCL / BASE|1 Kg|1|ETHYL 3- (CYCLOPROPYLAMINO)-2-(2,4- DICHLORO-5-FLUOROBENZOYL) ACRYLATE|1.240 kg| |||2|PIPERAZINE ANHYDROUS|0.390 kg|

Case No.	22 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005702AM24
RA File Number	052404000669 AM20
Licence No and<br>Date	0510413373/17/01/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that there is no<br>justification for enhancement as the norms were fixed based on the information/technical details given after Personal<br>Hearing. Hence, it was decided torejectthe case maintaining thestatus quo.

Case No.	23 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005395AM24
RA File Number	522404000068 AM20
Licence No and<br>Date	5210043358/06/03/2020
Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
ORGANO-INORGANIC COMPOUNDS,	<br>1 Kg	1	1,5-PENTANEDIOL	1.486 kg
HETEROCYCLIC COMPOUNDS,
NUCLEIC ACIDS AND THEIR SALTS
AND SULPHONAMIDES ( Delta-
Valerolactone)

The Committee co<br>	The Committee co<br>	nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>	nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>	nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>	nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>	nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>	nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>	nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>	nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>	nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>
Vol.

ratify adhoc norms under Para 4.07 of HBP |nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP | |---|---|---|---|---|---|---|---|---|---|---| |Vol. I as per details given below or as applied by the firm, whichever is less :- Exort Product Qt Sl NoImort Items Qt||||||||||| ||Exort Product|||Qt|Sl No|Imort Items||||Qt| ||p|||y.|**. . **|p||||y.| |||||||||||| ||ORGANO-IN |ORGANIC COMPOUNDS, || 1 Kg|1|1,5-PENTANEDIOL||||1.486 kg| ||HETEROCYC |LIC COMPOUNDS, ||||||||| ||NUCLEIC A AND SULPH Valerolactone|IDS AND THEIR SALTS ONAMIDES ( Delta- ||||||||| |||||||||||| |||||||||||| |RA concerned ma||take further necessar action as per above decision of NC||||||||| |y y .||||||||||| |||||||||||| |Case No.|||24 / NC/3/MEET/Sep/202324/14|||||||| |Case Status|||Case Approved|||||||| |Party Name|||AETHER INDUSTRIES LIMITED|||||||| |Meeting Number an||d Date|NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023|||||||| |HQ File Number|||HQRNORM REVIW00005398AM24|||||||| |RA File Number|||522404000004 AM21|||||||| |Licence No and Da||te|5210043426/08/06/2020|||||||| |Norms Committee||Decision:||||||||| |||||||||||| |The Committee co ||nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP ||||||||| |Vol. I as per detail||s given below or as applied by the firm, whichever is less :-||||||||| |Export Product Qty. **Sl. No.

ed to ratify adhoc norms under Para 4.07 of HBP ||||||||| |Vol. I as per detail||s given below or as applied by the firm, whichever is less :-||||||||| |Export Product Qty. Sl. No. Import Items Qty. 1 2,6 DICHLOROTOLUENE 1.90 kg 2 TETRAHYDROFURAN 1.50 kg UNSATURATED ACYCLIC MONOCARBOXYLIC ACIDS, THEIR ANHYDRIDES, HALIDES, PEROXIDES, PEROXYACIDS(AND THEIR DERIVATIVES, BENZOYL PEROXIDE AND BENZOYL CHLORIDE,3-METHOXY-2- METHYL BENZOYL CHLORIDE.) 1 Kg 3 DIMETHYLSULFOXIDE 1.37 kg RA concerned may take further necessary action as per above decision of NC.||||||||||| ||Export Product|||Qty.|**Sl. No. **|Import Items||||Qty.| ||UNSATURATED ACYCLIC MONOCARBOXYLIC ACIDS, THEIR|||1 Kg|1|2,6 DICHLOROTOLUENE||||1.90 kg| || ANHYDRIDES, HALIDES, PEROXIDES, PEROXYACIDS(AND ||||2||TETRAH|YDROFURAN||1.50 kg| ||THEIR DERIVATIVES, BENZOYL PEROXIDE AND BENZOYL CHLORIDE,3-METHOXY-2- METHYL BENZOYL CHLORIDE.)|||||||||| ||||||3||DIMETH|YLSULFOXIDE||1.37 kg| |||||||||||| ||||||||||||

UDIN00321775AM24

ES, BENZOYL PEROXIDE AND BENZOYL CHLORIDE,3-METHOXY-2- METHYL BENZOYL CHLORIDE.)|||||||||| ||||||3||DIMETH|YLSULFOXIDE||1.37 kg| |||||||||||| ||||||||||||

UDIN00321775AM24

Case No.	25 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005441AM24
RA File Number	039404000141 AM21
Licence No and<br>Date	0310836585/09/06/2020
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following<br>information/documents from the firm:-<br>Justification for low yield and complete chemical reaction with material balance.<br>i.

Case No.	26 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005399AM24
RA File Number	522404000016 AM21
Licence No and Date	5210043443/19/06/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol.

AM21| |Licence No and Date|5210043443/19/06/2020| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less :- Export Product Qty. Sl. No. Import Items Qty. 1 N-OCTYLAMINE 0.825 kg AMINE-FUNCTION COMPOUNDS : ACYCLIC MONOAMINES, O-,M-,P- PHENYLENEDIAMINE,(DIAMINOTOLUENES AND THEIR DERIVATIVES, SALTS THEREOF,N-OCTYL D-GLUCAMINE.) 1 Kg 2 DEXTROSE ANHYDROUS 0.770 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	27 / NC/3/MEET/Sep/202324/14
Case Status<br>	Case Approved

UDIN00321775AM24

Par	ty Name		SHARP MINT	LIMITED
Me<br>and	eting Nu<br>Date	mber	NC/ 3/ MEET/	Sep/ 202324/	14 and	27/09/2023

HQ	File Nu	mber	HQRNORM R	EVIW000045	37AM2	3
RA	File Nu	mber	052404000265	AM21
Lic<br>Dat	ence No<br>e	and	0510415091/02	/09/2020

Nor<br>Th<br>Vo<br>RA	ms Com<br>e Comm<br>l. I as pe	mittee Decision:<br>ittee considered the ca<br>r details given below o		se as per agen<br>r as applied b	da and i	t was decided to ratify adhoc norms under Para		407 of HBP
					<br>y the fir	<br>m, whichever is less :-		.
	Export	Product			Qty.		**Sl. No.

per agen r as applied b|da and i|t was decided to ratify adhoc norms under Para|||407 of HBP|| |||||| y the fir| m, whichever is less :-|||.|| ||Export|Product|||Qty.||**Sl. No. **|Import Items||Qty.| ||THYM 5-MEN|OL CRYSTAL (2-ISO THYL PHENOL)||PROPYL-||||||| ||||||1 Kg||1|META CRESOL (M-CRESOL)||0.785 kg| |||||||||||| ||||||||2|ISO PROPYL ALCOHOL (IPA)||Not allowed.| |||||||||||| ||MENT|HOL|||1 Kg||1|META CRESOL (M-CRESOL)||1.50 kg| ||||||||2|ISO PROPYL ALCOHOL (IPA)||0.90 kg| |||||||||||| ||concern|ed may take further ne||cessary actio||||||| ||||||n as per|above decision of NC.||||| |||||||||||| |Cas|e No.||28 / NC/3/MEE|T/Sep/20232|4/14|||||| |Cas|e Status||Case Deferred|||||||| |Par|ty Name||SRF LIMITED|||||||| |Me and|eting Nu Date|mber|NC/ 3/ MEET/|Sep/ 202324/|14 and|27/09/2023||||| |||||||||||| |HQ|File Nu|mber|HQRNORM R|EVIW000047|17AM2|4||||| |RA|File Nu|mber|052404000258|AM21||||||| |Lic Dat|ence No e|and|0510415088/02|/09/2020||||||| |||||||||||| |Nor The inf|ms Com commit ormation Pro clea i.|mittee Decision: tee considered the requ /documents from the f vide the readable doc r chemical reaction s||est of firm for irm:- uments such howing mole||||||| ||||||review/f|ixation of ad-hoc norms and it was decided to call|||for following|| ||||||as com cular w|plete technical details as per Annexure to Ap eight and yield.|||pendix 4E and|| ||||||||||||

-hoc norms and it was decided to call|||for following|| ||||||as com cular w|plete technical details as per Annexure to Ap eight and yield.|||pendix 4E and|| ||||||||||||

Case No.	28 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004717AM24
RA File Number	052404000258 AM21
Licence No and<br>Date	0510415088/02/09/2020
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following
information/documents from the firm:-
Provide the readable documents such as complete technical details as per Annexure to Appendix 4E and<br>i.
clear chemical reaction showing molecular weight and yield.

UDIN00321775AM24

Case No.	29 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005701AM24
RA File Number	052404000405 AM21
Licence No and<br>Date	0510415761/06/11/2020
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that there is no
justification for enhancement as the norms were fixed based on the information/technical details given after Personal
Hearing. Hence, it	was decided torejectthe case maintaining thestatus quo.

tion for enhancement as the norms were fixed based on the information/technical details given after Personal|| |Hearing. Hence, it|was decided torejectthe case maintaining thestatus quo.|

Case No.	30 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005163AM24
RA File Number	NA
Licence No and<br>Date	0310839717/25/11/2020
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	31 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004711AM24
RA File Number	039404000659 AM21
Licence No and<br>Date	0310839748/26/11/2020
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following
information/documents from the firm:-
Requirement of Raw Material is more than as asked for. Please clarify.<br>1.
We may call sample shipping bills from the firm and call the comments of TE.<br>2.

Case No. 32 / NC/3/MEET/Sep/202324/14

UDIN00321775AM24

n as asked for. Please clarify.** 1.|| |We may call sample shipping bills from the firm and call the comments of TE. 2.||

Case No. 32 / NC/3/MEET/Sep/202324/14

UDIN00321775AM24

Case Status	Case Deferred
Party Name	MAC-CHEM PRODUCTS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005491AM24
RA File Number	NA
Licence No and<br>Date	0311000185/17/12/2020
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Cas	e Status		Case Deferred
Par	ty Name		MAC-CHEM P	RODUCTS (	INDIA)	PRIVATE LIMITED
Me<br>and	eting Nu<br>Date	mber	NC/ 3/ MEET/	Sep/ 202324/	14 and 2	7/09/2023

HQ	File Nu	mber	HQRNORM R	EVIW000054	91AM24
RA	File Nu	mber	NA
Lic<br>Dat	ence No<br>e	and	0311000185/17	/12/2020

Nor<br>Th	ms Com<br>e case is	mittee Decision:<br>under consideration		for want of c		f TE
					ommen	s o .

Cas	e No.		33 / NC/3/MEE	T/Sep/20232	4/14
Cas	e Status		Case Approved
Par	ty Name		OPTIMUS DR	UGS PRIVAT	E LIMI	TED
Me<br>and	eting Nu<br>Date	mber	NC/ 3/ MEET/	Sep/ 202324/	14 and 2	7/09/2023

HQ	File Nu	mber	HQRNORM R	EVIW000057	18AM24
RA	File Nu	mber	09AA0400267	5 AM21
Lic<br>Dat	ence No<br>e	and	0911000050/18	/12/2020

and 2|7/09/2023|||| |||||||||||| |HQ|File Nu|mber|HQRNORM R|EVIW000057||18AM24||||| |RA|File Nu|mber|09AA0400267|5 AM21||||||| |Lic Dat|ence No e|and|0911000050/18|/12/2020||||||| |||||||||||| |Nor Th pr No gi RA|ms Com e Com oduct/im .091100 ven belo|mittee Decision: mittee considered the port product in meetin 1493 dated 03.09.202 w or as applied by the||case as per gNo. NC/3/ 1, it was dec firm, whichev||d|d ki f h li dii f|||| |||||||agena MEET/S ided to f er is les|an tang cue rom te earer ecson ep/202223/8 dated 23/09/2022against advan ix ad-hoc norms under Para 4.07 of HBP Vol. s:-||r same export ce authorization I as per details|| |||||||||||| ||E|xport Product||||||||| |||||||Qty.|Sl. No.|Import Items||Qty.| |||||||||||| ||Pyrim sodium tetrahy carbox|idinone acid, so ((S)-4-oxo-4,6,7,8- dropyrrolo [1,2-a]p ylate)||dium salt yrimidine-6-||1 Kg|1|Methyl L-pyroglutamate||2.70 kg| ||||||||2|Tihl i||227 k| |||||||||rety amne||. g| ||||||||3|2,5 Norbornadiene||1.73 kg| |||||||||||| ||||||||4|Chloro sulfonyl isocyanate||2.778 kg| |||||||||||| ||||||||5|Isopropyl alcohol||4.02 kg| ||concern|ed may take further ne||cessary actio||||||| |||||||n as per|above decision of NC||||

UDIN00321775AM24

yl isocyanate||2.778 kg| |||||||||||| ||||||||5|Isopropyl alcohol||4.02 kg| ||concern|ed may take further ne||cessary actio||||||| |||||||n as per|above decision of NC||||

UDIN00321775AM24


Cas	e No.		34 / NC/3/MEE	T/Sep/20232		4/14
Cas	e Status		Case Approved

Par	ty Name		OPTRIX LAB	ORATORIES		PRIVA	TE LIMITED
Me<br>and	eting Nu<br>Date	mber	NC/ 3/ MEET/	Sep/ 202324/		14 and	27/09/2023
HQ	File Nu	mber	HQRNORM R	EVIW000053		34AM2	4
RA	File Nu	mber	09AA0400318	4 AM21
Lic<br>Dat	ence No<br>e	and	0911000114/13	/01/2021

Nor<br>Th<br>pr<br>au<br>as<br>RA	ms Com<br>e Com<br>oduct/im<br>thorizati<br>per deta	mittee Decision:<br>mittee considered the<br>port product in me<br>onNo.0911001974 da<br>ils given below or as a		case as per<br>etingNo.<br>ted 01.12.20<br>pplied by the		agenda	and taking cue from the earlier decision f	or same export
						NC/3/M<br>21, it w<br>firm, w	EET/Mar/202122/16 dated 08/04/2022a<br>as decided to fix ad-hoc norms under Para 4.07<br>hichever is less:-	gainst advance<br>of HBP Vol. I

	E	xport Product		Qty.	Sl.

r>firm, w||EET/Mar/202122/16 dated 08/04/2022a as decided to fix ad-hoc norms under Para 4.07 hichever is less:-|gainst advance of HBP Vol. I|| ||||||||||||| ||E|xport Product|||Qty.|Sl. N|||||| ||||||||o.|I|mport Items||Qty.| ||||||||||||| ||FAVI (FAVI|PIRAVIR PIRAVIR)|||1 Kg|1||6|bromo 3 hydroxypyrazine 2 carboxamide||2.32 kg| |||||||2||T|riethylamine||2.15 kg| ||||||||||||| |||||||3||N|N Dimethylformamide||5.00 kg| |||||||4||T|ri n butylamine||3.40 kg| |||||||5|||||| |||||||||D|IMETHYL SULFOXIDE||2.59 kg| ||concern|ed may take further ne|||cessary actio||||||| ||||||||n as per||above decision of NC.||| ||||||||||||| |Cas|e No.||35 / NC/3/MEE||T/Sep/20232||||||| ||||||||4/14||||| |Cas|e Status||Case Approved||||||||| |Par|ty Name||DEEPAK NOV||OCHEM TE||CHNOL||OGIES LIMITED||| |Me and|eting Nu Date|mber|NC/ 3/ MEET/||Sep/ 202324/||||||| ||||||||14 and||27/09/2023||| |HQ|File Nu|mber|HQRNORM R||EVIW000055||16AM2||4||| |RA|File Nu|mber|318304000040||AM21||||||| |Lic Dat|ence No e|and|3111000130/03||/02/2021||||||| |Nor|ms Com|mittee Decision:||||||||||

Case No.	35 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005516AM24
RA File Number	318304000040 AM21
Licence No and<br>Date	3111000130/03/02/2021
Norms Committee Decision:

UDIN00321775AM24

4 and 27/09/2023| |HQ File Number|HQRNORM REVIW00005516AM24| |RA File Number|318304000040 AM21| |Licence No and Date|3111000130/03/02/2021| |Norms Committee Decision:||

UDIN00321775AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Mar/202223/24 dated 13/04/2023 against advance authorization No.3110066979 dated 13/02/2018 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product			Qty.	Sl. No.	Import Items	Qty.
DNOVO<br>BP838(	Tetra	Methyl	<br>1 Kg	1	2,6 xylenol	1.507 kg
Bisphenol A)

Case No.	36 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005704AM24
RA File Number	05AA04000952 AM22
Licence No and<br>Date	0511002092/06/04/2021
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that there is no
justification for enhancement as the norms were fixed based on the information/technical details given after Personal
Hearing. Hence, it	was decided torejectthe case maintaining thestatus quo.

tion for enhancement as the norms were fixed based on the information/technical details given after Personal|| |Hearing. Hence, it|was decided torejectthe case maintaining thestatus quo.|

Case No.		37 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM REVIW00005514AM24
RA File Number		31AA04000589 AM22
Licence No and<br>Date		3111000338/18/05/2021
Norms Committee Decision:
The Committee	considered the case as per agenda and taking cue from the earlier decision for same export
product/import	product in meetingNo. NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance
authorizationNo.3110066979 dated 13/02/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I

UDIN00321775AM24

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

Export Product			Qty.	Sl. No.	Import Items	Qty.
DNOVO<br>BP838(	Tetra	Methyl	<br>1 kg	1	2,6 xylenol	1.507 kg
Bisphenol A)

the firm, whichever is less:-

Export Product			Qty.	Sl. No.	Import Items	Qty.
DNOVO<br>BP838(	Tetra	Methyl	<br>1 kg	1	2,6 xylenol	1.507 kg
Bisphenol A)

Case No.<br>38 / NC/3/MEET/Sep/202324/14
Case Status<br>Case Approved
Party Name<br>DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number<br>HQRNORM REVIW00005295AM24
RA File Number<br>31AA04024656 AM22
Licence No and<br>Date<br>3111000586/20/09/2021
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 meetingNoNC/3/MEET/May/202323/4 dated 26/05/2023.against advance authorization
No.3111001989 dated 25/01/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No. Import Items	Qty.
1<br>2 6 xylenol<br>2,6 XYLIDINE<br>300 MT	420 MT
2<br>Catalyst	0.48 MT
RA concerned may take further necessary action as per above decision of NC.

Case No.	39 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED

UDIN00321775AM24

her necessary action as per above decision of NC.|||

Case No.	39 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED

UDIN00321775AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00006805AM23
RA File Number	04AA04015436 AM22
Licence No and<br>Date	0411001511/22/09/2021
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	40 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005706AM24
RA File Number	05AA04089568 AM22
Licence No and<br>Date	0511005321/11/10/2021
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that there is no
justification for enhancement as the norms were fixed based on the information/technical details given after Personal
Hearing. Hence, it	was decided torejectthe case maintaining thestatus quo.

Case No.	41 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	LUPIN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005265AM24
RA File Number	03AA040109357 AM22
Licence No and<br>Date	0311007760/18/10/2021
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

W00005265AM24| |RA File Number|03AA040109357 AM22| |Licence No and Date|0311007760/18/10/2021| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE.|

Case No.	42 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005296AM24
RA File Number	31AA04027993 AM22
Licence No and	3111000637/21/10/2021

UDIN00321775AM24

Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting NoNC/3/MEET/May/202323/4 dated 26/05/2023. against advance authorization No.3111001989 dated 25/01/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

	Export Product	Qty.	Sl. No.	Import Items	Qty.
2,6	XYLIDINE	300 MT	1	2 6 xylenol	420 MT
			2	Catalyst	0.48 MT

elow or as applied by the firm, whichever is less:-

	Export Product	Qty.	Sl. No.	Import Items	Qty.
2,6	XYLIDINE	300 MT	1	2 6 xylenol	420 MT
			2	Catalyst	0.48 MT

Case No.<br>43 / NC/3/MEET/Sep/202324/14
Case Status<br>Case Approved
Party Name<br>DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number<br>HQRNORM REVIW00005515AM24
RA File Number<br>31AA04028367 AM22
Licence No and<br>Date<br>3111000631/21/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for	same export
product/import product in meetingNo. NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance
authorizationNo.3110066979 dated 13/02/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No. Import Items	Qty.
DNOVO<br>BP838(<br>Tetra<br>Methyl<br>1 Kg<br>1<br>2,6 xylenol	1.507 kg
Bisphenol A)
RA concerned may take further necessary action as per above decision of NC.

UDIN00321775AM24

|DNOVO BP838( Tetra Methyl 1 Kg 1 2,6 xylenol|1.507 kg|| |Bisphenol A)||| |RA concerned may take further necessary action as per above decision of NC.|||

UDIN00321775AM24

Case No.<br>44 / NC/3/MEET/Sep/202324/14
Case Status<br>Case Approved
Party Name<br>DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number<br>HQRNORM REVIW00005250AM24
RA File Number<br>31AA04017311 AM22
Licence No and<br>Date<br>3111000729/25/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo. NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance
authorizationNo.3111001714 dated 26/09/2022, 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<br>Qty.<br>Sl. No. Import Items	Qty.
1<br>OCP 50<br>ORTHO CRESOL<br>1 MT	1.00 MT
2<br>Methanol	0.998 MT
RA concerned may take further necessary action as per above decision of NC.

duct Qty. Sl. No. Import Items|Qty.|| |1 OCP 50 ORTHO CRESOL 1 MT|1.00 MT|| |2 Methanol|0.998 MT|| |RA concerned may take further necessary action as per above decision of NC.|||

Case No.<br>45 / NC/3/MEET/Sep/202324/14	Case No.<br>45 / NC/3/MEET/Sep/202324/14	Case No.<br>45 / NC/3/MEET/Sep/202324/14
Case Status<br>Case Approved
Party Name<br>MAXTAR BIO GENICS
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ	File Number<br>HQRNORM REVIW00005236AM24
RA File Number<br>05AA040106605 AM22
Licence No and<br>Date<br>0511006619/03/12/2021
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.

UDIN00321775AM24

NYSTATIN TABLETS	1	Number	1	NYSTATIN	104 mg.
				(Potency NMT 4855 IU/mg)

Case No.	46 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00345828AM22
RA File Number	09AX04000205 AM22
Licence No and<br>Date	0911002465/07/02/2022
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Y 00345828AM22| |RA File Number|09AX04000205 AM22| |Licence No and Date|0911002465/07/02/2022| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE.|

Case No.	47 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005364AM24
RA File Number	03AX04001369 AM22
Licence No and<br>Date	0311011710/23/02/2022
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not
provided any technical justification / information for enhancement. Hence, it was decided torejectthe case
maintaining thestatus quo.

Case No.	48 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	PROEC ENERGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005029AM24
RA File Number	05AX04001262 AM22
Licence No and<br>Date	0511010975/14/03/2022

UDIN00321775AM24

Norms Committee Decision:

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

Case No.	49 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005291AM24
RA File Number	31AX04000028 AM23
Licence No and<br>Date	3111001358/17/05/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	50 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	VIPPY INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005383AM24
RA File Number	56AX04000008 AM23
Licence No and<br>Date	5611001042/11/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc 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.<br>SOYA LECITHIN (Liquid)<br>1MT<br>1<br>CRUDE LECITHIN<br>1.01 MT<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	51 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	FREESIA CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023

UDIN00321775AM24

51 / NC/3/MEET/Sep/202324/14| |---|---| |Case Status|Case Approved| |Party Name|FREESIA CHEMICALS| |Meeting Number and Date|NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023|

UDIN00321775AM24

HQ File Number<br>HQRNORM REVIW00005536AM24
RA File Number<br>03AX04002018 AM23
Licence No and<br>Date<br>0311016342/14/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda	and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance authorization
No.0311008508 dated 12/11/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as		per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No. Import Items	Qty.
Cyclopentanone<br>1 kg	1<br>Adipic Acid	1.93 kg
RA concerned may take further necessary action as per above decision of NC.

s less:-|||| |Export Product Qty.|Sl. No. Import Items|Qty.|| |Cyclopentanone 1 kg|1 Adipic Acid|1.93 kg|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	52 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004780AM24
RA File Number	NA
Licence No and<br>Date	0311016601/26/07/2022
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following
information/documents from the firm:-
Requirement of Raw Material is more than as asked for. Please clarify.<br>1.
We may call sample shipping bills from the firm and call the comments of TE.<br>2.

Case No.	53 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005227AM24
RA File Number	31AX04000141 AM23
Licence No and<br>Date	3111001623/17/08/2022
Norms Committee Decision:

UDIN00321775AM24

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

Case No.	54 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	KREATIVE ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005406AM24
RA File Number	09AX04000474 AM23
Licence No and<br>Date	0911003550/26/08/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and on the basis of information provided by<br>the firm, it was decided to revise adhoc norms as under :-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>2-ETHYL<br>ANILINE<br>/<br>2-ETHYL<br>BENZENEAMINE<br>1.058 kg<br>2<br>2,3-DIHYDROFURANE<br>0.330 kg<br>3<br>METHYL 3 OXO PENTONOATE<br>0.455 kg<br>4<br>Methanol<br>1.133 kg<br>5<br>Toluene<br>1.00 kg<br>6<br>Sodium Nitrite<br>0.40 kg<br>ETODOLAC<br>METHYL<br>ESTER(ETODOLAC<br>METHYL<br>ESTER)<br>1 Kg<br>7<br>Sodium Sulfite<br>2.20 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	55 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	INDO AMINES LIMITED

UDIN00321775AM24

e further necessary action as per above decision of NC.||

Case No.	55 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	INDO AMINES LIMITED

UDIN00321775AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005451AM24
RA File Number	03AX04003351 AM23
Licence No and<br>Date	0311018148/25/09/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and on the basis of information provided by<br>the firm, it was decided to revise adhoc norms as under :-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>STYRENE<br>0.720 kg<br>STYRENATED PHENOL OR IAL SP<br>1 Kg<br>2<br>PHENOL<br>0.257 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	56 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	SHREE MAHADEV INTERMEDIATE
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005358AM24
RA File Number	34AX04000640 AM23
Licence No and<br>Date	3411002862/04/10/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following<br>information/documents from the firm:-<br>Percentage of hexane in Export product.<br>I.

ered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following information/documents from the firm:- Percentage of hexane in Export product. I.||

Case No.	57 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005140AM24

UDIN00321775AM24

RA File Number	08AX04001050 AM23
Licence No and<br>Date	0811006214/10/10/2022
Norms Committee Decision:
The case is under	consideration for want of comments of TE

Case No.<br>58 / NC/3/MEET/Sep/202324/14
Case Status<br>Case Approved
Party Name<br>SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number<br>HQRNORM REVIW00005742AM24
RA File Number<br>50AX04000071 AM23
Licence No and<br>Date<br>5011000702/06/12/2022
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less :-
Export Product<br>Qty.	Sl. No. Import Items	Qty.
Sunflower Lecithin (Liquid)<br>1 MT	1<br>Crude Sunflower Lecithin	1.01 MT
RA concerned may take further necessary action as per above decision of NC.

ct Qty.|Sl. No. Import Items|Qty.|| |Sunflower Lecithin (Liquid) 1 MT|1 Crude Sunflower Lecithin|1.01 MT|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	59 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005141AM24
RA File Number	08AX04001419 AM23
Licence No and<br>Date	0811006678/07/12/2022
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	60 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved

UDIN00321775AM24

Party Name	Party Name	KREATIVE ORGANICS PRIVATE LIMITED	KREATIVE ORGANICS PRIVATE LIMITED	KREATIVE ORGANICS PRIVATE LIMITED	KREATIVE ORGANICS PRIVATE LIMITED	KREATIVE ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM REVIW00005407AM24
RA File Number		09AX04000790 AM23
Licence No and<br>Date		0911004140/09/12/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and on the basis of information provided by<br>the firm, it was decided to revise adhoc norms as under :-<br>Export Product<br>Qty.<br>Sl. No.

considered the request of firm for review of adhoc norms and on the basis of information provided by the firm, it was decided to revise adhoc norms as under :- Export Product Qty. Sl. No. Import Items Qty. 1 2-ETHYL ANILINE / 2-ETHYL BENZENEAMINE 1.058 kg 2 2,3-DIHYDROFURANE 0.330 kg 3 METHYL 3 OXO PENTONOATE 0.455 kg 4 Methanol 1.133 kg 5 Toluene 1.00 kg 6 Sodium Nitrite 0.40 kg ETODOLAC METHYL ESTER(ETODOLAC METHYL ESTER) 1 Kg 7 Sodium Sulfite 2.20 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||ETODOLAC METHYL ESTER(ETODOLAC METHYL ESTER)|| 1 Kg|1|2-ETHYL ANILINE / 2-ETHYL BENZENEAMINE| 1.058 kg| |||||2|2,3-DIHYDROFURANE|0.330 kg| |||||3|METHYL 3 OXO PENTONOATE|0.455 kg| |||||4|Methanol|1.133 kg| |||||5|Toluene|1.00 kg| |||||6|Sodium Nitrite|0.40 kg| |||||7|Sodium Sulfite|2.20 kg| |||||above decision of NC.|||

Case No.	61 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005552AM24
RA File Number	NA
Licence No and<br>Date	0711006015/26/12/2022

UDIN00321775AM24

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/Dec/202122/12 dated 17/12/2021 against advance authorization No. 0711001465 dated 12/07/2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product		Qty.	Sl. No.	Import Items	Qty.
Sterile Water for Injection 10mL		1 Number	1	13mm GraySerum Chlorobutyl	<br>Net+ 1%
Vial(Sterile Water for injection, filled in				R/S-RFS-C14226422GS6TP3
10mL Vial and capped with 13mm
GreySerum<br>ChlorobutyI	Rubber
Stopper)

Case No.	62 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00006267AM23
RA File Number	09AX04000893 AM23
Licence No and<br>Date	0911004453/13/02/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

PPLY 00006267AM23| |RA File Number|09AX04000893 AM23| |Licence No and Date|0911004453/13/02/2023| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	63 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00006487AM23
RA File Number	09AX04001024 AM23
Licence No and<br>Date	0911004510/21/02/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

UDIN00321775AM24

Case No.	Case No.	64 / NC/3/MEET/Sep/202324/14	64 / NC/3/MEET/Sep/202324/14	64 / NC/3/MEET/Sep/202324/14	64 / NC/3/MEET/Sep/202324/14	64 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		BALAJI AMINES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00005209AM24
RA File Number		NA
Licence No and Date		3111002043/23/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance<br>authorizationNo.3110067740 dated 19/05/2020, 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.

dated 19/05/2020**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 METHANOL 0.37 kg 2 AMMONIA ANHYDROUS 0.16 kg N-METHYL-2- PYRROLIDONE(ORGANIC CHEMICAL) 1 kg 3 GAMMA BUTYROLACTONE 0.90 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||N-METHYL-2- PYRROLIDONE(ORGANIC CHEMICAL)||1 kg|1|METHANOL|0.37 kg| |||||2|AMMONIA ANHYDROUS|0.16 kg| |||||3|GAMMA BUTYROLACTONE|0.90 kg| |||||above decision of NC.|||

Case No.	65 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00006770AM23
RA File Number	03AX04005861 AM23
Licence No and<br>Date	0311021934/06/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No. 66 / NC/3/MEET/Sep/202324/14

UDIN00321775AM24

r agenda and it was decided to call the firm for attending Norms Committee to explain its case.||Personal Hearing before|

Case No. 66 / NC/3/MEET/Sep/202324/14

UDIN00321775AM24

Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00006807AM23
RA File Number	09AX04001097 AM23
Licence No and<br>Date	0911004646/08/03/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	67 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	CANPEX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00006911AM23
RA File Number	31AX04000365 AM23
Licence No and<br>Date	3111002080/10/03/2023
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>CoA report of calcium cyanamide.<br>1.<br>Also, sample shipping bills and bill of entry of the export products and statement of export import of the<br>Authorization.<br>2.

irm: - CoA report of calcium cyanamide. 1. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization. 2.||

Case No.	68 / NC/3/MEET/Sep/202324/14
Case Status	Case Rejected
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004887AM24
RA File Number	03AX04005815 AM23
Licence No and<br>Date	0311022080/11/03/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

Case No.	69 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred

UDIN00321775AM24

Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00000292AM24
RA File Number	03AX04000045 AM24
Licence No and<br>Date	0311022935/19/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00000292AM24| |RA File Number|03AX04000045 AM24| |Licence No and Date|0311022935/19/04/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	70 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00005199AM24
RA File Number	03AX04000135 AM24
Licence No and<br>Date	0311022977/20/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo NC/3/MEET/Jul/202324/9 dated 28.07.2023against advance authorization<br>No.0311018319 dated 03/10/2022, 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.<br>NAS-5((2-Diazo<br>-1-Napthol-5-Sulfonic<br>Acid,<br>Sodium Salt))<br>1 kg<br>1<br>Tobias Acid<br>(Purity 97%)<br>1.618 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	71 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00000325AM24
RA File Number	03AX04000169 AM24
Licence No and	0311022998/21/04/2023

UDIN00321775AM24

Date

Norms Committee Decision:

UDIN00321775AM24

Date

Norms Committee Decision:

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

Case No.	72 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM REVIW00004946AM24
RA File Number	03AX04000416 AM24
Licence No and<br>Date	0311023239/01/05/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following<br>information/documents from the firm:-<br>Calculation sheet to arrive at the quantity of raw material asked on the basis of percentage yield as<br>given.<br>i.<br>Production/Consumption data for last 1 year duly certified by GST.<br>ii.

i. Calculation sheet to arrive at the quantity of raw material asked on the basis of percentage yield as given.

roduction/Consumption data for last 1 year duly certified by GST.** ii.||

i. Calculation sheet to arrive at the quantity of raw material asked on the basis of percentage yield as given.

Case No.	Case No.	73 / NC/3/MEET/Sep/202324/14	73 / NC/3/MEET/Sep/202324/14	73 / NC/3/MEET/Sep/202324/14	73 / NC/3/MEET/Sep/202324/14	73 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		KREATIVE ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM REVIW00005408AM24
RA File Number		09AX04000133 AM24
Licence No and<br>Date		0911005034/15/05/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and on the basis of information provided by<br>the firm, it was decided to revise adhoc norms as under :-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>2-ETHYL<br>ANILINE<br>/<br>2-ETHYL<br>BENZENEAMINE<br>1.058 kg<br>ETODOLAC<br>METHYL<br>ESTER(ETODOLAC<br>METHYL<br>1 Kg
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	ETODOLAC<br>METHYL<br>ESTER(ETODOLAC<br>METHYL		<br> <br>1 Kg	1	2-ETHYL<br>ANILINE<br>/<br>2-ETHYL<br>BENZENEAMINE	<br>1.058 kg

UDIN00321775AM24

Product||Qty.|Sl. No.|Import Items|Qty.| ||ETODOLAC METHYL ESTER(ETODOLAC METHYL|| 1 Kg|1|2-ETHYL ANILINE / 2-ETHYL BENZENEAMINE| 1.058 kg|

UDIN00321775AM24

2	2,3-DIHYDROFURANE	0.330 kg
3	METHYL 3 OXO PENTONOATE	0.455 kg
4	Methanol	1.133 kg
5	Toluene	1.00 kg
6	Sodium Nitrite	0.40 kg
7	Sodium Sulfite	2.20 kg

Case No.	74 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	CREDO LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004484AM24
RA File Number	09AX04000330 AM24
Licence No and<br>Date	0911005429/18/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>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>Indomethacin SR Pellets 27.5%<br>3000 kg<br>1<br>Indomethacin<br>833.25 kg<br>RA concerned may take further necessary action as per above decision of NC.

y. Sl. No. Import Items Qty. Indomethacin SR Pellets 27.5% 3000 kg 1 Indomethacin 833.25 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	75 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	CREDO LIFE SCIENCES PRIVATE LIMITED

UDIN00321775AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004485AM24
RA File Number	09AX04000329 AM24
Licence No and<br>Date	0911005430/18/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>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>Azithromycin Taste Mask Granules<br>7.5%((Each 1g taste mask Granules /<br>Pellets contains Azithromycin as<br>Azithromycin Dihydrate IP/USD 75 mg))<br>515 Kg<br>1<br>Azithromycin Dihydrate<br>39.011 kg<br>RA concerned may take further necessary action as per above decision of NC.

ains Azithromycin as Azithromycin Dihydrate IP/USD 75 mg)) 515 Kg 1 Azithromycin Dihydrate 39.011 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	76 / NC/3/MEET/Sep/202324/14	76 / NC/3/MEET/Sep/202324/14	76 / NC/3/MEET/Sep/202324/14	76 / NC/3/MEET/Sep/202324/14	76 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		HUMAN PHARMA LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00004492AM24
RA File Number		08AX04000577 AM24
Licence No and<br>Date		0811008785/18/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>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>CLOBETASOL PROPIONATE<br>1 kg<br>1<br>BETAMETHASONE<br>1.00 kg/kg
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	CLOBETASOL PROPIONATE		1 kg	1	BETAMETHASONE	1.00 kg/kg

UDIN00321775AM24

TE 1 kg 1 BETAMETHASONE 1.00 kg/kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||CLOBETASOL PROPIONATE||1 kg|1|BETAMETHASONE|1.00 kg/kg| ||||||||

UDIN00321775AM24

RA	concerned may take further necessary action as per	concerned may take further necessary action as per	concerned may take further necessary action as per	above decisi

Case No.		77 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		SENTISS PHARMA PRIVATE LIMITED

Meeting Number
<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00004508AM24
RA File Number		05AX04001074 AM24
Licence No and<br>Date		0511019932/19/07/2023
Norms Committee		Decision:

The Committee<br>product/import pr<br>N0511018527		considered the case as per agenda and taking cue from the earlier decision for same export<br>oduct in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization<br>td 25/04/2023i didd fi dh d P 407 f HBP Vl I dil
o. ae, t was ece to x a-oc norms uner ara . o o. as per etas<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.
	Export Product		Qty.	Sl.

x a-oc norms uner ara . o o. as per etas given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty.|||||||||| ||Export Product||Qty.|Sl. No.|Import Items|||Qty.|| ||||||||||| ||Brinex / Brinex-M / Brinarga / Brinera||1 Vial|1|Brinzolamide Micronized Sterile|||51.00 mg/Vial|| ||(Brinzolamide|Opthalmic Suspension|||||||| ||1%)- 5ml(Brin |ex / Brinex-M / Brinarga |||||||| ||/Brinera (Brin |zolamide Opthalmic |||||||| ||Suspension 1|)- 5ml)|||||||| ||||||||||| ||||||||||| |||k fh i ii f|||||||| |R concerned ma||y tae urter necessary acton as per above decson o NC.|||||||| ||||||||||| ||||||||||| |Case No.||78 / NC/3/MEET/Sep/202324/14|||||||| |Case Status||Case Approved|||||||| |Party Name||SUN PHARMACEUTICAL INDUSTRIES LIMITED|||||||| |Meeting Number|||||||||| | and Date||NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023|||||||| ||||||||||| |HQ File Number||HQRNORM APPLY 00004509AM24|||||||| ||||||||||| |RA File Number||05AX04000991 AM24|||||||| ||||||||||| |Licence No and|||||||||| |Date||0511019931/19/07/2023|||||||| |Norms Committee||Decision:|||||||| ||||||||||| |The Committee ||considered the case as per agenda and taking cue from the earlier decision for same export |||||||| |product/import p||roduct in meetingNo. NC/3/MEET/Dec/202223/15 dated 29/12/2022against advance|||||||| |||||||||||

agenda and taking cue from the earlier decision for same export |||||||| |product/import p||roduct in meetingNo. NC/3/MEET/Dec/202223/15 dated 29/12/2022against advance|||||||| |||||||||||

Case No.		78 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00004509AM24
RA File Number		05AX04000991 AM24
Licence No and<br>Date		0511019931/19/07/2023
Norms Committee Decision:
The Committee	considered the case as per agenda and taking cue from the earlier decision for same export
product/import	product in meetingNo. NC/3/MEET/Dec/202223/15 dated 29/12/2022against advance

UDIN00321775AM24

authorization No.0511013184 dated 14/06/2022 , 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.
Moxifloxacin HCL and<br>Dexamethasone Sodium Phosphate<br>Eye Drops 0.5%w/v, 0.1% w/v,<br>5ml((MILFLOX DM, MILFODOX,<br>MIFLOCO DELTA) (Each ml<br>contain Moxifloxacin Base 5mg. equi.<br>to Moxifloxacin HCL 5.45mg. &<br>Dexamethasone Phosphate<br>1mg equi. to Dexamethasone Sodium<br>Phosphate 1.1mg	54071<br>Numbers	1	Moxifloxacin Hydrochloride	1547.09 gram
		2	Dexamethasone<br>Sodium<br>Phosphate	<br>312.26 gram

amethasone Phosphate 1mg equi. to Dexamethasone Sodium Phosphate 1.1mg|54071 Numbers|1|Moxifloxacin Hydrochloride|1547.09 gram| |||2|Dexamethasone Sodium Phosphate| 312.26 gram|

Case No.	79 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004538AM24
RA File Number	31AX04000105 AM24
Licence No and<br>Date	3111002491/20/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	80 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	SMS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004543AM24
RA File Number	09AX04000362 AM24
Licence No and<br>Date	0911005455/20/07/2023
Norms Committee Decision:

UDIN00321775AM24

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

5AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
TENOFOVIR<br>DISOPROXIL<br>FUMARATE(TENOFOVIR<br>DISOPROXIL FUMARATE)	<br>1 kg	1	(R)-9-[2-(PHOSPHONO<br>METHOXY)<br>PROPYL]<br>ADENINE<br>MONO<br>HYDRATE (PMPA)	<br> <br>0.769 kg
		2	CHLORO<br>METHYL-2-<br>ISOPROPYL<br>CARBONATE	1.3527 kg
		3	N-METHYL-2-<br>PYRROLIDONE	1.4478 kg
		4	TRI ETHYL AMINE	0.45 kg
		5	ISO PROPYL ALCOHOL	2.113 kg
		6	FUMARIC ACID	0.34 kg
		7	METHANOL	0.548 kg

Case No.	81 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004551AM24
RA File Number	03AX04001742 AM24
Licence No and<br>Date	0311025596/21/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.

UDIN00321775AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
AZELAIC ACID GEL 15 percent<br>(Pack Size 50 Grams) (Net Wt. of<br>Azelaic Acid is 1800.00 Kgs.)	240000<br>numbers	1	Azelaic Acid	1836 kg

t	Qty.	Sl. No.	Import Items	Qty.
AZELAIC ACID GEL 15 percent<br>(Pack Size 50 Grams) (Net Wt. of<br>Azelaic Acid is 1800.00 Kgs.)	240000<br>numbers	1	Azelaic Acid	1836 kg

Case No.	Case No.	82 / NC/3/MEET/Sep/202324/14	82 / NC/3/MEET/Sep/202324/14	82 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		SMS PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00004557AM24
RA File Number		09AX04000365 AM24
Licence No and Date		0911005461/21/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Dec/202223/15 dated 29/12/2022against advance<br>authorizationNo.0911003220 dated 22/06/2022, 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.<br>1<br>2,4,5<br>TRIFLUOROPHENYLACETIC<br>ACID<br>1.146 kg<br>2<br>MELDRUM ACID<br>0.88 kg<br>3<br>3-(TERIFLUOROMETHYL)-5,6,7,8-<br>TETRAHYDRI-[1,2,4] TRIAZOLO[4,3-<br>a] PYRAZINE HYDROCHLORIDE<br>0.75 kg<br>4<br>DI-TERTIARY<br>BUTYL<br>DICARBONATE (DIBOC)<br>1.50 kg<br>SITAGLIPTIN<br>HYDROCHLORIDE(SITAGLIPTIN<br>HYDROCHLORIDE)<br>1 kg
	Export Product		Qty.	Sl.

YRAZINE HYDROCHLORIDE 0.75 kg 4 DI-TERTIARY BUTYL DICARBONATE (DIBOC) 1.50 kg SITAGLIPTIN HYDROCHLORIDE(SITAGLIPTIN HYDROCHLORIDE) 1 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||SITAGLIPTIN HYDROCHLORIDE(SITAGLIPTIN HYDROCHLORIDE)||1 kg|1|2,4,5 TRIFLUOROPHENYLACETIC ACID| 1.146 kg| |||||2|MELDRUM ACID|0.88 kg| |||||3|3-(TERIFLUOROMETHYL)-5,6,7,8- TETRAHYDRI-[1,2,4] TRIAZOLO[4,3- a] PYRAZINE HYDROCHLORIDE|0.75 kg| |||||4|DI-TERTIARY BUTYL DICARBONATE (DIBOC)| 1.50 kg|

UDIN00321775AM24

5	TETRAHYDROFURAN	2.56 kg
6	ISO PROPYL ALCOHOL	3.75 kg
7	METHANOL	7.77 kg
8	N-HEPTANE	1.80 kg
9	TERTIARY BUTANOL (T-BUTANOL)	2.17 kg
10	R-(+)-Alpha-Phenylethylamine	1.00 kg
11	SODIUM BOROHYDRIDE	0.30 kg

ROPYL ALCOHOL|3.75 kg| ||||7|METHANOL|7.77 kg| ||||8|N-HEPTANE|1.80 kg| ||||9|TERTIARY BUTANOL (T-BUTANOL)|2.17 kg| ||||10|R-(+)-Alpha-Phenylethylamine|1.00 kg| ||||11|SODIUM BOROHYDRIDE|0.30 kg|

Case No.	Case No.	83 / NC/3/MEET/Sep/202324/14	83 / NC/3/MEET/Sep/202324/14	83 / NC/3/MEET/Sep/202324/14	83 / NC/3/MEET/Sep/202324/14	83 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00004563AM24
RA File Number		09AX04000331 AM24
Licence No and<br>Date		0911005462/21/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>Glyoxylic acid 50 %<br>0.69 kg<br>2<br>Sodium bisulphite<br>0.55 kg<br>3<br>2,5-dihydroxy-1,4-dithiane<br>0.28 kg<br>5-Hydroxy-1,3-oxathiolane-2-<br>carboxylicacid(1R,2S,5R) menthyl ester<br>1 kg
	Export Product		Qty.	Sl. No.	Import Items<br>	Qty.
	5-Hydroxy-1,3-oxathiolane-2-<br>carboxylicacid(1R,2S,5R) menthyl ester		1 kg	1	Glyoxylic acid 50 %<br>	0.69 kg
				2	Sodium bisulphite<br>	0.55 kg
				3	2,5-dihydroxy-1,4-dithiane<br>	0.28 kg

5-Hydroxy-1,3-oxathiolane-2- carboxylicacid(1R,2S,5R) menthyl ester||1 kg|1|Glyoxylic acid 50 % |0.69 kg| |||||2|Sodium bisulphite |0.55 kg| |||||3|2,5-dihydroxy-1,4-dithiane |0.28 kg|

Case No.	Case No.	83 / NC/3/MEET/Sep/202324/14	83 / NC/3/MEET/Sep/202324/14	83 / NC/3/MEET/Sep/202324/14	83 / NC/3/MEET/Sep/202324/14	83 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00004563AM24
RA File Number		09AX04000331 AM24
Licence No and<br>Date		0911005462/21/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>Glyoxylic acid 50 %<br>0.69 kg<br>2<br>Sodium bisulphite<br>0.55 kg<br>3<br>2,5-dihydroxy-1,4-dithiane<br>0.28 kg<br>5-Hydroxy-1,3-oxathiolane-2-<br>carboxylicacid(1R,2S,5R) menthyl ester<br>1 kg
	Export Product		Qty.	Sl. No.	Import Items<br>	Qty.
	5-Hydroxy-1,3-oxathiolane-2-<br>carboxylicacid(1R,2S,5R) menthyl ester		1 kg	1	Glyoxylic acid 50 %<br>	0.69 kg
				2	Sodium bisulphite<br>	0.55 kg
				3	2,5-dihydroxy-1,4-dithiane<br>	0.28 kg

UDIN00321775AM24

-2- carboxylicacid(1R,2S,5R) menthyl ester||1 kg|1|Glyoxylic acid 50 % |0.69 kg| |||||2|Sodium bisulphite |0.55 kg| |||||3|2,5-dihydroxy-1,4-dithiane |0.28 kg|

UDIN00321775AM24

4	Formaldehyde	0.46 kg
5	N-Hexane	0.44 kg
6	Toluene	0.22 kg
7	Cyclohexane	0.55 kg
8	L-(-) Menthol 99%	0.725 kg

Case No.	84 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004566AM24
RA File Number	03AX04001745 AM24
Licence No and<br>Date	0311025639/21/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo NC/3/MEET/Jul/202324/9 dated 28.07.2023against advance authorization<br>No.0311018319 dated 03/10/2022, 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.

8319 dated 03/10/2022**, 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. NAS-5((2-Diazo -1-Napthol-5-Sulfonic Acid, Sodium Salt)) 1 kg 1 Tobias Acid (Purity 97%) 1.618 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	85 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved

UDIN00321775AM24

Party Name	MICRO LABS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004569AM24
RA File Number	07AX04000627 AM24
Licence No and Date	0711008790/21/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo.NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance authorizationNo.0711005013 dated 16/08/2022,<br>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<br>is less:-<br>Export Product<br>Qty.<br>Sl.

3 dated 16/08/2022**, 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. OLOPATADINE HYDROCHLORIDE OPTHALMIC SOLUTION 0.1W/V 5 ML (EACH ML CONTAINS 1.11 MG OF OLOPATIDINE HYDROCHLORIDE)(OLOPATADINE HYDROCHLORIDE OPTHALMIC SOLUTION 0.1% W/V 5 ML (EACH ML CONTAINS 1.11 MG OF OLOPATIDINE HYDROCHLORIDE) Net Contents: 205.35GMS) 37000 Numbers 1 OLOPATADINE HYDROCHLORIDE BP/EP/IP/USP 209.457 gram OLOPATADINE HYDROCHLORIDE OPTHALMIC SOLUTION 0.2 W/V 2.5 ML (EACH ML CONTAINS 2.22 MG OF OLOPATIDINE HYDROCHLORIDE)(OLOPATADINE HYDROCHLORIDE OPTHALMIC SOLUTION 0.2% W/V 2.5 ML (EACH ML CONTAINS 2.22 MG OF OLOPATIDINE HYDROCHLORIDE) Net Contents: 632.70 GMS) 114000 Numbers 1 OLOPATADINE HYDROCHLORIDE BP/EP/IP/USP 645.354 gram RA concerned may take further necessary action as per above decision of NC.||

Case No.	86 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	BIODEAL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004579AM24
RA File Number	05AX04001053 AM24
Licence No and<br>Date	0511019975/24/07/2023

UDIN00321775AM24

UDIN00321775AM24

Nor<br>Th<br>I as<br>RA	ms Committee Decision:<br>e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>per details given below or as applied by the firm, whichever is less:-	ms Committee Decision:<br>e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>per details given below or as applied by the firm, whichever is less:-	ms Committee Decision:<br>e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>per details given below or as applied by the firm, whichever is less:-	ms Committee Decision:<br>e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>per details given below or as applied by the firm, whichever is less:-	ms Committee Decision:<br>e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>per details given below or as applied by the firm, whichever is less:-
	Export Product	Qty.	Sl.

agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. per details given below or as applied by the firm, whichever is less:-| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty.| ||NASAL SPRAY(MADE FROM PUMP- 50-VP6-SNAP20 NASAL ADAPTOR WITH CHEMICALS AS PER THE DRUG LICENSE)|217800 pieces|1|NASAL ADAPTOR|Relevant on Net to Net basis with accountability.| ||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 adhoc 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.	87 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	BIODEAL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004581AM24
RA File Number	05AX04001054 AM24
Licence No and<br>Date	0511019976/24/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>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>NASAL ADAPTOR(PUMP-100-VP6<br>SNAP-20)<br>217800 pieces 1<br>NASAL ADAPTOR<br>Relevant on Net to Net<br>basis<br>with<br>accountability.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	88 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred

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

Case No.	88 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred

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Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004589AM24
RA File Number	03AX04001845 AM24
Licence No and<br>Date	0311025665/24/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	89 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ELPPE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004593AM24
RA File Number	03AX04001792 AM24
Licence No and<br>Date	0311025670/24/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004593AM24| |RA File Number|03AX04001792 AM24| |Licence No and Date|0311025670/24/07/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	90 / NC/3/MEET/Sep/202324/14	90 / NC/3/MEET/Sep/202324/14	90 / NC/3/MEET/Sep/202324/14	90 / NC/3/MEET/Sep/202324/14	90 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Meeting Number and<br>Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00004599AM24
RA File Number		09AX04000193 AM24
Licence No and Date		0911005467/24/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>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>Plunger Rod<br>450000 Numbers<br>2<br>Auto Injector Front<br>Relevant on Net-<br>to-Net basis with<br>accountability.<br>Sumatriptan Injection -6mg/0.5ml<br>(Sumatriptan Injection -6mg/0.5ml)<br>450000<br>Numbers
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Sumatriptan Injection -6mg/0.5ml<br>(Sumatriptan Injection -6mg/0.5ml)		450000<br>Numbers	1	Plunger Rod	450000 Numbers
				2	Auto Injector Front	Relevant on Net-<br>to-Net basis with<br>accountability.

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br>(Sumatriptan Injection -6mg/0.5ml)||450000 Numbers|1|Plunger Rod|450000 Numbers| |||||2|Auto Injector Front|Relevant on Net- to-Net basis with accountability.|

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3<br>Auto Injector Rear<br>Relevant on Net-<br>to-Net basis with<br>accountability.<br>4<br>47277910, HYPAK SCF1MLL<br>27GA1/2IN-5BEVRNS7025<br>IMP (Prefillable Glass Barrel<br>with Needle)<br>450000 Numbers<br>5<br>47211219,<br>HYPAK<br>BSCF1MLL<br>W4432/50GR<br>SI1000<br>(Gray<br>StopperCat:47211219<br>US<br>47285010-Frn)<br>450000 Numbers<br>RA concerned may take further necessary action as per above decision of NC.			3	Auto Injector Rear	Relevant on Net-<br>to-Net basis with<br>accountability.
			4	47277910, HYPAK SCF1MLL<br>27GA1/2IN-5BEVRNS7025<br>IMP (Prefillable Glass Barrel<br>with Needle)	<br> <br>450000 Numbers
			5	47211219,<br>HYPAK<br>BSCF1MLL<br>W4432/50GR<br>SI1000<br>(Gray<br>StopperCat:47211219<br>US<br>47285010-Frn)	<br> <br> <br> <br>450000 Numbers

rel with Needle)| 450000 Numbers| ||||5|47211219, HYPAK BSCF1MLL W4432/50GR SI1000 (Gray StopperCat:47211219 US 47285010-Frn)| 450000 Numbers|

Case No.	91 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004600AM24
RA File Number	09AX04000383 AM24
Licence No and<br>Date	0911005468/24/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo.0911004487 dated 17/02/2023, 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.<br>1<br>ORTHO PHENYLENEDIAMINE<br>0.550 kg<br>SALISOL HS (PBSA) / Ensulizole (2-<br>Phenylbenzimidazole-5-sulfonic acid)<br>1 kg<br>2<br>BENZALDEHYDE<br>0.545 kg<br>RA concerned may take further necessary action as per above decision of NC.

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izole (2- Phenylbenzimidazole-5-sulfonic acid) 1 kg 2 BENZALDEHYDE 0.545 kg RA concerned may take further necessary action as per above decision of NC.||

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Case No.	92 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004622AM24
RA File Number	05AX04001146 AM24
Licence No and<br>Date	0511020026/25/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	93 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004624AM24
RA File Number	05AX04001077 AM24
Licence No and<br>Date	0511020033/25/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/6 dated 14/06/2023against advance authorization<br>No.0511017491 dated 24/02/2023, 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.

dated 24/02/2023**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. Visallergol Eye Drops 0.2 Percent 2.5ml Vials (Visallergol Eye Drops 0.2 Percent 2.5ml Vials) 1 Number Vial 1 Olopatadine HCL 5.61 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	94 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023

UDIN00321775AM24

HQ File Number	HQRNORM APPLY 00004626AM24
RA File Number	52AX04000117 AM24
Licence No and<br>Date	5211005254/25/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	95 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004633AM24
RA File Number	05AX04001154 AM24
Licence No and<br>Date	0511020039/25/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance<br>authorizationNo.0511014979 dated 23/09/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

rt product in meetingNo. NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance authorizationNo.0511014979 dated 23/09/2022, 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. TOBRISS (TOBRAMYCIN 0.3 PERCENT) EYE DROPS 5 ML VIAL 1 Number Vial 1 Tobramycin Sulphate 19.057 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	96 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004634AM24
RA File Number	05AX04001158 AM24
Licence No and<br>Date	0511020040/25/07/2023
Norms Committee Decision:

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The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Apr/202223/1 dated 29/04/2022 against advance authorization No.0511003876 dated 28/07/2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
INOKAIN EYE DROPS 0.4 PERCENT 5 ML<br>VIAL (Each ml contains Benoxinate<br>Hydrochloride 4 mg))	1 vial	1	Benoxinate HCL	20.4 mg

ort Product	Qty.	Sl. No.	Import Items	Qty.
INOKAIN EYE DROPS 0.4 PERCENT 5 ML<br>VIAL (Each ml contains Benoxinate<br>Hydrochloride 4 mg))	1 vial	1	Benoxinate HCL	20.4 mg

Case No.	97 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004638AM24
RA File Number	03AX04001847 AM24
Licence No and<br>Date	0311025741/25/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	98 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004639AM24
RA File Number	03AX04001846 AM24
Licence No and<br>Date	0311025742/25/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

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

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Case No.	99 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004640AM24
RA File Number	03AX04001848 AM24
Licence No and<br>Date	0311025745/25/07/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.<br>100 / NC/3/MEET/Sep/202324/14
Case Status<br>Case Approved
Party Name<br>MEDREICH LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number<br>HQRNORM APPLY 00004647AM24
RA File Number<br>07AX04000636 AM24
Licence No and<br>Date<br>0711008812/26/07/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to		fix adhoc norms under Para 4.07 of HBP Vol.
I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty.
Colestyramine for Oral Suspension Light<br>1 Sachet	1	Colestyramine Resin	4.08 gram/sachet
Powder 4g Sachet(Each Sachet Contains:
4g of Colestyramine)
RA concerned may take further necessary action as per above decision		of NC.

et|1|Colestyramine Resin|4.08 gram/sachet|| |Powder 4g Sachet(Each Sachet Contains:||||| |4g of Colestyramine)||||| |RA concerned may take further necessary action as per above decision||of NC.|||

Case No.	101 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004654AM24
RA File Number	08AX04000710 AM24

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Licence No and 0811008720/26/07/2023 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Case No.	102 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004659AM24
RA File Number	03AX04001873 AM24
Licence No and<br>Date	0311025786/27/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004659AM24| |RA File Number|03AX04001873 AM24| |Licence No and Date|0311025786/27/07/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	103 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004674AM24
RA File Number	09AX04000385 AM24
Licence No and<br>Date	0911005497/27/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization<br>No.0911004707 dated 16/03/2023, 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.<br>Daptomycin for Injection 500mg/vial<br>(Consist of 250 Kgs Daptomycin)<br>500000 Numbers<br>1<br>Daptomycin<br>275 kg<br>RA concerned may take further necessary action as per above decision of NC.

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0mg/vial (Consist of 250 Kgs Daptomycin) 500000 Numbers 1 Daptomycin 275 kg RA concerned may take further necessary action as per above decision of NC.||

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Case No.	104 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004677AM24
RA File Number	34AX04000343 AM24
Licence No and<br>Date	3411003955/27/07/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	Case No.	104 / NC/3/MEET/Sep/202324/14	104 / NC/3/MEET/Sep/202324/14	104 / NC/3/MEET/Sep/202324/14	104 / NC/3/MEET/Sep/202324/14	104 / NC/3/MEET/Sep/202324/14	104 / NC/3/MEET/Sep/202324/14	104 / NC/3/MEET/Sep/202324/14	104 / NC/3/MEET/Sep/202324/14	104 / NC/3/MEET/Sep/202324/14	104 / NC/3/MEET/Sep/202324/14
Case Status		Case Deferred
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number
and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00004677AM24
RA File Number		34AX04000343 AM24
Licence No and		3411003955/27/07/2023
Date
Norms Committee		Decision:
Th i d		idi f f f TE
e case s uner co		nseraton or want o comments o .

Case No.		105 / NC/3/MEET/Sep/202324/14

|||||||| |Th i d||idi f f f TE|||||||||| |e case s uner co||nseraton or want o comments o .|||||||||| ||||||||||||| |Case No.||105 / NC/3/MEET/Sep/202324/14|||||||||| ||||||||||||| |Case Status||Case Approved|||||||||| |Party Name||PIRAMAL PHARMA LIMITED|||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023|||||||||| |HQ File Number||HQRNORM APPLY 00004684AM24|||||||||| |RA File Number||03AX04001926 AM24|||||||||| |Licence No and||0311025822/28/07/2023|||||||||| |Date|||||||||||| |Norms Committee ||Decision: |||||||||| |The Committee c dt/it||onsidered the case as per agenda and taking cue from the earlier d dt i tiN NC/3/MEET/A/202324/11 dtd 28/0|||||||ecision for same export /2023it d||| |proucmpor p authorizationNo.||rouc n meengo. ug ae 0311021390 dated 13/02/2023, it was decided to fix ad-hoc norms under|||||||agans avance Para 4.07 of HBP Vol. I||| |as|per details give| n below or as applied by the firm, whichever is less:-|||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Export Pro|duct|||Qty.||Sl. No.|Import Items||Qty.|| ||||||||||||| ||Bempedoic Aci|d and Ezetimibe Fixed Dose Combination|||1 Number||1|Bempedoic Acid||18990 mg|| || Tablets (Each T| ablet content Bempedoic Acid 180mg and||||||||.

t Items||Qty.|| ||||||||||||| ||Bempedoic Aci|d and Ezetimibe Fixed Dose Combination|||1 Number||1|Bempedoic Acid||18990 mg|| || Tablets (Each T| ablet content Bempedoic Acid 180mg and||||||||. .|| ||Ezetimibe 10m |g(Net content of Bempedoic Acid 3492 kg |||||||||| ||and Ezetimibe |194 kg in total Export Qty) (AA for Free of |||||2|Ezetimibe||10.55 mg.|| ||cost material as RBI Master Cir material being|per Para 4.11 of HBP & Para 4.19 of FTP & cular C-26 Disallowing remittances for supplied free of cost.)|||||||||| ||||||||||||| ||h b|lid l f b flfill f flli dii|||||||||| ||Note:Te aov Export 1.|norms are va ony or suje Product being Patented Medi|ct to umen cine, be filed w|t o oo ith USF||wng contons:- DA as an NDA (New Drug Application|||||)| || ||||||||||| ||Export to USA and Europe only. 2. Firm holding Certificate of Manufact 3.||uring Exclusi|vity.|||||||| ||||||||||||| |||||||||||||

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Case No.	106 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004700AM24
RA File Number	09AX04000394 AM24
Licence No and<br>Date	0911005507/28/07/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

PPLY 00004700AM24| |RA File Number|09AX04000394 AM24| |Licence No and Date|0911005507/28/07/2023| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	107 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004703AM24
RA File Number	03AX04001875 AM24
Licence No and<br>Date	0311025854/28/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jul/202324/9 dated 28/07/2023against advance authorization<br>No.0311016511 dated 22/07/2022, 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.<br>BELGUARD PBSA<br>(Phenyl benzimidazole Sulfonic Acid).<br>1 kg<br>1<br>Ortho Phenylene Diamine<br>0.4925 kg<br>RA concerned may take further necessary action as per above decision of NC

Case No.	108 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved

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0.4925 kg RA concerned may take further necessary action as per above decision of NC||

Case No.	108 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved

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Party Name	BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004704AM24
RA File Number	03AX04001876 AM24
Licence No and<br>Date	0311025855/28/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jul/202324/9 dated 28/07/2023against advance authorization<br>No.0311016511 dated 22/07/2022, 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.<br>BELGUARD PBSA<br>(Phenyl benzimidazole Sulfonic Acid).<br>1 kg<br>1<br>Ortho Phenylene Diamine<br>0.4925 kg<br>RA concerned may take further necessary action as per above decision of NC.

Qty. BELGUARD PBSA (Phenyl benzimidazole Sulfonic Acid). 1 kg 1 Ortho Phenylene Diamine 0.4925 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	109 / NC/3/MEET/Sep/202324/14	109 / NC/3/MEET/Sep/202324/14	109 / NC/3/MEET/Sep/202324/14	109 / NC/3/MEET/Sep/202324/14	109 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00004719AM24
RA File Number		08AX04000820 AM24
Licence No and<br>Date		0811008938/30/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization<br>No.0811007877 dated 17/04/2023, 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.<br>CLOZAPINE TABLETS (CLOZAPYL<br>1 Number<br>1<br>CLOZAPINE BP<br>102.00 mg/tablet
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	CLOZAPINE TABLETS (CLOZAPYL		1 Number	1	CLOZAPINE BP	102.00 mg/tablet

UDIN00321775AM24

100MG)(EACH UNCOATED TABLET CONTAINS : CLOZAPINE B.P 100 MG NET CONTENT OF CLOZAPINE BP SHOULD NOT BE LESS THAN 96.250 KGS. IN EXPORT ITEM)

OZAPINE BP|102.00 mg/tablet|

UDIN00321775AM24

100MG)(EACH UNCOATED TABLET CONTAINS : CLOZAPINE B.P 100 MG NET CONTENT OF CLOZAPINE BP SHOULD NOT BE LESS THAN 96.250 KGS. IN EXPORT ITEM)

Case No.	110 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	OCTOCHEM PHARMA AND FLAVOURS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004731AM24
RA File Number	05AX04001184 AM24
Licence No and<br>Date	0511020129/31/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization<br>No.0511018315 dated 13/04/2023, 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.<br>Menthol Crystals(Menthol / Menthol<br>Crystals (HAVING NET WAIT OF<br>EXPORT INPUTS L-Menthol /Menthol<br>40000 KGS & Indigenous, 10000 KGS))<br>1 kg<br>1<br>L-Menthol<br>1.02 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	111 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	KELVIN NATURAL MINT PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004732AM24
RA File Number	05AX04001031 AM24

UDIN00321775AM24

UDIN00321775AM24

Licence No and 0511019800/31/07/2023 Date Norms Committee Decision:

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

Case No.	112 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004735AM24
RA File Number	34AX04000351 AM24
Licence No and<br>Date	3411003964/31/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/May/202223/4dated17/06/2022against advance<br>authorizationNo. 3410046526 dated 05/11/2020, 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.<br>Acetone<br>112.0 MT<br>1<br>Cumene<br>58.863 MT<br>RA concerned may take further necessary action as per above decision of NC.

s:- Export Product Qty. Sl. No. Import Items Qty. Acetone 112.0 MT 1 Cumene 58.863 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	113 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	NIFTY LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004736AM24
RA File Number	09AX04000399 AM24
Licence No and<br>Date	0911005517/31/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No. 114 / NC/3/MEET/Sep/202324/14

UDIN00321775AM24

Case Status	Case Deferred
Party Name	LECILITE INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004750AM24
RA File Number	50AX04000034 AM24
Licence No and<br>Date	5011000972/31/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	115 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004751AM24
RA File Number	03AX04001897 AM24
Licence No and<br>Date	0311025909/31/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004751AM24| |RA File Number|03AX04001897 AM24| |Licence No and Date|0311025909/31/07/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	116 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004779AM24
RA File Number	08AX04000819 AM24
Licence No and<br>Date	0811008977/01/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	117 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	GITANJALI CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004784AM24
RA File Number	03AX04001927 AM24
Licence No and	0311025944/02/08/2023

UDIN00321775AM24

Date

Norms Committee Decision:

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

Case No.	118 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004788AM24
RA File Number	07AX04000660 AM24
Licence No and<br>Date	0711008872/02/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments from TE.

LY 00004788AM24| |RA File Number|07AX04000660 AM24| |Licence No and Date|0711008872/02/08/2023| |Norms Committee Decision: The case is under consideration for want of comments from TE.||

Case No.	119 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004796AM24
RA File Number	34AX04000209 AM24
Licence No and<br>Date	3411003978/02/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	120 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004798AM24
RA File Number	34AX04000210 AM24
Licence No and<br>Date	3411003980/02/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

UDIN00321775AM24

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

UDIN00321775AM24

Case No.	121 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	DEV BHOOMI ENTERPRISES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004815AM24
RA File Number	05AX04001219 AM24
Licence No and<br>Date	0511020221/03/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	122 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004817AM24
RA File Number	03AX04002007 AM24
Licence No and<br>Date	0311025988/03/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

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

Case No.	123 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00004819AM24
RA File Number	03AX04001998 AM24
Licence No and<br>Date	0311025990/03/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	124 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023

UDIN00321775AM24

HQ File Number	HQRNORM APPLY 00004820AM24
RA File Number	03AX04001995 AM24
Licence No and<br>Date	0311025992/03/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

/Sep/202|324/14|||||||||| |Cas|e Status|Case Approved||||||||||| |Par|ty Name|DEEPAK PHENOLICS LI|MITED|||||||||| |Me and|eting Number Date|NC/ 3/ MEET/ Sep/ 20232|4/ 14 and||27/09/2023|||||||| |||||||||||||| |HQ|File Number|HQRNORM APPLY 0000|5003AM2||4|||||||| |RA|File Number|34AX04000346 AM24||||||||||| |||||||||||||| |Lic Dat|ence No and e|3411004014/11/08/2023||||||||||| |Nor Th|ms Committee Decision: e Committee considered the case as p||er agenda||and takin|||g cue from the earlier decision for s||||ame export| ||||||||||||||

Case No.		154 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00005003AM24
RA File Number		34AX04000346 AM24
Licence No and<br>Date		3411004014/11/08/2023
Norms Committee	Decision:
The Committee	considered the case as per agenda and taking cue from the earlier decision for same export

UDIN00321775AM24

product/import product in meeting No. NC/3/MEET/May/202223/4 dated 17/06/2022 against advance authorization No. 3410046526 dated 05/11/2020 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
Acetone	250 MT	1	Cumene	130.807 MT

f 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.
Acetone	250 MT	1	Cumene	130.807 MT

Case No.	155 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005011AM24
RA File Number	32AX04000274 AM24
Licence No and<br>Date	3211005388/11/08/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.<br>156 / NC/3/MEET/Sep/202324/14
Case Status<br>Case Approved
Party Name<br>OPTIMUS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number<br>HQRNORM APPLY 00005018AM24
RA File Number<br>09AX04000442 AM24
Licence No and<br>Date<br>0911005624/11/08/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.
I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty.

as decided to fix adhoc norms under Para 4.07 of HBP Vol.||||| |I as per details given below or as applied by the firm, whichever is less:-||||| |Export Product Qty.|Sl. No.|Import Items|Qty.||

Case No.<br>156 / NC/3/MEET/Sep/202324/14
Case Status<br>Case Approved
Party Name<br>OPTIMUS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number<br>HQRNORM APPLY 00005018AM24
RA File Number<br>09AX04000442 AM24
Licence No and<br>Date<br>0911005624/11/08/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.
I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty.

UDIN00321775AM24

Cabergoline, 0.5 mg Tablet		1 Number	1	Cabergoline	0.51 mg
((Each<br>tablet<br>Contains	-
Cabergoline, 0.5 mg))

t Items|Qty.||

UDIN00321775AM24

Cabergoline, 0.5 mg Tablet		1 Number	1	Cabergoline	0.51 mg
((Each<br>tablet<br>Contains	-
Cabergoline, 0.5 mg))

Case No.	157 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	OPTIMUS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005019AM24
RA File Number	09AX04000445 AM24
Licence No and<br>Date	0911005625/11/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>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>Prochloroperazine Maleate Tablets<br>5mg<br>(Each<br>tablet<br>contains<br>Prochloroperazine Maleate eq. to 5<br>mg Prochloroperazine)<br>1 Number<br>1<br>Prochloroperazine Maleate 8.10 mg<br>Prochloroperazine Maleate Tablets<br>10mg<br>(Each<br>tablet<br>contains<br>Prochloroperazine Maleate eq. to<br>10 mg Prochloroperazine)<br>1 Number<br>2<br>Prochloroperazine Maleate 16.20 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	158 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023

UDIN00321775AM24

UDIN00321775AM24

HQ File Number	HQRNORM APPLY 00005070AM24
RA File Number	03AX04002091 AM24
Licence No and<br>Date	0311026346/16/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	Case No.	159 / NC/3/MEET/Sep/202324/14	159 / NC/3/MEET/Sep/202324/14	159 / NC/3/MEET/Sep/202324/14	159 / NC/3/MEET/Sep/202324/14	159 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00005071AM24
RA File Number		08AX04000910 AM24
Licence No and<br>Date		0811009097/16/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/8dated30/06/2023against advance authorization<br>No. 0811007966 dated 25/04/2023, 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.

7966 dated 25/04/2023**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 60 MG EACH FILM COATED EXTENDED RELEASE TABLETS(CONTAINS: DILUTED ISMN (50% DILUTED WITH LACTOSE MONOHYDRATE) USP EQUIVALENT TO ISOSORBIDE MONONITRATE 60MG, NET CONTENT OF ACTIVE INGREDIENT ISOSORBIDE MONONITRATE SHOULD NOT BE LESS THAN 1980.000 KGS.) 1 Number 1 Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP 122.40 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 60 MG EACH FILM COATED EXTENDED RELEASE TABLETS(CONTAINS: DILUTED ISMN (50% DILUTED WITH LACTOSE MONOHYDRATE) USP EQUIVALENT TO ISOSORBIDE MONONITRATE 60MG, NET CONTENT OF ACTIVE INGREDIENT ISOSORBIDE MONONITRATE SHOULD NOT BE LESS THAN 1980.000 KGS.)||1 Number|1|Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP| 122.40 mg|

UDIN00321775AM24

SS THAN 1980.000 KGS.)||1 Number|1|Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP| 122.40 mg|

UDIN00321775AM24

ISOSORBIDE<br>MONONITRATE EXTENDED<br>RELEASE TABLETS USP 120<br>MG EACH FILM COATED<br>EXTENDED RELEASE<br>TABLETS(CONTAINS:<br>DILUTED ISMN (50%<br>DILUTED WITH LACTOSE<br>MONOHYDRATE) USP<br>EQUIVALENT TO<br>ISOSORBIDE<br>MONONITRATE 120MG, NET<br>CONTENT OF ACTIVE<br>INGREDIENT ISOSORBIDE<br>MONONITRATE SHOULD<br>NOT BE<br>LESS THAN 1320.000 KGS.)<br>1 Number<br>2<br>Isosorbide Mononitrate 50<br>percent<br>Assay.<br>Diluted<br>ISMN (50% diluted with<br>lactose monohydrate) USP<br>244.80 mg<br>RA concerned may take further necessary action as per above decision of NC.	ISOSORBIDE<br>MONONITRATE EXTENDED<br>RELEASE TABLETS USP 120<br>MG EACH FILM COATED<br>EXTENDED RELEASE<br>TABLETS(CONTAINS:<br>DILUTED ISMN (50%<br>DILUTED WITH LACTOSE<br>MONOHYDRATE) USP<br>EQUIVALENT TO<br>ISOSORBIDE<br>MONONITRATE 120MG, NET<br>CONTENT OF ACTIVE<br>INGREDIENT ISOSORBIDE<br>MONONITRATE SHOULD<br>NOT BE<br>LESS THAN 1320.000 KGS.)	1 Number	2	Isosorbide Mononitrate 50<br>percent<br>Assay.<br>Diluted<br>ISMN (50% diluted with<br>lactose monohydrate) USP	<br> <br> <br>244.80 mg

S THAN 1320.000 KGS.)|1 Number|2|Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP| 244.80 mg| |---|---|---|---|---|---|

Case No.	160 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005073AM24
RA File Number	08AX04000916 AM24
Licence No and<br>Date	0811009102/16/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE

Case No.	161 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005074AM24
RA File Number	03AX04002206 AM24
Licence No and<br>Date	0311026357/16/08/2023
Norms Committee Decision:

UDIN00321775AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
Maropitant Injection 10 mg / ml.(Each ml<br>contains : Maropitant Citrate 14.484 mg.<br>Equivalent to Maropitant 10 mg Pack Size<br>: 20 ml. Total Maropitant Citrate<br>Consumed along with wastages &<br>overages - 2.100 Kg.)	<br>1 Number	1	Maropitant<br>Citrate<br>Monohydrate	<br>304.135 mg

Case No.	162 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005075AM24
RA File Number	08AX04000894 AM24
Licence No and<br>Date	0811009108/16/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	163 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	TOPNOTCH CHEMICALS PVT LTD
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005079AM24
RA File Number	03AX04002155 AM24
Licence No and Date	0311026363/16/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/May/202324/5dated08/06/2023against advance<br>authorizationNo. 0311021389 dated 13/02/2023, 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:-

UDIN00321775AM24

1021389 dated 13/02/2023**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00321775AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
LUMEFANTRINE(LUMEFANTRINE)	1 kg	1	9H FLUORENE	0.90 kg
		2	Di N Butylamine	0.50 kg
		3	Sodium Borohydride	0.060 kg
		4	Para<br>Chloro<br>Benzaldehyde	<br>0.3476 kg
		5	Di Methyl Formamide	0.555 kg

Case No.	Case No.	164 / NC/3/MEET/Sep/202324/14	164 / NC/3/MEET/Sep/202324/14	164 / NC/3/MEET/Sep/202324/14	164 / NC/3/MEET/Sep/202324/14	164 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00005081AM24
RA File Number		03AX04002198 AM24
Licence No and<br>Date		0311026365/16/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/May/202324/5dated08/06/2023against advance authorization<br>No. 0311021389 dated 13/02/2023, 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.<br>(in mg)<br>Atorvastatin Calcium Tablets USP 10mg((Net<br>Content of Import Sr. No.

en below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. (in mg) Atorvastatin Calcium Tablets USP 10mg((Net Content of Import Sr. No. 1 is 1541.025 kgs, Atorvastatin Calcium Propylene Glycol Solvate 1 Number Tablet 1 11.415||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in mg)| ||Atorvastatin Calcium Tablets USP 10mg((Net Content of Import Sr. No. 1 is 1541.025 kgs,|| 1 Number Tablet|1|Atorvastatin Calcium Propylene Glycol Solvate| 11.415|

UDIN00321775AM24

Sr. No. 2 is 8718.030 kg, Sr.<br>No. 3 is 2436.615 kg, Sr. No. 4 is 1515<br>Nos.))	Sr. No. 2 is 8718.030 kg, Sr.<br>No. 3 is 2436.615 kg, Sr. No. 4 is 1515<br>Nos.))			USP

			2	Microcrystalline<br>Cellulose<br>(MCC) NF (Avicel PH 102)	<br>6	4.578

			3	Calcium Acetate	18.049
			4	Silica<br>Gel<br>Dessicants<br>-<br>Packaged Activated Carbon	<br> <br>Relevant<br>as<br>per<br>packing
				<br>(Strippax Sorbent)	<br> <br> <br>policy


Atorvastatin Calcium T	blets USP 20	1 Number	5	Atorvastatin<br>Calcium	<br>22830
<br>mg((Net Content of Imp	<br>ort Sr. No. 1 is	<br>Tablet		<br> <br>Propylene Glycol Solvate	<br> <br>.
<br>205.470 kgs, Sr. No. 2 i	<br>s 1164.843 kg, Sr.			<br>USP

No.

Net Content of Imp| ort Sr. No. 1 is|||| Tablet|||| Propylene Glycol Solvate|| .|| || 205.470 kgs, Sr. No. 2 i| s 1164.843 kg, Sr.|||||||| USP|||| ||||||||||||||| ||No. 3 is 324.810 kg, Sr. |No. 4 is 101000||||||6||Milli Clll|| 129427|| ||Nos.))|||||||||crocrystane euose (MCC) NF (Avicel PH 102)|| .|| ||||||||||||||| |||||||||7||Calcium Acetate||36.090|| |||||||||8||Silica Gel Dessicants - Packaed Activated Carbon|| Relevant as er ackin|| |||||||||||g (Strippax Sorb| ent)| p pg policy|| ||||||||||||||| ||Atorvastatin Calcium Tablets U Content of Import Sr. No. 1 is 3 Sr. No. 2 is 21833.568 kg, Sr. No. 3 is 6088.070 kg, Sr. No Nos.))||SP 40mg 857.337 . 4 is 949||((Net kgs,| 1 N Tab|umber let|9||Atorvastatin Propylene G |Calcium lycol Solvate| 45.595|| ||||||400|||||USP|||| |||||||||||| | || |||||||||10||Microcrystalli (MCC) NF (A|ne Cellulose vicel PH 102)| 258.08|| |||||||||11||Calcium Aceta|te|71.963|| ||||||||||||||| |||||||||12||Silica Gel Packaged Act |Dessicants - ivated Carbon | Relevant as per packing || |||||||||||(Strippax Sorb|ent)|policy|| ||||||| |||||| || ||Atorvastatin Calcium Tablets USP 80mg((Net Content of Import Sr. No. 1 is 2052.000 kgs, Sr. No. 2 is 11659.635 kg,||||| 1 Number Tablet||13||Atorvastatin Calcium Propylene Glycol Solvate USP|| 91.20|| |||||||||||||||

UDIN00321775AM24

is 2052.000 kgs, Sr. No. 2 is 11659.635 kg,||||| 1 Number Tablet||13||Atorvastatin Calcium Propylene Glycol Solvate USP|| 91.20|| |||||||||||||||

UDIN00321775AM24

Sr. No.	3 is 3260.903 kg, Sr. No. 4 is 252000	14<br>Microcrystalline	Cellulose	Cellulose	<br>518.206	<br>518.206
Nos.))		(MCC) NF (Avicel	PH 102)
		15<br>Calcium Acetate			144.929
		16<br>Silica<br>Gel<br>Dessicants		-	<br>Relevant		<br>as
		Packaged Activated Carbon			<br>per	packing
		(Strippax Sorbent)			policy
Note: The above norms are valid only for subject to fulfillment of following conditions:
1.	Export Product being Patented Medicine, be filed with USFDA filing<br>		ANDA	(A New			Drug
	Application) of Apotex Corp, US. Agent for Apotex Inc., Canada.
2.	Export to USA only.<br>
3.	Firm holding Certificate of Manufacturing Exclusivity.<br>

Case No.	165 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	PIL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005085AM24
RA File Number	05AX04001384 AM24
Licence No and<br>Date	0511020419/16/08/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

PPLY 00005085AM24| |RA File Number|05AX04001384 AM24| |Licence No and Date|0511020419/16/08/2023| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	166 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005087AM24
RA File Number	07AX04000732 AM24
Licence No and<br>Date	0711008971/16/08/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

UDIN00321775AM24

Case No.	167 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	SRI KRISHNA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005088AM24
RA File Number	09AX04000448 AM24
Licence No and<br>Date	0911005633/16/08/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	168 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005094AM24
RA File Number	03AX04002037 AM24
Licence No and<br>Date	0311026386/17/08/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing		<br>before
Norms Committee to explain its case.

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

Case No.	169 / NC/3/MEET/Sep/202324/14	169 / NC/3/MEET/Sep/202324/14	169 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/	14	and 27/09/2023
HQ File Number	HQRNORM APPLY 00005101AM24
RA File Number	03AX04002203 AM24
Licence No and<br>Date	0311026394/17/08/2023
Norms Committee Decision:
The Committee considered the case as per agenda			and it was decided to		fix adhoc norms under Para 4.07 of HBP Vol.
I as per details given below or as applied by the firm, whichever is less:-
Export Product			Qty.	Sl. No.	Import Items	Qty.

UDIN00321775AM24

|SELAMECTIN 6% SPOT ON 0.25 ML TUBE(Each ml Contains Selamectin 60 mg Net Quantity of Selamectin Consumed Including Wastages & Overages : 1.500 Kg.) 90912 Number 1 SELAMECTIN 1.372 kg SELAMECTIN 6% SPOT ON 0.50 ML TUBE(Each ml Contains Selamectin 60 mg Net Quantity of Selamectin Consumed Including Wastages & Overages : 6.000 Kg.) 181836 Number2 SELAMECTIN 5.541 kg SELAMECTIN 6% SPOT ON 0.75 ML TUBE(Each ml Contains Selamectin 60 mg Net Quantity of Selamectin Consumed Including Wastages & Overages : 11.200 Kg) 226278 Number3 SELAMECTIN 10.38 kg SELAMECTIN 6% SPOT ON 1 ML TUBE(Each ml<br

br>Contains Selamectin 60 mg Net Quantity of Selamectin<br>Consumed Including Wastages & Overages : 11.200 Kg)<br>226278 Number3<br>SELAMECTIN<br>10.38 kg<br>SELAMECTIN 6% SPOT ON 1 ML TUBE(Each ml<br>Contains Selamectin 60 mg Net Quantity of Selamectin<br>Consumed Including Wastages & Overages : 7.200 Kg)<br>109096 Number4<br>SELAMECTIN<br>6.594 kg<br>SELAMECTIN 6% SPOT ON 2 ML TUBE(Each ml<br>Contains Selamectin 60 mg Net Quantity of Selamectin<br>Consumed<br>Including Wastages & Overages : 9.200 Kg)<br>69699 Number 5<br>SELAMECTIN<br>8.488 kg<br>SELAMECTIN 6% SPOT ON 4 ML TUBE(Each ml<br>Contains Selamectin 60 mg Net Quantity of Selamectin<br>Consumed<br>Including Wastages & Overages : 5.600 Kg)<br>21213 Number 6<br>SELAMECTIN<br>5.193 kg<br>RA concerned may take further necessary action as per above decision of NC.	SELAMECTIN 6% SPOT ON 0.25 ML TUBE(Each ml<br>Contains Selamectin 60 mg Net Quantity of Selamectin<br>Consumed Including Wastages & Overages : 1.500 Kg.)	90912 Number	1	SELAMECTIN	1.372 kg
	SELAMECTIN 6% SPOT ON 0.50 ML TUBE(Each ml<br>Contains Selamectin 60 mg Net Quantity of Selamectin<br>Consumed Including Wastages & Overages : 6.000 Kg.)	181836 Number	2	SELAMECTIN	5.541 kg
	SELAMECTIN 6% SPOT ON 0.75 ML TUBE(Each ml<br>Contains Selamectin 60 mg Net Quantity of Selamectin<br>Consumed Including Wastages & Overages : 11.200 Kg)	226278 Number	3	SELAMECTIN	10.38 kg

41 kg| ||SELAMECTIN 6% SPOT ON 0.75 ML TUBE(Each ml Contains Selamectin 60 mg Net Quantity of Selamectin Consumed Including Wastages & Overages : 11.200 Kg)|226278 Number|3|SELAMECTIN|10.38 kg| ||SELAMECTIN 6% SPOT ON 1 ML TUBE(Each ml Contains Selamectin 60 mg Net Quantity of Selamectin Consumed Including Wastages & Overages : 7.200 Kg)|109096 Number|4|SELAMECTIN|6.594 kg| ||SELAMECTIN 6% SPOT ON 2 ML TUBE(Each ml Contains Selamectin 60 mg Net Quantity of Selamectin Consumed Including Wastages & Overages : 9.200 Kg)|69699 Number|5|SELAMECTIN|8.488 kg| ||SELAMECTIN 6% SPOT ON 4 ML TUBE(Each ml Contains Selamectin 60 mg Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.600 Kg)|21213 Number|6|SELAMECTIN|5.193 kg|

Case No.	170 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005104AM24
RA File Number	09AX04000416 AM24
Licence No and<br>Date	0911005648/17/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202223/18dated23/01/2023against advance authorization<br>No. 0911003577 dated 02/09/2022, 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:-

UDIN00321775AM24

1003577 dated 02/09/2022**, 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:-||

UDIN00321775AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Aztreonam for Injection USP 1<br>Gram<br>1 Number<br>1<br>Aztreonam and Arginine<br>1.10 gram/vial<br>Aztreonam for Injection USP 500<br>mg<br>1 Number<br>2<br>Aztreonam and Arginine<br>0.55 gram/vial<br>RA concerned may take further necessary action as per above decision of NC	Export Product	Qty.	Sl. No.	Import Items	Qty.
	Aztreonam for Injection USP 1<br>Gram	<br>1 Number	1	Aztreonam and Arginine	1.10 gram/vial
	Aztreonam for Injection USP 500<br>mg	<br>1 Number	2	Aztreonam and Arginine	0.55 gram/vial

Case No.	171 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005109AM24
RA File Number	03AX04001779 AM24
Licence No and<br>Date	0311025949/18/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005109AM24| |RA File Number|03AX04001779 AM24| |Licence No and Date|0311025949/18/08/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	172 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005111AM24
RA File Number	03AX04002232 AM24
Licence No and<br>Date	0311026425/18/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	173 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023

UDIN00321775AM24

HQ File Number	HQRNORM APPLY 00005112AM24
RA File Number	03AX04002227 AM24
Licence No and<br>Date	0311026426/18/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

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

Case No.	174 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005113AM24
RA File Number	03AX04002231 AM24
Licence No and<br>Date	0311026428/18/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	Case No.	175 / NC/3/MEET/Sep/202324/14	175 / NC/3/MEET/Sep/202324/14	175 / NC/3/MEET/Sep/202324/14	175 / NC/3/MEET/Sep/202324/14	175 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00005115AM24
RA File Number		03AX04001837 AM24
Licence No and<br>Date		0311026433/18/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Dec/202223/15dated29/12/2022against advance authorization<br>No. 0311015328 dated 07/06/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

ct in meetingNo. NC/3/MEET/Dec/202223/15dated29/12/2022against advance authorization No. 0311015328 dated 07/06/2022, 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. Maxigesic cold & flu Hot Drink 500mg/150mg Sachets (Paracetamol & Ibuprofen Sachets 1 Number 1 Ibuprofen Lysine Salt IH 258.88 mg / Sachet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Maxigesic cold & flu Hot Drink 500mg/150mg Sachets (Paracetamol & Ibuprofen Sachets||1 Number|1|Ibuprofen Lysine Salt IH|258.88 mg / Sachet|

UDIN00321775AM24

|500 mg & 150 mg)(Maxigesic cold & flu Hot Drink 500mg/150mg Sachets (Paracetamol & Ibuprofen Sachets 500 mg & 150 mg) (Net content of Ibuprofen Lysine Salt IH API 2829.76 kg)) Maxigesic cold & flu Hot Drink 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg) (Net content(Maxigesic cold & flu Hot Drink 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg) (Net content of Ibuprofen Lysine Salt IH API 2315.27 kg)) 1 Number 2 Ibuprofen Lysine Salt IH 517.77 mg / Sachet RA concerned may take further necessary action as per above decision of NC.|500 mg & 150 mg)(Maxigesic cold & flu Hot Drink 500mg/150mg Sachets (Paracetamol & Ibuprofen Sachets 500 mg & 150 mg) (Net content of Ibuprofen Lysine Salt IH API 2829.76 kg))|||||

|500 mg & 150 mg)(Maxigesic cold & flu Hot Drink 500mg/150mg Sachets (Paracetamol & Ibuprofen Sachets 500 mg & 150 mg) (Net content of Ibuprofen Lysine Salt IH API 2829.76 kg))||||| |---|---|---|---|---|---| ||Maxigesic cold & flu Hot Drink 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg) (Net content(Maxigesic cold & flu Hot Drink 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg) (Net content of Ibuprofen Lysine Salt IH API 2315.27 kg))| 1 Number|2|Ibuprofen Lysine Salt IH|517.77 mg / Sachet|

Case No.	176 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005116AM24
RA File Number	03AX04002228 AM24
Licence No and<br>Date	0311026434/18/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	177 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005117AM24
RA File Number	03AX04002230 AM24

UDIN00321775AM24

UDIN00321775AM24

Licence No and<br>Date	0311026435/18/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	Case No.	178 / NC/3/MEET/Sep/202324/14	178 / NC/3/MEET/Sep/202324/14	178 / NC/3/MEET/Sep/202324/14	178 / NC/3/MEET/Sep/202324/14	178 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00005119AM24
RA File Number		05AX04001339 AM24
Licence No and<br>Date		0511020475/18/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/24dated13/04/2023against advance<br>authorizationNo. 0311014211 dated 27/04/2022, 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.

4211 dated 27/04/2022**, 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. 1 Ciprofloxacin 16.819 kg Ciprofloxacin and Dexamethasone Sterile Otic Suspension 7.5ml((Each ml contains Ciprofloxacin 3mg. & Dexamethasone 1mg (Equivalent to 14625.00 Gm. Ciprofloxacin and 4875.00 Gm. Dexamethasone Bulk Drug)) 650000 Number 2 Dexamethasone (Micronised) 5.119 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Ciprofloxacin and Dexamethasone Sterile Otic Suspension 7.5ml((Each ml contains Ciprofloxacin 3mg. & Dexamethasone 1mg (Equivalent to 14625.00 Gm. Ciprofloxacin and 4875.00 Gm. Dexamethasone Bulk Drug))|| 650000 Number|1|Ciprofloxacin|16.819 kg| |||||2|Dexamethasone (Micronised)|5.119 kg| |||||above decision of NC.|||

Case No.	179 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005126AM24
RA File Number	03AX04002247 AM24

UDIN00321775AM24

Licence No and 0311026446/18/08/2023 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

4| |RA File Number|03AX04002247 AM24|

UDIN00321775AM24

Licence No and 0311026446/18/08/2023 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Case No.	180 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005137AM24
RA File Number	52AX04000128 AM24
Licence No and<br>Date	5211005508/21/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	181 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005146AM24
RA File Number	08AX04000944 AM24
Licence No and<br>Date	0811009157/21/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	182 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005152AM24
RA File Number	05AX04001449 AM24
Licence No and<br>Date	0511020498/21/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	183 / NC/3/MEET/Sep/202324/14

UDIN00321775AM24

br>Date|0511020498/21/08/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.|| ||| |Case No.|183 / NC/3/MEET/Sep/202324/14|

UDIN00321775AM24

Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005153AM24
RA File Number	05AX04001447 AM24
Licence No and<br>Date	0511020506/21/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	184 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005154AM24
RA File Number	05AX04001448 AM24
Licence No and<br>Date	0511020507/21/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	185 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005165AM24
RA File Number	03AX04002258 AM24
Licence No and<br>Date	0311026486/22/08/2023
Norms Committee Decision:<br> The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

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

Case No.	186 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	SHARP MINT LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005169AM24
RA File Number	05AX04001349 AM24

UDIN00321775AM24

Licence No and 0511020338/22/08/2023 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Case No.	187 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005187AM24
RA File Number	03AX04002259 AM24
Licence No and<br>Date	0311026527/23/08/2023
Norms Committee Decision:<br> The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

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

Case No.	188 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005188AM24
RA File Number	03AX04002257 AM24
Licence No and<br>Date	0311026528/23/08/2023
Norms Committee Decision:<br> The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	189 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005192AM24
RA File Number	03AX04002292 AM24
Licence No and<br>Date	0311026535/23/08/2023
Norms Committee Decision:<br> The Committee considered the case as per agenda and it was decided to call the firm for attending		Personal Hearing<br>before

UDIN00321775AM24

Norms Committee to explain its case.

The Committee considered the case as per agenda and it was decided to call the firm for attending||Personal Hearing before|

UDIN00321775AM24

Norms Committee to explain its case.

Case No.	190 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005202AM24
RA File Number	34AX04000404 AM24
Licence No and<br>Date	3411004043/23/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	191 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	SPAR PHARMA LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005203AM24
RA File Number	09AX04000344 AM24
Licence No and<br>Date	0911005672/23/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	192 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005258AM24
RA File Number	03AX04002280 AM24
Licence No and<br>Date	0311026646/28/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005258AM24| |RA File Number|03AX04002280 AM24| |Licence No and Date|0311026646/28/08/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	193 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023

UDIN00321775AM24

and Date	and Date
HQ File Number		HQRNORM APPLY 00005259AM24
RA File Number		03AX04002254 AM24
Licence No and<br>Date		0311026647/28/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Dec/202223/15dated29/12/2022against advance authorization<br>No. 0311015328 dated 07/06/2022, 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.<br>1<br>EASTMAN (TM) CELLULOSE<br>ACETATE (CA 398-10NF/EP)<br>38.88 mg<br>2<br>SENTRY POLYOX WSR N80 FP<br>NF<br>80.52 mg<br>OXYBUTYNIN CHLORIDE<br>EXTENDED RELEASE TAB USP 5<br>MG.(Each tablet contains (i) Eastman<br>(TM Cellulose Acetate (CA 398-<br>10NF/EP)- 38.88 mg (ii) Sentry Polyox<br>WSR N80 FP NF- 80.52 mg (iii) Sentry<br>Polyox WSR 303 NF- 41.10 mg.

SE TAB USP 5 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 38.88 mg (ii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iii) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 285.049 Kgs (ii) 590.332 Kgs (iii) 301.325 Kgs.) 1 Number 3 SENTRY POLYOX WSR 303 NF 41.10 mg 4 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 38.88 mg 5 SENTRY POLYOX WSR N80 FP NF 80.77 mg OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 38.88 mg (ii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iii) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 261.938 Kgs (ii) 544.156 Kgs (iii) 276.895 Kgs ) 1 Number 6 SENTRY POLYOX WSR 303 NF 41.10 mg 7 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 38.88 mg 8 SENTRY POLYOX WSR N80 FP NF 81.02 mg OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 15 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (ii) Sentry Polyox WSR N80 FP NF- 81.02 mg (iii) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 179.762 Kgs (ii) 1 Number 9 SENTRY POLYOX WSR 303 NF 41.10 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB USP 5 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 38.88 mg (ii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iii) Sentry Polyox WSR 303 NF- 41.10 mg.

SE TAB USP 5 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 38.88 mg (ii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iii) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 285.049 Kgs (ii) 590.332 Kgs (iii) 301.325 Kgs.)||1 Number|1|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 38.88 mg| |||||2|SENTRY POLYOX WSR N80 FP NF| 80.52 mg| |||||3|SENTRY POLYOX WSR 303 NF|41.10 mg| ||OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 38.88 mg (ii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iii) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 261.938 Kgs (ii) 544.156 Kgs (iii) 276.895 Kgs )||1 Number|4|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 38.88 mg| |||||5|SENTRY POLYOX WSR N80 FP NF| 80.77 mg| |||||6|SENTRY POLYOX WSR 303 NF|41.10 mg| ||OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 15 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (ii) Sentry Polyox WSR N80 FP NF- 81.02 mg (iii) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 179.762 Kgs (ii)||1 Number|7|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 38.88 mg| |||||8|SENTRY POLYOX WSR N80 FP NF| 81.02 mg| |||||9|SENTRY POLYOX WSR 303 NF|41.10 mg|

UDIN00321775AM24

374.596 Kgs (iii) 190.026 Kgs. )

br>ACETATE (CA 398-10NF/EP)| 38.88 mg| |||||8|SENTRY POLYOX WSR N80 FP NF| 81.02 mg| |||||9|SENTRY POLYOX WSR 303 NF|41.10 mg|

UDIN00321775AM24

374.596 Kgs (iii) 190.026 Kgs. )

Case No.	194 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005263AM24
RA File Number	08AX04001023 AM24
Licence No and<br>Date	0811009216/28/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	195 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005273AM24
RA File Number	03AX04002281 AM24
Licence No and<br>Date	0311026687/28/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Sep/202324/13 dated 14/09/2023against advance authorization<br>No.0311025490 dated 17/07/2023, 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.

dated 17/07/2023**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. HEXAFLUOROISOPROPYL METHYL ETHER(HFMOP) 1 kg 1 HEXA FLUOROISO PROPANOL 0.970 kg RA concerned may take further necessary action as per above decision of NC.||

UDIN00321775AM24

Case No.	196 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005277AM24
RA File Number	03AX04002457 AM24
Licence No and Date	0311026693/29/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 5/82-ALC4/2018 dated 25/07/2018against advance authorization<br>No.0410163746 dated 29/11/2017, 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.<br>AMANTADINE HYDROCHLORIDE<br>100 MG<br>1 Number<br>1<br>AMANTADINE<br>HYDROCHLORIDE<br>102 mg/Tablet<br>RA concerned may take further necessary action as per above decision of NC.

tems Qty. AMANTADINE HYDROCHLORIDE 100 MG 1 Number 1 AMANTADINE HYDROCHLORIDE 102 mg/Tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	197 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005281AM24
RA File Number	08AX04000923 AM24
Licence No and<br>Date	0811009151/29/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	198 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	DEV BHOOMI ENTERPRISES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005292AM24

UDIN00321775AM24

RA File Number	05AX04001460 AM24
Licence No and<br>Date	0511020678/29/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

75AM24

RA File Number	05AX04001460 AM24
Licence No and<br>Date	0511020678/29/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	199 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005304AM24
RA File Number	05AX04001532 AM24
Licence No and<br>Date	0511020697/29/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance authorization<br>No.0711003862 dated 26/04/2022it 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.<br>Losartan Potassium 25 mg Tablets<br>1<br>Losartan Potassium Ph.Eur<br>(UK)<br>25.50 mg<br>Losartan Potassium 50 mg Tablets<br>2<br>Losartan Potassium Ph.Eur<br>(UK)<br>51.00 mg<br>Losartan Potassium 100 mg Tablets<br>3<br>Losartan Potassium Ph.Eur<br>(UK)<br>102.00 mg<br>RA concerned may take further necessary action as per above decision of NC.

Eur (UK) 51.00 mg Losartan Potassium 100 mg Tablets 3 Losartan Potassium Ph.Eur (UK) 102.00 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	200 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	PARAGON FINE AND SPECIALITY CHEMICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005306AM24

UDIN00321775AM24

RA File Number	08AX04000985 AM24
Licence No and<br>Date	0811009232/29/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	201 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005318AM24
RA File Number	34AX04000425 AM24
Licence No and<br>Date	3411004065/30/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/May/202223/4dated17/06/2022against advance<br>authorizationNo. 3410046526 dated 05/11/2020, 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.

6526 dated 05/11/2020**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. Acetone 250 MT 1 Cumene 130.807 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	202 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	ANNORA PHARMA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005325AM24
RA File Number	09AX04000657 AM23
Licence No and Date	0911005513/30/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:-

UDIN00321775AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
VALGANCICLOVIR POWDER FOR<br>ORAL SOLUTION 50 mg/ml (100 ML)<br>(VALGANCICLOVIR POWDER FOR<br>ORAL SOLUTION 50 mg/ml (100 ML))	1 Number	1	VALGANCICLOVIR HCL<br>USP	<br>5.791 gram

-|---|---|---| |VALGANCICLOVIR POWDER FOR ORAL SOLUTION 50 mg/ml (100 ML) (VALGANCICLOVIR POWDER FOR ORAL SOLUTION 50 mg/ml (100 ML))|1 Number|1|VALGANCICLOVIR HCL USP| 5.791 gram|

Case No.	Case No.	203 / NC/3/MEET/Sep/202324/14	203 / NC/3/MEET/Sep/202324/14	203 / NC/3/MEET/Sep/202324/14	203 / NC/3/MEET/Sep/202324/14	203 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		MERIDIAN ENTERPRISES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00005331AM24
RA File Number		03AX04002440 AM24
Licence No and<br>Date		0311026761/31/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Nov/202223/12dated18/11/2022against advance<br>authorizationNo. 0311013150 dated 21/03/2022, 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.<br>Dequalinium Chloride Oral Spray<br>(Dequadin Oral Spray) 25 ML<br>Bottle. (Each ml contains:<br>Dequalinium Chloride 0.5<br>percent(Dequalinium Chloride Oral<br>Spray (Dequadin Oral Spray) 25<br>ML Bottle.

inium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent(Dequalinium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent (net content of Input per ml=5mg,Net content per 25ml bottle = 125mg Total net content = 5.196125 Kgs)) 1 Number 1 Dequalinium Chloride 127.50 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Dequalinium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent(Dequalinium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent (net content of Input per ml=5mg,Net content per 25ml bottle = 125mg Total net content = 5.196125 Kgs))||1 Number|1|Dequalinium Chloride|127.50 mg|

UDIN00321775AM24

Case No.	204 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	EMCURE PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005336AM24
RA File Number	31AX04000151 AM24
Licence No and<br>Date	3111002604/31/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005336AM24| |RA File Number|31AX04000151 AM24| |Licence No and Date|3111002604/31/08/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	205 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	MANNITAB PHARMA SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005338AM24
RA File Number	31AX04000075 AM24
Licence No and<br>Date	3111002606/31/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	206 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005346AM24
RA File Number	03AX04002495 AM24
Licence No and<br>Date	0311026784/31/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/8dated30/06/2023against advance authorization<br>No. 0311022610 dated 31/03/2023, 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:-

UDIN00321775AM24

1022610 dated 31/03/2023**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00321775AM24


Export Product	Qty.	Sl. No.	Import Items	Qty.<br>(in mg)
Atorvastatin Calcium Tablets USP 10mg((Net<br>Content of Import Sr. No. 1 is 308.205 kgs,<br>Sr. No. 2 is 1743.606 kg, Sr No. 3 is 487.323<br>kg, Sr. No. 4 is 303000 Nos.))	<br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>11.415
		2	Microcrystalline<br>Cellulose<br>(MCC) NF (Avicel PH 102)	<br>64.578
		3	Calcium Acetate	18.049
		4	Silica<br>Gel<br>Dessicants<br>-<br>Packaged Activated Carbon<br>(Strippax Sorbent)	<br> <br>Relevant<br>as<br>per<br>packing<br>policy
Atorvastatin Calcium Tablets USP 20<br>mg((Net Content of Import Sr. No. 1 is<br>205.470 kgs, Sr. No. 2 is 1164.843 kg, Sr.<br>No. 3 is 324.810 kg, Sr. No. 4 is 101000<br>Nos.))	1 Number<br>Tablet	5	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>22.830
		6	Microcrystalline<br>Cellulose<br>(MCC) NF (Avicel PH 102)	<br>129.427
		7	Calcium Acetate	36.090
		8	Silica<br>Gel<br>Dessicants<br>-<br>Packaged Activated Carbon<br>(Strippax Sorbent)	<br> <br>Relevant<br>as<br>per<br>packing<br>policy
Atorvastatin Calcium Tablets USP 40mg((Net<br>Content of Import Sr. No. 1 is 3857.337 kgs,<br>Sr. No. 2 is 21833.568 kg, Sr. No. 3 is<br>6088.070 kg, Sr. No.

vant as per packing policy| ||Atorvastatin Calcium Tablets USP 40mg((Net Content of Import Sr. No. 1 is 3857.337 kgs, Sr. No. 2 is 21833.568 kg, Sr. No. 3 is 6088.070 kg, Sr. No. 4 is 949400 Nos.))| 1 Number Tablet|9|Atorvastatin Calcium Propylene Glycol Solvate USP| 45.595| ||||10|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)| 258.08| ||||11|Calcium Acetate|71.963| ||||12|Silica Gel Dessicants -|Relevant as|

100

UDIN00321775AM24

			Packaged Activated Carbon<br>(Strippax Sorbent)	<br>per<br>packing<br>policy
Atorvastatin Calcium Tablets USP 80mg((Net<br>Content of Import Sr. No. 1 is 2052.000 kgs,<br>Sr. No. 2 is 11659.635 kg, Sr. No. 3 is<br>3260.903 kg, Sr. No. 4 is 252500 Nos.))	<br>1 Number<br>Tablet	13	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>91.20
		14	Microcrystalline<br>Cellulose<br>(MCC) NF (Avicel PH 102)	<br>518.206
		15	Calcium Acetate	144.929
		16	Silica<br>Gel<br>Dessicants<br>-<br>Packaged Activated Carbon<br>(Strippax Sorbent)	<br> <br>Relevant<br>as<br>per<br>packing<br>policy
Note: The above norms are valid only for subject to fulfillment of following conditions:<br>Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug<br>**Application) of Apotex Corp, US.

s are valid only for subject to fulfillment of following conditions:** Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex Corp, US. Agent for Apotex Inc., Canada. 1. Export to USA only. 2. Firm holding Certificate of Manufacturing Exclusivity. 3.||||| ||concerned may take further necessary action as per above decision of NC|||||

Case No.	207 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005348AM24
RA File Number	04AX04000283 AM24
Licence No and<br>Date	0411005945/31/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	208 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023

101

UDIN00321775AM24

and Date
HQ File Number	HQRNORM APPLY 00005353AM24
RA File Number	26AX04000049 AM24
Licence No and<br>Date	2611001116/31/08/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005353AM24| |RA File Number|26AX04000049 AM24| |Licence No and Date|2611001116/31/08/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	209 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005362AM24
RA File Number	03AX04002504 AM24
Licence No and<br>Date	0311026799/01/09/2023
Norms Committee Decision:<br>The committee considered the case as per agenda and it was decided to fix ad-hoc norms as perSION A-412.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	210 / NC/3/MEET/Sep/202324/14
Case Status	Case Deferred
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005389AM24
RA File Number	03AX04002443 AM24
Licence No and<br>Date	0311026825/01/09/2023

|Meeting Number and Date|NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023| |HQ File Number|HQRNORM APPLY 00005389AM24| |RA File Number|03AX04002443 AM24| |Licence No and Date|0311026825/01/09/2023| |Norms Committee Decision: The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to callfor following information/documents from the firm:- Step wise manufacturing process. i. Complete chemical reactions with molecular and structural formula and molecular weight alongwith stage wise percentage yield on molar basis. ii. All technical details as per annexure to appendix 4E for chemical products. iii. Stichometric balance between import and export on molar basis. iv. Details of indigenous input with quantity. v.||

102 This document has been digitally signed by T SONGZALIAN, Deputy DGFT on 18-10-2023 15:44:48.

UDIN00321775AM24

Case No.	211 / NC/3/MEET/Sep/202324/14
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number	HQRNORM APPLY 00005390AM24
RA File Number	03AX04002458 AM24
Licence No and<br>Date	0311026835/01/09/2023
Norms Committee Decision:<br>The committee considered the case as per agenda and it was decided to fix ad-hoc norms as perSION A-412.<br>RA concerned may take further necessary action as per above decision of NC.

on: The committee considered the case as per agenda and it was decided to fix ad-hoc norms as perSION A-412. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	212 / NC/3/MEET/Sep/202324/14	212 / NC/3/MEET/Sep/202324/14	212 / NC/3/MEET/Sep/202324/14	212 / NC/3/MEET/Sep/202324/14	212 / NC/3/MEET/Sep/202324/14
Case Status		Case Approved
Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 14 and 27/09/2023
HQ File Number		HQRNORM APPLY 00005403AM24
RA File Number		03AX04002446 AM24
Licence No and<br>Date		0311026848/04/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Apr/202324/1dated28/04/2023against advance authorization<br>No. 0311020724 dated 16/01/2023, 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.<br>(in mg.)<br>1<br>EASTMAN<br>(TM)<br>CELLULOSE<br>ACETATE (CA 398-10NF/EP)<br>29.70<br>2<br>SENTRY POLYOX WSR N80 FP<br>NF<br>178.10<br>GLIPIZIDE EXTENDED RELEASE<br>TABLETS 10 MG.(Each tablet<br>contains (i) Eastman (TM Cellulose<br>Acetate (CA 398- 10NF/EP)- 29.70<br>mg (ii) Sentry Polyox WSR N80 FP<br>NF- 178.10 mg (iii) Sentry Polyox<br>WSR 303 NF- 100 mg.

br>TABLETS 10 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 29.70 mg (ii) Sentry Polyox WSR N80 FP NF- 178.10 mg (iii) Sentry Polyox WSR 303 NF- 100 mg. Net content (i) 820.16 Kgs (ii) 1 Number 3 SENTRY POLYOX WSR 303 NF 100.00||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in mg.)| ||GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 29.70 mg (ii) Sentry Polyox WSR N80 FP NF- 178.10 mg (iii) Sentry Polyox WSR 303 NF- 100 mg. Net content (i) 820.16 Kgs (ii)||1 Number|1|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 29.70| |||||2|SENTRY POLYOX WSR N80 FP NF| 178.10| |||||3|SENTRY POLYOX WSR 303 NF|100.00|

103

UDIN00321775AM24

|4918.18 Kgs (iii) 2761.47 Kgs.) 4 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 20.40 5 SENTRY POLYOX WSR N80 FP NF 89.05 GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG.( Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 20.40 mg (ii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iii) Sentry Polyox WSR 303 NF- 50 mg.

E<br>TABLETS 5 MG.( Each tablet<br>contains (i) Eastman (TM Cellulose<br>Acetate (CA 398- 10NF/EP)- 20.40<br>mg (ii) Sentry Polyox WSR N80 FP<br>NF- 89.05 mg (iii) Sentry Polyox<br>WSR 303 NF- 50 mg. Net content (i)<br>430.05 Kgs (ii)<br>1877.27 Kgs (iii) 1054.06 Kgs.)<br>6<br>SENTRY POLYOX WSR 303 NF<br>50.00<br>7<br>EASTMAN<br>(TM)<br>CELLULOSE<br>ACETATE (CA 398-10NF/EP)<br>20.40<br>8<br>SENTRY POLYOX WSR N80 FP<br>NF<br>89.05<br>GLIPIZIDE EXTENDED RELEASE<br>TABLETS 2.5 MG.(Each tablet<br>contains (i) Eastman (TM Cellulose<br>Acetate (CA 398-<br>10NF/EP)- 20.40 mg (ii) Sentry<br>Polyox WSR N80 FP NF- 89.05 mg<br>(iii) Sentry Polyox WSR 303 NF- 50<br>mg. Net content (i) 231.08 Kgs (ii)<br>1008.71 Kgs (iii) 566.37 Kgs.)<br>9<br>SENTRY POLYOX WSR 303 NF<br>50.00<br>RA concerned may take further necessary action as per above decision of NC.	4918.18 Kgs (iii) 2761.47 Kgs.)
	GLIPIZIDE EXTENDED RELEASE<br>TABLETS 5 MG.( Each tablet<br>contains (i) Eastman (TM Cellulose<br>Acetate (CA 398- 10NF/EP)- 20.40<br>mg (ii) Sentry Polyox WSR N80 FP<br>NF- 89.05 mg (iii) Sentry Polyox<br>WSR 303 NF- 50 mg.

E TABLETS 5 MG.( Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 20.40 mg (ii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iii) Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 430.05 Kgs (ii) 1877.27 Kgs (iii) 1054.06 Kgs.)||4|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 20.40| ||||5|SENTRY POLYOX WSR N80 FP NF| 89.05| ||||6|SENTRY POLYOX WSR 303 NF|50.00| ||GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 20.40 mg (ii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iii) Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 231.08 Kgs (ii) 1008.71 Kgs (iii) 566.37 Kgs.)||7|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 20.40|

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