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/202324/13 DATED: 14/09/2023

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/202324/13 dated 14/09/2023 of Norms Committee - III for the year 2023-24 was held on 14/09/2023 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:-

	Name and Designation of Representatives
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 06-10-2023 17:12:39.

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Case Details and Decision(s):

Case Details and Decision(s):
Case No.<br>1 / NC/3/MEET/Sep/202324/13
Case Status<br>Case Approved
Party Name<br>STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number<br>HQRNORM APPLY 00002528AM24
RA File Number<br>NA
Licence No and<br>Date<br>NA
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. 4/82-ALC4/2018 dated 19/06/2018against advance		authorizationNo.0510405555 dated07/02/2018, 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.	Sl. No.	Import Items	Qty.
Piperacillin and Tazobactam sodium<br>1 kg.	1	Piperacillin Acid (Intermediate)	0.891 kg.
sterile
	2	Tazobactam Acid (Intermediate)	0.109 kg.
RA concerned may take further necessary action as per above decision of NC.

Case No.	2 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004206AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The case is under consideration for want of comments of TE.

09/2023| |HQ File Number|HQRNORM APPLY 00004206AM24| |RA File Number|NA| |Licence No and Date|NA| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	3 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
MeetingNumber	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023

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and Date
HQ File Number	HQRNORM APPLY 00004450AM24
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>To indicate name of reactants and product in the chemical reaction.<br>1.<br>Certificate of Analysis (COA) report of import and export of the items.<br>2.<br>Complete justification for the low yield of the reaction (at each stage), indicating the<br>impurities/isomers/precipitation formed during the reaction.<br>3.<br>Production/Consumption data duly endorsed by GST.<br>4.

w yield of the reaction (at each stage), indicating the** impurities/isomers/precipitation formed during the reaction. 3. Production/Consumption data duly endorsed by GST. 4.||

Case No.	4 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004480AM23
RA File Number	NA
Licence No and<br>Date	0910067796/null
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.	5 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005130AM23
RA File Number	072404000200 AM21
Licence No and<br>Date	NA
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.

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

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Case No.	6 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004197AM24
RA File Number	092404000413 AM12
Licence No and<br>Date	0910050238/15/12/2011
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.	7 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00007337AM23
RA File Number	039504000262 AM13
Licence No and<br>Date	0310705888/22/08/2012
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.

rms 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.	8 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004475AM23
RA File Number	092404000017 AM14
Licence No and<br>Date	0910055800/19/04/2013
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.	9 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred

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Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00003005AM24
RA File Number	092404000287 AM14
Licence No and<br>Date	0910057785/01/10/2013
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.	10 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00003009AM24
RA File Number	092404000044 AM15
Licence No and<br>Date	0910059969/01/05/2014
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.	11 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004477AM23
RA File Number	092404000139 AM15
Licence No and<br>Date	0910060467/17/06/2014
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.

rms 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.	12 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQFile Number	HQRNORM REVIW00003004AM24

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RA File Number	092404000421 AM15
Licence No and<br>Date	0910061287/21/11/2014
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	13 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004605AM23
RA File Number	092404000348 AM17
Licence No and<br>Date	0910064196/28/09/2016
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.

rms 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.	14 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000261AM24
RA File Number	039404000617 AM17
Licence No and<br>Date	0310808312/06/10/2016
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	15 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001056AM24
RA File Number	039404000918 AM17
Licence No and<br>Date	0310810510/13/01/2017
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/Aug/202324/11 dated 22/08/2023 against advance authorization No.0310813394 dated 18/05/2017 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

advance authorization No.0310813394 dated 18/05/2017 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
N-Methyl Pyrrolidone<br>(Purity Minimum 99.8%, Moisture Less<br>Than 1000 PPM)	<br>1 kg.	1	N-Methyl Pyrrolidone<br>(Purity Maximum 86.27%, Moisture 5% to<br>7%)	<br>1.23 kg.

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

Case No.	16 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001308AM24
RA File Number	039404001096 AM17
Licence No and<br>Date	0310811634/06/03/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo. 0310822662 dated 27/07/2018, 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>N METHYL MORPHOLINE OXIDE 50% / IAL<br>NMMO 50%<br>1 kg.<br>1<br>MORPHOLINE<br>0.46 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 17 / NC/3/MEET/Sep/202324/13

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br>NMMO 50% 1 kg. 1 MORPHOLINE 0.46 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 17 / NC/3/MEET/Sep/202324/13

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Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000263AM24
RA File Number	039404001181 AM17
Licence No and<br>Date	0310812323/03/04/2017
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	18 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000262AM24
RA File Number	039404000295 AM18
Licence No and<br>Date	0310814908/31/07/2017
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	19 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004483AM23
RA File Number	092404000309 AM18
Licence No and<br>Date	0910065528/29/09/2017
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.

rms 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.	20 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004604AM23

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RA File Number	092404000430 AM18
Licence No and<br>Date	0910065723/07/12/2017
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.	21 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00007155AM23
RA File Number	052404000370 AM18
Licence No and<br>Date	0510404862/12/12/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Nov/202223/14 dated 07/12/2022against advance<br>authorizationNo. 0510405089 dated 26/12/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

n meetingNo.NC/3/MEET/Nov/202223/14 dated 07/12/2022against advance authorizationNo. 0510405089 dated 26/12/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 PHTHALIC ANHYDRIDE 0.372 kg. PVC PLASTICIZER (DINP) 1 kg. 2 ISO NONANOL 0.726 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	22 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004486AM23
RA File Number	092404000459 AM18
Licence No and<br>Date	0910065758/19/12/2017

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Norms Committee Decision:

The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided to reject the case maintaining the status quo.

Case No.	23 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00007162AM23
RA File Number	052404000447 AM18
Licence No and<br>Date	0510405090/26/12/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Nov/202223/14 dated 07/12/2022against advance<br>authorizationNo. 0510405089 dated 26/12/2017, 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>1<br>PHTHALIC ANHYDRIDE<br>0.372 kg.<br>PVC PLASTICIZER (DINP)<br>1 kg.<br>2<br>ISO NONANOL<br>0.726 kg.<br>RA concerned may take further necessary action as per above decision of NC.

br>Qty. 1 PHTHALIC ANHYDRIDE 0.372 kg. PVC PLASTICIZER (DINP) 1 kg. 2 ISO NONANOL 0.726 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	24 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005115AM23
RA File Number	072404000271 AM18
Licence No and<br>Date	0710112636/04/01/2018
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

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provided any technical justification / information for enhancement. Hence, it was decided to reject the case maintaining the status quo.

Case No.	25 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000265AM24
RA File Number	039404000822 AM18
Licence No and<br>Date	0310818765/30/01/2018
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00000265AM24| |RA File Number|039404000822 AM18| |Licence No and Date|0310818765/30/01/2018| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	26 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004481AM23
RA File Number	092404000036 AM19
Licence No and<br>Date	0910066244/18/05/2018
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.	27 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00006968AM23
RA File Number	039404000258 AM19
Licence No and<br>Date	0310821966/27/06/2018
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	28 / NC/3/MEET/Sep/202324/13

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Date|0310821966/27/06/2018| |Norms Committee Decision: The case is under consideration for want of comments of TE.|| ||| |Case No.|28 / NC/3/MEET/Sep/202324/13|

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Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000260AM24
RA File Number	039404000753 AM19
Licence No and<br>Date	0310825758/18/12/2018
Norms Committee Decision:<br>The case is under consideration for want of comments of TE

Case No.	29 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000752AM24
RA File Number	052404000438 AM19
Licence No and<br>Date	0510410372/25/04/2019
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	30 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000818AM24
RA File Number	082404000026 AM20
Licence No and<br>Date	0810145127/30/04/2019
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00000818AM24| |RA File Number|082404000026 AM20| |Licence No and Date|0810145127/30/04/2019| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	31 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000154AM24
RA File Number	318304000044 AM20
Licence No and	3110067449/20/06/2019

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Date

Norms Committee Decision:

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

Complete justification of increasing the quantity of hydrogen peroxide and methanol indicating yield of reaction.
Production/consumption data duly endorsed by GST.

Case No.	32 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	CONCORD BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001262AM24
RA File Number	082404000101 AM20
Licence No and<br>Date	0810145581/27/06/2019
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.	33 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004484AM23
RA File Number	092404000269 AM20
Licence No and<br>Date	0910067906/20/08/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms andit 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.	34 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004761AM23

UDIN00290959AM24

RA File Number	039404000395 AM20
Licence No and<br>Date	0310831546/13/09/2019
Norms Committee Decision:<br>The case is under consideration for want of factory/plant visit report from TE.

mber	039404000395 AM20
Licence No and<br>Date	0310831546/13/09/2019
Norms Committee Decision:<br>The case is under consideration for want of factory/plant visit report from TE.

Case No.	35 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00002001AM24
RA File Number	092404000540 AM20
Licence No and<br>Date	0910068421/28/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	36 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004487AM23
RA File Number	092404000593 AM20
Licence No and<br>Date	0910068522/27/02/2020
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.

rms 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.	37 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00007119AM23
RA File Number	052404000024 AM21
Licence No and<br>Date	0510414104/04/05/2020
Norms Committee Decision:

UDIN00290959AM24

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

Case No.	38 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005116AM23
RA File Number	072404000032 AM21
Licence No and<br>Date	0710116423/06/05/2020
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.	39 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	OLIVE HEALTH CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00007206AM23
RA File Number	039504000069 AM21
Licence No and<br>Date	0310836213/15/05/2020
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00007206AM23| |RA File Number|039504000069 AM21| |Licence No and Date|0310836213/15/05/2020| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	40 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000119AM24
RA File Number	318304000008 AM21
Licence No and<br>Date	3110067739/19/05/2020
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/Jun/202223/5dated08/07/2022against advance authorizationNo. 3111000156 dated 11/02/2021,<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:-

UDIN00290959AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Anisole	1 kg.	1	Phenol	0.92 kg.
		2	Methanol	0.36 kg.

d by the firm, whichever is less:-||

UDIN00290959AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Anisole	1 kg.	1	Phenol	0.92 kg.
		2	Methanol	0.36 kg.

Case No.	41 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000814AM24
RA File Number	072404000046 AM21
Licence No and<br>Date	0710116483/22/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo. NC/3/MEET/Mar/202223/22dated24/03/2022against advance authorizationNo. 0711005540 dated<br>21/10/2022, 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<br>firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>GLYCINE<br>0.97 kg.<br>MAGNESIUM<br>BISGLYCINATE<br>/<br>MAGNESIUM GLYCINE COMPLEX<br>1 kg.<br>2<br>MAGNESIUM OXIDE<br>0.26 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	42 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023

UDIN00290959AM24

NC/3/MEET/Sep/202324/13| |---|---| |Case Status|Case Approved| |Party Name|TADIMETY AROMATICS PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023|

UDIN00290959AM24

and Date
HQ File Number	HQRNORM REVIW00001400AM24
RA File Number	072404000054 AM21
Licence No and<br>Date	0710116526/29/05/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Rosecrystals Ex Benzaldehyde<br>(Trichloro-Phengl Methyl Corbinyl Acetate)<br>1 kg<br>1<br>Benzaldehyde<br>0.465 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	43 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000095AM24
RA File Number	522404000013 AM21
Licence No and<br>Date	5210043424/08/06/2020
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00000095AM24| |RA File Number|522404000013 AM21| |Licence No and Date|5210043424/08/06/2020| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	44 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005117AM23
RA File Number	072404000092 AM21
Licence No and<br>Date	0710116675/29/06/2020
Norms Committee Decision:

UDIN00290959AM24

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/Sep/202324 dated 14/09/2023 against advance authorization No. 0710116675 dated 29/06/2020 , 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.
ZINC GLUCONATE - POWDER	1 kg.	1	ZINC<br>GLUCONATE<br>-<br>GRANULAR	<br>1.01 kg.

Case No.	45 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000121AM24
RA File Number	318304000020 AM21
Licence No and<br>Date	3110067788/08/07/2020
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00000121AM24| |RA File Number|318304000020 AM21| |Licence No and Date|3110067788/08/07/2020| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	46 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005118AM23
RA File Number	072404000105 AM21
Licence No and<br>Date	0710116735/13/07/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms andit 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. 47 / NC/3/MEET/Sep/202324/13

UDIN00290959AM24

Case Status	Case Deferred
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001550AM24
RA File Number	092404000185 AM21
Licence No and<br>Date	0910068991/22/07/2020
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.	48 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005119AM23
RA File Number	072404000118 AM21
Licence No and<br>Date	0710116798/27/07/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Sep/202324dated14/09/2023against advance authorization<br>No. 0710116675 dated 29/06/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>ZINC GLUCONATE - POWDER<br>1 kg.<br>1<br>ZINC GLUCONATE - GRANULAR<br>1.01 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	49 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001904AM24
RA File Number	502404000009 AM21

UDIN00290959AM24

Licence No and 5010002703/07/08/2020 Date Norms Committee Decision:

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

Case No.	50 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000135AM24
RA File Number	318304000034 AM21
Licence No and<br>Date	3110067826/14/08/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo.3110067673 dated 06/02/2020, 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>1<br>Phenol<br>0.74 kg.<br>2<br>Methanol<br>0.283 kg.<br>Acetyl Anisole<br>(4 Methoxy Acetophenone)<br>1 kg.<br>3<br>Acetic Anhydride PURITY 99%<br>0.755 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	51 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005121AM23
RA File Number	072404000146 AM21
Licence No and<br>Date	0710116939/28/08/2020

UDIN00290959AM24

Norms Committee Decision:

Case No.	52 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005122AM23
RA File Number	072404000145 AM21
Licence No and<br>Date	0710116940/28/08/2020
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.	Case No.	53 / NC/3/MEET/Sep/202324/13	53 / NC/3/MEET/Sep/202324/13	53 / NC/3/MEET/Sep/202324/13	53 / NC/3/MEET/Sep/202324/13	53 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM REVIW00001413AM24
RA File Number		072404000153 AM21
Licence No and Date		0710116971/08/09/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting**No.

116971/08/09/2020||||| |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/Sep/202122/8 dated 24/09/2021against advance authorization No. 0710115523 dated 03/10/2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. Phenoxy Ethyl Iso Butyrate 1 kg 1 PHENOXY ETHANOL 0.70 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Phenoxy Ethyl Iso Butyrate||1 kg|1|PHENOXY ETHANOL|0.70 kg.| ||||||||

UDIN00290959AM24

Case No.	54 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000137AM24
RA File Number	318304000087 AM21
Licence No and<br>Date	3110067912/02/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo.3110067673 dated 06/02/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

product in meetingNo.NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance authorizationNo.3110067673 dated 06/02/2020, 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 Phenol 0.74 kg. 2 Methanol 0.283 kg. Acetyl Anisole (4 Methoxy Acetophenone) 1 kg. 3 Acetic Anhydride PURITY 99% 0.755 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	55 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004763AM23
RA File Number	039404000500 AM21
Licence No and<br>Date	0310839257/02/11/2020
Norms Committee Decision:<br>The case is under consideration for want of factory/plant visit report from TE.

UDIN00290959AM24

Case No.	56 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001504AM24
RA File Number	09AA04002748 AM21
Licence No and<br>Date	0911000023/15/12/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

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

Case No.	57 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000254AM24
RA File Number	03AA04011698 AM21
Licence No and<br>Date	0311000235/21/12/2020
Norms Committee Decision:<br>The case is under consideration for want of comments of TE

Case No.	58 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001514AM24
RA File Number	09AA04003656 AM21
Licence No and<br>Date	0911000173/11/01/2021
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.	59 / NC/3/MEET/Sep/202324/13
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023

UDIN00290959AM24

3/MEET/Sep/202324/13| |---|---| |Case Status|Case Rejected| |Party Name|SRINI PHARMACEUTICALS PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023|

UDIN00290959AM24

and Date
HQ File Number	HQRNORM REVIW00004478AM23
RA File Number	09AA04002915 AM21
Licence No and<br>Date	0911000179/12/01/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

Case No.	Case No.	60 / NC/3/MEET/Sep/202324/13	60 / NC/3/MEET/Sep/202324/13	60 / NC/3/MEET/Sep/202324/13	60 / NC/3/MEET/Sep/202324/13	60 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM REVIW00001610AM24
RA File Number		31AA04006764 AM21
Licence No and<br>Date		3111000201/08/03/2021
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/Oct/202122/9 dated 15/10/2021against advance authorizationNo. 3110067767 dated 22/06/2020<br>, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

n meetingNo.NC/3/MEET/Oct/202122/9 dated 15/10/2021against advance authorizationNo. 3110067767 dated 22/06/2020 , 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 MONOETHANOLAMINE 1.06 kg. ETHYLENE DI AMINE 1 kg. 2 AMMONIA ANHYDROUS 0.294 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||ETHYLENE DI AMINE||1 kg.|1|MONOETHANOLAMINE|1.06 kg.| |||||2|AMMONIA ANHYDROUS|0.294 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	61 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001336AM24
RA File Number	31AA04007907 AM21
Licence No and	3111000255/30/03/2021

UDIN00290959AM24

Date

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

Case No.	62 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001461AM24
RA File Number	07AA04004515 AM22
Licence No and Date	0711001152/21/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Sep/202122/8 dated 24/09/2021against advance authorization<br>No. 0710115523 dated 03/10/2019, 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:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br> Phenoxy Ethyl Iso Butyrate<br>1 kg<br>1<br>PHENOXY ETHANOL<br>0.70 kg.<br>RA concerned may take further necessary action as per above decision of NC.

No. Import Items Qty. Phenoxy Ethyl Iso Butyrate 1 kg 1 PHENOXY ETHANOL 0.70 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	63 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00006291AM23
RA File Number	52AA04003511 AM22
Licence No and<br>Date	5211000803/01/06/2021
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/May/202223/4 dated 17/06/2022against advance authorizationNo.5210042463 dated

UDIN00290959AM24

22/12/2017 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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

t Product	Qty.	Sl. No.	Import Items	Qty.
1-(3-CHLORO PHENYL) 4-(3-<br>CHLORO PROPYL) PIPERAZINE<br>HCL	1 kg.	1	1,3-BROMO CHLORO PROPANE 99<br>PERCENTAGE MIN	<br>1.045 kg.

Case No.	64 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001319AM24
RA File Number	03AA04017165 AM22
Licence No and<br>Date	0311004253/02/06/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	65 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001333AM24
RA File Number	03AA04018281 AM22
Licence No and<br>Date	0311004321/04/06/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	66 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred

UDIN00290959AM24

Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001323AM24
RA File Number	03AA04015087 AM22
Licence No and<br>Date	0311004561/12/06/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

File Number|03AA04015087 AM22| |Licence No and Date|0311004561/12/06/2021| |Norms Committee Decision: The case is under consideration for want of report of factory/plant visit from TE.||

Case No.	67 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005688AM23
RA File Number	08AA04009431 AM22
Licence No and<br>Date	0811001850/25/06/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	68 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004361AM24
RA File Number	34AA04002140 AM22
Licence No and<br>Date	3411000771/28/06/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	69 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001194AM24
RA File Number	03AA04024851 AM22
Licence No and<br>Date	0311004989/29/06/2021

UDIN00290959AM24

The case is under consideration for want of report of factory/plant visit from TE.

UDIN00290959AM24

The case is under consideration for want of report of factory/plant visit from TE.

Case No.	70 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001292AM24
RA File Number	03AA04035672 AM22
Licence No and<br>Date	0311005214/08/07/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	71 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001310AM24
RA File Number	03AA04025361 AM22
Licence No and<br>Date	0311005326/12/07/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

File Number|03AA04025361 AM22| |Licence No and Date|0311005326/12/07/2021| |Norms Committee Decision: The case is under consideration for want of report of factory/plant visit from TE.||

Case No.	72 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001518AM24
RA File Number	09AA04007265 AM22
Licence No and<br>Date	0911001194/12/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	73 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred

UDIN00290959AM24

Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001313AM24
RA File Number	03AA04027532 AM22
Licence No and<br>Date	0311005407/15/07/2021
Norms Committee Decision:<br>The case is under consideration for want of factory/plant visit from TE.

AM24| |RA File Number|03AA04027532 AM22| |Licence No and Date|0311005407/15/07/2021| |Norms Committee Decision: The case is under consideration for want of factory/plant visit from TE.||

Case No.	74 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	CUTCH OIL AND ALLIED INDUSTRIES 1949 PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000967AM24
RA File Number	02AA04015335 AM22
Licence No and<br>Date	0211001003/28/07/2021
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Certificate of Analysis (COA) report of both Export and Import items indicating composition and moisture<br>content.<br>1.<br>Stage wise of wastage of Raw materials with Justification.<br>2.

Case No.	75 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001604AM24
RA File Number	31AA04000987 AM22
Licence No and<br>Date	3111000484/28/07/2021

| |Meeting Number and Date|NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023| |HQ File Number|HQRNORM REVIW00001604AM24| |RA File Number|31AA04000987 AM22| |Licence No and Date|3111000484/28/07/2021| |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/Aug/202324/11 dated 22/08/2023against advance authorizationNo.3111000548 dated 26/08/2021, 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:-||

UDIN00290959AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>MONO ETHANOL AMINE<br>1.184 kg.<br>DI ETHYLENE TRI AMINE<br>1 kg.<br>2<br>AMMONIA ANHYDROUS<br>0.165 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty.
	DI ETHYLENE TRI AMINE	1 kg.	1	MONO ETHANOL AMINE	1.184 kg.
			2	AMMONIA ANHYDROUS	0.165 kg.

Case No.	76 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001316AM24
RA File Number	03AA04060052 AM22
Licence No and<br>Date	0311006318/22/08/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE

File Number|03AA04060052 AM22| |Licence No and Date|0311006318/22/08/2021| |Norms Committee Decision: The case is under consideration for want of report of factory/plant visit from TE||

Case No.	77 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001363AM24
RA File Number	03AA04063825 AM22
Licence No and<br>Date	0311006317/22/08/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	78 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001317AM24
RA File Number	03AA04060785 AM22
Licence No and	0311006386/24/08/2021

UDIN00290959AM24

Date

The case is under consideration for want of report of factory/plant visit from TE.

Case No.	79 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001355AM24
RA File Number	03AA04068130 AM22
Licence No and<br>Date	0311006626/01/09/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

File Number|03AA04068130 AM22| |Licence No and Date|0311006626/01/09/2021| |Norms Committee Decision: The case is under consideration for want of report of factory/plant visit from TE.||

Case No.	80 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001356AM24
RA File Number	03AA04074695 AM22
Licence No and<br>Date	0311006805/08/09/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	81 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001343AM24
RA File Number	03AA04010926 AM22
Licence No and<br>Date	0311006852/10/09/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	82 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred

UDIN00290959AM24

r>The case is under consideration for want of report of factory/plant visit from TE.||

Case No.	82 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred

UDIN00290959AM24

Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001468AM24
RA File Number	34AA04006805 AM22
Licence No and<br>Date	3411001099/10/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	83 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00002093AM24
RA File Number	03AA040106210 AM22
Licence No and Date	0311007383/30/09/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>FAMCICLOVIR<br>250MG<br>TABLETS(FAMCICLOVIR<br>250MG TABLETS<br>1 Number<br>1<br>9-(4-ACETOXY-3-<br>ACETOXYMETHYLBUT-<br>1YL)-2-AMINO-6-<br>CHLOROPURINE<br>318.747 mg<br>RA concerned may take further necessary action as per above decision of NC.

G TABLETS 1 Number 1 9-(4-ACETOXY-3- ACETOXYMETHYLBUT- 1YL)-2-AMINO-6- CHLOROPURINE 318.747 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	84 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001306AM24
RA File Number	03AA040109530 AM22
Licence No and<br>Date	0311007595/08/10/2021

UDIN00290959AM24

The case is under consideration for want of report of factory/plant visit from TE.

Case No.	85 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001328AM24
RA File Number	03AA040109754 AM22
Licence No and<br>Date	0311007605/10/10/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	86 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001293AM24
RA File Number	03AA040110377 AM22
Licence No and<br>Date	0311007674/13/10/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

le Number|03AA040110377 AM22| |Licence No and Date|0311007674/13/10/2021| |Norms Committee Decision: The case is under consideration for want of report of factory/plant visit from TE.||

Case No.	87 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000153AM24
RA File Number	31AA04028703 AM22
Licence No and<br>Date	3111000643/25/10/2021
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/Jun/202324/8 dated 30/06/2023against advance authorizationNo.3110067929 dated 20/11/2020,<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:-

UDIN00290959AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
1,3-Dicyclo Hexyl Carbodimide (DCC)	1 kg.	1	Cyclohexylamine (CHA)	1.41 kg.
		2	Methanol	0.08 kg.
		3	Phosphorus Qxy Chloride	1.49 kg.
		4	Ammonia	0.72 kg.

*| |---|---|---|---|---|---| ||1,3-Dicyclo Hexyl Carbodimide (DCC)|1 kg.|1|Cyclohexylamine (CHA)|1.41 kg.| ||||2|Methanol|0.08 kg.| ||||3|Phosphorus Qxy Chloride|1.49 kg.| ||||4|Ammonia|0.72 kg.|

Case No.	88 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00002990AM24
RA File Number	03AA040110548 AM22
Licence No and<br>Date	0311007891/25/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	89 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001361AM24
RA File Number	03AA040115878 AM22
Licence No and<br>Date	0311008179/02/11/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	90 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred

UDIN00290959AM24

The case is under consideration for want of report of factory/plant visit from TE.||

Case No.	90 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred

UDIN00290959AM24

Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00007115AM23
RA File Number	05AA04097736 AM22
Licence No and<br>Date	0511006029/10/11/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	91 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001304AM24
RA File Number	03AA040120589 AM22
Licence No and<br>Date	0311008617/17/11/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	92 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001344AM24
RA File Number	03AA040124209 AM22
Licence No and<br>Date	0311009064/01/12/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

le Number|03AA040124209 AM22| |Licence No and Date|0311009064/01/12/2021| |Norms Committee Decision: The case is under consideration for want of report of factory/plant visit from TE.||

Case No.	93 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001345AM24
RA File Number	03AA040124200 AM22
Licence No and<br>Date	0311009326/09/12/2021

UDIN00290959AM24

The case is under consideration for want of report of factory/plant visit from TE.

Case No.	94 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001321AM24
RA File Number	03AA040130524 AM22
Licence No and<br>Date	0311009529/16/12/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	95 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001346AM24
RA File Number	03AA040123994 AM22
Licence No and<br>Date	0311009655/21/12/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE

ile Number|03AA040123994 AM22| |Licence No and Date|0311009655/21/12/2021| |Norms Committee Decision: The case is under consideration for want of report of factory/plant visit from TE||

Case No.	96 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001357AM24
RA File Number	03AX04000252 AM22
Licence No and<br>Date	0311009654/21/12/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	97 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
PartyName	ENCUBE ETHICALS PRIVATE LIMITED

UDIN00290959AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001329AM24
RA File Number	03AX04000251 AM22
Licence No and<br>Date	0311009744/24/12/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

Case No.	98 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001354AM24
RA File Number	03AX04000229 AM22
Licence No and<br>Date	0311009746/24/12/2021
Norms Committee Decision:<br>The case is under consideration for want of report of factory/plant visit from TE.

File Number|03AX04000229 AM22| |Licence No and Date|0311009746/24/12/2021| |Norms Committee Decision: The case is under consideration for want of report of factory/plant visit from TE.||

Case No.	99 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000165AM24
RA File Number	03AX04000308 AM22
Licence No and<br>Date	0311009920/30/12/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE

Case No.	100 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005602AM23
RA File Number	08AX04000177 AM22
Licence No and<br>Date	0811003727/10/01/2022
Norms Committee Decision:

UDIN00290959AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Aug/202324/11 dated 22/08/2023 against advance authorization No. 0811002528 dated 07/09/2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

dvance authorization No. 0811002528 dated 07/09/2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

|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/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated 07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 61.87 mg/vial METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number Vial 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH.

9% in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1237.39 mg/vial METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 306.867 mg/vial METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 5 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 590.57 mg/vial METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 6 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1181.15 mg/vial METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML METHOTREXATE 1 Number Vial 7 5737.00 mg/vial|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/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated 07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

in meetingNo. NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated 07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 61.87 mg/vial METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number Vial 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1237.39 mg/vial METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 306.867 mg/vial METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 5 METHOTREXATE EP / BP / IP / USP / PH.

9% in API) 306.867 mg/vial METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 5 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 590.57 mg/vial METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 6 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1181.15 mg/vial METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML METHOTREXATE 1 Number Vial 7 5737.00 mg/vial|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/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated 07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 61.87 mg/vial METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.

PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 61.87 mg/vial METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number Vial 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1237.39 mg/vial METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 306.867 mg/vial METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 5 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 590.57 mg/vial METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 6 METHOTREXATE EP / BP / IP / USP / PH.

49% in API) 590.57 mg/vial METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 6 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1181.15 mg/vial METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML METHOTREXATE 1 Number Vial 7 5737.00 mg/vial|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/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated 07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 61.87 mg/vial METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number Vial 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR.

PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1237.39 mg/vial METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 306.867 mg/vial METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 5 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 590.57 mg/vial METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 6 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1181.15 mg/vial METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML METHOTREXATE 1 Number Vial 7 5737.00 mg/vial|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/Aug/202324/11 dated 22/08/2023against advance authorization**No.

case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo. NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated 07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 61.87 mg/vial METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number Vial 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1237.39 mg/vial METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 METHOTREXATE EP / BP / IP / USP / PH.

12.49% in API) 1237.39 mg/vial METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 306.867 mg/vial METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 5 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 590.57 mg/vial METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 6 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1181.15 mg/vial METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML METHOTREXATE 1 Number Vial 7 5737.00 mg/vial|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/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated 07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.

firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 61.87 mg/vial METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number Vial 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1237.39 mg/vial METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 306.867 mg/vial METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 5 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 590.57 mg/vial METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.

PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 590.57 mg/vial METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 6 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1181.15 mg/vial METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML METHOTREXATE 1 Number Vial 7 5737.00 mg/vial| |---|---|---|---|---|---| ||Export Product|Qty.|**Sl. No. **|Import Items|Qty.| ||METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|1|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 61.87 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG)|1 Number Vial|2|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 618.70 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG)|1 Number Vial|3|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 1237.39 mg/vial| ||METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG)|1 Number Vial|4|METHOTREXATE EP / BP / IP / USP / PH.

ss than 12.49% in API)| 1237.39 mg/vial| ||METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG)|1 Number Vial|4|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 306.867 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|5|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 590.57 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|6|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 1181.15 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML|1 Number Vial|7|METHOTREXATE|5737.00 mg/vial|

UDIN00290959AM24

CONTAINS: METHOTREXATE PH. EP / BP / IP / USP / PH. EUR. EUR. 100MG [IN WHICH ACTIVE INGREDIENT METHOTREXATE (Moisture and Residual Solvents content not USED IS 13.375 KGS.]) less than 12.49% in API)

Case No.	101 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001606AM24
RA File Number	31AX04000040 AM22
Licence No and<br>Date	3111000876/14/01/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00001606AM24| |RA File Number|31AX04000040 AM22| |Licence No and Date|3111000876/14/01/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	102 / NC/3/MEET/Sep/202324/13	102 / NC/3/MEET/Sep/202324/13	102 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM REVIW00005603AM23
RA File Number		08AX04000340 AM22
Licence No and<br>Date		0811003916/28/01/2022
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/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated<br>07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>METHOTREXATE INJECTION BP<br>25MG/ML [2ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>25MG)<br>1 Number Vial<br>1<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture<br>and<br>Residual<br>Solvents<br>content not less than 12.49% in API)<br>61.87 mg/vial
	Export Product		Qty.	**Sl.

1 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 61.87 mg/vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)||1 Number Vial|1|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 61.87 mg/vial|

UDIN00290959AM24

|METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number Vial 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1237.39 mg/vial METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 306.867 mg/vial METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 5 METHOTREXATE EP / BP / IP / USP / PH.

9% in API)<br>306.867 mg/vial<br>METHOTREXATE INJECTION BP<br>25MG/ML [20ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>25MG)<br>1 Number Vial<br>5<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture<br>and<br>Residual<br>Solvents<br>content not less than 12.49% in API)<br>590.57 mg/vial<br>METHOTREXATE INJECTION BP<br>25MG/ML [40ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>25MG)<br>1 Number Vial<br>6<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture<br>and<br>Residual<br>Solvents<br>content not less than 12.49% in API)<br>1181.15 mg/vial<br>METHOTREXATE INJECTION BP<br>100MG/ML [50ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>100MG [IN WHICH ACTIVE INGREDIENT<br>METHOTREXATE USED IS 41.525 KGS.])<br>1 Number Vial<br>7<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture<br>and<br>Residual<br>Solvents<br>content not less than 12.49% in API)<br>5737.00 mg/vial<br>RA concerned may take further necessary action as per above decision of NC.	METHOTREXATE INJECTION BP<br>100MG/ML [5 ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>100 MG)	1 Number Vial	2	METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture<br>and<br>Residual<br>Solvents<br>content not less than 12.49% in API)	<br>618.70 mg/vial
	METHOTREXATE INJECTION BP<br>100MG/ML [10ML VIAL](EACH ML<br>CONTAINS: METHOREXATE PH. EUR.<br>100MG)	1 Number Vial	3	METHOTREXATE<br>EP / BP / IP / USP / PH.

.70 mg/vial| |---|---|---|---|---|---| ||METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG)|1 Number Vial|3|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 1237.39 mg/vial| ||METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG)|1 Number Vial|4|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 306.867 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|5|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 590.57 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|6|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 1181.15 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100MG [IN WHICH ACTIVE INGREDIENT METHOTREXATE USED IS 41.525 KGS.])|1 Number Vial|7|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 5737.00 mg/vial|

Case No.	103 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00006478AM23
RA File Number	03AX04001106 AM22

UDIN00290959AM24

Licence No and 0311011140/06/02/2022 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Case No.	104 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	EMCURE PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001969AM24
RA File Number	31AX04000077 AM22
Licence No and<br>Date	3111001114/02/03/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00001969AM24| |RA File Number|31AX04000077 AM22| |Licence No and Date|3111001114/02/03/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	105 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	ALG CHEMICALS.
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001466AM24
RA File Number	03AX04000006 AM23
Licence No and<br>Date	0311014857/19/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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>1<br>Cetyl Dimethyl Amine 60<br>0.2519 kg.<br>Cetyl Trimethyl Ammonium Chloride<br>Solution 30%<br>1 kg.<br>2<br>ISOPROPYL ALCOHOL<br>0.1375 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00290959AM24

Case No.	106 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000608AM24
RA File Number	05AX04000553 AM23
Licence No and<br>Date	0511012820/26/05/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00000608AM24| |RA File Number|05AX04000553 AM23| |Licence No and Date|0511012820/26/05/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	107 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00005924AM23
RA File Number	03AX04001050 AM23
Licence No and<br>Date	0311015297/07/06/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	108 / NC/3/MEET/Sep/202324/13	108 / NC/3/MEET/Sep/202324/13	108 / NC/3/MEET/Sep/202324/13	108 / NC/3/MEET/Sep/202324/13	108 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM REVIW00006409AM23
RA File Number		08AX04000368 AM23
Licence No and<br>Date		0811005222/15/06/2022
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/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated<br>07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

in meetingNo. NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated 07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.|

Case No.	Case No.	108 / NC/3/MEET/Sep/202324/13	108 / NC/3/MEET/Sep/202324/13	108 / NC/3/MEET/Sep/202324/13	108 / NC/3/MEET/Sep/202324/13	108 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM REVIW00006409AM23
RA File Number		08AX04000368 AM23
Licence No and<br>Date		0811005222/15/06/2022
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/Aug/202324/11 dated 22/08/2023against advance authorizationNo. 0811002528 dated<br>07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00290959AM24

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

UDIN00290959AM24

|METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 61.87 mg/vial METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number Vial 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1237.39 mg/vial METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 306.867 mg/vial METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 5 METHOTREXATE EP / BP / IP / USP / PH.

9% in API)<br>306.867 mg/vial<br>METHOTREXATE INJECTION BP<br>25MG/ML [20ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>25MG)<br>1 Number Vial<br>5<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture<br>and<br>Residual<br>Solvents<br>content not less than 12.49% in API)<br>590.57 mg/vial<br>METHOTREXATE INJECTION BP<br>25MG/ML [40ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>25MG)<br>1 Number Vial<br>6<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture<br>and<br>Residual<br>Solvents<br>content not less than 12.49% in API)<br>1181.15 mg/vial<br>METHOTREXATE INJECTION BP<br>100MG/ML [50ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>100MG [IN WHICH ACTIVE INGREDIENT<br>METHOTREXATE USED IS 100.430 KGS.])<br>1 Number Vial<br>7<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture<br>and<br>Residual<br>Solvents<br>content not less than 12.49% in API)<br>5737.00 mg/vial<br>RA concerned may take further necessary action as per above decision of NC.	METHOTREXATE INJECTION BP<br>25MG/ML [2ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>25MG)	1 Number Vial	1	METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture<br>and<br>Residual<br>Solvents<br>content not less than 12.49% in API)	<br>61.87 mg/vial
	METHOTREXATE INJECTION BP<br>100MG/ML [5 ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>100 MG)	1 Number Vial	2	METHOTREXATE<br>EP / BP / IP / USP / PH.

7 mg/vial| |---|---|---|---|---|---| ||METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG)|1 Number Vial|2|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 618.70 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG)|1 Number Vial|3|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 1237.39 mg/vial| ||METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG)|1 Number Vial|4|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 306.867 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|5|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 590.57 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|6|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 1181.15 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML CONTAINS: METHOTREXATE PH.

EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 1181.15 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100MG [IN WHICH ACTIVE INGREDIENT METHOTREXATE USED IS 100.430 KGS.])|1 Number Vial|7|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)| 5737.00 mg/vial|

Case No. 109 / NC/3/MEET/Sep/202324/13

UDIN00290959AM24

Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000259AM24
RA File Number	03AX04001871 AM23
Licence No and<br>Date	0311015826/24/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain		Personal Hearing

Case No.	110 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00006007AM23
RA File Number	03AX04001989 AM23
Licence No and<br>Date	0311016055/04/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00006007AM23| |RA File Number|03AX04001989 AM23| |Licence No and Date|0311016055/04/07/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	111 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00000597AM24
RA File Number	03AX04002093 AM23
Licence No and<br>Date	0311016291/12/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	112 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004233AM24
RA File Number	NA

UDIN00290959AM24

Licence No and<br>Date	Licence No and<br>Date	3411002528/13/07/2022	3411002528/13/07/2022	3411002528/13/07/2022	3411002528/13/07/2022	3411002528/13/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/May/202324/5 dated 08/06/2023against advance<br>authorizationNo.3411002528 dated 13/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

dated 13/07/2022*, 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 NITRIC ACID 68 PERCENT Indigenously source 2 TOLUENE 0.661 kg. 3 SULPHURIC ACID 98 PERCENT Indigenously source ORTHO NITRO TOLUENE 1 kg. 4 SODA ASH 0.012 kg. RA concerned may take further necessary action as per above decision of NC||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||ORTHO NITRO TOLUENE||1 kg.|1|NITRIC ACID 68 PERCENT|Indigenously source| |||||2|TOLUENE|0.661 kg.| |||||3|SULPHURIC ACID 98 PERCENT|Indigenously source| |||||4|SODA ASH|0.012 kg.| |||||as per above decision of NC|||

Case No.	Case No.	113 / NC/3/MEET/Sep/202324/13	113 / NC/3/MEET/Sep/202324/13	113 / NC/3/MEET/Sep/202324/13	113 / NC/3/MEET/Sep/202324/13	113 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM REVIW00001337AM24
RA File Number		31AX04000114 AM23
Licence No and<br>Date		3111001569/19/07/2022

and Date||NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023||||| |HQ File Number||HQRNORM REVIW00001337AM24||||| |RA File Number||31AX04000114 AM23||||| |Licence No and Date||3111001569/19/07/2022||||| |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/Oct/202122/9 dated 15/10/2021against advance authorizationNo. 3110067767 dated 22/06/2020 , 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.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.|

UDIN00290959AM24

ETHYLENE DI AMINE	1	kg.	1	MONOETHANOLAMINE	1.06 kg.
			2	AMMONIA ANHYDROUS	0.294 kg.

Case No.	114 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001228AM24
RA File Number	31AX04000136 AM23
Licence No and<br>Date	3111001598/02/08/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00001228AM24| |RA File Number|31AX04000136 AM23| |Licence No and Date|3111001598/02/08/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	115 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00004178AM24
RA File Number	52AX04001623 AM23
Licence No and<br>Date	5211003147/01/09/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	116 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	PANACEA BIOTEC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00001464AM24
RA File Number	05AX04002301 AM23
Licence No and<br>Date	0511015737/10/11/2022
Norms Committee Decision:

UDIN00290959AM24

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

AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
Easyfive TT Vaccine DTwP-Hep B-<br>Hib- Pentavalent Vaccine (Each vial<br>of 5.0ml contains 10 dose) with<br>Vaccine<br>Vial Monitor	1000000 Vials	1	Diphtheria Bulk	13.33 Liter
		2	Tetanus Toxoid	5.23 Liter
		3	Pertussis Bulk	86.46 Liter
		4	Aluminium Phosphate Gel	68.75 kg.
		5	Electronic Temperature Data Logger	1262.5<br>Numbers
		6	Rubber Stopper	1015000<br>Numbers
		7	VVM Dot 14	1015000<br>Numbers
		8	Ags Hb Purification Mabs Column	5.4 Liter
		9	Tetanus Toxoid for Conjugation	6.15 Liter

Case No.	117 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM REVIW00002991AM24
RA File Number	03AX04004890 AM23
Licence No and<br>Date	0311020522/06/01/2023
Norms Committee Decision:

UDIN00290959AM24

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.

ion:||

UDIN00290959AM24

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.	118 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00002509AM24
RA File Number	08AX04000510 AM24
Licence No and<br>Date	0811008516/26/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	Case No.	119 / NC/3/MEET/Sep/202324/13	119 / NC/3/MEET/Sep/202324/13	119 / NC/3/MEET/Sep/202324/13	119 / NC/3/MEET/Sep/202324/13	119 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00002537AM24
RA File Number		09AX04000261 AM24
Licence No and<br>Date		0911005263/26/06/2023
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/Jun/202324/8 dated 30/06/2023against advance authorizationNo.0911004979 dated 08/05/2023,<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorizationNo.0911004979 dated 08/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 2-Azabicylo [2.2.1] hept-5-en-3-one (Vince lactam) 1.337 kg. 2 Sodium borohydride 0.214 kg. 3 L(+) Tartaric acid 0.900 kg. (1S, 4R)-Cis-4-Amino-2-cyclopentene-1-methanol tartrate (CAP-II) 1 kg. 4 D (-) tartaric acid 0.742 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||(1S, 4R)-Cis-4-Amino-2-cyclopentene-1-methanol tartrate (CAP-II)|| 1 kg.|1|2-Azabicylo [2.2.1] hept-5-en-3-one (Vince lactam)| 1.337 kg.| |||||2|Sodium borohydride|0.214 kg.| |||||3|L(+) Tartaric acid|0.900 kg.| |||||4|D (-) tartaric acid|0.742 kg.|

UDIN00290959AM24

o [2.2.1] hept-5-en-3-one (Vince lactam)| 1.337 kg.| |||||2|Sodium borohydride|0.214 kg.| |||||3|L(+) Tartaric acid|0.900 kg.| |||||4|D (-) tartaric acid|0.742 kg.|

UDIN00290959AM24

Case No.	Case No.	120 / NC/3/MEET/Sep/202324/13	120 / NC/3/MEET/Sep/202324/13	120 / NC/3/MEET/Sep/202324/13	120 / NC/3/MEET/Sep/202324/13	120 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00002538AM24
RA File Number		09AX04000263 AM24
Licence No and<br>Date		0911005264/26/06/2023
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/Jun/202324/8 dated 30/06/2023against advance authorizationNo.0911004979 dated 08/05/2023<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. No.

023** , 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 2-Azabicylo [2.2.1] hept-5-en-3-one (Vince lactam) 1.337 kg. 2 Sodium borohydride 0.214 kg. 3 L(+) Tartaric acid 0.900 kg. (1S, 4R)-Cis-4-Amino-2-cyclopentene-1-methanol tartrate (CAP-II) 1 kg. 4 D (-) tartaric acid 0.742 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty.| ||(1S, 4R)-Cis-4-Amino-2-cyclopentene-1-methanol tartrate (CAP-II)|| 1 kg.|1|2-Azabicylo [2.2.1] hept-5-en-3-one (Vince lactam)| 1.337 kg.| |||||2|Sodium borohydride|0.214 kg.| |||||3|L(+) Tartaric acid|0.900 kg.| |||||4|D (-) tartaric acid|0.742 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	121 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00002539AM24
RA File Number	09AX04000262 AM24
Licence No and	0911005265/26/06/2023

UDIN00290959AM24

Date

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Jun/202324/8 dated 30/06/2023 against advance authorization No.0911004979 dated 08/05/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
(1S,<br>4R)-Cis-4-Amino-2-cyclopentene-1-methanol<br>tartrate (CAP-II)	<br>1 kg.	1	2-Azabicylo [2.2.1] hept-5-en-3-one<br>(Vince lactam)	<br>1.337 kg.
		2	Sodium borohydride	0.214 kg.
		3	L(+) Tartaric acid	0.900 kg.
		4	D (-) tartaric acid	0.742 kg.

Case No.	Case No.	122 / NC/3/MEET/Sep/202324/13	122 / NC/3/MEET/Sep/202324/13	122 / NC/3/MEET/Sep/202324/13	122 / NC/3/MEET/Sep/202324/13	122 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00002540AM24
RA File Number		09AX04000259 AM24
Licence No and<br>Date		0911005266/26/06/2023
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 meeting**No.

005266/26/06/2023||||| |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/Jun/202324/8 dated 30/06/2023against advance authorizationNo.0911004979 dated 08/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 2-Azabicylo [2.2.1] hept-5-en-3-one (Vince lactam) 1.337 kg. (1S, 4R)-Cis-4-Amino-2-cyclopentene-1-methanol tartrate (CAP-II) 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty.| ||(1S, 4R)-Cis-4-Amino-2-cyclopentene-1-methanol tartrate (CAP-II)|| 1 kg.|1|2-Azabicylo [2.2.1] hept-5-en-3-one (Vince lactam)| 1.337 kg.|

Case No.	Case No.	122 / NC/3/MEET/Sep/202324/13	122 / NC/3/MEET/Sep/202324/13	122 / NC/3/MEET/Sep/202324/13	122 / NC/3/MEET/Sep/202324/13	122 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00002540AM24
RA File Number		09AX04000259 AM24
Licence No and<br>Date		0911005266/26/06/2023

and Date||NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023||||| |HQ File Number||HQRNORM APPLY 00002540AM24||||| |RA File Number||09AX04000259 AM24||||| |Licence No and Date||0911005266/26/06/2023||||| |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/Jun/202324/8 dated 30/06/2023against advance authorizationNo.0911004979 dated 08/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 2-Azabicylo [2.2.1] hept-5-en-3-one (Vince lactam) 1.337 kg. (1S, 4R)-Cis-4-Amino-2-cyclopentene-1-methanol tartrate (CAP-II) 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty.| ||(1S, 4R)-Cis-4-Amino-2-cyclopentene-1-methanol tartrate (CAP-II)|| 1 kg.|1|2-Azabicylo [2.2.1] hept-5-en-3-one (Vince lactam)| 1.337 kg.|

UDIN00290959AM24

2<br>Sodium borohydride<br>0.214 kg.<br>3<br>L(+) Tartaric acid<br>0.900 kg.<br>4<br>D (-) tartaric acid<br>0.742 kg.<br>RA concerned may take further necessary action as per above decision of NC.			2	Sodium borohydride	0.214 kg.
			3	L(+) Tartaric acid	0.900 kg.
			4	D (-) tartaric acid	0.742 kg.

may take further necessary action as per above decision of NC.			2	Sodium borohydride	0.214 kg.
			3	L(+) Tartaric acid	0.900 kg.
			4	D (-) tartaric acid	0.742 kg.

Case No.	Case No.	123 / NC/3/MEET/Sep/202324/13	123 / NC/3/MEET/Sep/202324/13	123 / NC/3/MEET/Sep/202324/13	123 / NC/3/MEET/Sep/202324/13	123 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00002555AM24
RA File Number		07AX04000358 AM24
Licence No and<br>Date		0711008391/26/06/2023
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 meetings No. NC/3/MEET/May/202324/5dated08/06/2023and No.NC/3/MEET/Sep/202122/8dated 24/09/2021 against<br>advance authorization sNo.0711002772 dated 31/12/2021andNo. 0710115523dated03/10/2019, it was decided to fix ad-hoc<br>norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

dated03/10/2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 PHENOXY ETHANOL 0.70 kg. Phenoxy Ethyl Iso Butyrate 0.83/Kg(2-(phenoxy)ethyl 2- methylpropanoate (2-Phenoxy Ethyl Iso Butyrate) CAS NO.103-60-6) 1 kg. 2 Iso Butyric Acid 0.498 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Phenoxy Ethyl Iso Butyrate 0.83/Kg(2-(phenoxy)ethyl 2- methylpropanoate (2-Phenoxy Ethyl Iso Butyrate) CAS NO.103-60-6)||1 kg.|1|PHENOXY ETHANOL|0.70 kg.| |||||2|Iso Butyric Acid|0.498 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	124 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00002558AM24
RA File Number	07AX04000359 AM24

UDIN00290959AM24

Licence No and 0711008395/26/06/2023 Date Norms Committee Decision:

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

Case No.	125 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00002564AM24
RA File Number	05AX04000851 AM24
Licence No and<br>Date	0511019523/26/06/2023
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. 13/82-ALC4/2018 dated 14/01/2019against advance authorizationNo.0510408318 dated 02/11/2018, it was<br>decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>Phthalic Anhydride<br>0.3797 kg.<br>PLASTICIZER (DI OCTYL PHTHALATE ) (<br>DOP)<br>1 kg.<br>2<br>2 Ethyl Hexanol<br>0.700 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ide 0.3797 kg. PLASTICIZER (DI OCTYL PHTHALATE ) ( DOP) 1 kg. 2 2 Ethyl Hexanol 0.700 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	126 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	BRAWN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00002565AM24
RA File Number	05AX04000837 AM24
Licence No and<br>Date	0511019527/26/06/2023
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.6/82-ALC4/2019 dated 16/08/2019against advance authorizationNo.

UDIN00290959AM24

0710086623 dated 28/02/2012 , 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.
Amikacin Sulphate Injection 100 mg<br>/2ML VIAL(Clear, colourless to pale<br>yellow solution filled in clear glass sealed<br>vials.)	1 Number	1	Amikacin Sulphate	143.16 mg. / 2 ml.<br>Vial
Amikacin Sulphate Injection 500 mg<br>/2ML VIAL(Clear, colourless to pale<br>yellow solution filled in clear glass sealed<br>vials.)	1 Number	2	Amikacin Sulphate	715.81 mg / 2 ml Vial

Case No.	Case No.	127 / NC/3/MEET/Sep/202324/13	127 / NC/3/MEET/Sep/202324/13	127 / NC/3/MEET/Sep/202324/13	127 / NC/3/MEET/Sep/202324/13	127 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00002566AM24
RA File Number		05AX04000866 AM24
Licence No and<br>Date		0511019528/26/06/2023
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/202223/6dated09/09/2022against advance authorization<br>No. 0511008298dated27/01/2022,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>Visallergol Eye Drops 0.2 Percent 2.5ml<br>1 Number Vial<br>1<br>Olopatadine HCL<br>5.61 mg
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Visallergol Eye Drops 0.2 Percent 2.5ml		1 Number Vial	1	Olopatadine HCL	5.61 mg

UDIN00290959AM24

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

| ||Visallergol Eye Drops 0.2 Percent 2.5ml||1 Number Vial|1|Olopatadine HCL|5.61 mg| ||||||||

UDIN00290959AM24

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

Case No.	128 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00002572AM24
RA File Number	08AX04000392 AM24
Licence No and<br>Date	0811008526/26/06/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	129 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00002683AM24
RA File Number	08AX04000542 AM24
Licence No and<br>Date	0811008532/27/06/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00002683AM24| |RA File Number|08AX04000542 AM24| |Licence No and Date|0811008532/27/06/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	130 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00002690AM24
RA File Number	05AX04000863 AM24
Licence No and<br>Date	0511019538/27/06/2023
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. 0511016274dated09/12/2022,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:-

UDIN00290959AM24

Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>Brimonidine Tartrate 0.1% Solution 5ml<br>Santabrim<br>942359.0 Vials<br>1<br>Brimonidine Tartrate<br>4.80 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items<br>	Qty.
	Brimonidine Tartrate 0.1% Solution 5ml<br>Santabrim	<br>942359.0 Vials	1	Brimonidine Tartrate<br>	4.80 kg.

n of NC.	Export Product	Qty.	Sl. No.	Import Items<br>	Qty.
	Brimonidine Tartrate 0.1% Solution 5ml<br>Santabrim	<br>942359.0 Vials	1	Brimonidine Tartrate<br>	4.80 kg.

Case No.	131 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00002713AM24
RA File Number	09AX04000257 AM24
Licence No and<br>Date	0911005276/27/06/2023
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/202223/1dated29/04/2022against advance authorization<br>No. 0911002161dated27/12/2021,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>IBREXAFUNGERP CITRATE<br>1 kg.<br>1<br>ENFUMAFUNGIN<br>4.55 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	132 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00002728AM24
RA File Number	08AX04000519 AM24
Licence No and	0811008542/27/06/2023

UDIN00290959AM24

Date Norms Committee Decision:

Items Qty. Co-codamol 8/500 tablets (Codeine Phosphate Hemihydrate 8mg and Paracetamol 500mg) (Each Tablet contains Codeine Phosphate Hemihydrate 8mg and Paracetamol 500mg (Net Wt. Codeine Phosphate Hemihydrate 320.00 KGS)) 1 Number 1 Codeine Phosphate Hemihydrate 8.16 mg. Co-codamol 15/500 tablets (Codeine Phosphate Hemihydrate 15mg and Paracetamol 500mg)(Each Tablet contains Codeine Phosphate Hemihydrate 15mg and Paracetamol 500mg (Net Wt.Codeine Phosphate Hemihydrate 780.00 KGS)) 1 Number 2 Codeine Phosphate Hemihydrate 15.30 mg. Co-codamol 30/500 tablets (Codeine Phosphate Codeine Phosphate 1 Number 3 30.60 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Co-codamol 8/500 tablets (Codeine Phosphate Hemihydrate 8mg and Paracetamol 500mg) (Each Tablet contains Codeine Phosphate Hemihydrate 8mg and Paracetamol 500mg (Net Wt. Codeine Phosphate Hemihydrate 320.00 KGS))||1 Number|1|Codeine Phosphate Hemihydrate|8.16 mg.| ||Co-codamol 15/500 tablets (Codeine Phosphate Hemihydrate 15mg and Paracetamol 500mg)(Each Tablet contains Codeine Phosphate Hemihydrate 15mg and Paracetamol 500mg (Net Wt.Codeine Phosphate Hemihydrate 780.00 KGS))||1 Number|2|Codeine Phosphate Hemihydrate|15.30 mg.| ||Co-codamol 30/500 tablets (Codeine Phosphate||1 Number|3|Codeine Phosphate|30.60 mg.|

UDIN00290959AM24

br>Hemihydrate 780.00 KGS))||1 Number|2|Codeine Phosphate Hemihydrate|15.30 mg.| ||Co-codamol 30/500 tablets (Codeine Phosphate||1 Number|3|Codeine Phosphate|30.60 mg.|

UDIN00290959AM24

Hemihydrate 30mg and Paracetamol 500mg<br>)(Each Tablet contains<br>Codeine Phosphate Hemihydrate 30mg and<br>Paracetamol 500mg (Net Wt.Codeine Phosphate<br>Hemihydrate 5220.00 KGS))<br>Hemihydrate<br>RA concerned may take further necessary action as per above decision of NC.	Hemihydrate 30mg and Paracetamol 500mg<br>)(Each Tablet contains<br>Codeine Phosphate Hemihydrate 30mg and<br>Paracetamol 500mg (Net Wt.Codeine Phosphate<br>Hemihydrate 5220.00 KGS))			Hemihydrate

Case No.	154 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00003912AM24
RA File Number	56AX04000209 AM24
Licence No and<br>Date	5611001998/04/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Soya Lecithin Liquid Food Grade (Non GMO)<br>1 MT<br>1<br>Soya Lecithin Liquid<br>1.01 MT<br>RA concerned may take further necessary action as per above decision of NC

br>Import Items Qty. Soya Lecithin Liquid Food Grade (Non GMO) 1 MT 1 Soya Lecithin Liquid 1.01 MT RA concerned may take further necessary action as per above decision of NC||

Case No.	155 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00003914AM24
RA File Number	04AX04000303 AM24
Licence No and<br>Date	0411005642/04/07/2023
Norms Committee Decision:

UDIN00290959AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Jun/202324/8 dated 30/06/2023 against advance authorization No.0411005642 dated 04/07/2023 , 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.
IBUPROFEN LYSINE (LYSINATE)	1 kg.	1	IBUPROFEN	0.683 kg.
		2	DL LYSINATE 50%	0.970 kg.

ver is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
IBUPROFEN LYSINE (LYSINATE)	1 kg.	1	IBUPROFEN	0.683 kg.
		2	DL LYSINATE 50%	0.970 kg.

Case No.	156 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00003915AM24
RA File Number	04AX04000302 AM24
Licence No and<br>Date	0411005643/04/07/2023
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/Jun/202324/8 dated 30/06/2023against advance authorizationNo.0411005085 dated 21/03/2023,<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. No.<br>Import Items<br>Qty.<br>IBUPROFEN DC (Directly Compressible) 90 grade<br>1 kg.<br>1<br>IBUPROFEN<br>0.909 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00290959AM24

* IBUPROFEN DC (Directly Compressible) 90 grade 1 kg. 1 IBUPROFEN 0.909 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00290959AM24

Case No.	157 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00003926AM24
RA File Number	03AX04001301 AM24
Licence No and<br>Date	0311025115/04/07/2023
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/Apr/202324/1 dated 28/04/2023against advance authorization<br>No. 0311019883dated09/12/2022, 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>Colesevelam HCL for oral suspension 3.75<br>GM ( Per Pack 30 Pouchs) (Total 35000<br>Packs) ((Net. Content of Colesevelam<br>Hydrochloride is 3937.500 kgs))<br>35000 Packs<br>1<br>Colesevelam<br>Hydrochloride<br>4134.375 kg.<br>RA concerned may take further necessary action as per above decision of NC

Colesevelam Hydrochloride is 3937.500 kgs)) 35000 Packs 1 Colesevelam Hydrochloride 4134.375 kg. RA concerned may take further necessary action as per above decision of NC||

Case No.	158 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00003937AM24
RA File Number	05AX04000876 AM24
Licence No and<br>Date	0511019620/04/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	159 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004114AM24

UDIN00290959AM24

RA File Number

08AX04000579 AM24

Licence No and Date

0811008604/05/07/2023

16dated08/03/2022**, 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. DOXYCYCLINE DISPERSIBLE TABLETS 100 MG(EACH UNCOATED DISPERSIBLE TABLET CONTAINS: DOXYCYCLINE MONOHYDRATE PH.EUR. EQ. TO DOXYCYCLINE 100 MG [IN WHICH ACTIVE INGREDIENT DOXYCYCLINE MONOHYDRATE USED IS 106.000 KGS.]) 1 Number 1 DOXYCYCLINE MONOHYDRATE EP / BP / IP / USP / PH. EUR. 102.908 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	160 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004115AM24
RA File Number	52AX04000093 AM24
Licence No and<br>Date	5211005099/05/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	161 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED

UDIN00290959AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004117AM24
RA File Number	08AX04000578 AM24
Licence No and<br>Date	0811008606/05/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004117AM24| |RA File Number|08AX04000578 AM24| |Licence No and Date|0811008606/05/07/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	162 / NC/3/MEET/Sep/202324/13	162 / NC/3/MEET/Sep/202324/13	162 / NC/3/MEET/Sep/202324/13	162 / NC/3/MEET/Sep/202324/13	162 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004118AM24
RA File Number		08AX04000580 AM24
Licence No and<br>Date		0811008607/05/07/2023
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/Jun/202324/8 dated 30/06/2023against advance authorizationNo. 0811007811 dated 06/04/2023,<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. No. Import Items<br>Qty.<br>CLOZAPINE TABLETS 25 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>25 MG)<br>1 Number<br>1<br>CLOZAPINE<br>EP / BP / IP / USP / PH. EUR.<br>25.50 mg/tablet<br>CLOZAPINE TABLETS 50 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>50 MG)<br>1 Number<br>2<br>CLOZAPINE<br>EP / BP / IP / USP / PH.

EP / BP / IP / USP / PH. EUR. 25.50 mg/tablet CLOZAPINE TABLETS 50 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 50 MG) 1 Number 2 CLOZAPINE EP / BP / IP / USP / PH. EUR. 51.00 mg/tablet CLOZAPINE TABLETS 100 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 100 MG) 1 Number 3 CLOZAPINE EP / BP / IP / USP / PH. EUR. 102.0 mg/tablet CLOZAPINE TABLETS 200 MG CLOZAPINE 1 Number 4 204.00 mg/tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||CLOZAPINE TABLETS 25 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 25 MG)||1 Number|1|CLOZAPINE EP / BP / IP / USP / PH. EUR.|25.50 mg/tablet| ||CLOZAPINE TABLETS 50 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 50 MG)||1 Number|2|CLOZAPINE EP / BP / IP / USP / PH. EUR.|51.00 mg/tablet| ||CLOZAPINE TABLETS 100 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 100 MG)||1 Number|3|CLOZAPINE EP / BP / IP / USP / PH. EUR.|102.0 mg/tablet| ||CLOZAPINE TABLETS 200 MG||1 Number|4|CLOZAPINE|204.00 mg/tablet|

UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 100 MG)||1 Number|3|CLOZAPINE EP / BP / IP / USP / PH. EUR.|102.0 mg/tablet| ||CLOZAPINE TABLETS 200 MG||1 Number|4|CLOZAPINE|204.00 mg/tablet|

Case No.	Case No.	162 / NC/3/MEET/Sep/202324/13	162 / NC/3/MEET/Sep/202324/13	162 / NC/3/MEET/Sep/202324/13	162 / NC/3/MEET/Sep/202324/13	162 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004118AM24
RA File Number		08AX04000580 AM24
Licence No and<br>Date		0811008607/05/07/2023
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/Jun/202324/8 dated 30/06/2023against advance authorizationNo. 0811007811 dated 06/04/2023,<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. No. Import Items<br>Qty.<br>CLOZAPINE TABLETS 25 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>25 MG)<br>1 Number<br>1<br>CLOZAPINE<br>EP / BP / IP / USP / PH. EUR.<br>25.50 mg/tablet<br>CLOZAPINE TABLETS 50 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>50 MG)<br>1 Number<br>2<br>CLOZAPINE<br>EP / BP / IP / USP / PH.

UDIN00290959AM24

(EACH UNCOATED TABLET			EP / BP / IP / USP / PH. EUR.
CONTAINS: CLOZAPINE PH.EUR.
200 MG [IN WHICH ACTIVE
INGREDIENT CLOZAPINE USED
IS 570.000 KGS.])

ACH UNCOATED TABLET			EP / BP / IP / USP / PH. EUR.
CONTAINS: CLOZAPINE PH.EUR.
200 MG [IN WHICH ACTIVE
INGREDIENT CLOZAPINE USED
IS 570.000 KGS.])

Case No.	Case No.	163 / NC/3/MEET/Sep/202324/13	163 / NC/3/MEET/Sep/202324/13	163 / NC/3/MEET/Sep/202324/13	163 / NC/3/MEET/Sep/202324/13	163 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004119AM24
RA File Number		08AX04000584 AM24
Licence No and<br>Date		0811008608/05/07/2023
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/Jun/202324/8 dated 30/06/2023against advance authorizationNo. 0811007811 dated 06/04/2023,<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. No. Import Items<br>Qty.<br>CLOZAPINE TABLETS 25 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>25 MG)<br>1 Number<br>1<br>CLOZAPINE<br>EP / BP / IP / USP / PH. EUR.<br>25.50 mg/tablet<br>CLOZAPINE TABLETS 50 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>50 MG)<br>1 Number<br>2<br>CLOZAPINE<br>EP / BP / IP / USP / PH.

EP / BP / IP / USP / PH. EUR. 25.50 mg/tablet CLOZAPINE TABLETS 50 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 50 MG) 1 Number 2 CLOZAPINE EP / BP / IP / USP / PH. EUR. 51.00 mg/tablet CLOZAPINE TABLETS 100 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 100 MG) 1 Number 3 CLOZAPINE EP / BP / IP / USP / PH. EUR. 102.0 mg/tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||CLOZAPINE TABLETS 25 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 25 MG)||1 Number|1|CLOZAPINE EP / BP / IP / USP / PH. EUR.|25.50 mg/tablet| ||CLOZAPINE TABLETS 50 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 50 MG)||1 Number|2|CLOZAPINE EP / BP / IP / USP / PH. EUR.|51.00 mg/tablet| ||CLOZAPINE TABLETS 100 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 100 MG)||1 Number|3|CLOZAPINE EP / BP / IP / USP / PH. EUR.|102.0 mg/tablet|

SP / PH. EUR.|51.00 mg/tablet| ||CLOZAPINE TABLETS 100 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 100 MG)||1 Number|3|CLOZAPINE EP / BP / IP / USP / PH. EUR.|102.0 mg/tablet|

Case No.	Case No.	163 / NC/3/MEET/Sep/202324/13	163 / NC/3/MEET/Sep/202324/13	163 / NC/3/MEET/Sep/202324/13	163 / NC/3/MEET/Sep/202324/13	163 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004119AM24
RA File Number		08AX04000584 AM24
Licence No and<br>Date		0811008608/05/07/2023
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/Jun/202324/8 dated 30/06/2023against advance authorizationNo. 0811007811 dated 06/04/2023,<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. No. Import Items<br>Qty.<br>CLOZAPINE TABLETS 25 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>25 MG)<br>1 Number<br>1<br>CLOZAPINE<br>EP / BP / IP / USP / PH. EUR.<br>25.50 mg/tablet<br>CLOZAPINE TABLETS 50 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>50 MG)<br>1 Number<br>2<br>CLOZAPINE<br>EP / BP / IP / USP / PH.

EP / BP / IP / USP / PH. EUR. 25.50 mg/tablet CLOZAPINE TABLETS 50 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 50 MG) 1 Number 2 CLOZAPINE EP / BP / IP / USP / PH. EUR. 51.00 mg/tablet CLOZAPINE TABLETS 100 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 100 MG) 1 Number 3 CLOZAPINE EP / BP / IP / USP / PH. EUR. 102.0 mg/tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||CLOZAPINE TABLETS 25 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 25 MG)||1 Number|1|CLOZAPINE EP / BP / IP / USP / PH. EUR.|25.50 mg/tablet| ||CLOZAPINE TABLETS 50 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 50 MG)||1 Number|2|CLOZAPINE EP / BP / IP / USP / PH. EUR.|51.00 mg/tablet| ||CLOZAPINE TABLETS 100 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 100 MG)||1 Number|3|CLOZAPINE EP / BP / IP / USP / PH. EUR.|102.0 mg/tablet|

UDIN00290959AM24

CLOZAPINE TABLETS 200 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>200 MG [IN<br>WHICH ACTIVE INGREDIENT<br>CLOZAPINE USED IS 1045.000<br>KGS.])<br>1 Number<br>4<br>CLOZAPINE<br>EP / BP / IP / USP / PH. EUR.<br>204.00 mg/tablet<br>RA concerned may take further necessary action as per above decision of NC.	CLOZAPINE TABLETS 200 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>200 MG [IN<br>WHICH ACTIVE INGREDIENT<br>CLOZAPINE USED IS 1045.000<br>KGS.])	1 Number	4	CLOZAPINE<br>EP / BP / IP / USP / PH. EUR.	204.00 mg/tablet

LOZAPINE PH.EUR. 200 MG [IN WHICH ACTIVE INGREDIENT CLOZAPINE USED IS 1045.000 KGS.])|1 Number|4|CLOZAPINE EP / BP / IP / USP / PH. EUR.|204.00 mg/tablet| |---|---|---|---|---|---|

Case No.	Case No.	164 / NC/3/MEET/Sep/202324/13	164 / NC/3/MEET/Sep/202324/13	164 / NC/3/MEET/Sep/202324/13	164 / NC/3/MEET/Sep/202324/13	164 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004120AM24
RA File Number		08AX04000523 AM24
Licence No and<br>Date		0811008610/05/07/2023
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. 0811007811 dated 06/04/2023, 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>CLOZAPINE TABLETS 25 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>25 MG)<br>1 Number<br>1<br>CLOZAPINE<br>EP / BP / IP / USP / PH. EUR.<br>25.50 mg/tablet<br>CLOZAPINE TABLETS 50 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>50 MG)<br>1 Number<br>2<br>CLOZAPINE<br>EP / BP / IP / USP / PH.

EP / BP / IP / USP / PH. EUR. 25.50 mg/tablet CLOZAPINE TABLETS 50 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 50 MG) 1 Number 2 CLOZAPINE EP / BP / IP / USP / PH. EUR. 51.00 mg/tablet CLOZAPINE TABLETS 100 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 1 Number 3 CLOZAPINE EP / BP / IP / USP / PH. EUR. 102.0 mg/tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||CLOZAPINE TABLETS 25 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 25 MG)||1 Number|1|CLOZAPINE EP / BP / IP / USP / PH. EUR.|25.50 mg/tablet| ||CLOZAPINE TABLETS 50 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 50 MG)||1 Number|2|CLOZAPINE EP / BP / IP / USP / PH. EUR.|51.00 mg/tablet| ||CLOZAPINE TABLETS 100 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR.||1 Number|3|CLOZAPINE EP / BP / IP / USP / PH. EUR.|102.0 mg/tablet|

UDIN00290959AM24

100 MG)<br>CLOZAPINE TABLETS 200 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>200 MG [IN WHICH ACTIVE<br>INGREDIENT CLOZAPINE USED<br>IS 96.500 KGS.])<br>1 Number<br>4<br>CLOZAPINE<br>EP / BP / IP / USP / PH. EUR.<br>204.00 mg/tablet<br>RA concerned may take further necessary action as per above decision of NC.	100 MG)
	CLOZAPINE TABLETS 200 MG<br>(EACH UNCOATED TABLET<br>CONTAINS: CLOZAPINE PH.EUR.<br>200 MG [IN WHICH ACTIVE<br>INGREDIENT CLOZAPINE USED<br>IS 96.500 KGS.])	1 Number	4	CLOZAPINE<br>EP / BP / IP / USP / PH. EUR.	204.00 mg/tablet

Case No.	165 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004173AM24
RA File Number	09AX04000306 AM24
Licence No and<br>Date	0911005317/05/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Propargyl Alcohol<br>0.573 kg.<br>2<br>Tertiary butyl alcohol<br>1.458 kg.<br>Cis Propenyl Phosphonic Acid (CPA)<br>1 kg.<br>3<br>Toluene<br>1.428 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	166 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED

UDIN00290959AM24

y action as per above decision of NC.||

Case No.	166 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED

UDIN00290959AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004176AM24
RA File Number	09AX04000307 AM24
Licence No and<br>Date	0911005318/05/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>Propargyl Alcohol<br>0.930 kg.<br>2<br>R Phenylethylamine<br>0.943 kg.<br>3<br>Tetiary butyl alcohol<br>1.840 kg.<br>Phosfomycin Phenyl Ethyl Amine<br>1 kg<br>4<br>Toluene<br>1.939 kg.<br>RA concerned may take further necessary action as per above decision of NC.

. 3 Tetiary butyl alcohol 1.840 kg. Phosfomycin Phenyl Ethyl Amine 1 kg 4 Toluene 1.939 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	167 / NC/3/MEET/Sep/202324/13	167 / NC/3/MEET/Sep/202324/13	167 / NC/3/MEET/Sep/202324/13	167 / NC/3/MEET/Sep/202324/13	167 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004221AM24
RA File Number		09AX04000286 AM24
Licence No and Date		0911005325/06/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00290959AM24

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

UDIN00290959AM24

1<br>6-Amino-2,2-Dimethyl-2H-Pyrido<br>[3,2-B][1,4]Oxazin-3(4H)-One<br>0.680 kg.<br>6-((5-FLUORO-2-((3,4,5-<br>TRIMETHOXYPHENYL)AMINO)<br>PYRIMIDIN-4-YL)AMINO)-2,2-<br>DIMETHYL-2H- PYRIDO[3,2-<br>B][1,4]OXAZIN-3(4H)-ONE<br>(Saturated, acyclic, hydrocarbons.)<br>1 kg.<br>2<br>5-Fluoro Pyrimidine-2,4-diol<br>(or) 5-Fluoruracil<br>0.613 kg.<br>RA concerned may take further necessary action as per above decision of NC.	6-((5-FLUORO-2-((3,4,5-<br>TRIMETHOXYPHENYL)AMINO)<br>PYRIMIDIN-4-YL)AMINO)-2,2-<br>DIMETHYL-2H- PYRIDO[3,2-<br>B][1,4]OXAZIN-3(4H)-ONE<br>(Saturated, acyclic, hydrocarbons.)<br>	1 kg.	1	6-Amino-2,2-Dimethyl-2H-Pyrido<br>[3,2-B][1,4]Oxazin-3(4H)-One	0.680 kg.
			2	5-Fluoro Pyrimidine-2,4-diol<br>(or) 5-Fluoruracil	0.613 kg.

Case No.	168 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004222AM24
RA File Number	09AX04000297 AM24
Licence No and<br>Date	0911005327/06/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004222AM24| |RA File Number|09AX04000297 AM24| |Licence No and Date|0911005327/06/07/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	169 / NC/3/MEET/Sep/202324/13	169 / NC/3/MEET/Sep/202324/13	169 / NC/3/MEET/Sep/202324/13	169 / NC/3/MEET/Sep/202324/13	169 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004223AM24
RA File Number		09AX04000300 AM24
Licence No and<br>Date		0911005335/06/07/2023
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. 8/82-ALC4/2019dated20/09/2019against advance authorizationNo.<br>0910067300 dated 19/03/2019, 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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Nise Gel 20g Tube<br>1 Number<br>1<br>CAPSAICIN<br>5.10 mg/ 20 gm Tube
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Nise Gel 20g Tube		1 Number	1	CAPSAICIN	5.10 mg/ 20 gm Tube

UDIN00290959AM24

APSAICIN 5.10 mg/ 20 gm Tube||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Nise Gel 20g Tube||1 Number|1|CAPSAICIN|5.10 mg/ 20 gm Tube|

UDIN00290959AM24

(Each tube contains 5 mg of Capsaicin)<br>Nise Gel 50g Tube<br>(Each tube contains 12.5 mg of Capsaicin)<br>1 Number<br>2<br>CAPSAICIN<br>12.75 mg/50 gm Tube<br>RA concerned may take further necessary action as per above decision of NC.	(Each tube contains 5 mg of Capsaicin)
	Nise Gel 50g Tube<br>(Each tube contains 12.5 mg of Capsaicin)	1 Number	2	CAPSAICIN	12.75 mg/50 gm Tube

Case No.	170 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	AROCHEMA INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004229AM24
RA File Number	26AX04000043 AM24
Licence No and<br>Date	2611001013/06/07/2023
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/202324/4dated26/05/2023against advance authorization<br>No.2611000839 dated 08/02/2023, 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.

** dated 08/02/2023, 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. 1 SCLAREOL 1.1768 kg. ORCANOX 1 kg. 2 TERT - AMYL ALCOHOL 1.00 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	171 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	BULI CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004235AM24
RA File Number	03AX04001475 AM24

UDIN00290959AM24

Licence No and 0311025181/06/07/2023 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Case No.	172 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004244AM24
RA File Number	09AX04000203 AM24
Licence No and<br>Date	0911005339/06/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004244AM24| |RA File Number|09AX04000203 AM24| |Licence No and Date|0911005339/06/07/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	173 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004246AM24
RA File Number	34AX04000258 AM24
Licence No and<br>Date	3411003871/06/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	174 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	VISWAAT CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004250AM24
RA File Number	03AX04001561 AM24
Licence No and<br>Date	0311025198/06/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No. 175 / NC/3/MEET/Sep/202324/13

UDIN00290959AM24

and Date|0311025198/06/07/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No. 175 / NC/3/MEET/Sep/202324/13

UDIN00290959AM24

Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004252AM24
RA File Number	09AX04000280 AM24
Licence No and Date	0911005341/06/07/2023
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/202223/18dated23/01/2023against advance authorization<br>No. 0911003510 dated 22/08/2022,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>Valganciclovir Tablets USP 450 mg<br>1 Number<br>1<br>Valganciclovir Hcl<br>(USP Amorphous)<br>506.24 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Qty.** Valganciclovir Tablets USP 450 mg 1 Number 1 Valganciclovir Hcl (USP Amorphous) 506.24 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	176 / NC/3/MEET/Sep/202324/13	176 / NC/3/MEET/Sep/202324/13	176 / NC/3/MEET/Sep/202324/13	176 / NC/3/MEET/Sep/202324/13	176 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004254AM24
RA File Number		09AX04000296 AM24
Licence No and<br>Date		0911005348/06/07/2023
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/Mar/202223/22dated24/03/2023against advance<br>authorizationNo. 0911004033 dated 28/11/2022,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>1<br>DL-Homocysteine thiolactone HCl<br>0.89 kg.<br>ERDOSTEINE<br>1 kg.
	Export Product		Qty.	Sl. No.<br>	Import Items	Qty.
	ERDOSTEINE		1 kg.	1<br>	DL-Homocysteine thiolactone HCl	0.89 kg.

olactone HCl 0.89 kg. ERDOSTEINE 1 kg.||||||| ||Export Product||Qty.|Sl. No. |Import Items|Qty.| ||ERDOSTEINE||1 kg.|1 |DL-Homocysteine thiolactone HCl|0.89 kg.|

Case No.	Case No.	176 / NC/3/MEET/Sep/202324/13	176 / NC/3/MEET/Sep/202324/13	176 / NC/3/MEET/Sep/202324/13	176 / NC/3/MEET/Sep/202324/13	176 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004254AM24
RA File Number		09AX04000296 AM24
Licence No and<br>Date		0911005348/06/07/2023
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/Mar/202223/22dated24/03/2023against advance<br>authorizationNo. 0911004033 dated 28/11/2022,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>1<br>DL-Homocysteine thiolactone HCl<br>0.89 kg.<br>ERDOSTEINE<br>1 kg.
	Export Product		Qty.	Sl. No.<br>	Import Items	Qty.
	ERDOSTEINE		1 kg.	1<br>	DL-Homocysteine thiolactone HCl	0.89 kg.

UDIN00290959AM24

2 Thiodi glycolic Acid 0.81 kg.

xport Product**||Qty.|Sl. No. |Import Items|Qty.| ||ERDOSTEINE||1 kg.|1 |DL-Homocysteine thiolactone HCl|0.89 kg.|

UDIN00290959AM24

2 Thiodi glycolic Acid 0.81 kg.

Case No.	177 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004286AM24
RA File Number	09AX04000315 AM24
Licence No and<br>Date	0911005356/07/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	178 / NC/3/MEET/Sep/202324/13	178 / NC/3/MEET/Sep/202324/13	178 / NC/3/MEET/Sep/202324/13	178 / NC/3/MEET/Sep/202324/13	178 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004287AM24
RA File Number		03AX04001565 AM24
Licence No and<br>Date		0311025232/07/07/2023
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/Apr/202324/1dated28/04/2023against advance authorization<br>No. 0311020457 dated 04/01/2023,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

duct in meetingNo. NC/3/MEET/Apr/202324/1dated28/04/2023against advance authorization No. **0311020457 dated 04/01/2023,**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. 1 Bempedoic Acid 189.90 mg. Bempedoic Acid and Ezetimibe Fixed Dose Combination Tablets((Each Tablet content Bempedoic Acid 180mg and Ezetimibe 10mg) (Net content of Bempedoic Acid 5400.000 kgs and Ezetimibe 300.000 kgs in total Export Qty) (AA for Free of cost material as per Para 4.11 of HBP & 1 Number 2 Ezetimibe 10.55 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Bempedoic Acid and Ezetimibe Fixed Dose Combination Tablets((Each Tablet content Bempedoic Acid 180mg and Ezetimibe 10mg) (Net content of Bempedoic Acid 5400.000 kgs and Ezetimibe 300.000 kgs in total Export Qty) (AA for Free of cost material as per Para 4.11 of HBP &||1 Number|1|Bempedoic Acid|189.90 mg.| |||||2|Ezetimibe|10.55 mg.|

UDIN00290959AM24

Para 4.19 of FTP ))

: The above norms are valid only for subject to fulfillment of following conditions:

Export product being Patented Medicine, be filed with USFDA as an NDA (New Drug Application).
Export to USA and Europe only.
Firm holding Certificate of Manufacturing Exclusivity.

ort product being Patented Medicine, be filed with USFDA as an NDA (New Drug Application).**

Export to USA and Europe only.
Firm holding Certificate of Manufacturing Exclusivity.

Case No.	179 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004291AM24
RA File Number	03AX04001312 AM24
Licence No and<br>Date	0311025237/07/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	180 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004296AM24
RA File Number	03AX04001358 AM24
Licence No and<br>Date	0311025245/10/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	181 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004297AM24
RA File Number	03AX04001495 AM24
Licence No and Date	0311025247/10/07/2023

UDIN00290959AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
FAROPENEM SODIUM	1 kg.	1	3R,4R)-4-ACETOXY-3-[(R)-1-(T-<br>BUTYLDIMETHYLSILYLOXY)ETHYL]-2-<br>AZITIDINONE;4-AA(AOSA)	1.20 kg.
		2	ALLYL OXALYL CHLORIDE	1.14 kg.

Case No.	182 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004299AM24
RA File Number	03AX04001599 AM24
Licence No and<br>Date	0311025255/10/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004299AM24| |RA File Number|03AX04001599 AM24| |Licence No and Date|0311025255/10/07/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	183 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	UNIMAX LABORATORIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004362AM24
RA File Number	05AX04000958 AM24
Licence No and<br>Date	0511019654/11/07/2023
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/202324/8dated30/06/2023against advance authorization<br>No. 0511018168 dated 18/04/2023,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details

UDIN00290959AM24

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

Export Product	Qty.	Sl. No.	Import Items<br>	Qty.
Amoxicillin Capsules BP, 500 mg.<br>(Each Capsules contains Amoxicillin BP<br>(As Trihydrate)	1 Number	1	Amoxicillin Trihydrate BP<br>	585.282 mg
Ampicillin Capsules BP, 500 mg.<br>(Each Capsules contains Ampicillin BP<br>(As Trihydrate)	1 Number	2	Ampicillin Trihydrate BP<br>	585.282 mg

Number|1|Amoxicillin Trihydrate BP |585.282 mg| |Ampicillin Capsules BP, 500 mg. (Each Capsules contains Ampicillin BP (As Trihydrate)|1 Number|2|Ampicillin Trihydrate BP |585.282 mg|

Case No.	Case No.	184 / NC/3/MEET/Sep/202324/13	184 / NC/3/MEET/Sep/202324/13	184 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004365AM24
RA File Number		09AX04000225 AM24
Licence No and<br>Date		0911005377/11/07/2023
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/202324/6dated14/06/2023against advance authorization<br>No. 0911004452 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>1<br>ADENINE<br>0.85 kg.<br>2<br>N,N-DIMETHYLFORMAMIDE<br>2.00 kg.<br>( R)-9-[2-phosphonomethoxy)<br>propyl] Adenine (Compounds<br>containing a pyrimidine ring<br>1 kg.
	Export Product		Qty.	**Sl. No.

.85 kg. 2 N,N-DIMETHYLFORMAMIDE 2.00 kg. ( R)-9-[2-phosphonomethoxy) propyl] Adenine (Compounds containing a pyrimidine ring 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty.| ||( R)-9-[2-phosphonomethoxy) propyl] Adenine (Compounds containing a pyrimidine ring||1 kg.|1|ADENINE|0.85 kg.| |||||2|N,N-DIMETHYLFORMAMIDE|2.00 kg.|

Case No.	Case No.	184 / NC/3/MEET/Sep/202324/13	184 / NC/3/MEET/Sep/202324/13	184 / NC/3/MEET/Sep/202324/13	184 / NC/3/MEET/Sep/202324/13	184 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004365AM24
RA File Number		09AX04000225 AM24
Licence No and<br>Date		0911005377/11/07/2023
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/202324/6dated14/06/2023against advance authorization<br>No. 0911004452 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.

/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. 1 ADENINE 0.85 kg. 2 N,N-DIMETHYLFORMAMIDE 2.00 kg. ( R)-9-[2-phosphonomethoxy) propyl] Adenine (Compounds containing a pyrimidine ring 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty.| ||( R)-9-[2-phosphonomethoxy) propyl] Adenine (Compounds containing a pyrimidine ring||1 kg.|1|ADENINE|0.85 kg.| |||||2|N,N-DIMETHYLFORMAMIDE|2.00 kg.|

UDIN00290959AM24

3	(R)-1,2-PROPYLENE CARBONATE	0.79 kg.
4	N-METHYL-2-PYRROLIDONE	0.21 kg.
5	Diethyl Para Toluene Sulfonyl Oxy<br>Methyl Phosphonate	1.00 kg.
6	Magnesium Tert. Butoxide	1.00 kg.

RBONATE|0.79 kg.| |---|---|---|---|---|---| ||||4|N-METHYL-2-PYRROLIDONE|0.21 kg.| ||||5|Diethyl Para Toluene Sulfonyl Oxy Methyl Phosphonate|1.00 kg.| ||||6|Magnesium Tert. Butoxide|1.00 kg.|

Case No.	185 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004384AM24
RA File Number	09AX04000287 AM24
Licence No and<br>Date	0911005380/12/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>Carboplatin (Diloxanide furoate, Cimetidine,<br>Oxyclozanide, Famotidine:)<br>1 kg.<br>1<br>Potassium tetrachloroplatinate<br>1.527 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	186 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004391AM24

UDIN00290959AM24

UDIN00290959AM24

RA File Number

05AX04001023 AM24

Licence No and Date

0511019756/12/07/2023

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/Oct/202122/10dated12/11/2021against advance authorization No. **0911000085 dated 23/12/2020,**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. Timolol Maleate Ophthalmic Solution, USP 0.5% (5 mL) 339623 Numbers 1 TIMOLOL MALEATE USP 11778.14 gm Timolol Maleate Ophthalmic Solution, USP 0.5% (10 mL) 169811 Numbers 2 TIMOLOL MALEATE USP 11778.10 gm RA concerned may take further necessary action as per above decision of NC.

Case No.	187 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004401AM24
RA File Number	34AX04000275 AM24
Licence No and<br>Date	3411003884/13/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004401AM24| |RA File Number|34AX04000275 AM24| |Licence No and Date|3411003884/13/07/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	188 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004404AM24
RA File Number	31AX04000095 AM24
Licence No and<br>Date	3111002460/13/07/2023

UDIN00290959AM24

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

Case No.	189 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004405AM24
RA File Number	03AX04001674 AM24
Licence No and<br>Date	0311025364/13/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	Case No.	Case No.	190 / NC/3/MEET/Sep/202324/13	190 / NC/3/MEET/Sep/202324/13
Case Status			Case Approved
Party Name			UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number			HQRNORM APPLY 00004414AM24
RA File Number			03AX04001595 AM24
Licence No and<br>Date			0311025375/13/07/2023
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.0311022366 dated 23/03/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

product in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization No.0311022366 dated 23/03/2023, 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:- Sl. No. Export Product SION No. 1 Erythromycin Base/Erythromycin A-215 2 Erythromycin Oxime Base (Erythromycin A-9 Oxime) A-2244||||| ||Sl. No.|Export Product||SION No.| ||1|Erythromycin Base/Erythromycin||A-215| ||2|Erythromycin Oxime Base (Erythromycin A-9 Oxime)||A-2244| ||||||

UDIN00290959AM24

Case No.	191 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004431AM24
RA File Number	07AX04000565 AM24
Licence No and<br>Date	0711008561/14/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 LISINOPRIL DIHYDRATE Ph.Eur 5.10 mg LISINOPRIL 5MG+AMLODIPINE 5MG TABLETS(LISINOPRIL 5MG+AMLODIPINE 5MG TABLETS (35.00KG)) 1 Number 2 AMLODIPINE BESILATE BP 5.10 mg 3 LISINOPRIL DIHYDRATE Ph.Eur 10.20 mg LISINOPRIL 10MG+AMLODIPINE 5MG TABLETS(LISINOPRIL 10MG+AMLODIPINE 5MG TABLETS (37.35 KG)) 1 Number 4 AMLODIPINE BESILATE BP 5.10 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	192 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004433AM24
RA File Number	03AX04001604 AM24
Licence No and<br>Date	0311025397/14/07/2023
Norms Committee Decision:

UDIN00290959AM24

The case is under consideration for want of report of factory/plant visit from TE.

AM24| |Licence No and Date|0311025397/14/07/2023| |Norms Committee Decision:||

UDIN00290959AM24

The case is under consideration for want of report of factory/plant visit from TE.

Case No.	193 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004440AM24
RA File Number	03AX04001669 AM24
Licence No and<br>Date	0311025403/14/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	194 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004443AM24
RA File Number	03AX04001084 AM24
Licence No and<br>Date	0311025417/14/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	195 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	BROOKS STERISCIENCE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004445AM24
RA File Number	34AX04000271 AM24
Licence No and<br>Date	3411003892/14/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	196 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED

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

Case No.	196 / NC/3/MEET/Sep/202324/13
Case Status	Case Deferred
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED

UDIN00290959AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004448AM24
RA File Number	07AX04000507 AM24
Licence No and<br>Date	0711008721/14/07/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	197 / NC/3/MEET/Sep/202324/13	197 / NC/3/MEET/Sep/202324/13	197 / NC/3/MEET/Sep/202324/13	197 / NC/3/MEET/Sep/202324/13	197 / NC/3/MEET/Sep/202324/13
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004467AM24
RA File Number		34AX04000290 AM24
Licence No and<br>Date		3411003905/17/07/2023
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/Aug/202223/6dated09/09/2022against advance authorizationNo. 3411001739 dated 28/01/2022<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. No.

ed 28/01/2022** , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Lidocaine USP 0.382 kg. Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 5 gm Tube(Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 5 gm Tube (Net content of active ingredients 10.00 kgs and 10.00 kgs)) 3000 Numbers 2 Prilocaine Base USP 0.382 kg. 3 Lidocaine USP 199.6585 kg. Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube(Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube (Net content of active ingredients 52.500 kgs and 52.500 kgs)) 261000 Numbers 4 Prilocaine Base USP 199.6585 kg. Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube(Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube (Net content of active ingredients 52.500 kgs 1000 Numbers 5 Lidocaine USP 1.5295 kg.||||||| ||Export Product||Qty.|Sl.

e(Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube (Net content of active ingredients 52.500 kgs 1000 Numbers 5 Lidocaine USP 1.5295 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 5 gm Tube(Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 5 gm Tube (Net content of active ingredients 10.00 kgs and 10.00 kgs))|| 3000 Numbers|1|Lidocaine USP|0.382 kg.| |||||2|Prilocaine Base USP|0.382 kg.| ||Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube(Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube (Net content of active ingredients 52.500 kgs and 52.500 kgs))|| 261000 Numbers|3|Lidocaine USP|199.6585 kg.| |||||4|Prilocaine Base USP|199.6585 kg.| ||Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube(Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube (Net content of active ingredients 52.500 kgs|| 1000 Numbers|5|Lidocaine USP|1.5295 kg.|

UDIN00290959AM24

gm tube(Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube (Net content of active ingredients 52.500 kgs|| 1000 Numbers|5|Lidocaine USP|1.5295 kg.|

UDIN00290959AM24

and 52.500 kgs))<br>Lidocaine Ointment USP 5% 35.44 gm<br>tube(Lidocaine Ointment USP 5% 35.44 gm tube<br>(Net content of active<br>ingredients 70.88 kgs))<br>1000 Numbers<br>6<br>Lidocaine USP<br>1.807 kg.<br>Lidocaine Ointment USP 5% 50 gm jar(Lidocaine<br>Ointment USP 5% 50 gm jar (Net content of active<br>ingredients 75.00<br>kgs))<br>1000 Numbers<br>7<br>Lidocaine USP<br>2.55 kg.<br>RA concerned may take further necessary action as per above decision of NC.	and 52.500 kgs))
	Lidocaine Ointment USP 5% 35.44 gm<br>tube(Lidocaine Ointment USP 5% 35.44 gm tube<br>(Net content of active<br>ingredients 70.88 kgs))	1000 Numbers	6	Lidocaine USP	1.807 kg.
	Lidocaine Ointment USP 5% 50 gm jar(Lidocaine<br>Ointment USP 5% 50 gm jar (Net content of active<br>ingredients 75.00<br>kgs))	1000 Numbers	7	Lidocaine USP	2.55 kg.

6|Lidocaine USP|1.807 kg.| ||Lidocaine Ointment USP 5% 50 gm jar(Lidocaine Ointment USP 5% 50 gm jar (Net content of active ingredients 75.00 kgs))|1000 Numbers|7|Lidocaine USP|2.55 kg.|

Case No.	198 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004472AM24
RA File Number	03AX04001698 AM24
Licence No and<br>Date	0311025490/17/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>HEXAFLUOROISOPROPYL<br>METHYL ETHER(HFMOP)<br>1 kg.<br>1<br>HEXA FLUORO ISO PROPANOL<br>0.970 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	199 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	ETERNIS FINE CHEMICALS LIMITED

UDIN00290959AM24

cessary action as per above decision of NC.||

Case No.	199 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	ETERNIS FINE CHEMICALS LIMITED

UDIN00290959AM24

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number		HQRNORM APPLY 00004474AM24
RA File Number		03AX04001700 AM24
Licence No and<br>Date		0311025497/17/07/2023
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/Feb/202223/20 dated 24/02/2023against advance authorizationNo. 0311014744 dated 17/05/2022<br>, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

tingNo.NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance authorizationNo. 0311014744 dated 17/05/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl.No. Import items. Qty. 1 PHENOL 1.15 kg. 2 XYLENE 0.50 kg. 3 MAGNESIUM TURNING 0.148 kg. 4 PARAFORMALDEHYDE 0.9177 kg. COUMARIN 1 kg. 5 ACETIC ANHYDRIDE 0.7356 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl.No.|Import items.|Qty.| ||COUMARIN||1 kg.|1|PHENOL|1.15 kg.| |||||2|XYLENE|0.50 kg.| |||||3|MAGNESIUM TURNING|0.148 kg.| |||||4|PARAFORMALDEHYDE|0.9177 kg.| |||||5|ACETIC ANHYDRIDE|0.7356 kg.| |||||as per above decision of NC.|||

Case No.	200 / NC/3/MEET/Sep/202324/13
Case Status	Case Approved
Party Name	SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202324/ 13 and 14/09/2023
HQ File Number	HQRNORM APPLY 00004476AM24
RA File Number	09AX04000351 AM24
Licence No and<br>Date	0911005426/17/07/2023
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.0911003827 **dated 18/10/202

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