IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-10-07

DGFT Committee Minutes

Document text

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Government of India Ministry of Commerce and Industry Department of Commerce

DIRECTORATE GENERAL OF FOREIGN TRADE

(DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Sep/202223/9 DATED: 07/10/2022

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/202223/9 dated 07/10/2022 of Norms Committee - III for the year 2022-23 was held on 07/10/2022 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:-

	Name and Designation of Representatives	Department
1	AJAY KUMAR,Deputy Director	Directorate General of Foreign Trade, Delhi
2	SHAISH KUMAR,Technical Authority	Technical Consultant,DGFT
3	DINESHNARAIN MATHUR,Technical<br>Authority	Technical Consultant,DGFT

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signe Name: Ajay Kumar( Deputy Director ) Name: Ajay Kumar( uty Director ) Date: 19-Oct-2022 12:55:42 Date: 19-Oct-2022 2:55:42 Reason: AJAY.DHIMAN88@GOV.IN Reason: AJAY. IAN88@GOV.IN Location: DGFT(HQ) Location: DGFTIHG)

This document has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 19-Oct-2022.

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Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022	Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00041071AM22
RA File Number<br>NA
Licence No and<br>Date<br>NA
Norms Committee Decision:
The Committee considered the case as per agenda and on	the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
1<br>Ciprofloxacin<br>Hydrochloride<br>1 kg	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)	5Fluorobenzoyl) Acrylate
2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	2 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	CORPORATE CHANNELS (INDIA) PVT. LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00002028AM23
RA File Number	132404000019 AM14
Licence No and<br>Date	1310044179/29/08/2013
Norms Committee Decision:
Deferred for comments of TE.

Case No.	3 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00160014AM22
RA File Number	039404000859 AM16
Licence No and	0310802380/09/02/2016

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Date

Norms Committee Decision:

The Committee considered the request of firm for review of adhoc norms and it was observed that the firm has not provided the purity in the description of Export Product and Import Item. Hence, the Committee decided to reject the case maintaining the status quo.

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

Case No.	4 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00001869AM23
RA File Number	052404000399 AM17
Licence No and<br>Date	0510400599/02/12/2016
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information/documents from the firm:
COA of import and export item.<br>i.
Stoichiometric balance on molar basis and yield to arrive at the quantity of raw material obtained.<br>ii.
Technical literature in support of its claim.<br>iii.
iv Production	/ Consumption data for the period 2017-18 duly certified by GST.

Case No.	5 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00001867AM23
RA File Number	052404000008 AM18
Licence No and<br>Date	0510402246/18/04/2017
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information/documents from the firm:
COA of import and export item.<br>i.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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ii. Stoichiometric balance on molar basis and yield to arrive at the quantity of raw material obtained.
iii. Technical literature in support of its claim.

iv Production / Consumption data for the period 2017-18 duly certified by GST.

Case No.	6 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00001870AM23
RA File Number	052404000297 AM18
Licence No and<br>Date	0510404439/31/10/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information/documents from the firm:<br>COA of import and export item.<br>i.<br>Stoichiometric balance on molar basis and yield to arrive at the quantity of raw material obtained.<br>ii.<br>Technical literature in support of its claim.<br>iii.<br>iv Production / Consumption data for the period 2017-18 duly certified by GST.

Case No.	7 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00160008AM22
RA File Number	039404000838 AM18
Licence No and<br>Date	0310818810/31/01/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information/documents from the firm:<br>Copy of Shipping Bills indicating percentage purity of export product.<br>i.<br>ii Copy of Bill of Entry indicating percentage purity of import item.

Case No.	8 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00000196AM23
RA File Number	342404000094 AM19
Licence No and<br>Date	3410044399/08/08/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information/documents from the firm:<br>Any Published Literature to indicate low yield of 70% in such type of process.

Case No.	9 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00000444AM23
RA File Number	022404000044 AM20
Licence No and<br>Date	0210209260/17/06/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance<br>authorization No.0210208260 dated 07.03.2018, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Noscapine BP USP Ph.Eur JP CP / Noscapine<br>Hydrochloride BP Ph.Eur<br>1 kg<br>1<br>Noscapine Crude Content 95%<br>1.158 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	10 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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and Date
HQ File Number	HQRNORM REVIW00001314AM23
RA File Number	039504000232 AM20
Licence No and<br>Date	0310829915/25/06/2019
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as
under:
Export product<br>Qty.		Sl. No.	Import items	Qty.
Tonalid	1 kg	1	D M B-1 (2, 3 Dimethyl 1 Butene)	0.896 kg
		2	Paracymene	0.750 kg
RA concerned may take further necessary		action as per	above decision of NC.

Case No.<br>11 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM REVIW00000446AM23
RA File Number<br>022404000056 AM20
Licence No and<br>Date<br>0210209307/12/07/2019
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for
same export product / import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance
authorization No.0210208260 dated 07.03.2018, it was decided to ratify adhoc norms under Para		4.07 of HBP Vol.
I as per details given below or as applied by the firm, whichever is	less:
Export product<br>Qty.<br>Sl. No.	Import items		Qty.
Noscapine BP USP Ph.Eur JP CP / Noscapine<br>1 kg<br>1	Noscapine Crude Content 95%		1.158 kg
Hydrochloride BP Ph.Eur

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.	Case No.	12 / NC/3/MEET/Sep/202223/9	12 / NC/3/MEET/Sep/202223/9	12 / NC/3/MEET/Sep/202223/9	12 / NC/3/MEET/Sep/202223/9	12 / NC/3/MEET/Sep/202223/9

Case Status		Case Approved

Party Name		VN CREATIVE CHEMICALS PRIVATE LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

HQ File Number		HQRNORM REVIW00001316AM23

RA File Number		039504000497 AM20

Licence No and<br>Date		0310831036/16/08/2019

Norms Committee Decision:<br>The Committee considered the request of<br>under:				firm for review of adhoc norms and it was decided to revise adhoc norms as




	Export produ	ct	Qty.	Sl. No.	Import items	Qty.

	Tonalid		1 k	1	D M B-1 (2 3 Dimethl 1 Butene)	0896 k
			g		, y	. g

				2	Paracymene	0.750 kg

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

Case No.		13 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM REVIW00001317AM23
RA File Number		039504000551 AM20
Licence No and		0310831364/04/09/2019
Date
Norms Committee<br>		Decision:<br>
The Committee co<br>under:		nsidered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as

Case No.	13 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00001317AM23
RA File Number	039504000551 AM20
Licence No and<br>Date	0310831364/04/09/2019
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as
under:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Export product	Qty.	Sl. No.	Import items	Qty.
Tonalid	1 kg	1	D M B-1 (2, 3 Dimethyl 1 Butene)	0.896 kg
		2	Paracymene	0.750 kg

Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>D M B-1 (2, 3 Dimethyl 1 Butene)<br>0.896 kg<br>Tonalid<br>1 kg<br>2<br>Paracymene<br>0.750 kg<br>	Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>D M B-1 (2, 3 Dimethyl 1 Butene)<br>0.896 kg<br>Tonalid<br>1 kg<br>2<br>Paracymene<br>0.750 kg<br>	Export product	Export product	Qty.	Sl. No.	Sl. No.	Sl. No.	Import items	Import items	Qty.
		Tonalid		1 kg	1			D M B-1 (2, 3 Dimethyl 1 Butene)		0.896 kg
					2			Paracymene		0.750 kg
RA concerned may take further necessary action as per above decision of NC.



Case No.			14 / NC/3/MEET/Sep/202223/9

Case Status			Case Approved

Party Name			PANACEA BIOTEC LIMITED
Mti Nb
eeng umer<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

HQ File Number			HQRNORM REVIW00001880AM23

RA File Number			052404000410 AM20
Li N d
cence o an<br>Date			0510412195/21/10/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance authorization No.<br>0510413419 dated 22.01.2020, it was decided to ratify adhoc 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> <br> <br> <br> <br>

	Export product			Qty.		Sl. No.	Import items		Qty.


	Easy Five TT		Vaccine	<br>1<br>Million		1<br>	Purified Diptheria Toxoid Concentrate		13.33 Litre
	DTwP-Hep		B-Hib-	Vials			Antigen Bulk @2050 Lf/ml
	Pentavalent Vac<br>vial of 0.5 ml<br>		cine (Each<br>contains 1	<br>
						2	Purified Tetanus Toxoid Concentrate		523 Litre
	dose)						<br>Antigen @1900 Lf/ml		.

						3	Inactivated Whole Cell Pertussis Bulk<br>		<br>86.46 Litre
							@192 OU/ml
						4	Rubber Stopper		1010000 Numbers
						5	AGS HB Purification MABS Column		5.4 Litre

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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6 Tetanus Toxoid for conjugation 6.15 Litre

Case No.	15 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00000521AM23
RA File Number	039504000760 AM20
Licence No and<br>Date	0310832692/11/11/2019
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was observed that at the time of filing
application, the consumption shown in Appendix 4E is 0.665 kg and 1.107 kg, however now while
filing review, the consumption shown in Appendix 4E is 0.735 kg and 1.232 kg. Furthermore, no justification has
been provided for enhancement of norms.
Hence, the Committee decided torejectthe case maintaining the status quo.
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>16 / NC/3/MEET/Sep/202223/9	Case No.<br>16 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ	File Number<br>HQRNORM REVIW00001320AM23
RA File Number<br>039504000849 AM20
Licence No and<br>Date<br>0310833213/04/12/2019
Norms Committee Decision:
The	Committee considered the request of firm for fixation of adhoc norms and it was decided to		ratify adhoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.<br>Sl. No.	Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Tonalid	1	kg	1	D M B-1 (2, 3 Dimethyl 1 Butene)	0.896 kg
			2	Paracymene	0.750 kg

Case No.	Case No.	Case No.	17 / NC/3/MEET/Sep/202223/9	17 / NC/3/MEET/Sep/202223/9	17 / NC/3/MEET/Sep/202223/9	17 / NC/3/MEET/Sep/202223/9	17 / NC/3/MEET/Sep/202223/9	17 / NC/3/MEET/Sep/202223/9

Case Status			Case Approved
Party Name			SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number			HQRNORM REVIW00000385AM23
RA File Number			022404000012 AM21
Licence No and<br>Date			0210209889/29/05/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance<br>authorization No.0210208260 dated 07.03.2018, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Noscapine BP USP Ph.Eur JP CP / Noscapine<br>Hydrochloride BP Ph.Eur<br>1 kg<br>1<br>Noscapine Crude Content 95%<br>1.158 kg<br>
	Export product			Qty.	Sl. No.		Import items	Qty.
	Noscapine BP USP Ph.Eur JP CP / Noscapine<br>Hydrochloride BP Ph.Eur			<br>1 kg	1		Noscapine Crude Content 95%	1.158 kg

RA concern		ed may take further necessary action as per above dec				ision of NC.



Case No			18 / NC/3/MEET/Sep/202223/9
.
Case Status			Case Approved
Party Name			SYNNAT PHARMA PRIVATE LIMITED

Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number			HQRNORM REVIW00000388AM23
RA File Number			022404000050 AM21
Licence No and<br>			0210210010/27/07/2020
Date

Case No.	18 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00000388AM23
RA File Number	022404000050 AM21
Licence No and<br>Date	0210210010/27/07/2020

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Norms Committee Decision:

The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Aug/202223/6 dated 09.09.2022 against advance authorization No. 0210208260 dated 07.03.2018 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Noscapine BP USP Ph.Eur JP CP / Noscapine<br>Hydrochloride BP Ph.Eur	<br>1 kg	1	Noscapine Crude Content 95%	1.158 kg

Case No.	19 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	KUSUMA PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00002033AM23
RA File Number	039404000198 AM21
Licence No and<br>Date	0310837494/29/07/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was observed that the firm has not<br>given any technical details in support of its request.<br>In view of above, the Committee decided torejectthe case maintain the status quo.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	20 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	KUSUMA PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00002036AM23
RA File Number	039404000356 AM21
Licence No and<br>Date	0310837963/28/08/2020
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

The Committee considered the request of firm for review of adhoc norms and it was observed that the firm has not given any technical details in support of its request.

In view of above, the Committee decided to reject the case maintain the status quo.

Case No.	21 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00001315AM23
RA File Number	039504000298 AM21
Licence No and<br>Date	0310838023/01/09/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as
under:
Export product<br>Qty.<br>Sl. No.<br>Import items		Qty.
Tonalid	1<br>D M B-1 (2, 3 Dimethyl 1 Butene)<br>1 kg	0.896 kg
	2<br>Paracymene	0.750 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	22 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00000568AM23
RA File Number	052404000295 AM21
Licence No and<br>Date	0510415273/21/09/2020
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following information/documents from the firm:

i. DML.

ii. Master Batch Formula .

iii. COA of import item from foreign supplier.

Case No.	Case No.	23 / NC/3/MEET/Sep/202223/9	23 / NC/3/MEET/Sep/202223/9	23 / NC/3/MEET/Sep/202223/9	23 / NC/3/MEET/Sep/202223/9	23 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001749AM21
RA File Number		039404001019 AM20
Licence No and<br>Date		0310838949/16/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	24 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	018205001750AM21
RA File Number	039404000978 AM20
Licence No and<br>Date	0310838950/16/10/2020

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Norms Committee Decision:

The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product		Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin	Hydrochloride	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)				5Fluorobenzoyl) Acrylate
			2	Piperazine Anhydrous	0.390 kg


Case No.		25 / NC/3/MEET/Sep/202223/9

Case Status		Case Approved

Party Name		AARTI DRUGS LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

HQ File Number		018205001751AM21

RA File Number		039404000297 AM21

Licence No and<br>Date		0310838951/16/10/2020

Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>d f h fi i didd if dh d P 407 f HBP Vl I dil i bl
ata rom oter rms, t was ece to raty aoc norms uner ara . o o. as per etas gven eow<br>lid b th fi hih i l
	r as appe y	rm, wcever s ess:



	Export product		Qty.	Sl. No.	Import items	Qty.

	Ciprofloxacin<br>	Hydrochloride<br>	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>	1.240 kg
	BP/EP/USP (Cip	rofloxacin)			5Fluorobenzoyl) Acrylate

				2	Piperazine Anhydrous	0.390 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.	Case No.	26 / NC/3/MEET/Sep/202223/9	26 / NC/3/MEET/Sep/202223/9	26 / NC/3/MEET/Sep/202223/9	26 / NC/3/MEET/Sep/202223/9	26 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001753AM21
RA File Number		039404000524 AM21
Licence No and<br>Date		0310838953/16/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	27 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	018205001755AM21
RA File Number	039404000184 AM21
Licence No and<br>Date	0310838958/16/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Export product	Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
		2	Piperazine Anhydrous	0.390 kg

Case No.	Case No.	28 / NC/3/MEET/Sep/202223/9	28 / NC/3/MEET/Sep/202223/9	28 / NC/3/MEET/Sep/202223/9	28 / NC/3/MEET/Sep/202223/9	28 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001745AM21
RA File Number		039404000392 AM21
Licence No and<br>Date		0310838931/16/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	29 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Party Name	Party Name	AARTI DRUGS LIMITED	AARTI DRUGS LIMITED	AARTI DRUGS LIMITED	AARTI DRUGS LIMITED	AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001746AM21
RA File Number		039404000516 AM21
Licence No and<br>Date		0310838932/16/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	Case No.	30 / NC/3/MEET/Sep/202223/9	30 / NC/3/MEET/Sep/202223/9	30 / NC/3/MEET/Sep/202223/9	30 / NC/3/MEET/Sep/202223/9	30 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001758AM21
RA File Number		039404000525 AM21
Licence No and<br>Date		0310838974/19/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>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.

Case No.	Case No.	30 / NC/3/MEET/Sep/202223/9	30 / NC/3/MEET/Sep/202223/9	30 / NC/3/MEET/Sep/202223/9	30 / NC/3/MEET/Sep/202223/9	30 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001758AM21
RA File Number		039404000525 AM21
Licence No and<br>Date		0310838974/19/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>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.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Ciprofloxacin	Hydrochloride	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)				5Fluorobenzoyl) Acrylate
			2	Piperazine Anhydrous	0.390 kg

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

Case No.<br>31 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>018205001759AM21
RA File Number<br>039404000528 AM21
Licence No and<br>Date<br>0310838975/19/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and on		the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	32 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	018205001767AM21
RA File Number	039404000526 AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Licence No and<br>Date<br>0310839001/20/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No. Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)	5Fluorobenzoyl) Acrylate
	2<br>Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>33 / NC/3/MEET/Sep/202223/9	Case No.<br>33 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>018205001769AM21
RA File Number<br>039404000527 AM21
Licence No and<br>Date<br>0310839017/20/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and on			the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
	BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
		2	Piperazine Anhydrous	0.390 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.	34 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	018205001770AM21
RA File Number	262404000018 AM21
Licence No and<br>Date	2610012921/20/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT<br>Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	35 / NC/3/MEET/Sep/202223/9	35 / NC/3/MEET/Sep/202223/9	35 / NC/3/MEET/Sep/202223/9	35 / NC/3/MEET/Sep/202223/9	35 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001766AM21
RA File Number		039404000548 AM21
Licence No and<br>Date		0310839000/20/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.<br>36 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>018205001778AM21
RA File Number<br>039404000412 AM21
Licence No and<br>Date<br>0310839084/23/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and on		the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	37 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	018205001779AM21
RA File Number	039404000411 AM21
Licence No and<br>Date	0310839085/23/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
		2	Piperazine Anhydrous	0.390 kg

Case No.	Case No.	38 / NC/3/MEET/Sep/202223/9	38 / NC/3/MEET/Sep/202223/9	38 / NC/3/MEET/Sep/202223/9	38 / NC/3/MEET/Sep/202223/9	38 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001788AM21
RA File Number		039404000410 AM21
Licence No and<br>Date		0310839173/28/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty<br>Sl. No. Import Item Name.<br>Qty.<br>1<br>2,4 Dichloro-5-Fluoro Acetophenone(DCFA)<br>0.877 kg<br>2<br>Dimethyl Carbonate<br>0.789 kg<br>3<br>Dimethyl Formamide<br>0.385 kg<br>4<br>Mono Ethyl Amine 70<br>0.439 kg<br>5<br>Piperazine Anhydrous<br>0.520 kg<br>Norfloxacin<br>1 kg
	Export Product<br>Norfloxacin		Qty	Sl. No.	Import Item Name.	Qty.
			1 kg	1	2,4 Dichloro-5-Fluoro Acetophenone(DCFA)	0.877 kg
				2	Dimethyl Carbonate	0.789 kg
				3	Dimethyl Formamide	0.385 kg
				4	Mono Ethyl Amine 70	0.439 kg
				5	Piperazine Anhydrous	0.520 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

6 Methanol 0.150 kg

6<br>Methanol<br>0.150 kg			Methanol	Methanol	Methanol	0.150 kg


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


Case No.		39 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved

Party Name		AARTI DRUGS LIMITED

Meeting Number
<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001789AM21

RA File Number		039404000346 AM21
Licence No and<br>Date		0310839184/28/10/2020
Norms Committee Decision:

The Committee co<br>d f h fi		nsidered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>i didd if dh d P 407 f HBP Vl I dil i bl
<br>o	ata rom oter r<br>r as applied by th	s, t was ece to raty a<br>firm whichever is less:		c norms uner ara . o o. as per etas gven eow
		,


	Exort roduct		Qt	Sl No	Imort items	Qt
	p p		y.	. .	p	y.

	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg

				2	Piperazine Anhydrous	0.390 kg




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


Case No.		40 / NC/3/MEET/Sep/202223/9

Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001805AM21
RA File Number		092404000389 AM21
Licence No and<br>Date		0910069418/29/10/2020
Norms Committee Decision:

Case No.	40 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	018205001805AM21
RA File Number	092404000389 AM21
Licence No and<br>Date	0910069418/29/10/2020
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

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

Export product	Qty.	Sl. No.	Import items		Qty.
(1R,2R)-2-amino-6-(4-nitrophenyl)-1-	1 kg	1	4-Pentyn-1-ol		1.22 kg
phenylhex-5-yn-1-ol hydrochloride
		2	Iodobenzene diacerate		4.78 kg
		3	Di-tert-butyl dicarbonate	(Boc anhydride)	3.16 kg
		4	KRED-208,<br>RVT-901	LYOPHILIZED	<br>0.030 kg
			ENZYME POWDER
		5	Beta-Nicotinamide adenine dinucleotide		<br>0.008 kg
			phosphate Sodium salt (beta-NADP-Na)
		6	P-Iodonitro benzene		0.904 kg

Case No.	Case No.	41 / NC/3/MEET/Sep/202223/9	41 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001804AM21
RA File Number		092404000388 AM21
Licence No and<br>Date		0910069417/29/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product		Qty.	Sl. No.	Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

1	4-Pentyn-1-ol	1.22 kg
2	Iodobenzene diacerate	4.78 kg
3	Di-tert-butyl dicarbonate (Boc anhydride)	3.16 kg
4	KRED-208,<br>RVT-901<br>LYOPHILIZED<br>ENZYME POWDER	<br>0.030 kg
5	Beta-Nicotinamide adenine dinucleotide<br>phosphate Sodium salt (beta-NADP-Na)	<br>0.008 kg
6	P-Iodonitro benzene	0.904 kg

Case No.	Case No.	42 / NC/3/MEET/Sep/202223/9	42 / NC/3/MEET/Sep/202223/9	42 / NC/3/MEET/Sep/202223/9	42 / NC/3/MEET/Sep/202223/9	42 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		018205001818AM21
RA File Number		039404001085 AM20
Licence No and<br>Date		0310839307/04/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty<br>Sl. No. Import Item Name.<br>Qty.<br>1<br>2,4 Dichloro-5-Fluoro Acetophenone(DCFA)<br>0.877 kg<br>2<br>Dimethyl Carbonate<br>0.789 kg<br>3<br>Dimethyl Formamide<br>0.385 kg<br>Norfloxacin<br>1 kg
	Export Product<br>Norfloxacin		Qty	Sl. No.	Import Item Name.	Qty.
			1 kg	1	2,4 Dichloro-5-Fluoro Acetophenone(DCFA)	0.877 kg
				2	Dimethyl Carbonate	0.789 kg
				3	Dimethyl Formamide	0.385 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

	4	Mono Ethyl Amine 70	0.439 kg
	5	Piperazine Anhydrous	0.520 kg
	6	Methanol	0.150 kg


			4	Mono Ethyl Amine 70						0.439 kg


			5	Piperazine Anhydrous						0.520 kg
6<br>Methanol<br>0.150 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.			6	Methanol						0.150 kg

Case No.		43 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>d D		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
an ate

HQ File Number		018205001826AM21

RA File Number		039404000596 AM21

Licence No and<br>Date		0310839361/05/11/2020

Norms Committee		Decision:
The Committee co		nsidered the case as per agenda and on the basis GST data furnished by the firm and comparative
data from other fir		ms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
o	r as applied by the	firm, whichever is less:
R
	Export product				Qty.		Sl. No.		Import items		Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP Cifli				<br>1 kg		1		Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Flbl Alt		1.240 kg
	(prooxacn)								uoroenzoy) cryae
							2		Pii Ahd		0390 k
									perazne nyrous		. g
	A concerned may take further nece			ssary act				b dii f C
						on a	s pe	r aove ecson o N.

C	ase No.	44 / NC/3/MEET/		Sep/2022		23/9
C	ase Status	Case Approved
P	arty Name	AARTI DRUGS		LIMITED

M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Se		p/ 20222		3/ 9 and		07/10/2022

Case No.	44 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

HQ File Number<br>018205001827AM21
RA File Number<br>039404000597 AM21
Licence No and<br>Date<br>0310839362/05/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and on		the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>45 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM REVIW00000390AM23
RA File Number<br>022404000099 AM21
Licence No and<br>Date<br>0210210204/09/11/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for
same export product / import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance
authorization No.0210208260 dated 07.03.2018, it was decided to ratify adhoc norms under Para		4.07 of HBP Vol.
I as per details given below or as applied by the firm, whichever is	less:
Export product<br>Qty.<br>Sl. No.	Import items		Qty.
Noscapine BP USP Ph.Eur JP CP / Noscapine<br>1 kg<br>1	Noscapine Crude Content 95%		1.158 kg
Hydrochloride BP Ph.Eur

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.<br>46 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>018205001844AM21
RA File Number<br>039404000423 AM21
Licence No and<br>Date<br>0310839485/11/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and on		the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	47 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	APEX DRUG HOUSE
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00001832AM23
RA File Number	03AA04013443 AM21
Licence No and<br>Date	0311000381/23/12/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms andit was observed that the firm has not
given any technical details in support of its request.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

In view of above, the Committee decided to reject the case.

Case No.	Case No.	48 / NC/3/MEET/Sep/202223/9	48 / NC/3/MEET/Sep/202223/9	48 / NC/3/MEET/Sep/202223/9	48 / NC/3/MEET/Sep/202223/9	48 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00063660AM21
RA File Number		03AA04018890 AM21
Licence No and<br>Date		0311001030/16/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	49 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00067209AM21
RA File Number	03AA04019643 AM21
Licence No and<br>Date	0311001122/21/01/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Export product	Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
		2	Piperazine Anhydrous	0.390 kg

Case No.	Case No.	50 / NC/3/MEET/Sep/202223/9	50 / NC/3/MEET/Sep/202223/9	50 / NC/3/MEET/Sep/202223/9	50 / NC/3/MEET/Sep/202223/9	50 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00067214AM21
RA File Number		03AA04019645 AM21
Licence No and<br>Date		0311001129/21/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.<br>51 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00067215AM21
RA File Number<br>03AA04019655 AM21
Licence No and<br>Date<br>0311001134/21/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on		the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	52 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00067217AM21
RA File Number	03AA04019654 AM21
Licence No and<br>Date	0311001138/21/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
			2	Piperazine Anhydrous	0.390 kg

Case No.	Case No.	53 / NC/3/MEET/Sep/202223/9	53 / NC/3/MEET/Sep/202223/9	53 / NC/3/MEET/Sep/202223/9	53 / NC/3/MEET/Sep/202223/9	53 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00068617AM21
RA File Number		03AA04020063 AM21
Licence No and<br>Date		0311001190/22/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	54 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

HQ File Number<br>HQRNORM APPLY 00068219AM21	HQ File Number<br>HQRNORM APPLY 00068219AM21
RA File Number<br>03AA04020020 AM21
Licence No and<br>Date<br>0311001191/22/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on		the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>55 / NC/3/MEET/Sep/202223/9	Case No.<br>55 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00069628AM21
RA File Number<br>03AA04020216 AM21
Licence No and<br>Date<br>0311001225/25/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on			the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
	BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

2 Piperazine Anhydrous 0.390 kg

Case No.	56 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00001578AM23
RA File Number	03AA04021189 AM21
Licence No and<br>Date	0311001372/01/02/2021
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following
information/documents from the firm:
Master Batch Formula given was found incomplete. Content of import item in Master Batch Formula was not<br>i.
shown.

Case No.<br>57 / NC/3/MEET/Sep/202223/9	Case No.<br>57 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00075441AM21
RA File Number<br>03AA04021687 AM21
Licence No and<br>Date<br>0311001421/02/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on			the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
	BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

2 Piperazine Anhydrous 0.390 kg

Case No.	58 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00000228AM23
RA File Number	31AA04006051 AM21
Licence No and<br>Date	3111000148/09/02/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was observed that the firm still has not<br>furnished its reply on DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	59 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00000695AM23
RA File Number	03AA04023340 AM21
Licence No and<br>Date	0311001698/16/02/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms andit was observed that the description of<br>import item No. 1 – Brimonidine does not match with the DML furnished by the firm.<br>In view of above, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of

Case No.	60 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00093160AM21
RA File Number		03AA04024760 AM21
Licence No and<br>Date		0311001926/26/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	Case No.	61 / NC/3/MEET/Sep/202223/9	61 / NC/3/MEET/Sep/202223/9	61 / NC/3/MEET/Sep/202223/9	61 / NC/3/MEET/Sep/202223/9	61 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00094934AM21
RA File Number		03AA04026242 AM21
Licence No and<br>Date		0311002125/02/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Ciprofloxacin<br>Hydrochloride<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>1 kg<br>1<br>1.240 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg

Case No.	Case No.	61 / NC/3/MEET/Sep/202223/9	61 / NC/3/MEET/Sep/202223/9	61 / NC/3/MEET/Sep/202223/9	61 / NC/3/MEET/Sep/202223/9	61 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00094934AM21
RA File Number		03AA04026242 AM21
Licence No and<br>Date		0311002125/02/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Ciprofloxacin<br>Hydrochloride<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>1 kg<br>1<br>1.240 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

BP/EP/USP (Ciprofloxacin)			5Fluorobenzoyl) Acrylate
		2	Piperazine Anhydrous	0.390 kg

Case No.	Case No.	62 / NC/3/MEET/Sep/202223/9	62 / NC/3/MEET/Sep/202223/9	62 / NC/3/MEET/Sep/202223/9	62 / NC/3/MEET/Sep/202223/9	62 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00096069AM21
RA File Number		03AA04027466 AM21
Licence No and<br>Date		0311002195/03/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	63 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00097305AM21
RA File Number	039404000673 AM21
Licence No and	0311001441/04/03/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Date

Norms Committee Decision:

Export product		Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin	Hydrochloride	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)				5Fluorobenzoyl) Acrylate
			2	Piperazine Anhydrous	0.390 kg

Case No.	64 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00000419AM23
RA File Number	05AA04037727 AM21
Licence No and<br>Date	0511001580/08/03/2021
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following
information/documents from the firm:
Approved composition of export product as per DML.<br>i.
Master Batch Formula.<br>ii.
Wastage claimed.<br>iii.

Case No.	65 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00000226AM23
RA File Number	31AA04006435 AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Licence No and 3111000179/08/03/2021 Date Norms Committee Decision: The Committee considered the request of firm for review of adhoc norms and it was observed that the firm still has not furnished its reply on DGFT Portal. Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.<br>66 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00098942AM21
RA File Number<br>03AA04022238 AM21
Licence No and<br>Date<br>0311001500/08/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on		the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	67 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00100470AM21
RA File Number	03AA04028406 AM21
Licence No and	0311002391/10/03/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Date

Norms Committee Decision:

Export product		Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin	Hydrochloride	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)				5Fluorobenzoyl) Acrylate
			2	Piperazine Anhydrous	0.390 kg

Case No.<br>68 / NC/3/MEET/Sep/202223/9	Case No.<br>68 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00100472AM21
RA File Number<br>03AA04028410 AM21
Licence No and<br>Date<br>0311002393/10/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on			the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
	BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
		2	Piperazine Anhydrous	0.390 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.	Case No.	69 / NC/3/MEET/Sep/202223/9	69 / NC/3/MEET/Sep/202223/9	69 / NC/3/MEET/Sep/202223/9	69 / NC/3/MEET/Sep/202223/9	69 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00108415AM21
RA File Number		03AA04028192 AM21
Licence No and<br>Date		0311002303/22/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	70 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00108766AM21
RA File Number	039404000652 AM21
Licence No and<br>Date	0311002733/22/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Export product	Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
		2	Piperazine Anhydrous	0.390 kg

Case No.	Case No.	71 / NC/3/MEET/Sep/202223/9	71 / NC/3/MEET/Sep/202223/9	71 / NC/3/MEET/Sep/202223/9	71 / NC/3/MEET/Sep/202223/9	71 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00117194AM21
RA File Number		09AA04006983 AM21
Licence No and<br>Date		0911000644/31/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Azathioprine<br>150.00 kg<br>2<br>Cellulose Microcristalline<br>150.00 kg<br>3<br>Mannitol<br>150.00 kg<br>4<br>Corn Starch<br>42.00 kg<br>5<br>Croscarmellose Sodium<br>16.50 kg<br>AZATHIOPRINE 25mg<br>6000000<br>Number
	Export product		Qty.	Sl. No.	Import items	Qty.
	AZATHIOPRINE 25mg		6000000<br>Number	1	Azathioprine	150.00 kg
				2	Cellulose Microcristalline	150.00 kg
				3	Mannitol	150.00 kg
				4	Corn Starch	42.00 kg
				5	Croscarmellose Sodium	16.50 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

6	Povidone K	24.00 kg
7	Sodium Stearyl Fumarate	7.50 kg
8	Hypromellose	6.90 kg
9	Macrogol	1.20 kg


							6		Povidone K	24.00 kg


							7		Sodium Stearyl Fumarate	7.50 kg


							8		Hypromellose	6.90 kg



							9		Macrogol	1.20 kg
R	A concerned may take furthe		r necessary ac			tion as per		above decision of NC.


C	ase No.	72 / NC/3/	MEET/Sep/202			223/9
C	ase Status	Case Appro	ved


P	arty Name	GRANULE	S INDIA		LIM	ITED
M<br>a	eeting Number<br>	NC/ 3/ ME	ET/ Sep/ 2		0222
						3/ 9 a	nd 0	7/1	/2022
	nd Date
H	Q File Number	HQRNOR	M APPLY		001	17574	AM2	1
R	A File Number	09AA0400	5560 AM2		1

L<br>D	icence No and<br>ate	091100047	6/31/03/20		21

N<br>T<br>V	orms Committee Decision:
	he Committee considered the case as per agenda<br>ol. I as per details given below or as applied by						and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>the firm, whichever is less:




	xort rouct			t			o		mort tems	t
	p p			y.			. .		p	y.


	HYDROXYURE	A CAPSULES		<br>1350000			1		Hydroxyurea USP	675.00 kg
	500 mg
				Nb
				umer			2		Cllidl Sili Diid NF	203 k
									ooa con oxe	.


							3		Magnesium Stearate	0.68 kg

							4		Capsule size1	1363500
										Number







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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.<br>73 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00003027AM22
RA File Number<br>03AA04031763 AM21
Licence No and<br>Date<br>0311002768/05/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on		the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	74 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00003031AM22
RA File Number	039404000229 AM21
Licence No and<br>Date	0311002737/05/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
			2	Piperazine Anhydrous	0.390 kg

Case No.	75 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	NASENSE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00019535AM22
RA File Number	09AA04000085 AM22
Licence No and<br>Date	0911000683/15/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT<br>Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	76 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00020260AM22
RA File Number	34AA04000021 AM22
Licence No and<br>Date	3411000455/16/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:<br>Specific name of Vegetable Oil to be imported.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.	77 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	GARUDA CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00024406AM22
RA File Number	03AA04031910 AM21
Licence No and<br>Date	0311003270/22/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT<br>Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	78 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	BHAGWATI INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00029214AM22
RA File Number	08AA04001833 AM22
Licence No and<br>Date	0811001364/29/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT<br>Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	79 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00032713AM22
RA File Number	05AA04009888 AM22
Licence No and<br>Date	0511002414/04/05/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT Portal. Hence, the Committee decided to reject the case.

Case No.	80 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00033649AM22
RA File Number	34AA04000874 AM22
Licence No and<br>Date	3411000530/05/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT
Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	81 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00036920AM22
RA File Number	09AA04002104 AM22
Licence No and<br>Date	0911000798/10/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT
Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	82 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	SAGA LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

HQ File Number<br>HQRNORM REVIW00001672AM23
RA File Number<br>08AA04003764 AM22
Licence No and<br>Date<br>0811001516/18/05/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for
same export product / import item in Meeting No.NC/3/MEET/Sep/202122/8 dated 24.09.2021against advance
authorization No.0810147725 dated 11.05.2020, it was decided to ratify adhoc norms under Para 4.07	of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:
Export Product<br>Qty.<br>Sl. No. Import items		Qty.
Diosmin and Hesperidin Tablets 500 mg<br>1 Number<br>1<br>DIOSMIN + HESPERIDIN 9:1		<br>564.29 mg
(1091 KGS)<br>Tablet<br>(Assay NMT 93% and Water
content NLT 2.9%)
RA concerned may take further necessary action as per above decision of NC.

Case No.	83 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	NASENSE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00046900AM22
RA File Number	09AA04002898 AM22
Licence No and<br>Date	0911000881/20/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT
Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	84 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00047353AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

RA File Number<br>03AA04031724 AM21
Licence No and<br>Date<br>0311002771/21/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on		the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	85 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00047898AM22
RA File Number	07AA04004515 AM22
Licence No and<br>Date	0711001152/21/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT
Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	86 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	SAKAR HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00099634AM22
RA File Number	08AA04004104 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Licence No and 0811001574/25/05/2021 Date Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT Portal. Hence, the Committee decided to reject the case.

Case No.	Case No.	87 / NC/3/MEET/Sep/202223/9	87 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY	00101253AM22
RA File Number		34AA04001451 AM22
Licence No and<br>Date		3411000643/27/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export Product	Qty<br>Sl.	Import Item Name.	Qty.
		No.
	PIPERAZINE	1 kg<br>1	PIPERAZINE CRUDE OR PIPERAZINE MIXTURE	2.047 kg
	ANHYDROUS
			(Percentage purity NMT 48.1%)
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	88 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00102193AM22
RA File Number	08AA04005014 AM22
Licence No and<br>Date	0811001601/28/05/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Norms Committee Decision:

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

Export Product	Qty	Sl.<br>No.	Import Item Name.	Qty.
Formulated Aromatic<br>Amine<br>1<br>(Brown<br>liquid, curing agent for<br>epoxy resin)	<br> <br> <br>1 kg	1	Aniline / Aniline Oil	0.683 kg
		2	Methanol	0.158 kg
		3	Di Ethyl Toluene Diamine / Ethacure 100 / Lonzacure<br>DETDA 80 / DETDA 80 / DETDA	<br>0.202 kg
		4	Iso Phoron Diamine / Vestamine IPD / Baxxodur EC 201 /<br>Wanamine IPDA	<br>0.101 kg

Case No.	89 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00104366AM22
RA File Number	08AA04004876 AM22
Licence No and<br>Date	0811001618/01/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:<br>The firm has given chemical reactions, starting from Formaldehyde as import item is Methanol. Therefore, the firm<br>is requested to give complete chemistry from Methane.

Case No.	90 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00105763AM22
RA File Number	03AA04017165 AM22
Licence No and<br>Date	0311004253/02/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT
Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	91 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00107373AM22
RA File Number	03AA04018281 AM22
Licence No and<br>Date	0311004321/04/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT
Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	92 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00109350AM22
RA File Number	03AA04023320 AM22
Licence No and<br>Date	0311004415/08/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT
Portal. Hence, the Committee decided torejectthe case.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.	93 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00111363AM22
RA File Number	31AA04004163 AM22
Licence No and<br>Date	3111000397/10/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT
Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	94 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00113434AM22
RA File Number	03AA04015087 AM22
Licence No and<br>Date	0311004561/12/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT
Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	95 / NC/3/MEET/Sep/202223/9
Case Status	Case Rejected
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00113697AM22
RA File Number	31AA04007148 AM21
Licence No and<br>Date	3111000400/14/06/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT Portal. Hence, the Committee decided to reject the case.

Case No.<br>96 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00184798AM22
RA File Number<br>03AA04091486 AM22
Licence No and<br>Date<br>0311007000/15/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on		the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	97 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM REVIW00001812AM23
RA File Number	05AA040108674 AM22
Licence No and<br>Date	0511006625/03/12/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as under:

Export product	Qty.	Sl. No.	Import items	Qty.
Mydrimax Eye Drops 5 ml (Mydrimax Eye	<br>1 Number	1	Tropicamide	40.8 mg /
Drops 5 ml) (Each ml Containing 8 mg
Tropicamide)				5 ml vial

Case No.<br>98 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Deferred
Party Name<br>SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM REVIW00001552AM23
RA File Number<br>13AX04000009 AM22
Licence No and<br>Date<br>1311000821/15/12/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information/documents from the firm:
COA of import item indicating exact purity of import item alongwith Bill of Entry indicating exact<br>i.
percentage of purity.

i. COA of import item indicating exact purity of import item alongwith Bill of Entry indicating exact percentage of purity.

Case No.	99 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00287541AM22
RA File Number	03AA040131415 AM22
Licence No and<br>Date	0311009528/16/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
		2	Piperazine Anhydrous	0.390 kg

Case No.	Case No.	100 / NC/3/MEET/Sep/202223/9	100 / NC/3/MEET/Sep/202223/9	100 / NC/3/MEET/Sep/202223/9	100 / NC/3/MEET/Sep/202223/9	100 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00292375AM22
RA File Number		03AA040131528 AM22
Licence No and<br>Date		0311009652/21/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.<br>101 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00300612AM22
RA File Number<br>03AX04000458 AM22
Licence No and<br>Date<br>0311009880/29/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on	the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms	under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
1<br>Ciprofloxacin<br>Hydrochloride<br>1 kg	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)	5Fluorobenzoyl) Acrylate
2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>102 / NC/3/MEET/Sep/202223/9	Case No.<br>102 / NC/3/MEET/Sep/202223/9	Case No.<br>102 / NC/3/MEET/Sep/202223/9	Case No.<br>102 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00300738AM22
RA File Number<br>03AX04000454 AM22
Licence No and<br>Date<br>0311009888/29/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on				the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
	Export product	Qty.	Sl. No.	Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Ciprofloxacin	Hydrochloride	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)				5Fluorobenzoyl) Acrylate
			2	Piperazine Anhydrous	0.390 kg

Case No.<br>103 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00301808AM22
RA File Number<br>03AX04000439 AM22
Licence No and<br>Date<br>0311009908/30/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on	the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
1<br>Ciprofloxacin<br>Hydrochloride<br>1 kg	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)	5Fluorobenzoyl) Acrylate
2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	104 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00305699AM22
RA File Number	03AA040128756 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Licence No and<br>Date	Licence No and<br>Date	0311009997/03/01/2022	0311009997/03/01/2022	0311009997/03/01/2022	0311009997/03/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product	Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
			2	Piperazine Anhydrous	0.390 kg
			s per above decision of NC.

Case No.	Case No.	105 / NC/3/MEET/Sep/202223/9	105 / NC/3/MEET/Sep/202223/9	105 / NC/3/MEET/Sep/202223/9	105 / NC/3/MEET/Sep/202223/9	105 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00320476AM22
RA File Number		03AX04000684 AM22
Licence No and<br>Date		0311010562/17/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.<br>106 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00320474AM22
RA File Number<br>03AA040113369 AM22
Licence No and<br>Date<br>0311010560/17/01/2022
Norms Committee Decision:
The Committee considered the case as per agenda and on	the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
1<br>Ciprofloxacin<br>Hydrochloride<br>1 kg	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)	5Fluorobenzoyl) Acrylate
2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	107 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00322636AM22
RA File Number	03AA04044735 AM22
Licence No and<br>Date	0311010626/18/01/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Export Product	Qty	Sl. No.	Import Item Name.	Qty.
Norfloxacin	1 kg	1	2,4 Dichloro-5-Fluoro Acetophenone(DCFA)	0.877 kg
		2	Dimethyl Carbonate	0.789 kg
		3	Dimethyl Formamide	0.385 kg
		4	Mono Ethyl Amine 70	0.439 kg
		5	Piperazine Anhydrous	0.520 kg
		6	Methanol	0.150 kg

Case No.	Case No.	108 / NC/3/MEET/Sep/202223/9	108 / NC/3/MEET/Sep/202223/9	108 / NC/3/MEET/Sep/202223/9	108 / NC/3/MEET/Sep/202223/9	108 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00331312AM22
RA File Number		03AX04000872 AM22
Licence No and<br>Date		0311010876/25/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

2 Piperazine Anhydrous 0.390 kg

Case No.	Case No.	109 / NC/3/MEET/Sep/202223/9	109 / NC/3/MEET/Sep/202223/9	109 / NC/3/MEET/Sep/202223/9	109 / NC/3/MEET/Sep/202223/9	109 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00356040AM22
RA File Number		03AX04001181 AM22
Licence No and<br>Date		0311011428/15/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	110 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	MEGHMANI NOVOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00357589AM22
RA File Number	08AX04000262 AM22
Licence No and<br>Date	0811004084/16/02/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Deferred for comments of TE


Deferred for comme		nts of TE


Case No.		111 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Sep/ 202223/ 9 a			nd 07/10/2022
H	Q File Number	HQRNORM APPLY 00358825			AM22
R
	A File Number	03AX04001322 AM2	2
L<br>D	icence No and<br>ate	0311011513/17/02/20	22

N<br>T<br>i<br>0<br>g	orms Committee Decision:<br>he Committee considered the case as<br>mport item in Meeting No.NC/3/M<br>311005604 dated 25.07.2021, it was de<br>iven below or as applied by the firm, w		per agen<br>EET/Apr<br>cided to<br>hichever i		da and t<br>/202223		aking cue from earlier decision for same ex<br>/1 dated 29042022aainst advance auth			port product /<br>orization No
					<br>ratify ad<br>s less:		..g<br>hoc norms under Para 4.07 of HBP Vol. I<br>			.<br>as per details

	Export product			Qty.		Sl. No.		Import items	Qty.


	DI-NONYLATE	D		1 kg		1		DIPHENYLAMINE	0.4134 kg
	DIPHENYLAM	INE (YALUB DND)

						2		NONENE	0.4 kg

						3		ACTIVATED CLAY	0.05 kg



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

C N		112 / NC/3/MEET/S/202223/9
ase o.		ep
C Stt		C Ad
ase aus		ase pprove
P N		DANOPHARM CHEMICALS PRIVATE LIMITED
arty ame
Mi Nb
eetng umer<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

HQ File Number		HQRNORM APPLY 00358236AM22
RA Fil Nb		039404000737 AM20
e umer
Li N d
cence o an<br>Date		0311011493/17/02/2022

Norms Committee		Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /

Case No.	112 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	DANOPHARM CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00358236AM22
RA File Number	039404000737 AM20
Licence No and<br>Date	0311011493/17/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

import item in Meeting No. NC/3/MEET/Aug/202122/7 dated 13.08.2021 against advance authorization No. 0310831769 dated 24.09.2019 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Alpha-(2,4-dichlorophenyl)-<br>1H-imidazole-1-ethanol	1 kg	1	2,2,4 Trichloro Acetophenone	1.45 kg
		2	Imidazole	0.53 kg
		3	Sodium Carbonate	Not shown in the process
		4	Sodium Borohydride	0.10 kg
		5	Dimethyl Sulphoxide (DMSO)	0.42 kg
		6	Toluene	0.45 kg
		7	Sodium Hydroxide (NaOH)	0.10 kg
		8	Activated Carbon	0.050 kg

Case No.	113 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	PI INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00358447AM22
RA File Number	13AX04000083 AM22
Licence No and<br>Date	1311001018/17/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Export Product	Qty	Sl.	Import Item Name.	Qty.
		No.
PIA - 4 Chemical Name: 3-	1 kg	1	3-Chloro -2-Methyl aniline	0.620 kg
(bromomethyl)-2-chloro-4-
(methylsulfonyl)benzoic acid		2	Sodium Nitrite	0.366 kg
		3	Sodium Methyl Mercaptide	1.570 kg
		4	Bromine	0.634 kg

Case No.	Case No.	114 / NC/3/MEET/Sep/202223/9	114 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY	00358616AM22
RA File Number		34AX04000258 AM22
Licence No and<br>Date		3411001810/17/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export Product	Qty<br>Sl.	Import Item Name.	Qty.
		No.
	PIPERAZINE	1 kg<br>1	PIPERAZINE CRUDE OR PIPERAZINE MIXTURE	2.047 kg
	ANHYDROUS
			(Percentage purity NMT 48.1%)
<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.	115 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00359289AM22
RA File Number	03AX04001240 AM22
Licence No and<br>Date	0311011529/18/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Aug/202122/7 dated 13.08.2021against advance authorization No.<br>0310826282 dated 10.01.2019, it was decided to ratify adhoc 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>Sl. No. Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>SELAMECTIN (6 PERCENT SPOT<br>ON 0.25 ML TUBE)<br>100 Number<br>1<br>SELAMECTIN<br>1.53 gram<br>2<br>SELAMECTIN (6 PERCENT SPOT<br>ON 0.75 ML TUBE)<br>100 Number<br>1<br>SELAMECTIN<br>4.59 gram<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	116 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00359473AM22
RA File Number	03AX04001229 AM22
Licence No and<br>Date	0311011469/18/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents<br>from the firm:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

i. Description of all Excipients shown in items to be imported may be furnished as per their chemical name.
ii. Details of Packaging Material may be furnished.
iii. Copy of Master Batch Formula for export item indicating net content of inputs in each export.

Case No.	117 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00359641AM22
RA File Number	34AX04000278 AM22
Licence No and<br>Date	3411001821/18/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	118 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	KUBO COMBUSTION EFFICIENCY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00359704AM22
RA File Number	03AX04001024 AM22
Licence No and<br>Date	0311011564/18/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	119 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00359728AM22
RA File Number	08AX04000474 AM22
Licence No and<br>Date	0811004112/18/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents<br>from the firm:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

i. COA of import item from foreign supplier showing Actual Potency of import item.

ii Wastage claimed in each export product.

Case No.	120 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00359783AM22
RA File Number	34AX04000191 AM22
Licence No and<br>Date	3411001829/18/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents<br>from the firm:<br>Calculation for the requirement of inputs for the manufacture of export item, giving chemical reaction<br>and molecular weight of reactants & products, indicating yield with justification.<br>i.<br>Value of by product/s obtained in the chemical reaction, if any, giving invoice copy.<br>ii.

Case No.	Case No.	121 / NC/3/MEET/Sep/202223/9	121 / NC/3/MEET/Sep/202223/9	121 / NC/3/MEET/Sep/202223/9	121 / NC/3/MEET/Sep/202223/9	121 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00363471AM22
RA File Number		03AX04000968 AM22
Licence No and<br>Date		0311011657/22/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

2 Piperazine Anhydrous 0.390 kg


						2		Piperazine Anhydrous				0.390 kg



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




Case No.				122 / NC/3/MEET/Sep/202223/9
Case Status				Case Approved

Party Name				J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and<br>Date				NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number				HQRNORM APPLY 00363091AM22
R	A File Number			03AX04001339 AM22
L	icence No and Date			0311011646/22/02/2022
N<br>T<br>i<br>0<br>g	orms Committee Decision:
	he Committee considered the case as<br>mport item in Meeting No.NC/3/ME				per agend<br>ET/May/	a and t<br>202223/		aking cue from earlier decision for same ex<br>3 dated 27.05.2022against advance auth				port product /<br>orization No.
	310814635 dated 14.07.2017, it wa<br>iven below or as applied by the firm, w				s decided<br>hichever i	to ratify<br>s less:		adhoc norms under Para 4.07 of HBP Vol. I<br>				as per details

	Sl. No.	Export product					Qty.		Sl. No.	Import items	Qt	.
	1
		Benzydamine<br>Hydrochloride<br>An<br>Cetylpyridinium<br>Chloride<br>Ant<br>Inflammatory And Antiseptic Lozenge				d<br>i-<br>s	1000<br>Number		1	Benzydamine<br>Hydrochloride	3.06 gram
		<br>Sugar Free and(all other flavours. Each
		<br>lozenge	<br> <br>contains<br>(i)<br>Benzydamine						2	Cetylpyridinium Chloride	1.356 gram
		<br>Hydroch	<br> <br>loride-3mg (ii) Cetylpyridinium

		Chloride	- 1.33mg (iii) Isomalt ST-M -						3	Isomalt ST-M	2586.00 gram
		2586mg<br>14.778	. Net content (i) 33.333 Kgs (ii)<br>Kgs (iii) 28733.356 Kgs.)


	2	Benzyda	mine<br>Hydrochloride,<br>2,4-				1000		4	Benzydamine	3.06 gram
		Dichloro<br>Hydroch	benzyl Alcohol And Lidocaine<br>loride<br>Anaesthetic,<br>Anti-				Number			Hydrochloride
		Inflammatory,(Anti-Bacterial Lozenges<br>Sugar Free. Each lozenge contains (i)<br>Benzydamine Hydrochloride - 3mg (ii)<br>Isomalt ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)							5	Isomalt ST-M	2586.00 gram

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

3	Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each lozenge contains (i) Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-M -<br>2586mg. Net content (i) 12 Kgs. (ii)<br>10344 Kgs.)	<br> <br> <br> <br>1000<br>Number	6	Benzydamine<br>Hydrochloride	3.06 gram
			7	Isomalt ST-M	2586.00 gram
4	Cetylpyridinium<br>Chloride<br>And<br>Bromhexine Hydrochloride Antiseptic<br>Lozenges Sugar Free and all other<br>flavours.(Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium Chloride - 1.33mg (ii)<br>Isomalt ST-M - 2586 mg. Net content (i)<br>13.333 Kg (ii) 25924.878 Kg)	<br> <br> <br> <br> <br> <br>1000<br>Number	8	Cetylpyridinium Chloride	1.356 gram
			9	Isomalt ST-M	2586.00 gram
5	Cetylpyridinium<br>Chloride<br>And<br>Benzydamine Hydrochloride Antiseptic<br>Lozenges Suger Free. Each lozenge<br>contains((i) Cetylpyridinium Chloride-<br>1mg (ii) Isomalt ST-M - 2586mg. Net<br>content (i) 5.22 Kg (ii) 13498.92 Kg)	<br> <br> <br> <br> <br>1000<br>Number	10	Cetylpyridinium Chloride	1.02 gram
			11	Isomalt ST-M	2586.00 gram

Case No.	123 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00364287AM22
RA File Number	05AX04001048 AM22
Licence No and<br>Date	0511010134/23/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	124 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	MEGHMANI FINECHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00364297AM22
RA File Number	34AX04000289 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Licence No and 3411001842/23/02/2022 Date Norms Committee Decision:

Deferred for comments of TE.

Licence No and	Licence No and	3411001842/23/02/2022	3411001842/23/02/2022	3411001842/23/02/2022	3411001842/23/02/2022	3411001842/23/02/2022	3411001842/23/02/2022	3411001842/23/02/2022
Date
Norms Committee<br>Dfd f		Decision:<br>t f TE
eerre or commens o .

Case No.		125 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		MERIDIAN ENTERPRISES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00364380AM22
RA File Number		03AX04001359 AM22
Licence No and
Date		0311011694/23/02/2022
Norms Committee		Decision:
The Committee co<br>i i i		nsidered the case as per agenda and taking cue from earlier decision for same export product /<br>i NNC/3/MEET/S/202223/8 dtd 23092022i d hii N
mport tem n<br>0311005561 dated		eetng o.ep ae ..aganst avance autorzaton o.<br>23072021it was decided to ratify adhoc norms under Para 407 of HBP Vol I as per
<br>details given below		.., . .<br>or as applied by the firm, whichever is less:

	Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
				Qty.		Sl. No.	Import items	Qty.

	lii<br>hi<br>l<br>i						lii hli	l
	Dequanum<br> <br>(Dequadin Oral	orde<br>Ora<br>Pant<br>Paint) 25 ML Bottel		1 Number		1	Dequanum Corde	127.07 mg / Botte
	<br>(Each<br>ml<br>c	.<br>ontains:<br>Dequalinium
	<br>Choride 0.5 p	<br>ercent ((Dequalinium
	Chloride Oral<br>Paint) 25 M	Paint (Dequadin Oral<br>L Bottle. (Each ml
	contains: Dequ<br>	alinium Chloride 0.5<br>
	percent (net c<br>	ontent of Input per<br>
	ml=5mg,Net co<br>125mg Total net	ntent per 25ml bottle =<br>content = 2.597 kgs))
<br>RA concerned may take further necessary action as per above decision of NC.

C	ase No.	126 / NC/3/MEET/Sep/202223/9
C	ase Status	Case Approved
P	arty Name	KAIRAV CHEMOFA	RBE IND		USTRIE	S LIMITED
M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Sep/ 2	02223/ 9 a		nd 07/10	/2022
H	Q File Number<br>HQRNORM APPLY		00365021		AM22

Case No.	126 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00365021AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

RA File Number<br>03AX04001397 AM22
Licence No and<br>Date<br>0311011707/23/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same	export product /
import item in Meeting No.NC/3/MEET/Feb/202122/14dated21.02.2022 against advance authorization No.
0310831861dated27.09.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP	Vol. I as per
details given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No. Import items	Qty.
ACETONITRILE<br>(Purity<br>Min.<br>99.9%,<br>350 MT<br>1<br>ACETONITRILE – LOW	416.51 MT
Moisture less than 500 PPM)<br>PURITY (Purity 98%)
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	127 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	KUSUMA PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00365147AM22
RA File Number	03AX04001369 AM22
Licence No and<br>Date	0311011710/23/02/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	128 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00365148AM22
RA File Number	03AX04001134 AM22
Licence No and<br>Date	0311011711/23/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product		Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin	Hydrochloride	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)				5Fluorobenzoyl) Acrylate
			2	Piperazine Anhydrous	0.390 kg

Case No.	Case No.	129 / NC/3/MEET/Sep/202223/9	129 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		IPCA LABORATORIES	LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00365876AM22
RA File Number		03AX04001137 AM22
Licence No and<br>Date		0311011718/24/02/2022
Norms Committee Decision:
The Committee considered the case as per			agenda	and taking cue from earlier decision for			same export product /
import item in Meeting No.12/82-ALC4/2018 dated 12.12.2018against advance authorization No.0310820257
dated 04.04.2018,		it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or	as applied by the firm, whichever is less:
	Export product		Qty.		Sl. No.	Import items		Qty.
	METOPROLOL SUCCINATE		1 kg		1	Para Methoxy Ethyl Phenol (or)		0.7955 kg
						4- Methoxy Ethyl Phenol
					2	Epichlorohydrine		0.6179 kg
					3	Succinic Acid		0.4508 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

4 Mono Isopropyl Amine 0.6285 kg

Case No.<br>130 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00365877AM22
RA File Number<br>03AX04001350 AM22
Licence No and<br>Date<br>0311011719/24/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and on	the basis GST data furnished by the firm and comparative
data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
1<br>Ciprofloxacin<br>Hydrochloride<br>1 kg	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg
BP/EP/USP (Ciprofloxacin)	5Fluorobenzoyl) Acrylate
2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	131 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00366482AM22
RA File Number	05AX04001055 AM22
Licence No and<br>Date	0511010494/24/02/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Deferred for comments of TE.

Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.

Case No.		132 / NC/3/MEET/Sep/202223/9
Case Status		C Ad
	ase tatus	ase pprove
P	arty Name	ETERNIS FINE CHE	MICALS	LIMITE	D
M<br>a	eeting Number
	nd Date	NC/ 3/ MEET/ Sep/ 2	2223/ 9	nd 07/1	/2022
H	Q File Number	HQRNORM APPLY	00365875	AM22
R	A File Number	03AX04001138 AM2	2
L<br>D	icence No and<br>ate	0311011717/24/02/20	22

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


	Export product		Qty.	Sl. No.		Import items	Qty.


	AMYL CINNA	MIC ALDEHYDE	1 kg	1		HEPTALDEHYDE	0.577 kg
				2			2 k
						BENZLDEHYDE	0.9 g

				3		METHANOL	0.010 kg
<br>RA concerned may take further necessary action a
				s per above decision of NC.

Case No.		133 / NC/3/MEET/Sep/202223/9
Case Status		Case Deferred
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number		NC/ 3/ MEET/ S/ 202223/ 9 d 07/10/2022
and Date		ep an
HQ File Number		HQRNORM APPLY 00367536AM22
RA File Number		08AX04000483 AM22
Licence No and		0811004214/25/02/2022
Date
Norms Committee		Decision:
Dfd f		f TE
eerre or comm		nts o .

Case No.		134 / NC/3/MEET/Sep/202223/9

Case No.	133 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00367536AM22
RA File Number	08AX04000483 AM22
Licence No and<br>Date	0811004214/25/02/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No. 134 / NC/3/MEET/Sep/202223/9

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00367541AM22
RA File Number	08AX04000478 AM22
Licence No and<br>Date	0811004216/25/02/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	135 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00367543AM22
RA File Number	08AX04000490 AM22
Licence No and<br>Date	0811004217/25/02/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>136 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00367120AM22
RA File Number<br>03AX04001428 AM22
Licence No and<br>Date<br>0311011779/25/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and	it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
Sl. No. Export Product	Qty.	Sl. No.	Import Items	Qty.
METFORMIN<br>500MG<br>TABLETS((Each<br>1	<br>1 Number	1	DICYANDIAMIDE	289.17 mg
Metformin 500mg Tablet contains Metformin
HCL 500mg) equivalent to:- Dicyandiamide

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

	289.170 mg, DMF 188.700 mg. Total Net wt of		2	DMF	188.70 mg
	Export 68250 kgs (Cross SION Norms of
	Metformin<br>HCL<br>SION<br>No.A290<br>&
	Tablets/Capsules SION No A412.))
2	METFORMIN<br>850MG<br>TABLETS((Each	1 Number	3	DICYANDIAMIDE	491.589 mg
	Metformin 850mg Tablet contains Metformin
	HCL 850mg) equivalent to:- Dicyandiamide
	491.589 mg, DMF 320.790 mg. Total Net wt of		4	DMF	320.79 mg
	Export 6291.700 kgs (Cross SION Norms of
	Metformin<br>HCL<br>SION<br>No.A290<br>&
	Tablets/Capsules SION No A412.))
3	METFORMIN<br>1000MG<br>TABLETS((Each	<br>1 Number	5	DICYANDIAMIDE	578.34 mg
	Metformin 1000mg Tablet contains Metformin
	HCL 1000mg) equivalent to:-Dicyandiamide
	578.340 mg, DMF 377.400 mg. Total Net wt of		6	DMF	377.40 mg
	Export 6378.000 kgs (Cross SION Norms of
	Metformin<br>HCL<br>SION<br>No.A290<br>&
	Tablets/Capsules SION No A412.))

Case No.<br>137 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>VIVIMED LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00367797AM22
RA File Number<br>04AX04000240 AM22
Licence No and<br>Date<br>0411002766/25/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue			from earlier decision for same		export product /
import item in Meeting No.6/82-ALC4/2019 dated 16.08.2019against advance authorization No.0910067740 dated
03.07.2019, it was decided to ratify adhoc norms under	Para 4.07 of HBP Vol. I as per details given below or as
applied by the firm, whichever is less:
Sl. No. Export Product<br>Qty.		Sl. No.		Import Items	Qty.
1<br>Losartan Potassium Tablets<br>1 Number Tablet		1		Losartan Potassium or Losartan	<br>25.5 mg
USP - 25MG-90s				Potassium USP

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

			2	Mannitol (Pearlitol 160C)	101.9 mg
			3	Microcrystalline Cellulose	40.5 mg
			4	Croscarmellose Sodium	7.19 mg
			5	Povidone K	3.61 mg
			6	Magnesium Stearate	1.8 mg
			7	Opadry White	3.6 mg
2	Losartan Potassium Tablets<br>USP - 25MG-1000s	<br>1 Number Tablet	8	Losartan Potassium or Losartan<br>Potassium USP	<br>25.5 mg
			9	Mannitol (Pearlitol 160C)	101.9 mg
			10	Microcrystalline Cellulose	40.5 mg
			11	Croscarmellose Sodium	7.19 mg
			12	Povidone K	3.61 mg
			13	Magnesium Stearate	1.8 mg
			14	Opadry White	3.6 mg
3	Losartan Potassium Tablets<br>USP - 50MG-90s	<br>1 Number Tablet	15	Losartan Potassium or Losartan<br>Potassium USP	<br>51 mg
			16	Mannitol (Pearlitol 160C)	203.8 mg
			17	Microcrystalline Cellulose	81.0 mg
			18	Croscarmellose Sodium	14.38 mg
			19	Povidone K	7.22 mg
			20	Magnesium Stearate	3.6 mg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

			21	Opadry White	7.2 mg
4	Losartan Potassium Tablets<br>USP - 50MG-1000s	<br>1 Number Tablet	22	Losartan Potassium or Losartan<br>Potassium USP	<br>51 mg
			23	Mannitol (Pearlitol 160C)	203.8 mg
			24	Microcrystalline Cellulose	81.0 mg
			25	Croscarmellose Sodium	14.38 mg
			26	Povidone K	7.22 mg
			27	Magnesium Stearate	3.6 mg
			28	Opadry White	7.2 mg
5	Losartan Potassium Tablets<br>USP - 100MG-90s	<br>1 Number Tablet	29	Losartan Potassium or Losartan<br>Potassium USP	<br>102 mg
			30	Mannitol (Pearlitol 160C)	407.6 mg
			31	Microcrystalline Cellulose	162 mg
			32	Croscarmellose Sodium	28.76 mg
			33	Povidone K	14.44 mg
			34	Magnesium Stearate	7.2 mg
			35	Opadry White	14.4 mg
6	Losartan Potassium Tablets<br>USP - 100MG-1000s	<br>1 Number Tablet	36	Losartan Potassium or Losartan<br>Potassium USP	<br>102 mg
			37	Mannitol (Pearlitol 160C)	407.6 mg
			38	Microcrystalline Cellulose	162 mg
			39	Croscarmellose Sodium	28.76 mg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

		40	Povidone K	14.44 mg
		41	Magnesium Stearate	7.2 mg
		42	Opadry White	14.4 mg

Case No.	138 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00367121AM22
RA File Number	03AX04001357 AM22
Licence No and<br>Date	0311011780/25/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	139 / NC/3/MEET/Sep/202223/9	139 / NC/3/MEET/Sep/202223/9	139 / NC/3/MEET/Sep/202223/9	139 / NC/3/MEET/Sep/202223/9	139 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		INDO AMINES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00367123AM22
RA File Number		03AX04001414 AM22
Licence No and<br>Date		0311011782/25/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jul/202122/4 dated 15.07.2021against advance authorization No.<br>0311001846 dated 01.03.2021, it was decided to ratify adhoc 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.
	Export product		Qty.	Sl. No.	Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

LAURYL AMINE OR IAL LAD 1 kg 1 LAURIC ACID 1.48 kg

Case No.	Case No.	140 / NC/3/MEET/Sep/202223/9	140 / NC/3/MEET/Sep/202223/9	140 / NC/3/MEET/Sep/202223/9	140 / NC/3/MEET/Sep/202223/9	140 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00367127AM22
RA File Number		03AX04001176 AM22
Licence No and<br>Date		0311011786/25/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative<br>data from other firms, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	141 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00367304AM22
RA File Number	09AX04000261 AM22
Licence No and<br>Date	0911002566/25/02/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Deferred for comments of TE.

Case No.	142 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	AASHA BIOCHEM
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00370268AM22
RA File Number	10AX04000065 AM22
Licence No and<br>Date	1011000912/28/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	143 / NC/3/MEET/Sep/202223/9	143 / NC/3/MEET/Sep/202223/9	143 / NC/3/MEET/Sep/202223/9	143 / NC/3/MEET/Sep/202223/9	143 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00370611AM22
RA File Number		34AX04000302 AM22
Licence No and<br>Date		3411001872/28/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/3dated27.05.2022 against advance authorization No.<br>3410045298dated18.07.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Dimethyl Oxalate<br>1.25 kg<br>2<br>Sodium Methoxide Powder<br>0.856 kg<br>3<br>Sodium Methoxide Solution ( 30 % ) /Sodium<br>Methylate Solution ( 30 % )<br>1.52 kg<br>4<br>Dimethylformamide<br>0.55 kg<br>EDOT<br>(3,4-Ethylenedioxythiophene)<br>(Other Organo - Sulphur<br>Compounds )<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	EDOT<br>(3,4-Ethylenedioxythiophene)<br>(Other Organo - Sulphur<br>Compounds )		<br>1 kg	1	Dimethyl Oxalate	1.25 kg
				2	Sodium Methoxide Powder	0.856 kg
				3	Sodium Methoxide Solution ( 30 % ) /Sodium<br>Methylate Solution ( 30 % )	<br>1.52 kg
				4	Dimethylformamide	0.55 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

5	1,2-Dichloroethane / Ethylene Dichloride	1.835 kg
6	Sulfolane	0.26 kg
7	Sodium Sulphide ( 60 % min.) / Sodium Sulfide (<br>60% min)	<br>1.458 kg
8	Methyl Monochloro Acetate	2.454 kg

Case No.	144 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00370625AM22
RA File Number	34AX04000311 AM22
Licence No and<br>Date	3411001873/28/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:<br>By Product obtained during the reaction for manufacturing of export item giving its value with invoices.

Case No.	145 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00370690AM22
RA File Number	03AX04000957 AM22
Licence No and<br>Date	0311011997/28/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Export product	Qty.	Sl. No.	Import items	Qty.
METHYL ACETOACETATE (ACETO<br>ACETIC METHYL ESTER)	<br>1 kg	1	Acetic Acid	1.209 kg<br>(with 25% wastage
		2	Methanol	0.284 kg (with 3% wastage)

Case No.	Case No.	Case No.	146 / NC/3/MEET/Sep/202223/9	146 / NC/3/MEET/Sep/202223/9	146 / NC/3/MEET/Sep/202223/9	146 / NC/3/MEET/Sep/202223/9	146 / NC/3/MEET/Sep/202223/9
Case Status			Case Approved
Party Name			MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number			HQRNORM APPLY 00369904AM22
RA File Number			07AX04000402 AM22
Licence No and<br>Date			0711003263/28/02/2022
Norms Committee Decision:<br>The Committee considered case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Sterile Water for Injection 10mL<br>Vial(Sterile Water for injection,<br>filled in 10mL Vial and capped<br>with<br>13mm<br>GreySerum<br>ChlorobutyI Rubber Stopper &<br>13mm white colour Matte finish<br>Seals)<br>1 Number<br>1<br>13FO LQ 3766 white<br>MATTE TOP (13mm<br>white<br>Color<br>Matte<br>Seals)<br>Relevant as per packing<br>policy<br>with<br>Accountability clause<br>Sodium Chloride Injection USP<br>90mg per 10mL Vial.(10mL<br>Vial - filled with 90mg of<br>Sodium Chloride as bulk drug<br>2<br>1 Number<br>2<br>13FO LQ 3769 BLUE<br>MATTE TOP (13mm<br>Blue<br>Color<br>Matte<br>Seals)<br>Relevant as per packing<br>policy<br>with<br>Accountability clause
	Sl. No. <br>1<br>2	Export product<br>		Qty.	Sl. No.	Import items	Qty.
		Sterile Water for Injection 10mL<br>Vial(Sterile Water for injection,<br>filled in 10mL Vial and capped<br>with<br>13mm<br>GreySerum<br>ChlorobutyI Rubber Stopper &<br>13mm white colour Matte finish<br>Seals)		<br> <br> <br> <br> <br> <br>1 Number	1	13FO LQ 3766 white<br>MATTE TOP (13mm<br>white<br>Color<br>Matte<br>Seals)	Relevant as per packing<br>policy<br>with<br>Accountability clause
		Sodium Chloride Injection USP<br>90mg per 10mL Vial.(10mL<br>Vial - filled with 90mg of<br>Sodium Chloride as bulk drug		<br> <br> <br> <br>1 Number	2	13FO LQ 3769 BLUE<br>MATTE TOP (13mm<br>Blue<br>Color<br>Matte<br>Seals)	Relevant as per packing<br>policy<br>with<br>Accountability clause

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

	filled in 10mL Vial and capped
	with<br>13mm<br>GreySerum
	ChlorobutyI Rubber Stopper &
	& 13mm Blue colour Matte
	finish Seals)

filled in 10mL Vial and capped<br>with<br>13mm<br>GreySerum<br>ChlorobutyI Rubber Stopper &<br>& 13mm Blue colour Matte<br>finish Seals)<br> <br>RA concerned may take further necessary action as per above decision of NC.		filled in 10mL Via<br>with<br>13mm<br>ChlorobutyI Rubbe<br>& 13mm Blue c<br>finish Seals)




Case No.		147 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
and Date
HQ File Number		HQRNORM APPLY 00369996AM22
RA File Number		03AX04001474 AM22
Licence No and<br>		0311011969/28/02/2022
Date
Norms Committee		Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/4dated17.06.2022 against advance authorization No.<br>0311004509dated10.06.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:



	Export Product		Qty.	Sl. No.	Import items	Qty.

	DI-NONYLATE	D<br>DIPHENYLAMINE	<br>1 kg	1	DIPHENYLAMINE	0.4134 kg
	<br>(YALUB DND)
				2	NONENE	0.4 kg

				3	ACTIVATED CLAY	0.05 kg



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



Case No.		148 / NC/3/MEET/Sep/202223/9

Case Status		Case Approved

Party Name		SUVEN PHARMACEUTICALS LIMITED

Meeting Number		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

Case No.	148 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	SUVEN PHARMACEUTICALS LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

and Date	and Date
HQ File Number		HQRNORM APPLY 00370092AM22
RA File Number		09AX04000243 AM22
Licence No and<br>Date		0911002567/28/02/2022
Norms Committee Decision:<br>The Committee considered case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>L TERT LEUCINE<br>0.72 kg<br>2<br>ETHYL TRIFLUORO ACETATE<br>0.78 kg<br>3-METHYL-N-<br>(TRIFLUOROACETYL)-L-<br>VALINE(POWDER)<br>1 kg<br>3<br>HEPTANE<br>3.88 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	3-METHYL-N-<br>(TRIFLUOROACETYL)-L-<br>VALINE(POWDER)		1 kg	1	L TERT LEUCINE	0.72 kg
				2	ETHYL TRIFLUORO ACETATE	0.78 kg
				3	HEPTANE	3.88 kg
				per above decision of NC.

Case No.	Case No.	149 / NC/3/MEET/Sep/202223/9	149 / NC/3/MEET/Sep/202223/9	149 / NC/3/MEET/Sep/202223/9	149 / NC/3/MEET/Sep/202223/9	149 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		MERIDIAN ENTERPRISES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00370234AM22
RA File Number		03AX04001473 AM22
Licence No and<br>Date		0311011978/28/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>0311005561 dated 23.07.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Dequalinium<br>Chloride<br>Oral<br>Paint 1 Number<br>1<br>Dequalinium Chloride<br>127.07 mg /Bottle
	Export product		Qty.	Sl. No.	Import items	Qty.
	Dequalinium<br>Chloride<br>Oral<br>Paint		1 Number	1	Dequalinium Chloride	127.07 mg /Bottle

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

(Dequadin Oral Paint) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent(Dequalinium Chloride Oral Paint (Dequadin Oral Paint) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent (net content of Input per ml=5mg,Net content per 25ml bottle = 125mg Total net content = 2.597 kgs))

Case No.	150 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00371439AM22
RA File Number	09AA04017878 AM22
Licence No and<br>Date	0911002574/01/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:
Consumption coefficient for 1 kg Amoxicilin Bulk.<br>i.
Wastage applied on API for Tablets.<br>ii.
Copy of relevant DML.<br>iii.
iv Copy of Master Batch Formula.

Case No.	151 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00371441AM22
RA File Number	09AX04000232 AM22
Licence No and<br>Date	0911002575/01/03/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Deferred for comments of TE.

Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.

Case No.		152 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number
and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00371619AM22
RA File Number		31AX04000082 AM22
Licence No and
Date		3111001116/01/03/2022
Norms Committee		Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022against advance authorization No.<br>3111000614 dated 12.10.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
<br>given below or as applied by the firm, whichever is less:




	Export product		Qty.	Sl. No.	Import items	Qty.
	Al Ail		1 k	1	Phl	072 k
	cety nsoe		g		eno	. g
	(4 Methoxy Ace	tophenone)		2	Methanol	0.276 kg

				3	Acetic Anhydride	0.755 kg


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



Case No.		153 / NC/3/MEET/Sep/202223/9
Case Status		Case Deferred
Party Name		ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00371807AM22
RA File Number		09AX04000256 AM22
Licence No and<br>Date		0911002585/01/03/2022

N Ci Dii
orms ommttee		ecson:
Deferred for comme		nts of TE.

Case No.	153 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00371807AM22
RA File Number	09AX04000256 AM22
Licence No and<br>Date	0911002585/01/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Case No.	154 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00372524AM22
RA File Number	07AX04000434 AM22
Licence No and<br>Date	0711003323/02/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.5/82-ALC4/2019 dated 02.08.2019against advance authorization No.3110067352 dated<br>28.03.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>TRANEXAMIC<br>ACID<br>INJECTION<br>1000 MG / 10 ML BP/EP/USP/IP<br>(Net content 228.57 kg) TRANEXAMIC<br>ACID INJECTION 1000 MG / 10 ML<br>BP/EP/USP/IP (Net content 228.57 kg ))<br>1 Number<br>1<br>TRANEXAMIC ACID<br>1100 mg / 10 ml vial<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	155 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	HIMADRI SPECIALITY CHEMICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00372545AM22
RA File Number	02AX04000172 AM22
Licence No and<br>Date	0211002041/02/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents<br>from the firm:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

i. COA report of import item from foreign supplier.
ii. By-Product obtained during processing and its value with invoices.
iii. Indigenous items to use in process.

COA report of import item from foreign supplier.<br>i.<br>By-Product obtained during processing and its value with invoices.<br>ii.	COA report of import item from foreign supplier.<br>i.<br>By-Product obtained during processing and its value with invoices.<br>ii.	COA report of import item from foreign supplier.<br>i.<br>By-Product obtained during processing and its value with invoices.<br>ii.	COA report of import item from foreign supplier.<br>i.<br>By-Product obtained during processing and its value with invoices.<br>ii.	COA report of import item from foreign supplier.<br>i.<br>By-Product obtained during processing and its value with invoices.<br>ii.	COA report of import item from foreign supplier.<br>i.<br>By-Product obtained during processing and its value with invoices.<br>ii.	COA report of import item from foreign supplier.<br>i.<br>By-Product obtained during processing and its value with invoices.<br>ii.
<br>Indigenous items to use in process.<br>iii.




Case No.		156 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved

Part Name		SUVEN PHARMACEUTICALS LIMITED
y
Meetin Number
g<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00372701AM22

RA File Number		09AX04000259 AM22
Licence No and<br>Date		0911002597/02/03/2022
Norms Committee Decision:

The Committee co<br>d P 407 f		nsidered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>HBP Vl I dtil i bl lid b th fi hih i l
un	er ara . o	o. as per	eas gven eow or as appe y e rm, wcever s ess:


	Export produ	ct	Qty.	Sl. No.	Import items	Qty.

	3-METHYL-N	-	1 kg	1	L TERT LEUCINE	0.72 kg
	(TRIFLUOROACETYL)-L-<br>VALINE(POWDER)
				2	ETHYL TRIFLUORO ACETATE	0.78 kg

				3	HEPTANE	3.88 kg



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



Case No.		157 / NC/3/MEET/Sep/202223/9

Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00372853AM22
RA File Number		05AX04001101 AM22
Licence No and		0511010578/02/03/2022
Date
Norms Committee		Decision:

Case No.	157 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00372853AM22
RA File Number	05AX04001101 AM22
Licence No and<br>Date	0511010578/02/03/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Apr/202223/1 dated 29.04.2022 against advance authorization No. 0511006574 dated 02.12.2021 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Nepafenac Ophthalmic Suspension, 0.1Percent	<br>1 Number	1	Nepafenac	5.1 mg / Vial
w/v NEPALACT Sterile Eye Drops, 5ml)
(PRANAYAM)((Each ml
contains Nepafenac 1.0 mg (Equivalent to
130.000 Gram of Bulk Drug))

Case No.<br>158 / NC/3/MEET/Sep/202223/9	Case No.<br>158 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00372854AM22
RA File Number<br>05AX04001140 AM22
Licence No and<br>Date<br>0511010579/02/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it		was decided to ratify adhoc		norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
Export product	Qty.	Sl. No.	Import items		Qty.
Moxifloxacin HCL and Dexamethasone	<br>38000	1	Moxifloxacin Hydrochloride		1087.27 Gram
Sodium Phosphate Eye Drops 0.5%w/v,
0.1%<br>w/v,<br>5ml<br>(MILFLOX<br>DM,	<br>Number
MILFODOX,<br>(MIFLOCO<br>DELTA)		2	Dexamethasone	Sodium	219.45 Gram
(Each ml contain Moxifloxacin Base			Phosphate
5mg.<br>equi.<br>to<br>Moxifloxacin<br>HCL
5.45mg. & Dexamethasone Phosphate
1mg equi. to Dexamethasone Sodium

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Phosphate 1.1mg (Equi.to 1035.500gm Moxifloxacin HCL and 209.000gm Dexamethasone Sodium Phosphate ))

	Phosphate 1.1mg (Equi.to 1035.500gm<br>Moxifloxacin HCL and 209.000gm	Phosphate 1.1mg (Equi.to 1035.500gm<br>Moxifloxacin HCL and 209.000gm	Phosphate 1.1mg (Equi.to 1035.500gm<br>Moxifloxacin HCL and 209.000gm	<br>
	<br>Dexamethasone Sodium

	Phosphate ))


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



Case No.			159 / NC/3/MEET/Sep/202223/9
C Stt			C Ad
ase aus			ase pprove
Party Name			EMCURE PHARMACEUTICALS LIMITED
Meeting Number and<br>Date			NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number			HQRNORM APPLY 00373052AM22

RA File Number			31AX04000077 AM22

Licence No and Da		te	3111001114/02/03/2022

Norms Committee		Decision:
The Committee co<br>		nsidered the case as per agenda and taking cue from earlier decision for same export product /<br>
import item in M<br>		eeting No.NC/3/MEET/Jan/202122/13 dated 21.01.2022against advance authorization No.<br>
3111000570 dated<br>dtil i bl		08.09.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>lid b th fi hih i l
	as gven eo	or as appe y e rm, wcever s ess:

	Export product			Qty.	Sl. No.	Import items	Qty.
	CIPROBIOTIC FORT TAB 500MG<br>(CIPROFLOXACIN TABLETS<br>500MG)(EACH FILM COATED TABLET			1 Number	1	CIPROFLOXACIN<br>HYDROCHLORIDE<br>USP	555.00 mg
	CONTAIN<br>:<br>CIPROFLOXACIN
	HYDROCHLO	RIDE USP EQUIVALENT
	TO CIPROFL	OXACIN 500 MG [NET
	WEIGHT 2577.	33 KG])



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



Case No.		160 / NC/3/MEET/Sep/202223/9
Case Status		Case Deferred
Party Name		SRIAM LABS PRIVATE LIMITED
Meeting Number		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

Case No.	160 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	SRIAM LABS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

and Date
HQ File Number	HQRNORM APPLY 00374328AM22
RA File Number	09AX04000286 AM22
Licence No and<br>Date	0911002611/03/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>161 / NC/3/MEET/Sep/202223/9
Case Status<br>Case Approved
Party Name<br>VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number<br>HQRNORM APPLY 00374384AM22
RA File Number<br>03AX04001522 AM22
Licence No and<br>Date<br>0311012234/03/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and	taking cue from earlier decision for same export product /
import item in Meeting No.5/82-ALC4/2020 dated 09.10.2020against advance authorization No.0310834922 dated
18.02.2020, it was decided to ratify adhoc norms under	Para 4.07 of HBP Vol. I as per details given below or as
applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No. Import items	Qty.
CLINDAMYCIN HCL CAPSULES-<br>1 Number	1.<br>CLINDAMYCIN	173.53 mg
150MG	HYDROCHLORIDE EP
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	162 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	AROCHEMA INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00374231AM22
RA File Number	26AX04000019 AM22
Licence No and<br>Date	2611000488/03/03/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

The Committee considered the case as per agenda and it was decided to call for following information/documents from the firm:

i. Complete chemistry, molecular weight and percentage yield.
ii. Production / Consumption data duly certified by GST.
iii. By-Product obtained during processing and its value with invoices.

Case No.	163 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00374302AM22
RA File Number	09AX04000287 AM22
Licence No and<br>Date	0911002609/03/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Oct/202122/9 dated 15.10.2021 against advance authorization No.<br>0910069160 dated 10.09.2020, it was decided to ratify adhoc 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>(R)-2-(Diphenylmethyl)pyrrolidine<br>hydrochloride (RDPH-II)<br>1 kg<br>1<br>D-Proline/R-Proline<br>1.167 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	164 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	MISTAIR HEALTH AND HYGIENE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00375016AM22
RA File Number	03AX04001352 AM22
Licence No and<br>Date	0311012252/04/03/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Norms Committee Decision:

Deferred for comments of TE.

Case No.	165 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	SAKAR HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00375600AM22
RA File Number	08AX04000616 AM22
Licence No and<br>Date	0811004272/04/03/2022
Norms Committee Decision:<br>:The Committee considered the case as per agenda and it was decided to call for following information/documents from<br>the firm:<br>COA of import item from foreign supplier showing potency and wastage claimed on it.<br>i.

Case No.	Case No.	166 / NC/3/MEET/Sep/202223/9	166 / NC/3/MEET/Sep/202223/9	166 / NC/3/MEET/Sep/202223/9	166 / NC/3/MEET/Sep/202223/9	166 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00378292AM22
RA File Number		03AX04001523 AM22
Licence No and<br>Date		0311012331/07/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.9/82-ALC4/2019 dated 18.10.2019against advance authorization No.0310827603 dated<br>11.03.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>PROPIOPHENONE<br>0.922 kg<br>2-AMINO<br>-2-PHENYLBUTYRIC<br>ACID SODIUM SALT<br>1 kg<br>2<br>SODIUM CYANIDE (NaCN)<br>0.337 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	2-AMINO<br>-2-PHENYLBUTYRIC<br>ACID SODIUM SALT		<br>1 kg	1	PROPIOPHENONE	0.922 kg
				2	SODIUM CYANIDE (NaCN)	0.337 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23


Case No.		167 / NC/3/MEET/Sep/202223/9

Case Status		Case Approved

Party Name		APEX DRUG HOUSE

Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

HQ File Number		HQRNORM APPLY 00378735AM22

RA File Number		03AX04001508 AM22

Licence No and<br>Date		0311012345/07/03/2022

Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Oct/202122/10 dated 12.11.2021against advance authorization No.<br>
0311000381 dated 23.12.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>
given below or as a		pplied by the firm, whichever is less:


	Export product		Qty.	Sl. No.	Import items	Qty.


	Benzocaine &	Dequalinium Chloride	<br>1 Number	1.	Dequalinium Chloride BP	0.255 mg
	Lozenges(Benzo<br>Chloride Loze	caine<br>Dequalinium<br>nges (ELIDOL DUO	<br>
	(Raspberry Flavour) Each Lozenge<br>contains<br>Benzocaine<br>BP<br>10<br>mg,<br>Dequalinium Chloride 0.25 mg Net<br>Content: 1) Dequalinium Chloride BP -		<br> <br> <br>
	<br>370.3750 GRAMS 2) Benzocaine BP -		<br>
	<br>Kgs (Indigenous	<br>):22.222 KGS)



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




Case No.		168 / NC/3/MEET/Sep/202223/9
Case Status		Case Deferred

Party Name		FDC LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00378736AM22

RA Fil Nb		03AX04001550 AM22
e umer
Li N d		0311012347/07/03/2022
cence o an

Case No.	168 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00378736AM22
RA File Number	03AX04001550 AM22
Licence No and	0311012347/07/03/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Date

Norms Committee Decision:

Deferred for comments of TE.

Case No.	169 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00378768AM22
RA File Number	05AX04001194 AM22
Licence No and<br>Date	0511010747/07/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	170 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	VIVIMED LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00378088AM22
RA File Number	04AX04000278 AM22
Licence No and<br>Date	0411002806/07/03/2022
Norms Committee Decision:
Deferred for comments of TE

Case No.	171 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	PROLIFE BIO-CHEMICAL INDUSTRIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00378218AM22
RA File Number	03AX04001348 AM22
Licence No and Date	0311012324/07/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting	No.NC/3/MEET/Mar/202122/15 dated 17.03.2022against advance authorization No.
0311000521 dated 01.01.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

Export product	Qty.	Sl. No.	Import items	Qty.
METHYLAMINO-4-BROMO	1 kg	1.	1 NITROANTHRAQUINONE	1.00 kg
ANTHRAQUINONE



	Export product				Qty.	Sl. No.		Import items					Qty.


	METHYLAMIN			O-4-BROMO	1 kg	1.		1 NITROANTHRAQUINONE					1.00 kg
	ANTHRAQUIN			ONE



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


Case No.				172 / NC/3/MEET/Sep/202223/9
Case Status				Case Approved
Party Name				J B CHEMICALS AND PHARMACEUTICALS LIMITED

Meeting Number<br>				NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
and Date

HQ File Number				HQRNORM APPLY 00378220AM22

RA File Number				03AX04000917 AM22

Licence No and<br>Date				0311012325/07/03/2022

Norms Committee				ecision:
The Committee co				nsidered the case as per agenda and taking cue from earlier decision for same export product /
import item in M<br>0310837228 dated				eeting No.NC/3/MEET/Oct/202122/9 dated 15.10.2021 against advance authorization No.<br>16.07.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:



	Sl. No.	Export pr		oduct			Qty.			Sl. No.	Import items	Qty.



	1	B<br>	enzocai<br>	ne<br>and<br>Cetylpyridinium<br>Chloride<br>			<br> <br>1 Num		ber	1	Benzocaine	12.24 mg
		<br>C	naesthe<br>urrent,	tic Throat Lozenges. Flavours Black<br>Honey Lemon & Other(Flavours. Each			<br>
		<br>L<br>	<br>ozenge<br>	<br>Contains 12mg Benzocaine. Net content of<br>			<br>
		B	enzocai	ne - 181.818 Kgs.)

	2	B<br>	enzocaine<br>and<br>Cetylpyridinium<br>Chloride<br>				<br> <br>1 Num		ber	2	Benzocaine	10.20 mg
		Anaesthetic Throat Lozenges. Flavours Black<br>Current and Lime & Lemon and Other(Flavours.<br>Each Lozenge contains 10mg Benzocaine. Net<br>content of Benzocaine - 44.944 Kgs.)					<br> <br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

			<br> <br> <br>	<br> <br> <br>	<br> <br> <br>	<br> <br> <br>	<br>
	3	Benzocai<br>Dextrom<br>Throat L	ne,<br>Cetylpyridinium<br>Chloride<br>And<br>ethorphan<br>Hydrobromide<br>Anaesthetic<br>ozenes(Each Lozene Contains 125m				<br> <br> <br>1 Number	3	Benzocaine	1.275 mg
		<br>Benzocai	g. g .g<br>ne. Net content of Benzocaine - 23.669				<br>
		Kgs.)

	4	Life Bra	d Sore Throat & Nasal Conestion Relief				<br>1 Number	4	Benzocaine	1530 m
		g<br>Extra<br>Strength<br>(Flavours<br>Cherry/Honey<br>&<br>Lemon/Other flavours) Sugar(Free Lozenges. Each<br>Lozenge Contains Bezocaine 15 mg & Isomalt ST-<br>M 2571 Mg. Net Content Benzocaine 13.245 Kgs<br>and Isomalt ST-M - 2270.172 Kgs.)					<br> <br> <br> <br>			. g
								5	Isomalt ST-M	2571.00 mg
	5	Personnelle Oral Anesthetic Sore Throat Lozenges<br>Extra Strenght Sugar Free (Flavours Cherry/Honey					<br> <br>1 Number	6	Benzocaine	15.30 mg
		<br>Lemon/Other flavours)(Each Lozenge Contains					<br>
		<br>Bezocain	<br>e 15 mg & Isomalt ST-M 2571 Mg. Net				<br>	7	Isomalt ST-M	2571.00 mg
		Content<br>	Benzocaine 13.245 Kgs and Isomalt ST-M -<br>
		2270.172	Kgs.)
	6	Option+O<br>	ral Lozenges Sore Throat & Nasal<br> <br> <br> <br> <br>				<br> <br>1 Number	8	Benzocaine	15.30 mg
		Congesti<br>Ch/H	on<br>Relief<br>Extra<br>Strenght<br>(Flavours<br> <br>L<br>/Oh<br>flEh				<br>

		erry<br>Lozenge	oney<br>emon<br>ter<br>avours).(ac<br>Contains Bezocaine 15 mg & Isomalt ST-					9	Isomalt ST-M	2571.00 mg
		<br>M 2571<br>and Isom	<br>Mg. Net Content Benzocaine 13.245 Kgs<br>alt ST-M - 2270.172 Kgs.)
<br>R
	7	Biomedic Oral Anesthetic Lozenges Sore Throat &<br>Nasal Congestion Relief Extra Strength Cherry ST<br>& NC RELEX Lozenges((Flavours Cherry / Honey<br>Lemon/ Other flavours) Each Lozenge Contains<br>Bezocaine 15 mg & Isomalt ST-M 2571 Mg. Net<br>Content Benzocaine 13.245 Kgs and Isomalt ST-M -<br>2270.172 Kgs.)7					<br> <br> <br> <br> <br> <br>1 Number	10	Benzocaine	15.30 mg
								11	Isomalt ST-M	2571.00 mg

	8	Atoma Sore Thro<br>Strength Lozenge		at & Nasal<br>s Cherry/H	Congest<br>oney &	ion Relief Extra<br>Lemon Flavour.	<br> <br>1 Number	12	Benzocaine	15.30 mg
		<br>Each Lozenge Co<br>ST-M 2700 Mg<br>Kgs and Isomalt		<br>ntains(Bez<br>. Net Con<br>ST-M - 227	<br>ocaine 1<br>tent Ben<br>0.172 K	<br>5 mg & Isomalt<br>zocaine 13.245<br>gs.)	<br> <br>	13	Isomalt ST-M	2700.00 mg
	<br>A concerned may take further necessary action as per above decision of NC.


C	ase No.		173 / NC/3/MEET/Sep/202223/9
Case Status			Case Approved

Party Name			J B CHEMICALS AND PHARMACEUTICALS LIMITED

Meeting Number			NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

Case No.	173 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00236046AM23

and Date	and Date	and Date
HQ File Number			HQRNORM APPLY 00378226AM22
RA File Number			03AX04001471 AM22
Licence No and
Date			0311012326/07/03/2022
Norms Committee			Decision:

The Committee co			nsidered the case as per agenda and taking cue from earlier decision for same export product /
<br>i i i			<br>iC/3/MEET/l/202122/4 15072021i d hii
mport tem n			eetng No.NJu dated ..aganst avance autorzaton No.
0311002050 dated			03.03.2021, it was decided to ratify adhoc n					orms under Para 4.07 of HBP Vol. I as per details
given below or as a			pplied by the firm, whichever is less:




	Sl. No.	Export p	roduct				Qty.	Sl. No.	Import items	Qty.
	1
		Rinza sip	with Vitamin C (Flavours Orange/				1 Number	1	Caffeine Anhydrous Powder	30.30 mg /
		<br>Lemon/ Black Currant/ Other flavours)<br>					Sachet			<br>5 m sachet
		&(Rinza Sip (Flavours Orange/ Lemon/<br>Black currant/ Cranberr/ Hone Lemon/								g
		<br>Other flav	y y<br>ours). Each sachet of 5gm contains
		<br>Caffeine	<br>Anhydrous Powder 30mg. Net
		content<br>	of Caffeine Anhydrous Powder<br>
		923.64 K	s.)


	2	Rinza Ta<br>	blets. Each tablet Contains Caffeine<br>				<br> <br>1 Number<br>	2	Caffeine Anhydrous Powder	30.60 mg /<br>
		Anhydrou<br>	s Powder 30 mg and Paracetamol<br>				<br> <br>Tablet			30 mg tablet
		BP 500<br>Anhydrou	mg.(Net Content of Caffeine<br>s<br>Powder<br>-<br>960<br>Kgs<br>and				<br>

		<br>Paracetam	<br> <br> <br> <br> <br> <br>ol BP- 16000 Kgs)					3	Paracetamol BP	510 mg /
										500 mg tablet
	3
		Rinza Sip for Children (Flavours Raspberry/<br>other flavours). Each sachet of 3gm contains<br>Paracetamol BP - 280mg.(Net content- 576.92<br>Kgs.)					<br> <br> <br>1 Number<br>Sachet	4	Paracetamol BP	282.80 mg /<br>3 gm sachet


R	A concerned may take fu			rther nec	essary ac	tion as per above decision of NC.




C	ase No.			174 / NC	/3/MEE	T/Sep/202223/9

C	ase Status			Case Approved
P	arty Name			SMS PHARMACEUTICALS LIMITED
M	eeting Number an		d Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
H	Q Fil Nmbr			HQRNORM APPLY 00379575AM22
	e ue
R	A File Number			09AX04000173 AM22
L	icence No and Da		te	0911002637/08/03/2022

Case No.	174 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	SMS PHARMACEUTICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00379575AM22
RA File Number	09AX04000173 AM22
Licence No and Date	0911002637/08/03/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

100

UDIN00236046AM23

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Aug/202223/6 dated 09.09.2022 against advance authorization No. 0911002507 dated 11.02.2022 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
SITAGLIPTIN<br>HYDROCHLORIDE	1 kg	1	2,4,5 TRIFLUOROPHENYLACETIC ACID	1.146 kg
		2	MELDRUM ACID	0.88 kg
		3	3-(TERIFLUOROMETHYL)-5,6,7,8-TETRAHYDRI-<br>[1,2,4]<br>TRIAZOLO[4,3-a]<br>PYRAZINE<br>HYDROCHLORIDE	0.75 kg
		4	DI-TERTIARY BUTYL DICARBONATE (DIBOC)	1.50 kg
		5	TETRAHYDROFURAN	1.50 kg
		6	ISO PROPYL ALCOHOL	5.50 kg
		7	METHANOL	3.12 kg
		8	N-HEPTANE	1.80 kg
		9	METHYL DI CHLORIDE	12.18 kg
		10	TERTIARY BUTANOL (T-BUTANOL)	1.78 kg

Case No.	175 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	PI INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00379523AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

101

UDIN00236046AM23

RA File Number<br>13AX04000105 AM22
Licence No and<br>Date<br>1311001062/08/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
CCIM Chemical Name: 4-<br>1 kg	1	p-methylacetophenone	1.201 kg
Chloro-5-p-tolylimidazole-2-
carbonitrile
	2	Hydroxylamine sulfate	3.53 kg
	3	Glyoxal 40 % Min.	1.352 kg
	4	Dimethyl formamide	2.50 kg
<br>RA concerned may take further necessary action as per above decision of NC

Case No.	176 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00379532AM22
RA File Number	08AX04000605 AM22
Licence No and<br>Date	0811004316/08/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	177 / NC/3/MEET/Sep/202223/9
Case Status	Case Approved
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00379544AM22
RA File Number	08AX04000568 AM22
Licence No and	0811004319/08/03/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

102

UDIN00236046AM23

Date

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Jun/202122/2 dated 02.07.2021 against advance authorization No. 0811001489 dated 14.05.2021 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
N-(3-AMINOPROPYL) IMIDAZOLE	1 kg	1	IMIDAZOLE	0.68 kg
		2	SODIUM METHOXIDE POWDER	1.00 kg
		3	ACRYLONITRILE	0.466 kg

Case No.	Case No.	178 / NC/3/MEET/Sep/202223/9	178 / NC/3/MEET/Sep/202223/9	178 / NC/3/MEET/Sep/202223/9	178 / NC/3/MEET/Sep/202223/9	178 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		SUVEN PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00379551AM22
RA File Number		09AX04000299 AM22
Licence No and<br>Date		0911002631/08/03/2022
Norms Committee Decision:<br>The Committee considered case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>L TERT LEUCINE<br>0.72 kg<br>2<br>ETHYL TRIFLUORO ACETATE<br>0.78 kg<br>3-METHYL-N-<br>(TRIFLUOROACETYL)-L-<br>VALINE(POWDER)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	3-METHYL-N-<br>(TRIFLUOROACETYL)-L-<br>VALINE(POWDER)		1 kg	1	L TERT LEUCINE	0.72 kg
				2	ETHYL TRIFLUORO ACETATE	0.78 kg

Case No.	Case No.	178 / NC/3/MEET/Sep/202223/9	178 / NC/3/MEET/Sep/202223/9	178 / NC/3/MEET/Sep/202223/9	178 / NC/3/MEET/Sep/202223/9	178 / NC/3/MEET/Sep/202223/9
Case Status		Case Approved
Party Name		SUVEN PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number		HQRNORM APPLY 00379551AM22
RA File Number		09AX04000299 AM22
Licence No and<br>Date		0911002631/08/03/2022
Norms Committee Decision:<br>The Committee considered case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>L TERT LEUCINE<br>0.72 kg<br>2<br>ETHYL TRIFLUORO ACETATE<br>0.78 kg<br>3-METHYL-N-<br>(TRIFLUOROACETYL)-L-<br>VALINE(POWDER)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	3-METHYL-N-<br>(TRIFLUOROACETYL)-L-<br>VALINE(POWDER)		1 kg	1	L TERT LEUCINE	0.72 kg
				2	ETHYL TRIFLUORO ACETATE	0.78 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

103

UDIN00236046AM23

3 HEPTANE 3.88 kg

Case No.	179 / NC/3/MEET/Sep/202223/9
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number	HQRNORM APPLY 00380949AM22
RA File Number	34AX04000157 AM22
Licence No and<br>Date	3411001935/09/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	Case No.	Case No.	179 / NC/3/MEET/Sep/202223/9	179 / NC/3/MEET/Sep/202223/9	179 / NC/3/MEET/Sep/202223/9	179 / NC/3/MEET/Sep/202223/9	179 / NC/3/MEET/Sep/202223/9	179 / NC/3/MEET/Sep/202223/9	179 / NC/3/MEET/Sep/202223/9	179 / NC/3/MEET/Sep/202223/9
Case Status			Case Deferred
Party Name			ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 9 and 07/10/2022
HQ File Number			HQRNORM APPLY 00380949AM22
RA File Number			34AX04000157 AM22
Licence No and<br>Date			3411001935/09/03/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.			180 / NC/3/MEET/Sep/202223/9
Case Status			Case Approved
Party Name			SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number			NC/ 3/ MEET/ Se/ 202223/ 9 and 07/10/2022
and Date			p
HQ File Number			HQRNORM APPLY 00380993AM22
RA File Number			05AX04001235 AM22
Licence No and			0511010844/09/03/2022
Date
Norms Committee			Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Oct/202122/9 dated 15.10.2021against advance authorization No.<br>0510414338 dated 05.06.2020, it was decided to ratify adhoc 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>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Azelastine Hydrochloride Nasal Solution<br>(Nasal Spray) 0.1% 30ML. (Each Solution /<br>Spray<br>contains<br>30<br>Mg<br>Azelastine<br>Hydrochloride) (Equivalent to 52.500 Kg of<br>bulk drug))<br>1750000<br>Number<br>1<br>Azelastine<br>Hydrochloride<br>48.909 kg
	Sl N	Et dt					t	Sl N	It it	t
	. o.	xpor prouc					Qy.	. o.	mpor ems	Qy.
	1	Alti H		dhli	N	l Slti	<br>1750000	1	Alti	48909 k
		zeasne y<br>(Nasal Spray)<br>Spray<br>contai<br>Hydrochloride)<br>bulk drug))		rocor<br>0.1% 30M<br>ns<br>30<br>(Equival	e as<br>L. (Eac<br>Mg<br>ent to 5	ouon<br>h Solution /<br>Azelastine<br>2.500 Kg of	<br> <br> <br> <br><br>Number		zeasne<br>Hydrochloride	. g

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

104

UDIN00236046AM23

Azelastine<br>Hydrochloride<br>Ophthalmic	<br>7500000	Azelastine
Solution<br>0.05%<br>6ML.<br>(Each<br>Solution		Hydrochloride
contains 3 Mg Azelastine Hydrochloride)	<br>Number
(Equivalent to 22.500 Kg of bulk drug) (Total
Net Contents 75.000 Kg) )

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 19-Oct-2022 12:55:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

105

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