IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-09-23

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/202223/8 DATED: 23/09/2022

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/202223/8 dated 23/09/2022 of Norms Committee - III for the year 2022-23 was held on 23/09/2022 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:-

S.No.	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/202223/8
Case Status	Case Rejected
Party Name	GALAXY SURFACTANTS LTD

This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

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Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00286523AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was 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.	2 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00154955AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was 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.	3 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00231955AM22
RA File Number	039404000667 AM21
Licence No and<br>Date	NA
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.

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

Case No.	4 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	GALAXY SURFACTANTS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00286550AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was 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.	5 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00233239AM22
RA File Number	092404000478 AM21
Licence No and<br>Date	NA
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.	6 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	GALAXY SURFACTANTS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00286873AM22
RA File Number	NA
Licence No and<br>Date	NA

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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.	7 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00158260AM22
RA File Number	NA
Licence No and<br>Date	NA
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.	8 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00227958AM22
RA File Number	NA
Licence No and<br>Date	NA
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.	9 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	COVALENT LABORATORIES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

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an	d Date
H	Q File N	umber	HQRNORM APPLY 0023					4849AM		22
R	A File N
		umber	092404000480 AM21
L<br>D
	icence N<br>ate	o and	0911000006/null
N<br>T<br>im<br>	orms Co	mmittee Decision:
	he Com<br>port ite	mittee considered the case as<br>m in Meeting No.1/82-ALC					per agen<br>4/2019		da<br>dat	and t<br>ed 0	aking cue f<br>3.06.2019a	rom earli<br>gainst ad	er decision for same<br>vance authorization	ex<br>No	port product /<br>.0910067262

d<br>	ate .	.t was ece to rat					y aoc		nor	ms u	ner Para	7 o H	P Vo I as per eta	s	ven eow or
	<br>lid	,<br>b h fi hih i l					<br>					.	.
a	appe	y te	rm, wcever s ess:




	Export	Product		Qty	Sl. No.	Imp	ort Item		Na	me.				Qty	.



	Cefdinir			1 kg	1	7-Phenylacetamideo-3-Chloromethyl Cephalosporonic Acid<br>								<br>2.263 kg
						Para Methoxybenzyl Ester (GCLE)


					2	Triphenyl Phosphine								1.234 kg



					3	ethl-(Z)-2-hdroxlamino-2-(2-aminthiazole-4-)<br>acetate								1397 k
						yyyy<br> <br>								. g
						(EHATA)




					4	Methylene Chloride								14.87 kg




					5	Tetra Hydro Furan								2.06 kg


					6	Mthl								412 k
						eano								. g

					7	Activated Ca			rbon					0.055 kg




R	A concerned may		take further necessar				y action a		s per ab		ove decision of NC.

C	ase No.		10 / NC/3/MEET/Sep				/202223/8
C	ase Status		Case Rejected
P	arty Name		SMILAX LABORAT				ORIES LI
									MITED
M<br>an	eeting Number<br>d Date		NC/ 3/ MEET/ Sep/ 2				02223/ 8 a		nd 23/0		9/2022
H	Q File Number		HQRNORM APPLY				00302517		AM22

R	A File Number		NA
L	icence No and		NA

Case No.	10 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00302517AM22
RA File Number	NA
Licence No and	NA

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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.	11 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00172251AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was 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.	12 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00235354AM22
RA File Number	039404000658 AM21
Licence No and<br>Date	NA
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	13 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00272693AM22
RA File Number	NA

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Licence No and NA 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.	14 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00001497AM23
RA File Number	039504000262 AM13
Licence No and<br>Date	0310705888/22/08/2012
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following<br>information / documents from the firm:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.<br>vi Production / Consumption data for the year 2012-13 duly certified by Central Excise.

Case No.	15 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	CHEMCON SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00000083AM23
RA File Number	342404000102 AM15
Licence No and<br>Date	3410040406/28/07/2014
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.

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Case No.	16 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DAFFODIL PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00001402AM23
RA File Number	082404000449 AM15
Licence No and<br>Date	0810134978/31/03/2015
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following<br>information / documents from the firm:<br>COA of import item from foreign supplier.

Case No.	Case No.	17 / NC/3/MEET/Sep/202223/8	17 / NC/3/MEET/Sep/202223/8	17 / NC/3/MEET/Sep/202223/8	17 / NC/3/MEET/Sep/202223/8	17 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		018205001512AM16
RA File Number		052404000418 AM16
Licence No and<br>Date		0510396612/14/12/2015
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.10/82-ALC4/2018 dated 16.10.2018against advance authorization No.0510406058<br>dated 06.04.2018, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Pure Terephthalic Acid<br>0.437 kg<br>Di-Octyl Tere Phthalate (DOTP)<br>1 kg
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	Di-Octyl Tere Phthalate (DOTP)		1 kg	1	Pure Terephthalic Acid	0.437 kg

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2 2 Ethyl Hexanol 0.680 kg

Case No.	18 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00400043AM22
RA File Number	022404000109 AM18
Licence No and<br>Date	0210207904/24/10/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and as per GST Certificate furnished by the firm<br>for the year 2018-19, 2019-20 and 2020-21, it was decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Papaverine Hydrochloride BP/Ph.Eur/USP/JP<br>1 kg<br>1<br>Papaverine Crude Content 95%<br>1.158 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	19 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00401016AM22
RA File Number	022404000108 AM18
Licence No and<br>Date	0210207903/24/10/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and taking cue from earlier decision for same<br>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<br>Vol. I as per details given below or as applied by the firm, whichever is less:

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

Case No.	Case No.	20 / NC/3/MEET/Sep/202223/8	20 / NC/3/MEET/Sep/202223/8	20 / NC/3/MEET/Sep/202223/8	20 / NC/3/MEET/Sep/202223/8	20 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM REVIW00001502AM23
RA File Number		342404000341 AM18
Licence No and<br>Date		3410043908/22/02/2018
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.7/AM21 dated 24.12.2020against advance authorization No.<br>3410043505 dated 27.09.2017, 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.<br>1<br>2,6 Di-Ter-Butyl-Phenol / 2, 6 -DTBP<br>0.404 kg<br>2<br>Methyl Isobutyl Ketone (MIBK)<br>0.25 kg<br>3<br>Octanthiol / N-Octyl Mercaptan<br>0.522 kg<br>Songnox 5650/ 4- (4,6-<br>Bis(octylthio)-1,3,5-triazin-<br>2-yl)<br>amino)-2,6-di-tert-<br>butylphenol)<br>1 kg<br>4<br>Cyanuric Chloride<br>0.347 kg<br>RA concerned may take further necessary action as per above decision of NC
	Export product		Qty.	Sl. No.	Import items	Qty.
	Songnox 5650/ 4- (4,6-<br>Bis(octylthio)-1,3,5-triazin-<br>2-yl)<br>amino)-2,6-di-tert-<br>butylphenol)		1 kg	1	2,6 Di-Ter-Butyl-Phenol / 2, 6 -DTBP	0.404 kg
				2	Methyl Isobutyl Ketone (MIBK)	0.25 kg
				3	Octanthiol / N-Octyl Mercaptan	0.522 kg
				4	Cyanuric Chloride	0.347 kg
				action as per above decision of NC

Case No.	21 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved

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Party Name	Party Name	SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED	SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED	SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED	SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED	SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM REVIW00001501AM23
RA File Number		342404000294 AM19
Licence No and<br>Date		3410044750/12/12/2018
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.7/AM21 dated 24.12.2020against advance authorization No.<br>3410043505 dated 27.09.2017, 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.<br>1<br>2,6 Di-Ter-Butyl-Phenol / 2, 6 -DTBP<br>0.404 kg<br>2<br>Methyl Isobutyl Ketone (MIBK)<br>0.25 kg<br>3<br>Octanthiol / N-Octyl Mercaptan<br>0.522 kg<br>Songnox 5650/ 4- (4,6-<br>Bis(octylthio)-1,3,5-triazin-<br>2-yl)<br>amino)-2,6-di-tert-<br>butylphenol)<br>1 kg<br>4<br>Cyanuric Chloride<br>0.347 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Songnox 5650/ 4- (4,6-<br>Bis(octylthio)-1,3,5-triazin-<br>2-yl)<br>amino)-2,6-di-tert-<br>butylphenol)		1 kg	1	2,6 Di-Ter-Butyl-Phenol / 2, 6 -DTBP	0.404 kg
				2	Methyl Isobutyl Ketone (MIBK)	0.25 kg
				3	Octanthiol / N-Octyl Mercaptan	0.522 kg
				4	Cyanuric Chloride	0.347 kg
				action as per above decision of NC.

Case No.	22 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00400103AM22
RA File Number	022404000174 AM19
Licence No and<br>Date	0210209011/26/02/2019
Norms Committee Decision:<br>T<br>The Committee considered the request of firm for review of norms and as per GST Certificate furnished by the firm<br>for the year 2018-19, 2019-20 and 2020-21, it was decided to revise adhoc norms as under:

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

Case No.	23 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	HEMA DYECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00001544AM23
RA File Number	039404001141 AM19
Licence No and<br>Date	0310828400/16/04/2019
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:
Complete chemical reactions with molecular weight and structural formula.<br>i.
ii Stoichiometric balance between import and export on molar basis.

Case No.	Case No.	24 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		SYNNAT PHARMA PRIVATE	LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM REVIW00399967AM22
RA File Number		022404000009 AM20
Licence No and<br>Date		0210209153/08/05/2019
Norms Committee Decision:
The Committee considered the request of firm for			review of norms and as per GST Certificate furnished by the firm
for the year 2018-19, 2019-20 and 2020-21, it was			decided to revise		adhoc norms as under:
	Export product		Qty.	Sl. No.	Import items	Qty.
	Papaverine Hydrochloride BP/Ph.Eur/USP/JP		1 kg	1	Papaverine Crude Content 95%	1.158 kg

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Case No.	25 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00001539AM23
RA File Number	342404000083 AM20
Licence No and<br>Date	3410045200/10/06/2019
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>Production / Consumption data for the year 2019-20 duly certified by GST.<br>i.<br>ii Commercial Value of Low Boiler & High Boiler obtained during process.

Case No.	Case No.	26 / NC/3/MEET/Sep/202223/8	26 / NC/3/MEET/Sep/202223/8	26 / NC/3/MEET/Sep/202223/8	26 / NC/3/MEET/Sep/202223/8	26 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		018205000340AM20
RA File Number		039504000318 AM20
Licence No and<br>Date		0310830043/03/07/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>DILTIAZEM HYDROCHLORIDE<br>1304.65 kg<br>DILTIAZEM<br>HCL<br>SUSTAIN 2899 kg
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	DILTIAZEM<br>HCL<br>SUSTAIN		2899 kg	1	DILTIAZEM HYDROCHLORIDE	1304.65 kg

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2<br>EUDRAGIT L30 D55<br>3<br>EUDRAGIT RS 100<br>RELEASE PELLETS 45 % W/W<br>4<br>EUDRAGIT RL 100<br>Not to be imported<br>as per firm’s reply<br>dated 14.06.2022<br> <br>RA concerned may take further necessary action as per above decision of NC	RELEASE PELLETS 45 % W/W		2	EUDRAGIT L30 D55	Not to be imported<br>as per firm’s reply<br>dated 14.06.2022
			3	EUDRAGIT RS 100
			4	EUDRAGIT RL 100

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

Case No.	27 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	BHARAT SERUMS AND VACCINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205000446AM20
RA File Number	039404000313 AM20
Licence No and<br>Date	0310830591/25/07/2019
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/Jun202223/5 dated 08.07.2022 against advance authorization No.<br>0310839355 dated 05.11.2020, it was decided to ratify adhoc norms for import of 56.51 kg Human Normal<br>Immunoglobin Bulk for manufacturing of 10,000 vials of GAMMA IV 5 MG.<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	28 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205000490AM20
RA File Number	318304000051 AM20
Licence No and<br>Date	3110067490/02/08/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and based on GST data, it was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

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Export product	Qty.	Sl.<br>No.	Import items	Qty.
DNOVO BP818<br>(Tetra Methyl Bisphenol F)	1 kg	1	OCP 50 (O-Cresol and Phenol)	0.23136 kg
		2	Methanol	Not allowed
		3	Catalyst (Oxylic Acid)	0.004 kg
		4	Paraformaldehyde	0.14090 kg

Case No.	29 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205000528AM20
RA File Number	522104000085 AM20
Licence No and<br>Date	5210043146/14/08/2019
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	30 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205000529AM20
RA File Number	522104000086 AM20
Licence No and<br>Date	5210043147/14/08/2019
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No. 31 / NC/3/MEET/Sep/202223/8

UDIN00232627AM23

Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205000530AM20
RA File Number	522104000061 AM20
Licence No and<br>Date	5210043148/14/08/2019
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE

Case No.	32 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205000689AM20
RA File Number	318304000087 AM20
Licence No and<br>Date	3110067548/30/09/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and based on GST data, it was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>OCP 50 (O-Cresol and Phenol)<br>0.8258 kg<br>DNOVO BP838<br>(Tetramethyl Bisphenol A)<br>1 kg<br>2<br>Methanol<br>1.48 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	33 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205000909AM20

UDIN00232627AM23

RA File Number	522404000044 AM20
Licence No and<br>Date	5210043258/12/12/2019
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	34 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	DIPS BIOSCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00351717AM22
RA File Number	039404000788 AM20
Licence No and<br>Date	0310833754/27/12/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was observed that the firm still has not<br>furnished copy of Master Batch Formula for each export product.<br>Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	35 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205000947AM20
RA File Number	052404000601 AM20
Licence No and<br>Date	0510413159/01/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith following documents / information:<br>Details of import and export are vague in nature. Please clarify.<br>i.<br>ii COA of import only indicating Aldehyde content. Please furnish complete COA of import		Personal Hearing
		<br>item.

UDIN00232627AM23

Case No.	36 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001022AM20
RA File Number	052404000669 AM20
Licence No and<br>Date	0510413373/17/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that inspite of two deficiency letters; the<br>information given by the firm is incomplete. The yields now given are low and do not match with reaction-<br>sequencing. Technical specification of main raw materials also not given. Hence, the Committee decided to call firm<br>for attending Personal Hearing<br> before Norms Committee to explain its case.

The Committee considered the case as per agenda and it was observed that inspite of two deficiency letters; the information given by the firm is incomplete. The yields now given are low and do not match with reactionsequencing. Technical specification of main raw materials also not given. Hence, the Committee decided to call firm for attending Personal Hearing before Norms Committee to explain its case.

Case No.	37 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00404233AM22
RA File Number	039404000908 AM20
Licence No and<br>Date	0310834502/28/01/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was observed that the description of<br>Export Product mentioned in the subject Advance Authorization is different from the description provide in DML.<br>Hence, it was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.

Case No.	38 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001130AM20
RA File Number	522404000068 AM20
Licence No and<br>Date	5210043358/06/03/2020
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	39 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred

UDIN00232627AM23

Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001136AM20
RA File Number	052404000749 AM20
Licence No and<br>Date	0510413850/12/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that inspite of two deficiency letters; the<br>information given by the firm is incomplete. The yields now given are low and do not match with reaction-<br>sequencing. Technical specification of main raw materials also not given. Hence, the Committee decided to call firm<br>for attending Personal Hearing<br> before Norms Committee to explain its case.

Case No.	40 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	JINDAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00405090AM22
RA File Number	039404000003 AM21
Licence No and<br>Date	0310835903/25/04/2020
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	41 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	JINDAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00405134AM22
RA File Number	039404000005 AM21
Licence No and<br>Date	0310835906/25/04/2020
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	42 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	KUMAR ORGANIC PRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00000645AM23

19 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

RA File Number

072404000030 AM21

Licence No and Date

0710116410/01/05/2020

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: Step wise manufacturing process. i. Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis. ii. Complete technical details as per Annexure to Appendix 4E for chemical products. iii. Stoichiometric balance between import and export on molar basis. iv. Details of indigenous input with quantity. v.

Case No.	43 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001363AM21
RA File Number	522404000004 AM21
Licence No and<br>Date	5210043426/08/06/2020
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	44 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001365AM21
RA File Number	522404000003 AM21
Licence No and<br>Date	5210043427/09/06/2020
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	45 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

20 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

HQ File Number	018205001386AM21
RA File Number	522404000017 AM21
Licence No and<br>Date	5210043441/16/06/2020
Norms Committee Decision:
The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	46 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001405AM21
RA File Number	522404000016 AM21
Licence No and<br>Date	5210043443/19/06/2020
Norms Committee Decision:
The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.<br>47 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Approved
Party Name<br>SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM REVIW00001504AM23
RA File Number<br>342404000064 AM21
Licence No and<br>Date<br>3410046174/23/06/2020
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and taking cue from		earlier decision for
same export product / import item in Meeting No.7/AM21 dated 24.12.2020against advance authorization No.
3410043505 dated 27.09.2017, 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>Songnox 5650/ 4- (4,6-<br>1 kg	2,6 Di-Ter-Butyl-Phenol / 2, 6 -DTBP	0.404 kg
Bis(octylthio)-1,3,5-triazin-
2<br>2-yl)<br>amino)-2,6-di-tert-	Methyl Isobutyl Ketone (MIBK)	0.25 kg

Case No.<br>47 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Approved
Party Name<br>SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM REVIW00001504AM23
RA File Number<br>342404000064 AM21
Licence No and<br>Date<br>3410046174/23/06/2020
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and taking cue from		earlier decision for
same export product / import item in Meeting No.7/AM21 dated 24.12.2020against advance authorization No.
3410043505 dated 27.09.2017, 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>Songnox 5650/ 4- (4,6-<br>1 kg	2,6 Di-Ter-Butyl-Phenol / 2, 6 -DTBP	0.404 kg
Bis(octylthio)-1,3,5-triazin-
2<br>2-yl)<br>amino)-2,6-di-tert-	Methyl Isobutyl Ketone (MIBK)	0.25 kg

UDIN00232627AM23

butylphenol)		3	Octanthiol / N-Octyl Mercaptan	0.522 kg
		4	Cyanuric Chloride	0.347 kg

Case No.	48 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001409AM21
RA File Number	522404000018 AM21
Licence No and<br>Date	5210043446/23/06/2020
Norms Committee Decision:
:The Committee considered the case as per agenda and it was decided to call for following information /
documents from the firm:
Complete calculation for the requirement of raw material (both imported and indigenous).<br>i.
Chemical reaction with molecular weight and yield percentage.<br>ii.
It has been observed from process flow diagram that there is only condensation of import items for<br>iii.
making export item and both import and export items appear to be same therefore to give COA report
of import and export items.
Production of export item vis-à-vis Consumption of all the raw materials (both imported and<br>iv.
indigenous)) for last three years duly certified by GST / CA.

iii. It has been observed from process flow diagram that there is only condensation of import items for making export item and both import and export items appear to be same therefore to give COA report of import and export items.
iv. Production of export item vis-à-vis Consumption of all the raw materials (both imported and indigenous)) for last three years duly certified by GST / CA.

Case No.	49 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	CONCORD BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001614AM21
RA File Number	082404000395 AM20
Licence No and<br>Date	0810148478/03/09/2020
Norms Committee Decision:
The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm
was not proper. Hence, it was decided to call the firm forPersonal Hearing<br>		before Norms Committee alongwith
following documents / information:

UDIN00232627AM23

i. Production / Consumption data duly certified by Central Taxes & GST Authorities for the specific Export Quantities as approved by FDA, Gujarat.

Case No.	50 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001756AM21
RA File Number	039404000825 AM20
Licence No and<br>Date	0310838959/16/10/2020
Norms Committee Decision:
Deferred for comments of TE.

Case No.	51 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001858AM21
RA File Number	039404000644 AM21
Licence No and<br>Date	0310839600/19/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the Export and Import Item description is
confusing and have no relevance with process details and material balance given by the firm. Hence, it was decided
rejectthe case.
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	52 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001869AM21
RA File Number	052404000441 AM21
Licence No and	0510415972/24/11/2020

23 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Date

Norms Committee Decision:

The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	53 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	018205001864AM21
RA File Number	039404000659 AM21
Licence No and<br>Date	0310839748/26/11/2020
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.<br>54 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Approved
Party Name<br>MALWA OXYGEN & INDUSTRIAL GASES PRIVATE LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00235076AM22
RA File Number<br>562404000035 AM21
Licence No and Date<br>5610006002/27/11/2020
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.8/AM20 dated 20.09.2019against advance authorization No.5610004949 dated
12.07.2016, 5610005103 dated 22.03.2017, 5610005123 dated 24.04.2017, 5610005139 dated		18.05.2017,
5610005253 dated 26.10.2017, 5610005252 dated 26.10.2017, and 5610005395 dated 08.05.2018, 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.
1<br>BIS(4-FLUROPHENYL)<br>1 kg	FLUOROBENZOYL (4- ) CHLORIDE	1.00 kg

UDIN00232627AM23

KETONE OR 4,4		2	FLUOROBENZENE	1.10 kg
DIFLUOROBENZOPHENONE
		3	METHYLE ALCOHOL	0.60 kg

Case No.	55 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00400260AM22
RA File Number	02AA04006385 AM21
Licence No and<br>Date	0211000088/24/12/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and as per GST Certificate furnished by the firm<br>for the year 2018-19, 2019-20 and 2020-21, it was decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>PAPAVERINE HYDROCHLORIDE BP/PH<br>EUR/USP/JP<br>1 kg<br>1<br>PAPAVERINE<br>CRUDE<br>CONTENT 95 PERCENT<br>1.158 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	56 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00103707AM21
RA File Number	05AA04039234 AM21
Licence No and<br>Date	0511001736/15/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee alongwith sample of Export Product and import items with complete specification

UDIN00232627AM23

Case No.	57 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	GLOBE CHEMIE
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00116704AM21
RA File Number	31AA04006841 AM21
Licence No and<br>Date	3111000253/30/03/2021
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.	Case No.	Case No.	58 / NC/3/MEET/Sep/202223/8	58 / NC/3/MEET/Sep/202223/8	58 / NC/3/MEET/Sep/202223/8	58 / NC/3/MEET/Sep/202223/8	58 / NC/3/MEET/Sep/202223/8
Case Status			Case Approved
Party Name			PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number			HQRNORM APPLY 00117698AM21
RA File Number			03AA04033579 AM21
Licence No and<br>Date			0311002962/31/03/2021
Norms Committee Decision:<br>Shri Devesh Desai, Associate Vice President, Shri Sunil Kumar Jain, General Manager – Production and Shri Prashant Khilare,<br>Manager Commercial; attended the Personal Hearing and explained their case. The Committee after deliberations decided to ratify<br>adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP<br>11.415 mg<br>2<br>Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)<br>64.578 mg<br>3<br>Calcium Acetate<br>18.049 mg<br>4<br>Plastic Bottles 75CC white HDPE<br>Round 38mm<br>Relevant as per<br>packing policy<br>1<br>Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 1454.24kgs,<br>Sr. No. 2 is 8054.6kg, Sr. No. 3 is<br>2287.27kg, Sr. No. 4 is 1466227<br>Nos., Sr. No. 8 is 1466227 Nos., Sr.<br>No. 12 is 1466227 Nos))<br>1 Number<br>Tablet
	Sl. No.	Export Product		Qty.	Sl. No.	Import items	Qty.
	1	Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 1454.24kgs,<br>Sr. No. 2 is 8054.6kg, Sr. No. 3 is<br>2287.27kg, Sr. No. 4 is 1466227<br>Nos., Sr. No. 8 is 1466227 Nos., Sr.<br>No. 12 is 1466227 Nos))		<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>11.415 mg
					2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>64.578 mg
					3	Calcium Acetate	18.049 mg
					4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy

UDIN00232627AM23

			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
			6	Strippax Sorbent 50 C & 50 SG 2gm<br>(Silica Gel Dessicants)	<br>Relevant as per<br>packing policy
2	Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 1000 tabs)((Net<br>wt. of Import Sr. No. 1 is<br>1869.86kgs,<br>Sr.<br>No.<br>2<br>is<br>10355.89kg,<br>Sr.<br>No.<br>3<br>is<br>2940.77kg, Sr. No. 5 is 169663<br>Nos., Sr. No. 9 is 169663 Nos., Sr.<br>No. 12 is 169663 Nos))	<br> <br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>11.415 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>64.578 mg
			3	Calcium Acetate	18.049 mg
			4	250cc Rnd White 53/400 Hdpe Sclair<br>58a (Plastic Bottles 250CC white<br>HDPE Round 38mm)	<br> <br>Relevant as per<br>packing policy
			5	Blue 53mm Pp Cap Lp-E & Triseal<br>F217hy (Plastics Caps/Closures PP<br>53MM-400 Blue PP)	<br> <br>Relevant as per<br>packing policy
			6	Strippax Sorbent 50 C & 50 SG 2gm<br>(Silica Gel Dessicants)	<br>Relevant as per<br>packing policy
3	Atorvastatin Calcium Tablets USP<br>20mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 301.17kgs,<br>Sr. No. 2 is<br>1673.87kg, Sr. No. 3 is 475.07kg,<br>Sr. No. 4 is 151815 Nos., Sr. No. 8<br>is 151815 Nos., Sr. No. 12 is<br>151815 Nos))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>22.830 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>129.427 mg
			3	Calcium Acetate	36.090 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
			6	Strippax Sorbent 50 C & 50 SG 2gm<br>(Silica Gel Dessicants)	<br>Relevant as per<br>packing policy

UDIN00232627AM23

					<br>			<br> <br>	<br>	<br>
4	Atorvasta<br>40 P	tin Calcium Tablets U<br>k Si 90 bN		SP<br>	<br> <br>1 Num<br>Tbl	ber	1	Atorvastatin<br>Calcium<br>Propylene<br>Gll Sl USP	<br>45.		595 mg
	mg (<br>of Impor<br>Sr. No. 2	c ze tas)((et<br>t Sr. No. 1 is 8102.73k<br>is 44878.92kg, Sr. No.		t.<br>gs,<br>3	<br> <br> <br>aet			yco ovate


	<br>is 1274	<br>4.09kg, Sr. No. 4		<br>is	<br>		2	Microcrystalline Cellulose (MCC) NF<br>	<br>258		.08 mg
	2042244<br>	Nos., Sr. No. 8 is 2042244<br>						(Avicel PH 102)
	Nos., Sr.	No. 12 is 2042244 Nos))
							3	Calcium Acetate	71.963 mg


							4	Plastic Bottles 75CC white HDPE	<br>Relevant as er
								<br>Round 38mm	<br>p<br>packing policy


							5	CR38400APJT865<br>BLUE<br>PP465	<br>Relevant as per
								<br> <br> <br>1400 (Plastics Caps/Closures PP	<br> <br> <br>packing policy
								38MM-400 Blue CR)



							6	Strippax Sorbent 50 C & 50 SG 2gm	<br>Relevant as per
								<br>(Silica Gel Dessicants)	<br> <br>packing policy


5	Atorvastatin Cal		cium Tablets USP		<br>1 Number		1	Atorvastatin<br>Calcium<br>Propylene	<br>91.20 mg
	80mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 3324.20kgs,<br>Sr. No. 2 is 18500.44kg, Sr. No. 3<br>is 5249.65kg, Sr. No. 6 is 418922<br>Nos., Sr. No. 8 is 418922 Nos., Sr.<br>No. 11 is 418922 Nos))				<br> <br> <br> <br> <br>Tablet			<br>Glycol Solvate USP	<br>
							2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>518.206 mg


							3	Calcium Acetate	1	44	.929 mg

									<br>
							4	Plastic Bottles 120CC white HDPE<br>Round 38mm	<br>R<br>p	e<br>ac	evant as per<br>king policy

							5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>R<br>p	el<br>ac	evant as per<br>king policy

							6	Strippax Sorbent 50 C & 50 SG 2gm	<br>R	elevant as per
								(Silica Gel Dessicants)	packing policy
6	Ai Cli Tbl USP				<br>1 Nb		1	Ai<br>Cli<br>Pl	<br>9120
	torvast<br>80mg (P	tn acum aets<br>ack Size 1000 tabs)((Net			<br> <br>umer<br>Tablet			torvastatn<br>acum<br>ropyene<br>Glycol Solvate USP	<br>. mg
	wt. of	Import Sr. No. 1 is
	3843.60k<br>	gs,<br>Sr.<br>No.<br>2<br>is<br> <br> <br> <br> <br>			<br>		2	Mitlli Clll (MCC) NF	<br>518206
	21391.10<br>6069.90k	kg,<br>Sr.<br>No.<br>3<br>is<br>g Sr. No. 7 is 43594 Nos.			<br>			crocrysane euose<br>(Avicel PH 102)	<br>. mg
	<br>Sr. No. 1	, ,<br>0 is 43594 Nos., Sr. No.			<br>
	11 is 435	94 Nos))
							3	Calcium Acetate	144.929 mg

UDIN00232627AM23

	4	1500cc Round Extrusion 89/400 Neck<br>White (Plastic Bottles 1500CC white<br>HDPE Round 38mm)	<br> <br>Relevant as per<br>packing policy
	5	CC8940AFS837 WHITE PP551 CT<br>89 400SP (Plastics Caps/Closures PP<br>89MM-400 White Plain)	<br> <br>Relevant as per<br>packing policy
	6	Strippax Sorbent 50 C & 50 SG 2gm<br>(Silica Gel Dessicants)	<br>Relevant as per<br>packing policy
Note: The above norms are valid only for subject to fulfillment of following conditions:<br>Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex<br>Corp, US. Agent for Apotex Inc., Candada.<br>1.<br>Export to USA only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.

Case No.	59 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00004824AM22
RA File Number	05AA04000952 AM22
Licence No and<br>Date	0511002092/06/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that inspite of two deficiency letters; the<br>information given by the firm is incomplete. The yields now given are low and do not match with reaction-<br>sequencing. Technical specification of main raw materials also not given. Hence, the Committee decided to call firm<br>for attending Personal Hearing<br> before Norms Committee to explain its case.

Case No.	60 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00024975AM22
RA File Number	34AA04000433 AM22
Licence No and	3411000488/23/04/2021

UDIN00232627AM23

Date

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.	Export product	Qty.	Sl.	Import items	Qty.
No.			No.
1	Phenol	2218 MT	1	Cumene	1956.72 MT
1	Acetone	1353 MT	2	Cumene	1193.29 MT

Case No.	61 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00001514AM23
RA File Number	03AA04011100 AM22
Licence No and<br>Date	0311003600/06/05/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	62 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00039055AM22
RA File Number	05AA04009662 AM22
Licence No and<br>Date	0511002560/12/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that each injection is having potency of 25,000
units. However, the firm has applied for total import quantity of 900 units against export of 33,783 injections. No

UDIN00232627AM23

norms can be proposed in its present form.

In view of above discrepancy, it was decided to call firm for attending Personal Hearing before Norms Committee alongwith relevant documents to explain its case.

Case No.	63 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00001551AM23
RA File Number	13AA04002353 AM22
Licence No and<br>Date	1311000341/19/05/2021
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 item indicating exact purity of import item alongwith Bill of Entry indicating exact<br>percentage of purity.<br>i.

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

Case No.	Case No.	64 / NC/3/MEET/Sep/202223/8	64 / NC/3/MEET/Sep/202223/8	64 / NC/3/MEET/Sep/202223/8	64 / NC/3/MEET/Sep/202223/8	64 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00099246AM22
RA File Number		03AA04000112 AM22
Licence No and<br>Date		0311004037/25/05/2021
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
	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

UDIN00232627AM23

2 Piperazine Anhydrous 0.390 kg

				2	Piperazine Anhydrous	0.390 kg


RA concerned ma		take further necessar action as er above decision of NC
		y p .

Case No.		65 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00099853AM22
RA File Number		03AA04006277 AM22
Licence No and<br>Date		0311004052/25/05/2021
N<br>T<br>d<br>o	orms Committee Decision:<br>he Committee considered the case as per agend			a and on the basis GST data furnished by the firm and comparative
	ata from other firms, it was decided to<br>r as applied by the firm, whichever is le		ratify adh<br>ss:	oc norm	s under Para 4.07 of HBP Vol. I as per detai	ls given below

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


RA concerned ma		take further necessar action a		s er above decision of NC
		y		p .

Case No.		66 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00100048AM22
RA File Number		03AA04010840 AM22
Licence No and<br>Date		0311004059/25/05/2021
Norms Committee Decision:

Case No.	66 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00100048AM22
RA File Number	03AA04010840 AM22
Licence No and<br>Date	0311004059/25/05/2021
Norms Committee Decision:

UDIN00232627AM23

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<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.	67 / NC/3/MEET/Sep/202223/8	67 / NC/3/MEET/Sep/202223/8	67 / NC/3/MEET/Sep/202223/8	67 / NC/3/MEET/Sep/202223/8	67 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00100049AM22
RA File Number		03AA04014004 AM22
Licence No and<br>Date		0311004060/25/05/2021
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.

UDIN00232627AM23

Case No.<br>68 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00100557AM22
RA File Number<br>03AA04029700 AM21
Licence No and<br>Date<br>0311002516/27/05/2021
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.	69 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00104785AM22
RA File Number	039404000639 AM21
Licence No and<br>Date	0311002735/01/06/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	70 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
MeetingNumber	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

UDIN00232627AM23

and Date	and Date
HQ File Number		HQRNORM APPLY 00106683AM22
RA File Number		03AA04021287 AM22
Licence No and<br>Date		0311004284/03/06/2021
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.	71 / NC/3/MEET/Sep/202223/8	71 / NC/3/MEET/Sep/202223/8	71 / NC/3/MEET/Sep/202223/8	71 / NC/3/MEET/Sep/202223/8	71 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00106682AM22
RA File Number		03AA04021320 AM22
Licence No and<br>Date		0311004283/03/06/2021
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
	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

Case No.	Case No.	71 / NC/3/MEET/Sep/202223/8	71 / NC/3/MEET/Sep/202223/8	71 / NC/3/MEET/Sep/202223/8	71 / NC/3/MEET/Sep/202223/8	71 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00106682AM22
RA File Number		03AA04021320 AM22
Licence No and<br>Date		0311004283/03/06/2021
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
	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

UDIN00232627AM23

2 Piperazine Anhydrous 0.390 kg

Case No.<br>72 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00107444AM22
RA File Number<br>03AA04021339 AM22
Licence No and<br>Date<br>0311004322/04/06/2021
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.	73 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	KALKI HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00001509AM23
RA File Number	34AA04002336 AM22
Licence No and<br>Date	3411000712/09/06/2021
Norms Committee Decision:

UDIN00232627AM23

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:

Complete chemistry, molecular weight and percentage yield on molar basis for each step.

Case No.	Case No.	74 / NC/3/MEET/Sep/202223/8	74 / NC/3/MEET/Sep/202223/8	74 / NC/3/MEET/Sep/202223/8	74 / NC/3/MEET/Sep/202223/8	74 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00112663AM22
RA File Number		03AA04022427 AM22
Licence No and<br>Date		0311004537/11/06/2021
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.	75 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00120846AM22
RA File Number	03AA04028717 AM22
Licence No and<br>Date	0311004808/22/06/2021
Norms Committee Decision:

UDIN00232627AM23

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>76 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00130745AM22
RA File Number<br>03AA04042926 AM22
Licence No and<br>Date<br>0311005095/05/07/2021
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.

UDIN00232627AM23

Case No.	77 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00131778AM22
RA File Number	34AA04004352 AM22
Licence No and<br>Date	3411000801/06/07/2021
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/Jan/202021/4 dated 12.02.2021against advance authorization No.<br>3410045200 dated 10.06.2019, 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> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Gamma Nonalactone (Aldehyde C18)<br>1 kg<br>1<br>N-Hexanol<br>0.900 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	78 / NC/3/MEET/Sep/202223/8	78 / NC/3/MEET/Sep/202223/8	78 / NC/3/MEET/Sep/202223/8	78 / NC/3/MEET/Sep/202223/8	78 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		SUVEN PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00133260AM22
RA File Number		09AA04007209 AM22
Licence No and Date		0911001161/07/07/2021
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.<br>No.<br>Import items<br>Qty.
	Export product		Qty.	Sl.<br>No.	Import items	Qty.

UDIN00232627AM23

1	1 5 DIMETHYL3OXOPENTANEDIOATE	1.51 kg
2	DIMETHYL<br>FORMAMIDE<br>DIMETHYL<br>ACETAL	<br>1.15 kg
3	2 METHYL TETRAHYDROFURAN	1.50 kg
4	XTALFLUOR E	1.80 kg
5	Bis Cinnamyl Palladium II Chloride	0.06 kg
6	4<br>5<br>Bis<br>DIPHENYLPHOSPHINO<br>9<br>9<br>DIMETHYLXANTHENE	<br>0.076 kg
7	METHYL TERT BUTYL ETHER	0.40 kg
8	ACETONITRILE	0.40 kg
9	2 2 AMINOETHYLAMINO ETHANOL	Not shown in<br>the process

Case No.	Case No.	79 / NC/3/MEET/Sep/202223/8	79 / NC/3/MEET/Sep/202223/8	79 / NC/3/MEET/Sep/202223/8	79 / NC/3/MEET/Sep/202223/8	79 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		SUVEN PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00133263AM22
RA File Number		09AA04003483 AM22
Licence No and Date		0911001162/07/07/2021
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.<br>No.<br>Import items<br>Qty.
	Export product		Qty.	Sl.<br>No.	Import items	Qty.

Case No.	Case No.	79 / NC/3/MEET/Sep/202223/8	79 / NC/3/MEET/Sep/202223/8	79 / NC/3/MEET/Sep/202223/8	79 / NC/3/MEET/Sep/202223/8	79 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		SUVEN PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00133263AM22
RA File Number		09AA04003483 AM22
Licence No and Date		0911001162/07/07/2021
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.<br>No.<br>Import items<br>Qty.
	Export product		Qty.	Sl.<br>No.	Import items	Qty.

UDIN00232627AM23

1<br>L TERT LEUCINE<br>0.72 kg<br>2<br>ETHYLTRIFLUOROACETATE<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.	3-METHYL-N-<br>(TRIFLUOROACETYL)-L-<br>VALINE(POWDER)	1 kg	1	L TERT LEUCINE	0.72 kg
			2	ETHYLTRIFLUOROACETATE	0.78 kg
			3	HEPTANE	3.88 kg

Case No.	Case No.	Case No.	80 / NC/3/MEET/Sep/202223/8	80 / NC/3/MEET/Sep/202223/8	80 / NC/3/MEET/Sep/202223/8	80 / NC/3/MEET/Sep/202223/8	80 / NC/3/MEET/Sep/202223/8
Case Status			Case Approved
Party Name			ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number			HQRNORM APPLY 00133324AM22
RA File Number			34AA04004084 AM22
Licence No and<br>Date			3411000813/07/07/2021
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>Sl. No. Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Clobetasol Propionate Cream(Clobetasol Propionate Cream USP<br>0.05 percentage 15 gm net content of active ingredients 75.00<br>gm.)<br>10000<br>Number<br>2<br>Clobetasol Propionate Cream(Clobetasol Propionate Cream USP<br>0.05 percentage 30 gm net content of active ingredients 360.00<br>gm.)<br>24000<br>Number<br>3<br>Clobetasol Propionate Cream(Clobetasol Propionate Cream USP<br>0.05 percentage 45 gm net content of active ingredients 652.50<br>gm.)<br>29000<br>Number<br>4<br>Clobetasol Propionate Cream(Clobetasol Propionate Cream USP<br>0.05 percentage 60 gm net content of active ingredients 960 gm.)<br>32000<br>Number<br>Clobetasol Propionate Topical Solution(Clobetasol Propionate<br>Topical Solution USP 0.05 percentage 25ml net content of active<br>5<br>4000<br>Number<br>1<br>CLOBETASOL<br>PROPIONATE<br>USP<br>MICRONIZED<br>4003.80 gram
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	Clobetasol Propionate Cream(Clobetasol Propionate Cream USP<br>0.05 percentage 15 gm net content of active ingredients 75.00<br>gm.)		<br> <br>10000<br>Number	1	CLOBETASOL<br>PROPIONATE<br>USP<br>MICRONIZED	<br>4003.80 gram
	2	Clobetasol Propionate Cream(Clobetasol Propionate Cream USP<br>0.05 percentage 30 gm net content of active ingredients 360.00<br>gm.)		<br> <br>24000<br>Number
	3	Clobetasol Propionate Cream(Clobetasol Propionate Cream USP<br>0.05 percentage 45 gm net content of active ingredients 652.50<br>gm.)		<br> <br>29000<br>Number
	4	Clobetasol Propionate Cream(Clobetasol Propionate Cream USP<br>0.05 percentage 60 gm net content of active ingredients 960 gm.)		<br>32000<br>Number
	5	Clobetasol Propionate Topical Solution(Clobetasol Propionate<br>Topical Solution USP 0.05 percentage 25ml net content of active		<br> <br>4000<br>Number

UDIN00232627AM23

	ingredients 50 gm.)
6	Clobetasol Propionate Topical Solution(Clobetasol Propionate<br>Topical Solution USP 0.05 percentage 50 ml net content of active<br>ingredients 150.00 gm.)	<br> <br>6000<br>Number
7	Clobetasol Propionate Topical Shampoo(Clobetasol Propionate<br>Shampoo, 0.05 percentage 118 ml net content of active<br>ingredients 1250.80 gm.)	<br> <br>21200<br>Number
8	Clobetasol Propionate Spray(Clobetasol Propionate Spray, 0.05<br>percentage 59 ml net content of active ingredients 177.00 gm.)	<br>6000<br>Number
9	Clobetasol Propionate Spray(Clobetasol Propionate Spray, 0.05<br>percentage 125 ml net content of active ingredients 250.00 gm.)	<br>4000<br>Number

Case No.	Case No.	81 / NC/3/MEET/Sep/202223/8	81 / NC/3/MEET/Sep/202223/8	81 / NC/3/MEET/Sep/202223/8	81 / NC/3/MEET/Sep/202223/8	81 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		BALAJI AMINES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00134044AM22
RA File Number		31AA04019601 AM22
Licence No and<br>Date		3111000445/08/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and based on GST data, it was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>DIETHYLENE GLYCOL<br>1.279 kg<br>2<br>AMMONIA ANHYDROUS<br>0.217 kg<br>MORPHOLINE<br>(ORGANIC CHEMICAL)<br>1 kg
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	MORPHOLINE<br>(ORGANIC CHEMICAL)		1 kg	1	DIETHYLENE GLYCOL	1.279 kg
				2	AMMONIA ANHYDROUS	0.217 kg

UDIN00232627AM23

3<br>HYDROGEN<br>Not allowed, as it is procured<br>indigenously.<br>4<br>MORPHOLINE CATALYST<br>Not allowed as no catalogue<br>is available.<br> <br>RA concerned may take further necessary action as per above decision of NC.			3	HYDROGEN	Not allowed, as it is procured<br>indigenously.
			4	MORPHOLINE CATALYST	Not allowed as no catalogue<br>is available.

Case No.	82 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00135125AM22
RA File Number	30AA04009718 AM22
Licence No and<br>Date	3011000867/09/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	83 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	CERIGO ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00135220AM22
RA File Number	03AA04027670 AM22
Licence No and<br>Date	0311005241/09/07/2021
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>In second export item quantity of raw material asked for is less than calculated theoretical quantity, as<br>per the chemistry. Please clarify it.<br>i.<br>Production of export item vis-à-vis Consumption of all the raw materials (both imported and<br>indigenous)) for last three years duly certified by GST / CA.<br>ii.

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

i. In second export item quantity of raw material asked for is less than calculated theoretical quantity, as per the chemistry. Please clarify it.
ii. Production of export item vis-à-vis Consumption of all the raw materials (both imported and indigenous)) for last three years duly certified by GST / CA.

Case No.	84 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved

UDIN00232627AM23

Party Name	SAVLA CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00135444AM22
RA File Number	03AA04044969 AM22
Licence No and<br>Date	0311005248/09/07/2021
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.<br>No.<br>Import items<br>Qty.<br>HIGH PURITY METHYL TERTIARY<br>BUTYL ETHER 99.8 PERCENTAGE<br>1 kg<br>1<br>MTBE (METHYL TERTIARY BUTYL<br>ETHER) (Purity less than 99.8%)<br>1.00 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	85 / NC/3/MEET/Sep/202223/8	85 / NC/3/MEET/Sep/202223/8	85 / NC/3/MEET/Sep/202223/8	85 / NC/3/MEET/Sep/202223/8	85 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00136446AM22
RA File Number		07AA04010172 AM22
Licence No and<br>Date		0711001451/11/07/2021
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.<br>No.<br>Import items<br>Qty.<br>1<br>ORTHO CHLORO TOLUENE<br>0.64 kg<br>ORPHENADRINE<br>1 kg
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	ORPHENADRINE		1 kg	1	ORTHO CHLORO TOLUENE	0.64 kg

UDIN00232627AM23

2	TETRA HYDRO FURAN	0.43 kg
3	TOLUENE	1.06 kg
4	ACETONE	Not shown in<br>the process
5	METHANOL

Case No.	86 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00136846AM22
RA File Number	34AA04005040 AM22
Licence No and<br>Date	3411000829/12/07/2021
Norms Committee Decision:<br>:The Committee considered the case as per agenda and it was decided to call for following information /<br>documents from the firm:<br>Copy of DML for export item.<br>i.<br>ii Complete chemistry, molecular weight, percentage yield on molar basis etc. as per Annexure to Appendix 4E.

Case No.	87 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00137048AM22
RA File Number	34AA04005105 AM22
Licence No and<br>Date	3411000838/12/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

UDIN00232627AM23

Case No.	88 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00137172AM22
RA File Number	08AA04014354 AM22
Licence No and<br>Date	0811001969/12/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Copy of COA of import item from foreign supplier showing Potency of Actual Import.

Case No.	89 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00138116AM22
RA File Number	26AA04002063 AM22
Licence No and<br>Date	2611000198/13/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>90 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Approved
Party Name<br>INDOCO REMEDIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00138657AM22
RA File Number<br>03AA04047965 AM22
Licence No and<br>Date<br>0311005362/14/07/2021
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/May/202223/3 dated 27.05.2022against advance authorization No.
0311005778 dated 31.07.2021, 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:

46 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

	Sl. No.	Export product	Export product	Export product	Qty.	Qty.	Qty.	Sl. No.	Import items	Qty.	Qty.
	1	Brimonidine Tartrate and Timolol<br>2mg/ml 5mg/ml Eye Drops solution (5			1 Number			1	Brimonidine	10.2 mg / bottle
		ml<br>Bottle)((Each<br>ml<br>Con<br>Brimonidine Tartrate 2mg and Ti<br>Maleate equivalent to Timolol		tains:<br>molol<br>5mg)				2	Timolol Maleate	25.50 mg / bo	ttle

		(Each 5 ml Contains:Brimo<br>Tartrate 10mg and Timolol Male<br>mg) - Net wt of (1) Brimo<br>Tartrate 8.000 kgs (2) Timolol M<br>20.000 kgs)		nidine<br>ate 25<br>nidine<br>aleate				3	Bottle	Relevant as<br>policy	per packing

								4	Cap	Relevant as<br>policy	per packing
								5	Dropper	Relevant as per packing<br>policy

	2	Brimonidine Tartrate and Timolol			<br>1 Number			6	Brimonidine	20.4 mg / bottle
		2mg/ml<br>	5mg/ml Eye Drops solution<br>		<br>

		(10 ml<br>Brimonid	Bottle)((Each ml Contains:<br>ine Tartrate 2mg and Timolol		<br>			7	Timolol Maleate	51.00 mg / bottle
		<br>Maleate	<br>equivalent to Timolol 5mg)		<br>
		<br>(Each 1<br>Tartrate<br>	<br>0 ml Contains: Brimonidine<br>20mg and Timolol Maleate 50<br>		<br> <br> <br>			8	Bottle	Relevant as per packing<br>olic
		mg ) -<br>Tartrate	Net wt of (1) Brimonidine<br>9500 ks (2) Timolol Maleate		<br>					py
		<br>23.750 k	. g<br>gs)
								9	Cap	Relevant as per packing<br>policy

								10	Dropper	Relevant as per packing<br>policy
	RA concerned may take further necessary action					as per above decision of NC.

C	ase No.		91 / NC/3/MEET/Sep/	202223/8
C	ase Status		Case Approved
P
	arty Name		R.L.FINE CHEM PRI	VATE LI		MITED
M<br>a	eeting Number<br>nd Date		NC/ 3/ MEET/ Sep/ 2	02223/ 8 a		nd 23/0	9/2022
H	Q File Number		HQRNORM APPLY	00143025		AM22

R	A File Number		07AA04016475 AM2	2
L<br>D	icence No and		0711001517/20/07/20	21
	ate
Norms Committee Decision:<br>The Committee considered the case as per agenda<br>Vol. 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:
,

Case No.	91 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00143025AM22
RA File Number	07AA04016475 AM22
Licence No and<br>Date	0711001517/20/07/2021
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:

UDIN00232627AM23

Export product	Qty.	Sl.<br>No.	Import items	Qty.
MECLIZINE<br>HYDROCHLORIDE<br>(IP/USP/BP)	1 kg	1	3 METHYL BENZYL CHLORIDE	0.391 kg
		2	TOLUENE	Not shown in process
		3	ACETONE	1.65 kg

Case No.	92 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00143924AM22
RA File Number	07AA04016516 AM22
Licence No and<br>Date	0711001521/21/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	93 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00145072AM22
RA File Number	05AA04057335 AM22
Licence No and Date	0511003777/22/07/2021
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.10/82-ALC4/2019 dated 29.11.2019against advance authorization No.0510411726<br>dated 03.09.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:

UDIN00232627AM23

Export product	Qty.	Sl. No.	Import items	Qty.
19 NORANDROSTENEDIONE 99<br>PERCENT	1 kg	1	LACTONE(D) INTERMEDIATE	1.40 kg
		2	CHLOROKET,(2-(3-CHLOROPROPYL)-<br>2,5,5-<br>TRIMETHYL-1,3-DIOXANE<br>INTERMEDIATE	<br>1.30 kg
		3	Tetrahydrofuran	3.50 kg

Case No.	94 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00145203AM22
RA File Number	34AA04005573 AM22
Licence No and<br>Date	3411000885/22/07/2021
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>COA report of both import and export items giving clearly percentage of it purity.<br>i.<br>Production of export item vis-à-vis Consumption of all the raw materials (both imported and<br>indigenous)) for last three years duly certified by GST / CA.<br>ii.<br>iii Total sales value of By-Product per kg of export item, giving evidence and also to subtract the quantity<br>of import item per kg of export from this value.

ii. Production of export item vis-à-vis Consumption of all the raw materials (both imported and indigenous)) for last three years duly certified by GST / CA.

Case No.	95 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00145220AM22

UDIN00232627AM23

RA File Number<br>34AA04004907 AM22
Licence No and<br>Date<br>3411000793/22/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Production of export item vis-à-vis Consumption of all the raw materials (both imported and<br>i.
indigenous)) for last three years duly certified by GST / CA.
As per the chemical reactions both Phenol and Acetone are formed from propylene, therefore, complete<br>ii.
calculation for requirement of Propylene for the manufacturing of Phenol, subtracting value of Acetone
for import value of Propylene

i. Production of export item vis-à-vis Consumption of all the raw materials (both imported and indigenous)) for last three years duly certified by GST / CA.

Case No.	96 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00144695AM22
RA File Number	07AA04016662 AM22
Licence No and<br>Date	0711001530/22/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Stepwise complete and balanced chemical reactions showing molecular weight and percentage yield on molar<br>i.
basis.
Requirement and recovery of solvents at each step.<br>ii.
iii Complete material balance.

Case No.	97 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	MERIDIAN ENTERPRISES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00145626AM22
RA File Number	03AA04051822 AM22
Licence No and<br>Date	0311005561/23/07/2021
Norms Committee Decision:

50 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

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 items	Qty.
Dequalinium<br>Chloride<br>Oral<br>Paint.<br>(Dequadin<br>Oral<br>Paint)<br>25<br>ML<br>Bottle.(Dequalinium<br>Chloride<br>Oral<br>Paint. (Dequadin Oral Paint) 25 ML<br>Bottle. (Each ml contains: Dequalinium<br>Chloride 0.5 percent (net content of<br>Input per ml=5mg, Net content per<br>25ml<br>bottle=125mg<br>Total<br>net<br>content=2.606kgs))	1 Number	1	Dequalinium Chloride	127.07 mg

Case No.	Case No.	98 / NC/3/MEET/Sep/202223/8	98 / NC/3/MEET/Sep/202223/8	98 / NC/3/MEET/Sep/202223/8	98 / NC/3/MEET/Sep/202223/8	98 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		ALTA LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00146194AM22
RA File Number		03AA04051472 AM22
Licence No and<br>Date		0311005584/23/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in M<br>eeting No.NC/3/MEET/Jan/202122/13 dated21.01.2022 against advance authorization No.0910068574dated13.03.2020,<br>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<br>is less:<br>Export Product<br>Qty<br>Sl.<br>No.<br>Import Item Name.<br>Qty.<br>1<br>Parahydroxy Benzoic Acid<br>0.80 kg<br>Propyl Paraben<br>1 kg
	Export Product<br>Propyl Paraben		Qty	Sl.<br>No.	Import Item Name.	Qty.
			1 kg	1	Parahydroxy Benzoic Acid	0.80 kg

UDIN00232627AM23

2 N Propanol 0.347 kg

<br>R						0.347 kg

	A concerned may take		further	necessar	y action as per above decision of NC.

C	ase No.	99	/ NC/	3/MEET/	Sep/202223/8
C	ase Status	C	ase Ap	proved
P	arty Name	B	DR PH	ARMAC	EUTICALS INTERNATIONAL PRIVATE LIMITED
M<br>a	eeting Number<br>nd Date	N	C/ 3/ M	EET/ Se	p/ 202223/ 8 and 23/09/2022

H	Q File Number	H	QRNO	RM APP	LY 00146728AM22
R	A File Number	03	AA04	046766 A	M22
L<br>D	icence No and<br>ate	03	11005	598/24/0	7/2021
Norms Committee Decision:<br>The firm vide e-mail dated28.09.2022has enclosed a copy of Surrender Letter dated11.04.2022. In view of above e-<br>mail of firm, the Committee decided towithdrawthe case.<br> RA concerned may take further necessary action as per above decision of NC.	orms Committee De<br>he firm vide e-mail<br>		cision:<br>dated <br>
				<br>28.09.20<br>	22has enclosed a copy of Surrender Letter dated11.04.2022. In<br>	view of above e-


Case No		100 / NC/3/MEET/Se/202223/8
.		p
Case Status		Case Aroved
		pp
Part Name		BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
y
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

HQ File Number		HQRNORM APPLY 00146729AM22

RA File Number		03AA04029068 AM22

Licence No and<br>Date		0311005599/24/07/2021

Norms Committee Decision:<br>The firm vide e-mail dated28.09.2022has enclosed a copy of Surrender Letter dated25.07.2022. In view of above e-<br>mail of firm, the Committee decided towithdrawthe case.<br> RA concerned may take further necessary action as per above decision of NC.


C
	ase No.	101 / NC/3/MEET/Se	p/202223/	8
C	ase Status	Case Deferred
P	arty Name	SYNOKEM PHARM	ACEUTIC	ALS LI	MITED
M	eeting Number
<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

Case No.	101 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SYNOKEM PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

UDIN00232627AM23

HQ File Number	HQRNORM APPLY 00147457AM22
RA File Number	05AA04059070 AM22
Licence No and<br>Date	0511003826/26/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Copy of DML for each export item showing Approved Composition.<br>i.
COA of import item from foreign supplier showing Actual Potency.<br>ii.
iii Detailed calculations in line with details given in Appendix 4E.

Case No.	102 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00148387AM22
RA File Number	52AA04010429 AM22
Licence No and<br>Date	5211001058/27/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	103 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00148419AM22
RA File Number	31AA04021097 AM22
Licence No and<br>Date	3111000476/27/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	104 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQFile Number	HQRNORM APPLY 00148514AM22

53 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

RA File Number	RA File Number	03AA04052584 AM22	03AA04052584 AM22	03AA04052584 AM22	03AA04052584 AM22	03AA04052584 AM22
Licence No and<br>Date		0311005674/27/07/2021
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.	105 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00148635AM22
RA File Number	07AA04017973 AM22
Licence No and<br>Date	0711001565/27/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	106 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	ZEE LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00149067AM22
RA File Number	05AA04057371 AM22
Licence No and<br>Date	0511003868/28/07/2021
Norms Committee Decision:

UDIN00232627AM23

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

DML with Approved Composition.

Case No.	107 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00150128AM22
RA File Number	03AA04054005 AM22
Licence No and<br>Date	0311005722/29/07/2021
Norms Committee Decision:
The firm vide e-mail dated28.09.2022has requested to grant them 30 days time to furnish their reply. The Committee
considered the request of firm and it was decided to grant them 30 days time to furnish their reply.

Case No.	Case No.	108 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00151178AM22
RA File Number		31AA04001432 AM22
Licence No and<br>Date		3111000494/30/07/2021
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.
3111000148 dated 09.02.2021, 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.<br>Sl. No. Import items	Qty.
	ETHYLENE	1<br>MONO ETHANOL AMINE<br>DI<br>AMINE<br>1 kg	1.0374 kg
	(ORGANIC CHEMICAL)
		2<br>AMMONIA ANHYDROUS	Not allowed, as it is
			shown indigenous

UDIN00232627AM23

Case No.	109 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00150724AM22
RA File Number	07AA04019266 AM22
Licence No and<br>Date	0711001603/30/07/2021
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.	110 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00150875AM22
RA File Number	05AA04055660 AM22
Licence No and<br>Date	0511003910/30/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Copy of DML for export item showing Approved Composition.<br>i.<br>COA of the export item.<br>ii.<br>iii Process details with wastage claimed.

Case No.	111 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	TOPNOTCH CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

56 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

HQ File Number<br>HQRNORM APPLY	00151931AM22	00151931AM22
RA File Number<br>03AA04052617 AM22
Licence No and<br>Date<br>0311005794/02/08/2021
Norms Committee Decision:
The Committee considered the case as	per agenda and taking cue from earlier decision for same export product in
Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022against advance authorization No.0311008136 dt.
01.11.2021, 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.
LUMEFANTRINE	1 kg	1	9H FLUORENE	0.90 kg
		2	Di N Butylamine	0.50 kg
		3	Sodium Borohydride	0.060 kg
		4	Para Chloro Benzaldehyde	0.3476 kg
		5	Di Methyl Formamide	0.555 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	112 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00152053AM22
RA File Number	34AA04005925 AM22
Licence No and<br>Date	3411000923/02/08/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is
incomplete. Hence, it was decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	113 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED

UDIN00232627AM23

Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/	202223/ 8 and 23/09/2022	202223/ 8 and 23/09/2022	202223/ 8 and 23/09/2022	202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00152085AM22
RA File Number<br>34AA04005924 AM22
Licence No and<br>Date<br>3411000924/02/08/2021
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.
3411000167 dated 29.01.2021, 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:
Export product	Qty.	Sl. No.		Import items	Qty.
Hexyl<br>Salicylate((n-Hexyl-ortho-	1 kg	1		n-Hexanol (Lorol C 6/ Nacol 6-99)	0.438 kg
Hydroxy Benzoate))
		2		Salicylic Acid	0.654 kg
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	114 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	ALKALI METALS LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00152742AM22
RA File Number	09AA04009415 AM22
Licence No and<br>Date	0911001301/03/08/2021
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.	115 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	FINE ORGANIC INDUSTRIES LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

UDIN00232627AM23

and Date
HQ File Number	HQRNORM APPLY 00153334AM22
RA File Number	03AA04058605 AM22
Licence No and<br>Date	0311005851/03/08/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	116 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	SHITAL CHEMICAL INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00154910AM22
RA File Number	34AA04006318 AM22
Licence No and<br>Date	3411000943/05/08/2021
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.<br>117 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Deferred
Party Name<br>DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00154532AM22
RA File Number<br>342404000041 AM21
Licence No and<br>Date<br>3411000939/05/08/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Production of export item vis-à-vis Consumption of all the raw materials (both imported and<br>i.
indigenous)) for last three years duly certified by GST / CA.
As per the chemical reactions both Phenol and Acetone are formed from propylene, therefore, complete<br>ii.
calculation for requirement of Propylene for the manufacturing of Phenol, subtracting value of Acetone
for import value of Propylene.

i. Production of export item vis-à-vis Consumption of all the raw materials (both imported and indigenous)) for last three years duly certified by GST / CA.

59 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Case No.	Case No.	118 / NC/3/MEET/Sep/202223/8	118 / NC/3/MEET/Sep/202223/8	118 / NC/3/MEET/Sep/202223/8	118 / NC/3/MEET/Sep/202223/8	118 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00154546AM22
RA File Number		03AA04058773 AM22
Licence No and<br>Date		0311005930/05/08/2021
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.	119 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00157208AM22
RA File Number	03AA04061662 AM22
Licence No and<br>Date	0311006047/09/08/2021
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:

UDIN00232627AM23

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.	120 / NC/3/MEET/Sep/202223/8	120 / NC/3/MEET/Sep/202223/8	120 / NC/3/MEET/Sep/202223/8	120 / NC/3/MEET/Sep/202223/8	120 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00158859AM22
RA File Number		03AA04062552 AM22
Licence No and<br>Date		0311006072/10/08/2021
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.	121 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	MEGHMANI NOVOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

UDIN00232627AM23

HQ File Number	HQRNORM APPLY 00160149AM22
RA File Number	08AA04019584 AM22
Licence No and<br>Date	0811002298/11/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Authentic Technical published Literature or any published Patent for the yield of 52.87% in this type of<br>reaction.

Case No.	122 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00161263AM22
RA File Number	52AA04010591 AM22
Licence No and<br>Date	5211001166/12/08/2021
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Portal. Deferred for comments of TE.

Case No.	Case No.	123 / NC/3/MEET/Sep/202223/8	123 / NC/3/MEET/Sep/202223/8	123 / NC/3/MEET/Sep/202223/8	123 / NC/3/MEET/Sep/202223/8	123 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		MEHK CHEMICALS PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00163371AM22
RA File Number		03AA04061020 AM22
Licence No and<br>Date		0311006197/16/08/2021
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.7/AM21 dated 24.12.2020against advance authorization No.0310827243 dated<br>22.02.2019, 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> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.
	Export product		Qty.	Sl.<br>No.	Import items	Qty.

Case No.	Case No.	123 / NC/3/MEET/Sep/202223/8	123 / NC/3/MEET/Sep/202223/8	123 / NC/3/MEET/Sep/202223/8	123 / NC/3/MEET/Sep/202223/8	123 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		MEHK CHEMICALS PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00163371AM22
RA File Number		03AA04061020 AM22
Licence No and<br>Date		0311006197/16/08/2021
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.7/AM21 dated 24.12.2020against advance authorization No.0310827243 dated<br>22.02.2019, 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> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.
	Export product		Qty.	Sl.<br>No.	Import items	Qty.

UDIN00232627AM23

FRUCTONE 1 kg 1 Ethyl Acetoacetate 0.830 kg

Case No.	124 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	SUNDYOTA NUMANDIS PROBIOCEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00163360AM22
RA File Number	08AA04021121 AM22
Licence No and<br>Date	0811002324/16/08/2021
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.	Case No.	125 / NC/3/MEET/Sep/202223/8	125 / NC/3/MEET/Sep/202223/8	125 / NC/3/MEET/Sep/202223/8	125 / NC/3/MEET/Sep/202223/8	125 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00168069AM22
RA File Number		03AA04065122 AM22
Licence No and<br>Date		0311006313/21/08/2021
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
	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

UDIN00232627AM23

2 Piperazine Anhydrous 0.390 kg

Case No.	Case No.	126 / NC/3/MEET/Sep/202223/8	126 / NC/3/MEET/Sep/202223/8	126 / NC/3/MEET/Sep/202223/8	126 / NC/3/MEET/Sep/202223/8	126 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00168174AM22
RA File Number		03AA04065311 AM22
Licence No and<br>Date		0311006321/22/08/2021
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.	127 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00169932AM22
RA File Number	03AA04069290 AM22
Licence No and<br>Date	0311006414/24/08/2021
Norms Committee Decision:

UDIN00232627AM23

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.	128 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	OSMED FORMULATIONS PVT. LTD.,
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00172452AM22
RA File Number	56AA04003575 AM22
Licence No and<br>Date	5611000465/27/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the description of export product was not<br>defined properly. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC

Case No.	129 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00173288AM22
RA File Number	03AA04074480 AM22
Licence No and<br>Date	0311006526/29/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative

UDIN00232627AM23

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.	130 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00176504AM22
RA File Number	31AA04025900 AM22
Licence No and<br>Date	3111000564/03/09/2021
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>Percentage purity of Export Product.<br>i.<br>Percentage yield of reaction.<br>ii.<br>iii Stoichiometric balance to arrive at the quantity of raw material asked for.

Case No.	131 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00176436AM22
RA File Number	09AA04010830 AM22
Licence No and<br>Date	0911001493/03/09/2021

UDIN00232627AM23

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 items	Qty.
sodium<br>(S)-4-oxo-4,6,7,8-<br>tetrahydropyrrolo<br>[1,2-<br>a]pyrimidine-6-<br>carboxylate((Pyrimidinone<br>acid, sodium salt))	1 kg	1	Methyl L-pyroglutamate	2.70 kg
		2	Triethyl amine	2.27 kg
		3	2,5-Norbornadiene	1.73 kg
		4	Chloro sulfonyl isocyanate	2.778 kg
		5	Isopropyl alcohol	4.02 kg
		6	Methyl tert butyl ether	5.91 kg

Case No.	132 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00177182AM22
RA File Number	05AA04076110 AM22
Licence No and<br>Date	0511004515/06/09/2021
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>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>ii.

UDIN00232627AM23

stage wise percentage yields on molar basis.

iii. Complete technical details as per Annexure to Appendix 4E for chemical products.
iv. Stoichiometric balance between import and export on molar basis. v. Details of indigenous input with quantity.

Case No.	133 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00177439AM22
RA File Number	09AA04011018 AM22
Licence No and<br>Date	0911001497/06/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	134 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00177562AM22
RA File Number	08AA04023793 AM22
Licence No and<br>Date	0811002515/06/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	135 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00177945AM22
RA File Number	05AA04070230 AM22
Licence No and<br>Date	0511004557/06/09/2021
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:

68 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

i. Step wise manufacturing process.
ii. Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis.
iii. Complete technical details as per Annexure to Appendix 4E for chemical products.
iv. Stoichiometric balance between import and export on molar basis.
v. Details of indigenous input with quantity.

Case No.	136 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DORF-KETAL CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00178330AM22
RA File Number	03AA04067379 AM22
Licence No and<br>Date	0311006748/07/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	137 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00178872AM22
RA File Number	34AA04007161 AM22
Licence No and<br>Date	3411001079/07/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	138 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00178977AM22
RA File Number	08AA04026034 AM22
Licence No and<br>Date	0811002528/07/09/2021
Norms Committee Decision:

69 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited from the firm.

Hence, it was decided to issue a Reminder to firm to submit its reply.

Case No.	Case No.	139 / NC/3/MEET/Sep/202223/8	139 / NC/3/MEET/Sep/202223/8	139 / NC/3/MEET/Sep/202223/8	139 / NC/3/MEET/Sep/202223/8	139 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00179282AM22
RA File Number		03AA04080758 AM22
Licence No and<br>Date		0311006784/08/09/2021
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/Dec/202122/12dated 17.12.2021against advance authorization No.<br>0311005125 dated 05.07.2021, 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.<br>1<br>PARA XYLENE<br>1.485 kg<br>2<br>PARAFORMALDEHYDE<br>1.032 kg<br>2,5-DIMETHYL<br>PHENYL<br>ACETYL CHLORIDE<br>1 kg<br>3<br>SODIUM CYANIDE<br>0.570 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	2,5-DIMETHYL<br>PHENYL<br>ACETYL CHLORIDE		<br>1 kg	1	PARA XYLENE	1.485 kg
				2	PARAFORMALDEHYDE	1.032 kg
				3	SODIUM CYANIDE	0.570 kg
				as per above decision of NC.

Case No.	140 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00179705AM22

UDIN00232627AM23

RA File Number

05AA04071036 AM22

Licence No and Date

0511004601/08/09/2021

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: Step wise manufacturing process. i. Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis. ii. Complete technical details as per Annexure to Appendix 4E for chemical products. iii. Stoichiometric balance between import and export on molar basis. iv. Details of indigenous input with quantity. v.

Case No.	141 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00180144AM22
RA File Number	05AA04077131 AM22
Licence No and<br>Date	0511004616/08/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	142 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00180145AM22
RA File Number	05AA04077016 AM22
Licence No and<br>Date	0511004617/08/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	143 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

71 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

HQ File Number	HQRNORM APPLY 00180146AM22
RA File Number	05AA04073979 AM22
Licence No and<br>Date	0511004618/08/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	144 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00180405AM22
RA File Number	09AA04012030 AM22
Licence No and Date	0911001527/09/09/2021
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. Sl.<br>No.<br>Import items<br>Qty.<br>EMPAGLIFLOZIN 1 kg 1<br>(2R3R4R5S6S)2(acetoxymethyl)6(4chloro3(4(((S)<br>tetrahydrofuran3yl)oxy)benzyl)phenyl)tetrahydro2Hpyran3,4,5triyltriacetate<br>0.700<br>kg<br> <br>RA concerned may take further necessary action as per above decision of NC

Case No.	145 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00181607AM22
RA File Number	05AA04061713 AM22
Licence No and<br>Date	0511004657/10/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the

UDIN00232627AM23

firm:

i. Step wise manufacturing process.
ii. Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis.
iii. Complete technical details as per Annexure to Appendix 4E for chemical products.
iv. Stoichiometric balance between import and export on molar basis.
v. Details of indigenous input with quantity.

Case No.	146 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00181671AM22
RA File Number	34AA04006805 AM22
Licence No and<br>Date	3411001099/10/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	147 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00181385AM22
RA File Number	08AA04024263 AM22
Licence No and<br>Date	0811002550/10/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	148 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	BIOMATRIX HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00181484AM22
RA File Number	08AA04023562 AM22
Licence No and<br>Date	0811002557/10/09/2021

73 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

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.
Erythromycin Stearate Oral Suspension<br>250mg/5ml(Each 5ml of reconstituted<br>suspension<br>contains<br>Erythromycin<br>Stearate BP Eq. to Erythromycin<br>250mg Total 628458 bottles) 100 ml<br>bottle	<br> <br> <br> <br> <br>628458<br>Number Bottles	1	Erythromycin Stearate BP	4578.094 kg

Case No.	149 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00183041AM22
RA File Number	03AA04090257 AM22
Licence No and<br>Date	0311006909/13/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	150 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00183913AM22
RA File Number	05AA04078246 AM22
Licence No and<br>Date	0511004729/14/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

UDIN00232627AM23

Case No.	Case No.	151 / NC/3/MEET/Sep/202223/8	151 / NC/3/MEET/Sep/202223/8	151 / NC/3/MEET/Sep/202223/8	151 / NC/3/MEET/Sep/202223/8	151 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00184742AM22
RA File Number		05AA04079139 AM22
Licence No and<br>Date		0511004763/15/09/2021
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/Jun/202223/5 dated 08.07.2022 against advance authorization No.<br>0311004745 dt. 19.06.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Meropenem for Injection<br>1 kg<br>1<br>Meropenem trihydrate Non Sterile<br>0.655 kg<br> RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Meropenem for Injection		1 kg	1	Meropenem trihydrate Non Sterile	0.655 kg
	RA concerned may take further necessary action as per above decision of NC.

Case No.	152 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00184161AM22
RA File Number	34AA04007354 AM22
Licence No and<br>Date	3411001111/15/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	153 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00184484AM22
RA File Number	05AA04076999 AM22
Licence No and<br>Date	0511004742/15/09/2021

UDIN00232627AM23

Norms Committee Decision:

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

i. Item of import and export are is same. Justification for import item.
ii. As per process, blending is done, indicate items which are blend.
iii. Complete COA of import item from foreign supplier.
iv. Bifurcation of wastage at each stage.
v. Production / Consumption data indicating specification of import and export for last two years duly certified by GST.

Case No.	154 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	CUCKOS PHARMACEUTICAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00184568AM22
RA File Number	33AA04006480 AM22
Licence No and<br>Date	3311000430/15/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	155 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00184658AM22
RA File Number	05AA04081685 AM22
Licence No and<br>Date	0511004757/15/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee alongwith following information / documents from the firm:<br>Item of import and export are same. Please furnish justification for import.<br>i.<br>As per process, blending is done, please indicate items which are blended.<br>ii.<br>Complete COA of import item from foreign supplier.<br>iii.<br>Complete COA of export.<br>iv.<br>Bifurcation of wastage at each stage.<br>v.		Personal Hearing

UDIN00232627AM23

vi Production / Consumption data for last two years duly certified by GST.

Case No.	156 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SANOFI INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00185047AM22
RA File Number	03AA04082679 AM22
Licence No and<br>Date	0311007007/16/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	157 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00185161AM22
RA File Number	13AA04016708 AM22
Licence No and Date	1311000571/16/09/2021
Norms Committee Decision:<br>T<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/Jun/202122/2 dated 02.07.2021against advance authorization No.<br>1311000341 dated 19.05.2021, 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.<br>AZODICARBONAMIDE<br>(BLOWING AGENT), PURITY<br>MINIMUM<br>99.50<br>PERCENT,<br>PARTICLE SIZE 4.5 TO 5.5<br>PERCENT MICRON<br>200000kg 1<br>AZODICARBONAMIDE CRUDE PURITY<br>MINIMUM 97 PERCENT PARTICLE SIZE<br>13 TO 15 PERCENT MICRON<br>201000 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	158 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved

UDIN00232627AM23

Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00185282AM22
RA File Number	31AA04026965 AM22
Licence No and<br>Date	3111000573/16/09/2021
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/Mar/202122/15 dated 17.03.2022against advance authorization No.<br>3111000148 dated 09.02.2021, 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.<br>1<br>MONO ETHANOL AMINE<br>1.0374 kg<br>ETHYLENE DI AMINE<br>1 kg<br>2<br>AMMONIA ANHYDROUS<br>Not allowed, as it is<br>shown indigenous<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	159 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00185767AM22
RA File Number	03AA04011760 AM22
Licence No and<br>Date	0311007030/16/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	160 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00186138AM22

UDIN00232627AM23

RA File Number

09AA04014031 AM22

Licence No and Date

0911001559/17/09/2021

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.3/82-ALC4/2020 dated 07.08.2020against advance authorization No.0910067389 dated 15.04.2019, 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. VRN-1 (Chloro Voriconazole) 1 kg 1 4-Chloro-6-ethyl-5-fluoro Pyrimidine 0.764 kg RA concerned may take further necessary action as per above decision of NC

Case No.	Case No.	Case No.	161 / NC/3/MEET/Sep/202223/8	161 / NC/3/MEET/Sep/202223/8	161 / NC/3/MEET/Sep/202223/8	161 / NC/3/MEET/Sep/202223/8	161 / NC/3/MEET/Sep/202223/8
Case Status			Case Approved
Party Name			SANOFI INDIA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number			HQRNORM APPLY 00186395AM22
RA File Number			03AA04094137 AM22
Licence No and<br>Date			0311007049/17/09/2021
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/Mar/202122/15 dated 17.03.2022against advance authorization No.<br>0311002322 dated 10.03.2021, 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>Sl. No. Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Festal Dragees (Tablets) Enterosoluble<br>10x10s((Total net Weight, Pancreatin<br>76800.00 Kgs Strength of Pancreatin<br>192mg/Tablet))<br>1 Number<br>Tablet<br>1<br>Pancreatin<br>195.84 mg<br>Festal N Dragees (Tablets) 2x10s((Total 1 Number<br>2<br>2<br>Pancreatin<br>216.75 mg
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	Festal Dragees (Tablets) Enterosoluble<br>10x10s((Total net Weight, Pancreatin<br>76800.00 Kgs Strength of Pancreatin<br>192mg/Tablet))		<br> <br> <br>1 Number<br>Tablet	1	Pancreatin	195.84 mg
	2	Festal N Dragees (Tablets) 2x10s((Total		1 Number	2	Pancreatin	216.75 mg

UDIN00232627AM23

net Weight, Pancreatin 5312.5 Kgs Tablet Strength of Pancreatin 212.50mg/Tablet))

Case No.	162 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00187904AM22
RA File Number	08AA04029099 AM22
Licence No and<br>Date	0811002644/20/09/2021
Norms Committee Decision:<br>Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri<br>Keyur Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The<br>Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited<br>from the firm.<br>Hence, it was decided to issue a Reminder<br> to firm to submit its reply.

Case No.	163 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00187990AM22
RA File Number	07AA04024759 AM22
Licence No and<br>Date	0711001935/20/09/2021
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>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.

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

UDIN00232627AM23

iv. Stoichiometric balance between import and export on molar basis.

v Details of indigenous input with quantity.

Case No.	164 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00188549AM22
RA File Number	31AA04024656 AM22
Licence No and<br>Date	3111000586/20/09/2021
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.2/82-ALC4/2018 dated 16.05.2018 against advance authorization No.3110066397 d<br>ated 15.11.2016, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2 6 xylenol<br>420 MT<br>2,6 XYLIDINE<br>300 MT<br>2<br>Catalyst<br>Not allow as specific description is not given<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	165 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	GANGWAL CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00187865AM22
RA File Number	03AA04083531 AM22
Licence No and<br>Date	0311007077/20/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

UDIN00232627AM23

Case No.	166 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	ASOJ SOFT CAPS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00190578AM22
RA File Number	34AA04007816 AM22
Licence No and<br>Date	3411001148/22/09/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	167 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00190805AM22
RA File Number	04AA04015436 AM22
Licence No and<br>Date	0411001511/22/09/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	168 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00191007AM22
RA File Number	03AA040103017 AM22
Licence No and<br>Date	0311007156/23/09/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	169 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00191008AM22
RA File Number	03AA040103051 AM22

82 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Licence No and<br>Date	0311007157/23/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing<br>
before Norms Committee to explain its case.

Case No.	170 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00192148AM22
RA File Number	03AA04091496 AM22
Licence No and<br>Date	0311007180/23/09/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	171 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00193597AM22
RA File Number	03AA04097753 AM22
Licence No and<br>Date	0311007198/25/09/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	172 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00193925AM22
RA File Number	03AA04092661 AM22
Licence No and<br>Date	0311007206/25/09/2021
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.10/AM20 dated 29.11.2019against advance authorization No.0310822432 dated

83 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

19.07.2018 , 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:

19.07.2018, 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>Sl. No. Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Amoxycillin Trihydrate<br>4.200 kg<br>2<br>CLAVULANATE<br>POTASSIUM<br>WITH SILICON DIOXIDE 1:1<br>2.3444 kg<br>3<br>SILICONE<br>DIOXIDE(SYLOID<br>244FP)<br>1.50 kg<br>4<br>115CC HDPE BOTTLES 75 ML<br>(250/62.5)<br>5<br>28-400 WHITE CLIC LOC CAP<br>WITH PRINTED FSM-1<br>1<br>Amoxicillin<br>and<br>Clavulanate<br>Potassium for Oral Suspension USP<br>250mg<br>/<br>62.5mg<br>(Pack<br>Size<br>75ml)(Each 5ml contains: Amoxycillin<br>Trihydrate<br>USP<br>equivalent<br>to<br>Amoxicillin<br>250mg,<br>Clavulanate<br>Potassium<br>USP<br>equivalent<br>to<br>Clavulanic Acid 62.50mg)<br>1000<br>Number<br>Pack<br>6<br>Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING<br>Relevant as per<br>packing policy	19.07.2018, 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>Sl. No. Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Amoxycillin Trihydrate<br>4.200 kg<br>2<br>CLAVULANATE<br>POTASSIUM<br>WITH SILICON DIOXIDE 1:1<br>2.3444 kg<br>3<br>SILICONE<br>DIOXIDE(SYLOID<br>244FP)<br>1.50 kg<br>4<br>115CC HDPE BOTTLES 75 ML<br>(250/62.5)<br>5<br>28-400 WHITE CLIC LOC CAP<br>WITH PRINTED FSM-1<br>1<br>Amoxicillin<br>and<br>Clavulanate<br>Potassium for Oral Suspension USP<br>250mg<br>/<br>62.5mg<br>(Pack<br>Size<br>75ml)(Each 5ml contains: Amoxycillin<br>Trihydrate<br>USP<br>equivalent<br>to<br>Amoxicillin<br>250mg,<br>Clavulanate<br>Potassium<br>USP<br>equivalent<br>to<br>Clavulanic Acid 62.50mg)<br>1000<br>Number<br>Pack<br>6<br>Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING<br>Relevant as per<br>packing policy	19.07.2018, 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>Sl. No. Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Amoxycillin Trihydrate<br>4.200 kg<br>2<br>CLAVULANATE<br>POTASSIUM<br>WITH SILICON DIOXIDE 1:1<br>2.3444 kg<br>3<br>SILICONE<br>DIOXIDE(SYLOID<br>244FP)<br>1.50 kg<br>4<br>115CC HDPE BOTTLES 75 ML<br>(250/62.5)<br>5<br>28-400 WHITE CLIC LOC CAP<br>WITH PRINTED FSM-1<br>1<br>Amoxicillin<br>and<br>Clavulanate<br>Potassium for Oral Suspension USP<br>250mg<br>/<br>62.5mg<br>(Pack<br>Size<br>75ml)(Each 5ml contains: Amoxycillin<br>Trihydrate<br>USP<br>equivalent<br>to<br>Amoxicillin<br>250mg,<br>Clavulanate<br>Potassium<br>USP<br>equivalent<br>to<br>Clavulanic Acid 62.50mg)<br>1000<br>Number<br>Pack<br>6<br>Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING<br>Relevant as per<br>packing policy	19.07.2018, 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>Sl. No. Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Amoxycillin Trihydrate<br>4.200 kg<br>2<br>CLAVULANATE<br>POTASSIUM<br>WITH SILICON DIOXIDE 1:1<br>2.3444 kg<br>3<br>SILICONE<br>DIOXIDE(SYLOID<br>244FP)<br>1.50 kg<br>4<br>115CC HDPE BOTTLES 75 ML<br>(250/62.5)<br>5<br>28-400 WHITE CLIC LOC CAP<br>WITH PRINTED FSM-1<br>1<br>Amoxicillin<br>and<br>Clavulanate<br>Potassium for Oral Suspension USP<br>250mg<br>/<br>62.5mg<br>(Pack<br>Size<br>75ml)(Each 5ml contains: Amoxycillin<br>Trihydrate<br>USP<br>equivalent<br>to<br>Amoxicillin<br>250mg,<br>Clavulanate<br>Potassium<br>USP<br>equivalent<br>to<br>Clavulanic Acid 62.50mg)<br>1000<br>Number<br>Pack<br>6<br>Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING<br>Relevant as per<br>packing policy	19.07.2018, 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>Sl. No. Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Amoxycillin Trihydrate<br>4.200 kg<br>2<br>CLAVULANATE<br>POTASSIUM<br>WITH SILICON DIOXIDE 1:1<br>2.3444 kg<br>3<br>SILICONE<br>DIOXIDE(SYLOID<br>244FP)<br>1.50 kg<br>4<br>115CC HDPE BOTTLES 75 ML<br>(250/62.5)<br>5<br>28-400 WHITE CLIC LOC CAP<br>WITH PRINTED FSM-1<br>1<br>Amoxicillin<br>and<br>Clavulanate<br>Potassium for Oral Suspension USP<br>250mg<br>/<br>62.5mg<br>(Pack<br>Size<br>75ml)(Each 5ml contains: Amoxycillin<br>Trihydrate<br>USP<br>equivalent<br>to<br>Amoxicillin<br>250mg,<br>Clavulanate<br>Potassium<br>USP<br>equivalent<br>to<br>Clavulanic Acid 62.50mg)<br>1000<br>Number<br>Pack<br>6<br>Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING<br>Relevant as per<br>packing policy	19.07.2018, 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>Sl. No. Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Amoxycillin Trihydrate<br>4.200 kg<br>2<br>CLAVULANATE<br>POTASSIUM<br>WITH SILICON DIOXIDE 1:1<br>2.3444 kg<br>3<br>SILICONE<br>DIOXIDE(SYLOID<br>244FP)<br>1.50 kg<br>4<br>115CC HDPE BOTTLES 75 ML<br>(250/62.5)<br>5<br>28-400 WHITE CLIC LOC CAP<br>WITH PRINTED FSM-1<br>1<br>Amoxicillin<br>and<br>Clavulanate<br>Potassium for Oral Suspension USP<br>250mg<br>/<br>62.5mg<br>(Pack<br>Size<br>75ml)(Each 5ml contains: Amoxycillin<br>Trihydrate<br>USP<br>equivalent<br>to<br>Amoxicillin<br>250mg,<br>Clavulanate<br>Potassium<br>USP<br>equivalent<br>to<br>Clavulanic Acid 62.50mg)<br>1000<br>Number<br>Pack<br>6<br>Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING<br>Relevant as per<br>packing policy	19.07.2018, 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>Sl. No. Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Amoxycillin Trihydrate<br>4.200 kg<br>2<br>CLAVULANATE<br>POTASSIUM<br>WITH SILICON DIOXIDE 1:1<br>2.3444 kg<br>3<br>SILICONE<br>DIOXIDE(SYLOID<br>244FP)<br>1.50 kg<br>4<br>115CC HDPE BOTTLES 75 ML<br>(250/62.5)<br>5<br>28-400 WHITE CLIC LOC CAP<br>WITH PRINTED FSM-1<br>1<br>Amoxicillin<br>and<br>Clavulanate<br>Potassium for Oral Suspension USP<br>250mg<br>/<br>62.5mg<br>(Pack<br>Size<br>75ml)(Each 5ml contains: Amoxycillin<br>Trihydrate<br>USP<br>equivalent<br>to<br>Amoxicillin<br>250mg,<br>Clavulanate<br>Potassium<br>USP<br>equivalent<br>to<br>Clavulanic Acid 62.50mg)<br>1000<br>Number<br>Pack<br>6<br>Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING<br>Relevant as per<br>packing policy	19.07.2018, 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>Sl. No. Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Amoxycillin Trihydrate<br>4.200 kg<br>2<br>CLAVULANATE<br>POTASSIUM<br>WITH SILICON DIOXIDE 1:1<br>2.3444 kg<br>3<br>SILICONE<br>DIOXIDE(SYLOID<br>244FP)<br>1.50 kg<br>4<br>115CC HDPE BOTTLES 75 ML<br>(250/62.5)<br>5<br>28-400 WHITE CLIC LOC CAP<br>WITH PRINTED FSM-1<br>1<br>Amoxicillin<br>and<br>Clavulanate<br>Potassium for Oral Suspension USP<br>250mg<br>/<br>62.5mg<br>(Pack<br>Size<br>75ml)(Each 5ml contains: Amoxycillin<br>Trihydrate<br>USP<br>equivalent<br>to<br>Amoxicillin<br>250mg,<br>Clavulanate<br>Potassium<br>USP<br>equivalent<br>to<br>Clavulanic Acid 62.50mg)<br>1000<br>Number<br>Pack<br>6<br>Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING<br>Relevant as per<br>packing policy




Sl No	Exort Product			Qt	Sl No	Imort Items	Qt
. .	p			y.	. .	p	y.


1	Amoxicillin<br>and<br>Cl	avulanate		<br>1000	1	Amoxycillin Trihydrate	4.200 kg
	Potassium for Oral Suspen<br>250mg<br>/<br>62.5mg<br>(Pa<br>75ml)(Each 5ml contains: A<br>Trihydrate<br>USP<br>equiva	sion USP<br>ck<br>Size<br>moxycillin<br>lent<br>to		<br> <br> <br> <br>Number<br>Pack
					2	CLAVULANATE<br>POTASSIUM<br>WITH SILICON DIOXIDE 1:1	2.3444 kg
	<br> <br>Amoxicillin<br>250mg,<br>Clavulanate<br>Potassium<br>USP<br>equivalent<br>to<br>Clavulanic Acid 62.50mg)			<br>
					3	SILICONE<br>DIOXIDE(SYLOID<br>244FP)	1.50 kg
					4	115CC HDPE BOTTLES 75 ML	Releant as
						<br>(250/62.5)


					5	28-400 WHITE CLIC LOC CAP
						WITH PRINTED FSM-1


					6	Cap 28/400 WHT CRC W/FS M-I
						WITH INDUCTION SEALING

2	Amoxicillin<br>and<br>Clav<br>Potassium for Oral Suspensio<br>250mg<br>/<br>62.5mg<br>(Pack<br>100ml)(Each<br>5ml<br>co		ulanate<br>n USP<br>Size<br>ntains:	1000<br>Number<br>Pack	7	Amoxycillin Trihydrate	5.649 kg
					8	CLAVULANATE<br>POTASSIUM<br>	3.126 kg
	Amoxycillin<br>Trihydrate<br>USP<br>equivalent to Amoxicillin 250mg,<br>Clavulanate<br>Potassium<br>USP<br>equivalent<br>to<br>Clavulanic<br>Acid<br>62.50mg)					WITH SILICON DIOXIDE 1:1
					9	SILICONE<br>DIOXIDE(SYLOID<br>244FP)	2.00 kg

					10	185 CC HDPE BOTTLES 100 ML<br>(250/62.5)
					11	28-400 WHITE CLIC LOC CAP<br>WITH PRINTED FSM-1
					12	Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING
3	Amoxicillin<br>and<br>Clavulanate			1000	13	Amoxycillin Trihydrate	8.274 kg

UDIN00232627AM23

	Pi f Ol Si USP	Pi f Ol Si USP	<br>Nb	14	CLALAATE<br>POTASSIM	4.6888 kg	4.6888 kg
	otassum or ra uspenson<br>250<br>/<br>625<br>Pk<br>	<br>i	<br> <br>umer<br>Pk		VUN<br>U<br>WITH SILICON DIOXIDE 11	. g
	mg<br> <br>.mg<br>(ac<br> <br>150l)(Eh<br>5l<br>t	ze<br>i	<br> <br>ac		:
	mac<br>m<br>con<br>Amoxcillin<br>Trihdrate<br>	ns:<br>SP	<br>

	y<br>y<br> <br>equivalent to Amoxicillin 250<br>Clavulanate Potassium USP euiv	<br>mg,<br>lent	<br> <br>	15	SILICONE<br>DIOXIDE(SYLOID<br>244FP)	3.00 kg
	q<br>to Clavulanic Acid 6250mg)
	.						per<br>y
				16	225 CC HDPE BOTTLES 150 ML	Relevant as
					(250/62.5)	packing polic
				17	28-400 WHITE CLIC LOC CAP
WITH PRINTED FSM-1<br>18<br>Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING					WITH PRINTED FSM-1
				18	Cap 28/400 WHT CRC W/FS M-I<br>WITH INDUCTION SEALING

	RA concerned ma take further necessar	RA concerned ma take further necessar	action as er above decision of NC
	y y		p .


Case No.<br>173 / NC/3/MEET/Sep/
	Case No.	173 / NC/3/MEET/Sep/	202223/8
	Case Status	Case Deferred
	Party Name	INDO AMINES LIMITED
	Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
	HQ File Number	HQRNORM APPLY 00194032AM22
	RA File Number	03AA04083866 AM22
	Licence No and<br>Date	0311007213/25/09/2021
	Norms Committee Decision:<br>Deferred for comments of TE

Case No.	174 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00194099AM22
RA File Number	03AA040106163 AM22
Licence No and<br>Date	0311007214/25/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the import items are confusing. Hence, it

UDIN00232627AM23

was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case.

Case No.	175 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00195372AM22
RA File Number	34AA04006808 AM22
Licence No and<br>Date	3411001180/27/09/2021
Norms Committee Decision:
Deferred for comments of TE.

	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.
	was ece o ca e o ae				g g<br> eoe os oee o expa s case.


<br>

	Case No.			175 / NC/3/MEET/S	ep/202223/8
	Case Status			Case Deferred
	Party Name			BEST VALUE CHE	M PRIVATE LIMITED

	Mti Nb
	eeng umer<br>d D			NC/ 3/ MEET/ Sep/	202223/ 8 and 23/09/2022
	an ate
	HQ File Number			HQRNORM APPL	Y 00195372AM22
	RA File Number			34AA04006808 AM	22
	Licence No and<br>Dt			3411001180/27/09/2	021
ae<br>Norms Committee Decision:<br>Deferred for comments of TE.<br> <br>	ae
	Norms Committee Decision:<br>Deferred for comments of TE.

	Case No.
	Case Status			Case Approved
	Party Name			VENOR PHARMA L		IMITED

	Mti Nb
	eeng umer<br>d D			NC/ 3/ MEET/ Sep/ 2		02223/ 8 and 23/09/2022
	an ate

	HQ File Number			HQRNORM APPLY		00195381AM22
	RA File Number			05AA04080206 AM2		2
	Licence No and
	Date			0511004978/27/09/20		21
	Norms Committee Decision:
	The Committee considered the case as per agenda and taking cue from earlier decision for same export produ<br>import item in Meeting No.NC/3/MEET/Dec/202122/12 dated 17.12.2021against advance authorization<br>6110001566 dated 28.11.2018, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per det<br>given below or as applied by the firm, whichever is less:

		Sl. No.	Export product				Qty.	Sl. No.	Import items	Qty.
		1	Tab.<br>Morphine<br>Sulphate<br>10<br>mg<br>(NR/PR/CR) (Finished Formulation of<br>Morphine Sulphate)				<br> <br>1 Number	1	Morphine Sulphate	10.2 mg
		2	Tab.<br>Morphine<br>Sulphate<br>30<br>mg<br>(NR/CR/PR) (Finished Formulation of<br>Morphine Sulphate)				1 Number	1	Morphine Sulphate	30.6 mg
		3	Tab. Morphine Sulphate 20 mg				1 Number	1	Morphine Sulphate	20.4 mg

	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.	was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.
	was ece o ca e o ae				g g<br> eoe os oee o expa s case.


<br>

	Case No.			175 / NC/3/MEET/S	ep/202223/8
	Case Status			Case Deferred
	Party Name			BEST VALUE CHE	M PRIVATE LIMITED

	Mti Nb
	eeng umer<br>d D			NC/ 3/ MEET/ Sep/	202223/ 8 and 23/09/2022
	an ate
	HQ File Number			HQRNORM APPL	Y 00195372AM22
	RA File Number			34AA04006808 AM	22
	Licence No and<br>Dt			3411001180/27/09/2	021
ae<br>Norms Committee Decision:<br>Deferred for comments of TE.<br> <br>	ae
	Norms Committee Decision:<br>Deferred for comments of TE.

	Case No.
	Case Status			Case Approved
	Party Name			VENOR PHARMA L		IMITED

	Mti Nb
	eeng umer<br>d D			NC/ 3/ MEET/ Sep/ 2		02223/ 8 and 23/09/2022
	an ate

	HQ File Number			HQRNORM APPLY		00195381AM22
	RA File Number			05AA04080206 AM2		2
	Licence No and
	Date			0511004978/27/09/20		21
	Norms Committee Decision:
	The Committee considered the case as per agenda and taking cue from earlier decision for same export produ<br>import item in Meeting No.NC/3/MEET/Dec/202122/12 dated 17.12.2021against advance authorization<br>6110001566 dated 28.11.2018, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per det<br>given below or as applied by the firm, whichever is less:

		Sl. No.	Export product				Qty.	Sl. No.	Import items	Qty.
		1	Tab.<br>Morphine<br>Sulphate<br>10<br>mg<br>(NR/PR/CR) (Finished Formulation of<br>Morphine Sulphate)				<br> <br>1 Number	1	Morphine Sulphate	10.2 mg
		2	Tab.<br>Morphine<br>Sulphate<br>30<br>mg<br>(NR/CR/PR) (Finished Formulation of<br>Morphine Sulphate)				1 Number	1	Morphine Sulphate	30.6 mg
		3	Tab. Morphine Sulphate 20 mg				1 Number	1	Morphine Sulphate	20.4 mg

UDIN00232627AM23

	(NR/CR/PR) (Finished formulations of<br>Morphine Sulphate)
4	Tab. Morphine Sulphate 15 mg<br>(NR/CR/PR) (Finished Formulation of<br>Morphine Sulphate)	1 Number	1	Morphine Sulphate	15.3 mg
5	Inj. Morphine Sulphate 10 mg (Finished<br>Formulation of Morphine Sulphate)	1 Number	1	Morphine Sulphate	11.00 mg
6	Inj. Morphine Sulphate 15 mg (Finished<br>Formulation of Morphine Sulphate)	1 Number	1	Morphine Sulphate	16.5 mg

Case No.	177 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00195497AM22
RA File Number	03AA040105795 AM22
Licence No and<br>Date	0311007265/27/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for export item indicating net content of inputs in each export.<br>iii.

Case No.	178 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00195617AM22
RA File Number	09AA04010498 AM22

UDIN00232627AM23

Licence No and 0911001381/28/09/2021 Date Norms Committee Decision:

Deferred for comments of TE.

Case No.	179 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00196160AM22
RA File Number	05AA04084244 AM22
Licence No and<br>Date	0511005004/28/09/2021
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.2/82-ALC4/2020 dated 10.07.2020against advance authorization No.0510411666<br>dated 28.08.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>TOBRISS<br>(TOBRAMYCIN<br>0.3<br>PERCENT) EYE DROPS 5 ML VIAL<br>1 Number Pack<br>1<br>Tobramycin Sulphate<br>19.057 mg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	180 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	NATURAL AND ESSENTIAL OILS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00196404AM22
RA File Number	07AA04026654 AM22
Licence No and<br>Date	0711002016/28/09/2021
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:

UDIN00232627AM23

Working Sheet to arrive at the quantity of raw material asked on the basis of percentage purity of import item.

Case No.	181 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00196547AM22
RA File Number	08AA04026264 AM22
Licence No and<br>Date	0811002728/28/09/2021
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/Jun/202223/5 dated 08.07.2022against advance authorization No.<br>0810148893 dated 26.10.2020, 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>Sl.<br>No.<br>Export Product<br>Qty<br>Sl.<br>No.<br>Import Item Name.<br>Qty.<br>1<br>ENOXAPARIN<br>SODIUM<br>INJECTION<br>(40MG<br>(0.40ML) NET CONTENTS<br>OF<br>BULK<br>DRUG<br>:<br>1.80KGS)<br>1 Number<br>1<br>ENOXAPARIN SODIUM IP EP (Low<br>molecular<br>weight<br>Heparin<br>)THIS<br>AUTHORISATION ISSUED AS PER<br>POLICY CIRCULAR No.9<br>44.00 mg<br>2<br>ENOXAPARIN<br>SODIUM<br>INJECTION (60MG (0.6ML)<br>NET CONTENTS OF BULK<br>DRUG: 6.60KGS.)<br>1 Number<br>2<br>ENOXAPARIN SODIUM IP EP (Low<br>molecular weight Heparin ) THIS<br>AUTHORISATION ISSUED AS PER<br>POLICY CIRCULAR No.9<br>66.00 mg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	182 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	FDC LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

UDIN00232627AM23

and Date
HQ File Number	HQRNORM APPLY 00195577AM22
RA File Number	03AA040106642 AM22
Licence No and<br>Date	0311007268/28/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has never furnished any details<br>regarding content of API. Hence, it was decided to call the firm for attendingPersonal Hearing<br> before Norms<br>Committee.

Case No.	183 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00197140AM22
RA File Number	09AA04015351 AM22
Licence No and<br>Date	0911001652/29/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the import items are confusing. Hence, it<br>was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.

Case No.	Case No.	184 / NC/3/MEET/Sep/202223/8	184 / NC/3/MEET/Sep/202223/8	184 / NC/3/MEET/Sep/202223/8	184 / NC/3/MEET/Sep/202223/8	184 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		PANACEA BIOTEC LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00197809AM22
RA File Number		05AA04085619 AM22
Licence No and<br>Date		0511005085/29/09/2021
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>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Easy Five TT Vaccine 1<br>Million<br>Purified Diptheria Toxoid Concentrate<br>1<br>13.33 Litre
	Export product		Qty.	Sl. No.	Import items	Qty.
	Easy Five TT Vaccine		1<br>Million	<br>1	Purified Diptheria Toxoid Concentrate	13.33 Litre

UDIN00232627AM23

	Antigen Bulk @2050 Lf/ml
2	Purified Tetanus Toxoid Concentrate<br>Antigen @1900 Lf/ml	5.23 Litre
3	Inactivated Whole Cell Pertussis Bulk<br>@192 OU/ml	<br>86.46 Litre
4	Rubber Stopper	1010000 Numbers
5	AGS HB Purification MABS Column	5.4 Litre
6	Tetanus Toxoid for conjugation	6.15 Litre

Case No.	Case No.	185 / NC/3/MEET/Sep/202223/8	185 / NC/3/MEET/Sep/202223/8	185 / NC/3/MEET/Sep/202223/8	185 / NC/3/MEET/Sep/202223/8	185 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		VACHICHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00198272AM22
RA File Number		07AA04028991 AM22
Licence No and<br>Date		0711002024/30/09/2021
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.<br>No.<br>Import items<br>Qty.<br>6-(2-PROPENY)-ERGOLINE-8-<br>CARBOXYLIC ACID CAS NO 81409-<br>74-7<br>1 kg<br>1<br>LYSERGOL<br>(9,10<br>DIDEHYDRO<br>6<br>METHYLERGOLINE -8B-METHANOL<br>CAS NO 602-85-7)<br>2.98 kg<br>
	Export product<br>		Qty.	Sl.<br>No.	Import items	Qty.
	6-(2-PROPENY)-ERGOLINE-8-<br>CARBOXYLIC ACID CAS NO 81409-<br>74-7<br>		1 kg	1	LYSERGOL<br>(9,10<br>DIDEHYDRO<br>6<br>METHYLERGOLINE -8B-METHANOL<br>CAS NO 602-85-7)	<br> <br>2.98 kg

UDIN00232627AM23

Case No.	186 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00198658AM22
RA File Number	03AA040106210 AM22
Licence No and Date	0311007383/30/09/2021
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/Jun/202223/5 dated 08.07.2022against advance authorization No.<br>0311004915 dated 25.06.2021, 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> <br>Export Product<br>Qty<br>Sl.<br>No.<br>Import Item Name.<br>Qty.<br>FAMCICLOVIR<br>250MG<br>TABLETS(FAMCICLOVIR<br>250MG TABLETS (Net content:<br>419.925 kgs Famciclovir))<br>1 Number<br>1<br>9-(4-ACETOXY-3-<br>ACETOXYMETHYLBUT-1YL)-2-<br>AMINO-6-CHLOROPURINE<br>318.747 mg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	187 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00199265AM22
RA File Number	03AA040107419 AM22
Licence No and<br>Date	0311007392/01/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	188 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred

UDIN00232627AM23

Party Name	ARJUNA NATURAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00199626AM22
RA File Number	10AA04009843 AM22
Licence No and<br>Date	1011000579/01/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	189 / NC/3/MEET/Sep/202223/8	189 / NC/3/MEET/Sep/202223/8	189 / NC/3/MEET/Sep/202223/8	189 / NC/3/MEET/Sep/202223/8	189 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		VINDHYA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00199999AM22
RA File Number		09AA04015699 AM22
Licence No and<br>Date		0911001666/01/10/2021
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.<br>No.<br>Import items<br>Qty.<br>1<br>Alpha Naphthol<br>0.667 kg<br>2<br>Ortho Dichloro Benzene<br>0.814 kg<br>3<br>Methanol<br>0.420 kg<br>4-(3-4,-DICHLOROPHENYL)-1-<br>TETRALONE<br>1 kg<br>4<br>Acetone<br>0.667 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	4-(3-4,-DICHLOROPHENYL)-1-<br>TETRALONE		1 kg	1	Alpha Naphthol	0.667 kg
				2	Ortho Dichloro Benzene	0.814 kg
				3	Methanol	0.420 kg
				4	Acetone	0.667 kg
				as per above decision of NC.

Case No.	190 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved

UDIN00232627AM23

Party Name	Party Name	Party Name	GLENMARK PHARMACEUTICALS LIMITED	GLENMARK PHARMACEUTICALS LIMITED	GLENMARK PHARMACEUTICALS LIMITED	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number			HQRNORM APPLY 00201263AM22
RA File Number			03AA040105862 AM22
Licence No and<br>Date			0311007434/03/10/2021
Norms Committee Decision:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Import items<br>Qty.<br>1<br>FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)<br>322660 Packs<br>2<br>FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)<br>322660 Packs<br>3<br>FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)<br>242000 Packs<br>4<br>FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)<br>968000 Packs<br>5<br>FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10<br>gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242<br>Kgs.)<br>96800<br>Packs<br>6<br>CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)<br>193600 Packs<br>FLUOCINOLONE<br>ACETONIDE BP<br>9.10 kg<br>7<br>CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)<br>64532<br>Packs<br>8<br>SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)<br>580800 Packs <br>9<br>SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)<br>193596 Packs <br>10<br>SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)<br>3873 Packs<br>11<br>SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)<br>193600 Packs
	Sl.<br>No.	Export Product		Qty.	Import items	Qty.
	1	FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)		<br>322660 Packs	FLUOCINOLONE<br>ACETONIDE BP	9.10 kg
	2	FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)		<br>322660 Packs
	3	FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)		<br>242000 Packs
	4	FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)		<br>968000 Packs
	5	FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10<br>gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242<br>Kgs.)		<br> <br>96800<br>Packs
	6	CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)		<br>193600 Packs
	7	CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)		<br>64532<br>Packs
	8	SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)		<br>580800 Packs
	9	SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)		<br>193596 Packs
	10	SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)		<br>3873 Packs
	11	SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)		<br>193600 Packs

UDIN00232627AM23

	12<br>13<br>14<br>15<br>16<br>17	SUPRICORT N CREAM 0.025% (Pack Size 15 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.242Kgs.)	<br>64532 Packs
		Flucort C Cream 0.01% (Pack Size 15 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.095 Kgs)	<br>63332 Packs
		FLUCORT C OINTMENT 0.025% (Pack Size 15 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)	<br>161330 Packs
		GLENCORT GEL 0.025% (Pack Size 5 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.452 Kgs.)	<br>361600 Packs
		GLENCORT GEL 0.025% (Pack Size 30 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.484 Kgs.)	<br>64535 Packs
		FLUCORT MZ SKIN OINTMENT 0.01% (Pack Size 15 gms)<br>(Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.145 Kgs.)	<br>96798 Packs

Case No.	191 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	TOPNOTCH CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00201444AM22
RA File Number	03AA040107739 AM22
Licence No and<br>Date	0311007441/04/10/2021
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.<br>No.<br>Import items<br>Qty.<br>ARTEMETHER<br>1 kg<br>1<br>ARTEMISININ<br>1.04 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

UDIN00232627AM23

Case No.	192 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00201651AM22
RA File Number	07AA04031322 AM22
Licence No and<br>Date	0711002073/04/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.<br>	193 / NC/3/MEET/Sep/202223/8
Case Status<br>	Case Deferred
Party Name<br>	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>	HQRNORM APPLY 00201659AM22
RA File Number<br>	07AA04034939 AM22
Licence No and<br>Date<br>	0711002076/04/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	Case No.	194 / NC/3/MEET/Sep/202223/8	194 / NC/3/MEET/Sep/202223/8	194 / NC/3/MEET/Sep/202223/8	194 / NC/3/MEET/Sep/202223/8	194 / NC/3/MEET/Sep/202223/8
Case Status			Case Approved
Party Name			ZENTIVA PRIVATE LIMITED
Meeting Number and<br>Date			NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number			HQRNORM APPLY 00203325AM22
RA File Number			03AA040108257 AM22
Licence No and Date			0311007485/05/10/2021
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/Mar/202122/16 dated 08.04.2022against advance authorization No.<br>0311008474 dated 11.11.2021, 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>Sl. No. Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>Hydrochlorothiazide<br>12.75 mg<br>Ramilich / Ramilich Comp / Ramipril<br>HCT<br>ZT/ZTV<br>5-12.5mg((Net<br>Wt.<br>1<br>1 Number
	Sl. No.	Export Product		Qty.	Sl. No.	Import Items	Qty.
	1	Ramilich / Ramilich Comp / Ramipril<br>HCT<br>ZT/ZTV<br>5-12.5mg((Net<br>Wt.		<br> <br>1 Number	1	Hydrochlorothiazide	12.75 mg

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/202122/16 dated 08.04.2022 against advance authorization No. 0311008474 dated 11.11.2021 , 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:

96 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

	Hydrochlorothiazide 87.50 KGS) (Net Wt.<br>Ramipril 35.00 KGS))		2	Ramipril	5.10 mg
2	Ramilich / Ramilich Comp / Ramipril<br>HCT<br>ZT/ZTV<br>2.5-12.5mg((Net<br>Wt.<br>Hydrochlorothiazide 62.50 KGS) (Net Wt.<br>Ramipril 12.50 KGS))	<br> <br> <br>1 Number	3	Hydrochlorothiazide	12.75 mg
			4	Ramipril	2.55 mg
3	Ramilich / Ramilich Comp / Ramipril<br>HCT<br>ZT/ZTV<br>5-25mg((Net<br>Wt.<br>Hydrochlorothiazide 566.25 KGS) (Net<br>Wt. Ramipril 113.25 KGS))	<br> <br> <br>1 Number	5	Hydrochlorothiazide	25.50 mg
			6	Ramipril	5.10 mg

Case No.	195 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00203408AM22
RA File Number	03AA040106862 AM22
Licence No and<br>Date	0311007492/05/10/2021
Norms Committee Decision:<br>:The Committee considered the case as per agenda and it was decided to ratify adhoc norms as perSION A-412.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	196 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00203505AM22
RA File Number	05AA04088609 AM22
Licence No and<br>Date	0511005220/05/10/2021
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/Dec/202122/12 dated 17.12.2021against advance authorization No.<br>0510409477 dated 25.01.2019 and 0510411049 dated 25.06.2019, it was decided to ratify adhoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Dec/202122/12 dated 17.12.2021 against advance authorization No. 0510409477 dated 25.01.2019 and 0510411049 dated 25.06.2019 , 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:

UDIN00232627AM23


	Export product	Qty.	Sl. No.	Import items	Qty.
	DI-BUTYL<br>PHTHALATE<br>(GRADE-M) (DBP-M)(DI-BUTYL<br>PHTHALATE (GRADE-M) (DBP-<br>M) (PACKED IN 2554 NOS. OF<br>HM-HDPE DRUMS MADE OF<br>HDPE GRANULES (21,709.000<br> <br> <br>	1 kg	1.	PHTHALIC ANHYDRIDE	0.56 kg
			2.	SABUTOL	0.595 kg
			3.	HDPE GRANULES (TOTAL	<br>Relevant as per packing
RA	KGS.<br>WITHOUT<br>WASTAGE))<br>(EACH DRUM SHALL WEIGHT<br>8.5<br>KG<br>AND<br>STORAGE<br>CAPACITY 235.000 KGS.))			WEIGHT = 22,794.450 KGS.)	policy
	concerned may take further necessary action as		per above decision of NC.

Case No.	Case No.	Case No.	Case No.	Case No.	197 / NC/3/MEET/Sep/202223/8	197 / NC/3/MEET/Sep/202223/8	197 / NC/3/MEET/Sep/202223/8	197 / NC/3/MEET/Sep/202223/8	197 / NC/3/MEET/Sep/202223/8
Case Status					Case Approved
Party Name					RECKITT BENCKISER (INDIA) PRIVATE LIMITED
Meeting Number and<br>Date					NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number					HQRNORM APPLY 00203209AM22
RA File Number					05AA04088730 AM22
Licence No and Date					0511005203/05/10/2021
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>0511000178 dated 15.12.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:

	Sl. No.	E	port product			Qty.	Sl. No.	Import items	Qty.
			<br> <br>			<br>
	1	D<br>P<br>S	SPRIN<br>REGUALAR<br>(ASPIRIN<br>H.EUR<br>300MG)<br>ACETYL<br>ALICYLIC ACID 300 mg Tablet			<br> <br> <br>1 Number<br>Tablet	1	CITIRIC ACID ANHYDROUS F4020	30.00 mg

		(ASPIRIN)					2	SACCHARIN BASE 55Ox	4.50 mg
							3	CALCIUM CARBONATE EP	90.00 mg


	2	DISPRIN		<br>REGUALAR<br>6X12X24		1 Number	4	CITIRIC ACID ANHYDROUS F4020	30.00 mg

UDIN00232627AM23

	(ASPIRIN<br>PH.EUR<br>300MG)<br>ACETYL SALICYLIC ACID 300 mg<br>Tablet (ASPIRIN)	<br> <br>Tablet	5	SACCHARIN BASE 55Ox	4.50 mg
			6	CALCIUM CARBONATE EP	90.00 mg
3	DISPRIN,ZA,EXTRA<br>(ASPIRIN<br>PH.EUR<br>500MG)<br>ACETYL<br>SALICYLIC ACID 500 mg Tablet<br>(ASPIRIN)	<br> <br> <br>1 Number<br>Tablet	7	CITIRIC ACID ANHYDROUS F4020	50.00 mg
			8	SACCHARIN BASE 55Ox	7.50 mg
			9	CALCIUM CARBONATE EP	150.00 mg
4	DSPRN,ZA,MELTS,(ASPIRIN<br>PH.EUR<br>300MG)<br>ACETYL<br>SALICYLIC ACID 300 mg Tablet<br>(ASPIRIN)	<br> <br>1 Number<br>Tablet	10	SACCHARIN BASE 55Ox	1.00 mg
			11	GLYCINE EP	133.30 mg
5	DISPRIN CARDIOCARE (ASPIRIN<br>BP 100MG) ACETYL SALICYLIC<br>ACID 100 mg Tablet (ASPIRIN)	<br> <br>1 Number<br>Tablet	12	SACCHARIN BASE 55Ox	0.334 mg
			13	GLYCINE EP	44.40 mg

Case No.	Case No.	198 / NC/3/MEET/Sep/202223/8	198 / NC/3/MEET/Sep/202223/8	198 / NC/3/MEET/Sep/202223/8	198 / NC/3/MEET/Sep/202223/8	198 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00204926AM22
RA File Number		03AA040107079 AM22
Licence No and<br>Date		0311007539/06/10/2021
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

UDIN00232627AM23

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

Case No.<br>199 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Deferred
Party Name<br>KALPSUTRA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00205042AM22
RA File Number<br>03AA040108575 AM22
Licence No and<br>Date<br>0311007542/07/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Quantity of Commercial Value of By-Products obtained.<br>i.
COA of import indicating content of Alpha Pinene.<br>ii.
Percentage yield of reaction.<br>iii.
iv Stoichiometric balance between import and export on molar basis.

Case No.	200 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00206478AM22
RA File Number	04AA04028427 AM22
Licence No and<br>Date	0411001606/08/10/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	201 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED

100

UDIN00232627AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00206565AM22
RA File Number	09AA04010507 AM22
Licence No and<br>Date	0911001380/08/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	202 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00208798AM22
RA File Number	05AA04089568 AM22
Licence No and<br>Date	0511005321/11/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	203 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00210066AM22
RA File Number	34AA04008458 AM22
Licence No and<br>Date	3411001256/12/10/2021
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>As per the chemical reactions both Phenol and Cumene are formed. Therefore complete calculation for<br>requirement of Cumene for the manufacturing of Phenol, subtracting value of Acetone for import value<br>of Cumene.<br>i.<br>Material balance.<br>ii.

i. As per the chemical reactions both Phenol and Cumene are formed. Therefore complete calculation for requirement of Cumene for the manufacturing of Phenol, subtracting value of Acetone for import value of Cumene.

Case No.	204 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred

101

UDIN00232627AM23

Party Name	NEON LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00210390AM22
RA File Number	03AA040106734 AM22
Licence No and<br>Date	0311007655/12/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	205 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00210670AM22
RA File Number	56AA04005794 AM22
Licence No and<br>Date	5611000556/12/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete specification and COA of import item from foreign supplier.<br>i.<br>Point out the difference in specification of import and export.<br>ii.<br>iii Production / Consumption data for last two years duly certified by GST.

Case No.	206 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AMARA LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00211472AM22
RA File Number	09AA04016055 AM22
Licence No and<br>Date	0911001711/13/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	207 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
PartyName	BENZO CHEM INDUSTRIES PVT LTD

102 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00211526AM22
RA File Number	03AA040110500 AM22
Licence No and<br>Date	0311007683/13/10/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	208 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00211729AM22
RA File Number	05AA04088434 AM22
Licence No and<br>Date	0511005403/13/10/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	209 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00211838AM22
RA File Number	05AA04081672 AM22
Licence No and<br>Date	0511005408/13/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee for explaining its case.

Case No.	210 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00212058AM22
RA File Number	03AA040109332 AM22
Licence No and<br>Date	0311007711/14/10/2021

103 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Norms Committee Decision:

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

Case No.	Case No.	Case No.	211 / NC/3/MEET/Sep/202223/8	211 / NC/3/MEET/Sep/202223/8
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number			HQRNORM APPLY 00214698AM22
RA File Number			03AA040110385 AM22
Licence No and<br>Date			0311007732/17/10/2021
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/Jan/202021/4 dated 12.02.2021against advance authorization No.<br>0310836566 dated 08.06.2020it 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>1<br>Mometasone Furoate Ointment 0.10 Percent (Pack 10gms) (Net Wt. of Mometasone<br>Furoate Micronized 0.200 Kgs.)<br>20000 Packs<br>2<br>Mometasone Furoate Ointment 0.10 Percent (Pack 15gms) (Net Wt. of Mometasone<br>Furoate Micronized 0.300 Kgs.)<br>20000 Packs<br>3<br>Mometasone Furoate Ointment 0.10 Percent /Momate Ointment 0.10 Percent (Pack<br>20gms) (Net Wt. of Mometasone Furoate Micro 0.400 Kgs.)<br>20000 Packs<br>4<br>Mometasone Furoate Ointment 0.10 Percent (Pack 30gms) (Net Wt. of Mometasone<br>Furoate Micronized 3.000 Kgs.)<br>100000 Packs<br>5<br>Mometasone Furoate Ointment 0.10 Percent (pack 45gms) (Net Wt. of Mometasone<br>Furoate Micronized 4.50 Kgs.)<br>100000 Packs<br>6<br>Mometasone Furoate Ointment 0.10 Percent (Pack 50gms) (Net Wt. of Mometasone<br>Furoate Micronized 1.00 Kgs.)<br>20000 Packs<br>Mometasone Furoate Ointment 0.10 Percent (pack 60gms) (Net Wt. of Mometasone<br>7<br>30000 Packs
	Sl. No.	Export Product		Qty.
	1	Mometasone Furoate Ointment 0.10 Percent (Pack 10gms) (Net Wt. of Mometasone<br>Furoate Micronized 0.200 Kgs.)		<br>20000 Packs
	2	Mometasone Furoate Ointment 0.10 Percent (Pack 15gms) (Net Wt. of Mometasone<br>Furoate Micronized 0.300 Kgs.)		<br>20000 Packs
	3	Mometasone Furoate Ointment 0.10 Percent /Momate Ointment 0.10 Percent (Pack<br>20gms) (Net Wt. of Mometasone Furoate Micro 0.400 Kgs.)		<br>20000 Packs
	4	Mometasone Furoate Ointment 0.10 Percent (Pack 30gms) (Net Wt. of Mometasone<br>Furoate Micronized 3.000 Kgs.)		<br>100000 Packs
	5	Mometasone Furoate Ointment 0.10 Percent (pack 45gms) (Net Wt. of Mometasone<br>Furoate Micronized 4.50 Kgs.)		<br>100000 Packs
	6	Mometasone Furoate Ointment 0.10 Percent (Pack 50gms) (Net Wt. of Mometasone<br>Furoate Micronized 1.00 Kgs.)		<br>20000 Packs
	7	Mometasone Furoate Ointment 0.10 Percent (pack 60gms) (Net Wt. of Mometasone		<br>30000 Packs

104

UDIN00232627AM23

	Furoate Micronized 1.800 Kgs.)	Furoate Micronized 1.800 Kgs.)	Furoate Micronized 1.800 Kgs.)
8	Mometasone Furoate Ointment 0.10 Percent (pack 100gms) (Net Wt. of Mometasone<br>Furoate Micronized 2.000 Kgs.)			<br>20000 Packs
9	Mometasone Furoate Tropical Solution USP 0.1 Percent (Lotion) (Pack 30ml) (Net<br>Wt. of Mometasone Furoate Micronized 0.900 Kgs.)			<br>30000 Packs
10	Mometasone Furoate Tropical Solution USP 0.1 Percent (Lotion) (Pack 60ml) (Net<br>Wt. of Mometasone Furoate Micronized 1.800 Kgs.)			<br>30000 Packs
11	Mometasone Furoate Cream 0.1 Percent (Pack 10gms) (Net Wt. of Mometasone<br>Furoate Micronized 0.700 Kgs.)			<br>70000 Packs
12	Mometasone Furoate Cream 0.1 Percent (Pack 15gms) (Net Wt. of Mometasone<br>Furoate Micronized 1.050 Kgs.)			<br>70000 Packs
13	Mometasone Furoate Cream 0.1 Percent (Pack 20gms) (Net Wt. of Mometasone<br>Furoate Micronized 1.40 Kgs.)			<br>70000 Packs
14	Mometasone Furoate Cream 0.1 Percent /Metactiv Cream 0.10 Percent (Pack<br>30gms) (Net Wt. of Mometasone Furoate Micronized 2.40 Kgs.)			<br>80000 Packs
15	Mometasone Furoate Cream 0.1 Percent (Pack 45gms) (Net Wt. of Mometasone<br>Furoate Micronized 3.600 Kgs.)			<br>80000 Packs
16	Mometasone Furoate Cream 0.1 Percent (Pack 50gms) (Net Wt. of Mometasone<br>Furoate Micronized 7.500 Kgs.)			<br>150000 Packs
17	Mometasone Furoate Cream 0.1 Percent (Pack 60gms) (Net Wt. of Mometasone<br>Furoate Micronized 17.400 Kgs.)			<br>290000 Packs
18	Mometasone Furoate Cream 0.1 Percent (Pack 100gms) (Net Wt. of Mometasone<br>Furoate Micronized 29.000 Kgs.)			<br>290000 Packs

Sl. No.		Import Items	Qty

105

UDIN00232627AM23

1 Mometasone Furoate Micronized 59.67 kg

Case No.	Case No.	Case No.	212 / NC/3/MEET/Sep/202223/8	212 / NC/3/MEET/Sep/202223/8	212 / NC/3/MEET/Sep/202223/8	212 / NC/3/MEET/Sep/202223/8	212 / NC/3/MEET/Sep/202223/8
Case Status			Case Approved
Party Name			MILAN LABORATORIES (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number			HQRNORM APPLY 00215619AM22
RA File Number			03AA040110497 AM22
Licence No and<br>Date			0311007757/18/10/2021
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>Sl. No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>PHENOXYMETHYL PENICILLIN TABLETS<br>BP<br>250<br>MG.((Each<br>Tablets<br>contains:Phenoxymethyl Penicillin Potassium<br>277.161 mg equivalent to Phenoxymethyl<br>Penicillin BP 250 mg) ( Total Net Content =<br>6798.898 Kgs ))<br>1 Number<br>1<br>Phenoxymethyl Penicillin<br>Potassium BP<br>277.161 mg<br>2<br>PHENOXYMETHYL PENICILLIN TABLETS<br>500 MG((Each Tablet contains Phenoxymethyl<br>Penicillin Potassium 554.322 mg equivalent to<br>Phenoxymethyl Penicillin BP 500mg ) ( Total<br>Net Content = 7799.311 Kgs ))<br>1 Number<br>2<br>Phenoxymethyl Penicillin<br>Potassium BP<br>554.322 mg<br>3<br>PHENOXYMETHYL<br>PENICILLIN<br>ORAL<br>SOLUTION BP 125 MG/5ML (SYRUP)(Each<br>5ml<br>contains:<br>Phenoxymethyl<br>penicillin<br>Potassium<br>138.580<br>mg<br>equivalent<br>to<br>Phenoxymethyl Penicillin BP 125mg) 100ML<br>Bottle. (Total Net Content = 2633.020 Kgs ))<br>1 Number<br>3<br>Phenoxymethyl Penicillin<br>Potassium BP<br>2771.60 mg<br>PHENOXYMETHYL<br>PENICILLIN<br>ORAL<br>Phenoxymethyl Penicillin<br>4<br>1 Number<br>4<br>5543.22 mg
	Sl. No.	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	1	PHENOXYMETHYL PENICILLIN TABLETS<br>BP<br>250<br>MG.((Each<br>Tablets<br>contains:Phenoxymethyl Penicillin Potassium<br>277.161 mg equivalent to Phenoxymethyl<br>Penicillin BP 250 mg) ( Total Net Content =<br>6798.898 Kgs ))		<br> <br> <br> <br> <br>1 Number	1	Phenoxymethyl Penicillin<br>Potassium BP	<br>277.161 mg
	2	PHENOXYMETHYL PENICILLIN TABLETS<br>500 MG((Each Tablet contains Phenoxymethyl<br>Penicillin Potassium 554.322 mg equivalent to<br>Phenoxymethyl Penicillin BP 500mg ) ( Total<br>Net Content = 7799.311 Kgs ))		<br> <br> <br> <br>1 Number	2	Phenoxymethyl Penicillin<br>Potassium BP	<br>554.322 mg
	3	PHENOXYMETHYL<br>PENICILLIN<br>ORAL<br>SOLUTION BP 125 MG/5ML (SYRUP)(Each<br>5ml<br>contains:<br>Phenoxymethyl<br>penicillin<br>Potassium<br>138.580<br>mg<br>equivalent<br>to<br>Phenoxymethyl Penicillin BP 125mg) 100ML<br>Bottle. (Total Net Content = 2633.020 Kgs ))		<br> <br> <br> <br> <br>1 Number	3	Phenoxymethyl Penicillin<br>Potassium BP	<br>2771.60 mg
	4	PHENOXYMETHYL<br>PENICILLIN<br>ORAL		<br>1 Number	4	Phenoxymethyl Penicillin	<br>5543.22 mg

Case No.	Case No.	Case No.	212 / NC/3/MEET/Sep/202223/8	212 / NC/3/MEET/Sep/202223/8	212 / NC/3/MEET/Sep/202223/8	212 / NC/3/MEET/Sep/202223/8	212 / NC/3/MEET/Sep/202223/8
Case Status			Case Approved
Party Name			MILAN LABORATORIES (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number			HQRNORM APPLY 00215619AM22
RA File Number			03AA040110497 AM22
Licence No and<br>Date			0311007757/18/10/2021
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>Sl. No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>PHENOXYMETHYL PENICILLIN TABLETS<br>BP<br>250<br>MG.((Each<br>Tablets<br>contains:Phenoxymethyl Penicillin Potassium<br>277.161 mg equivalent to Phenoxymethyl<br>Penicillin BP 250 mg) ( Total Net Content =<br>6798.898 Kgs ))<br>1 Number<br>1<br>Phenoxymethyl Penicillin<br>Potassium BP<br>277.161 mg<br>2<br>PHENOXYMETHYL PENICILLIN TABLETS<br>500 MG((Each Tablet contains Phenoxymethyl<br>Penicillin Potassium 554.322 mg equivalent to<br>Phenoxymethyl Penicillin BP 500mg ) ( Total<br>Net Content = 7799.311 Kgs ))<br>1 Number<br>2<br>Phenoxymethyl Penicillin<br>Potassium BP<br>554.322 mg<br>3<br>PHENOXYMETHYL<br>PENICILLIN<br>ORAL<br>SOLUTION BP 125 MG/5ML (SYRUP)(Each<br>5ml<br>contains:<br>Phenoxymethyl<br>penicillin<br>Potassium<br>138.580<br>mg<br>equivalent<br>to<br>Phenoxymethyl Penicillin BP 125mg) 100ML<br>Bottle. (Total Net Content = 2633.020 Kgs ))<br>1 Number<br>3<br>Phenoxymethyl Penicillin<br>Potassium BP<br>2771.60 mg<br>PHENOXYMETHYL<br>PENICILLIN<br>ORAL<br>Phenoxymethyl Penicillin<br>4<br>1 Number<br>4<br>5543.22 mg
	Sl. No.	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	1	PHENOXYMETHYL PENICILLIN TABLETS<br>BP<br>250<br>MG.((Each<br>Tablets<br>contains:Phenoxymethyl Penicillin Potassium<br>277.161 mg equivalent to Phenoxymethyl<br>Penicillin BP 250 mg) ( Total Net Content =<br>6798.898 Kgs ))		<br> <br> <br> <br> <br>1 Number	1	Phenoxymethyl Penicillin<br>Potassium BP	<br>277.161 mg
	2	PHENOXYMETHYL PENICILLIN TABLETS<br>500 MG((Each Tablet contains Phenoxymethyl<br>Penicillin Potassium 554.322 mg equivalent to<br>Phenoxymethyl Penicillin BP 500mg ) ( Total<br>Net Content = 7799.311 Kgs ))		<br> <br> <br> <br>1 Number	2	Phenoxymethyl Penicillin<br>Potassium BP	<br>554.322 mg
	3	PHENOXYMETHYL<br>PENICILLIN<br>ORAL<br>SOLUTION BP 125 MG/5ML (SYRUP)(Each<br>5ml<br>contains:<br>Phenoxymethyl<br>penicillin<br>Potassium<br>138.580<br>mg<br>equivalent<br>to<br>Phenoxymethyl Penicillin BP 125mg) 100ML<br>Bottle. (Total Net Content = 2633.020 Kgs ))		<br> <br> <br> <br> <br>1 Number	3	Phenoxymethyl Penicillin<br>Potassium BP	<br>2771.60 mg
	4	PHENOXYMETHYL<br>PENICILLIN<br>ORAL		<br>1 Number	4	Phenoxymethyl Penicillin	<br>5543.22 mg

106

UDIN00232627AM23

	SOLUTION BP 250 MG/5ML (SYRUP)(Each			Potassium BP
	5ml<br>contains:<br>Phenoxymethyl<br>penicillin
	Potassium<br>277.161<br>mg<br>equivalent<br>to
	Phenoxymethyl Penicillin BP 250mg) 100ML
	Bottle. ( Total Net Content = 2771.610 Kgs ))

Case No.	213 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	LUPIN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00215795AM22
RA File Number	03AA040109357 AM22
Licence No and<br>Date	0311007760/18/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	214 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00220585AM22
RA File Number	05AA04090983 AM22
Licence No and<br>Date	0511005557/21/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	215 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	BHAGWATI INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00219420AM22
RA File Number	08AA04033013 AM22
Licence No and<br>Date	0811002934/21/10/2021

107

UDIN00232627AM23

Norms Committee Decision:

Deferred for comments of TE.

Case No.	216 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00220068AM22
RA File Number	31AA04027993 AM22
Licence No and<br>Date	3111000637/21/10/2021
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.2/82-ALC4/2018 dated 16.05.2018 against advance authorization No.3110066397 d<br>ated 15.11.2016, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2 6 xylenol<br>420 MT<br>2,6 XYLIDINE<br>300 MT<br>2<br>Catalyst<br>Not allow as specific description not given<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	217 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00220580AM22
RA File Number	05AA04091063 AM22
Licence No and<br>Date	0511005553/21/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

108

UDIN00232627AM23

Case No.	218 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM REVIW00001519AM23
RA File Number	31AA04028264 AM22
Licence No and<br>Date	3111000632/21/10/2021
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>Wastage asked is high; to justify the consumption, please furnish Production / Consumption data duly certified<br>by GST on the letter head of GST Department.

Case No.	219 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00220582AM22
RA File Number	05AA04091028 AM22
Licence No and<br>Date	0511005555/21/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	220 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00220583AM22
RA File Number	05AA04091027 AM22
Licence No and<br>Date	0511005556/21/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	221 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred

109

UDIN00232627AM23

Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00221158AM22
RA File Number	07AA04035636 AM22
Licence No and<br>Date	0711002187/22/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	222 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00221196AM22
RA File Number	07AA04035640 AM22
Licence No and<br>Date	0711002189/22/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	223 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00221594AM22
RA File Number	08AA04033661 AM22
Licence No and<br>Date	0811002958/22/10/2021
Norms Committee Decision:<br>Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri<br>Keyur Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The<br>Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited<br>from the firm.<br>Hence, it was decided to issue a Reminder<br> to firm to submit its reply.

Case No.	224 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	THEMIS NUTRITIONALS PRIVATE LIMITED

110

UDIN00232627AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00221695AM22
RA File Number	03AA040108212 AM22
Licence No and<br>Date	0311007847/22/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	225 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00221961AM22
RA File Number	09AA04016348 AM22
Licence No and<br>Date	0911001751/22/10/2021
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.<br>No.<br>Import items<br>Qty.<br>N-[N-METHYL-N-((2-ISOPROPYL-4-<br>THIAZOLY)<br>METHYL)AMINO)<br>CARBONYL]-L-VALINE<br>1 kg<br>1<br>L-Valine<br>0.78 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	226 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00222021AM22
RA File Number	03AA040112432 AM22
Licence No and<br>Date	0311007856/22/10/2021

111

UDIN00232627AM23

Norms Committee Decision:

Deferred for comments of TE.

Case No.	227 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00225362AM22
RA File Number	05AA04093389 AM22
Licence No and<br>Date	0511005627/25/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and based on GST data, it was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Azelaic Acid Cream 30Gm. 20% W/W ( Each<br>Gram of Azelaic Acid Cream Contains Azelaic<br>Acid<br>0.2Gm<br>(<br>20%W/W)((Equivalent<br>to<br>85.200Kgs. of Bulk Drug ) (Pharmaceutical<br>Formulation / Standard Grade ))<br>14200<br>Number<br>1<br>Azelaic Acid<br>86.904 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	228 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	METROPOLITAN EXIMCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00225235AM22
RA File Number	03AA040108347 AM22
Licence No and<br>Date	0311007901/25/10/2021
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:

112

UDIN00232627AM23

i. Step wise manufacturing process.
ii. Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis.
iii. Complete technical details as per Annexure to Appendix 4E for chemical products.
iv. Stoichiometric balance between import and export on molar basis.
v. Details of indigenous input with quantity.

Case No.	229 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00226905AM22
RA File Number	05AA04094141 AM22
Licence No and<br>Date	0511005704/26/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that in this case, no chemical reaction done,<br>only Enzymatic Transformation happens. Hence, the Committee decided to refer the case toDepartment of<br>Biotechnology (DBT)for obtaining its comments.

Case No.	230 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00227461AM22
RA File Number	03AA04097792 AM22
Licence No and<br>Date	0311007966/27/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	231 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	SHREE JAYA LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00229681AM22
RA File Number	09AA04016739 AM22
Licence No and Date	0911001789/28/10/2021
Norms Committee Decision:

113 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

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 items	Qty.
5-DIFLUOROMETHOXY-<br>2MERCAPTO-1H-<br>BENZIMIDAZOLE	1 kg	1	PARACETAMOL	1.435 kg
		2	FREON GAS<br>(CHLORODIFLUOROMETHAN)	NOC by MOEF not<br>given.<br>Not<br>recommended

Case No.	232 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	KREATIVE ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00229743AM22
RA File Number	09AA04016534 AM22
Licence No and<br>Date	0911001791/28/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	233 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00229799AM22
RA File Number	05AA04094507 AM22
Licence No and<br>Date	0511005751/28/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

114

UDIN00232627AM23

Case No.	Case No.	234 / NC/3/MEET/Sep/202223/8	234 / NC/3/MEET/Sep/202223/8	234 / NC/3/MEET/Sep/202223/8	234 / NC/3/MEET/Sep/202223/8	234 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00231062AM22
RA File Number		03AA040112473 AM22
Licence No and<br>Date		0311008038/29/10/2021
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.	235 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00235646AM22
RA File Number	03AA040116357 AM22
Licence No and<br>Date	0311008044/29/10/2021
Norms Committee Decision:<br>The firm vide e-mail dated28.09.2022has enclosed a copy of Surrender Letter dated25.07.2022. In view of above e-<br>mail of firm, the Committee decided towithdrawthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No. 236 / NC/3/MEET/Sep/202223/8

115

UDIN00232627AM23

Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00230750AM22
RA File Number	09AA04016788 AM22
Licence No and<br>Date	0911001796/29/10/2021
Norms Committee Decision:
Deferred for comments of TE.

Case Status	Case Status	Case Deferred	Case Deferred	Case Deferred	Case Deferred	Case Deferred	Case Deferred	Case Deferred
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
H	Q File Number	HQRNORM APPLY 002307			50AM22
R	A File Number	09AA04016788 AM22
L<br>D
	icence No and<br>ate	0911001796/29/10/2021
N<br>D	orms Committee Decision:<br>eferred for comments of TE.


Case No.		237 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		INDOCO REMEDIES LIMITED
Meeting Number		NC/ 3/ MEET/ S/ 202223/ 8 d 23/09/2022
and Date		ep an
HQ File Number		HQRNORM APPLY 00237170AM22
RA File Number		03AA040116473 AM22
Licence No and<br>Date		0311008055/31/10/2021
Norms Committee		Decision:
The Committee co		sidered the case as er aenda and based on GST data it was decided to ratif adhoc norms under
<br>Para 4.07 of HBP		p g , y<br>Vol. I as per details given below or as applied by the firm, whichever is less:

	Export product			Qty.		Sl.<br>No.	Import items	Qty.
	Ketotifen Fumarate ophthalmic<br>solution ( 5ml Bottle )((Each<br>ml. Contains: Ketotifen (0.025			<br> <br> <br>1 Number		1	Ketotifen Fumarate	1.785 mg
								<br>
	percentage) Antihistamine ) (					2	Bottle	Relevant<br>as<br>per<br>packing<br>
	<br>Equivalent<br>to<br>K		<br>etotifen					policy

	Fumarate 0.035 percent<br>		age ) =<br>	<br>		3	Cap
	1.750 mg per bottle o<br>		f 5ml )<br>	<br>
	(Net Weight in Export P<br>is : 700 GRAMS))		roducts			4	Dropper




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

Case No.		238 / NC/3/MEET/Sep/202223/8

Case No. 238 / NC/3/MEET/Sep/202223/8

116

UDIN00232627AM23

Case Status	Case Approved
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00239319AM22
RA File Number	03AA040117252 AM22
Licence No and<br>Date	0311008158/02/11/2021
Norms Committee Decision:
The firm vide e-mail dated28.09.2022has enclosed a copy of Surrender Letter dated25.07.2022. In view of above e-
mail of firm, the Committee decided towithdrawthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	239 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00239466AM22
RA File Number	03AA040116810 AM22
Licence No and<br>Date	0311008170/02/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the reply furnished by the firm was not
complete. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.


Case No	240 / NC/3/MEET/Se/202223/8
.	p
Case Status	Case Deferred

Part Name	BHARAT PARENTERALS LIMITED
y
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

HQ File Number	HQRNORM APPLY 00239596AM22

RA File Number	34AA04008748 AM22

Licence No and<br>Date	3411001363/02/11/2021

Norms Committee Decision:<br>Deferred for comments of TE.

117 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Case No.	241 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00239722AM22
RA File Number	07AA04038456 AM22
Licence No and<br>Date	0711002275/02/11/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	Case No.	Case No.	241 / NC/3/MEET/Sep/202223/8	241 / NC/3/MEET/Sep/202223/8	241 / NC/3/MEET/Sep/202223/8	241 / NC/3/MEET/Sep/202223/8	241 / NC/3/MEET/Sep/202223/8	241 / NC/3/MEET/Sep/202223/8	241 / NC/3/MEET/Sep/202223/8	241 / NC/3/MEET/Sep/202223/8	241 / NC/3/MEET/Sep/202223/8	241 / NC/3/MEET/Sep/202223/8
Case Status			Case Deferred
Party Name
	arty Nam	e	GLOBAL CALCIUM PRI			ATE LIMITE		D
M<br>a	eeting N<br>nd Date	umber	NC/ 3/ MEET/ Sep/ 202223			/ 8 and 23/09/2		022
H	Q File N	umber	HQRNORM APPLY 00239			722AM22
R	A File N	umber	07AA04038456 AM22
L<br>D	icence N<br>ate	o and	0711002275/02/11/2021
N<br>D	orms Co<br>eferred f	mmittee Decision:<br>or comments of TE.

C	ase No.		242 / NC/3/MEET/Sep/2022			23/8
C	ase Statu	s	Case Approved
P	arty Nam	e	BELCHEM INDUSTRIES (			INDIA) PVT L		TD
M<br>a	eeting N<br>nd Date	umber	NC/ 3/ MEET/ Sep/ 202223			/ 8 and 23/09/2		022
H	Q File N	umber	HQRNORM APPLY 00239			808AM22
R	A File N	umber	03AA040117646 AM22
L<br>D	icence N<br>ate	o and	0311008190/02/11/2021
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.12/82-ALC4/2018 dated 12.12.2018against advance authorization No.0310820299<br>dated 06.04.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:	orms Co<br>he Com<br>	mmittee Decision:<br>mittee considered the case as per ag<br>				enda and taki<br>		ng cue<br>		from earlier decision for same e<br>		xport product /<br>

	E d						Sl N		I i
	xport prouct				Qty.		. o.		mport tems		Qty.

	1,3 DIMETHYLOL-5,<br>HYDANTOIN ((DMD<br>			5-DIMETHYL<br>M<br>	1 kg		1		5,5 DIMETHYL HYDANTOIN<br>ASSAY 99 Percentage MIN<br>		0.382 kg
	HYDANTOIN 52 Perc<br>			entage<br>					COLOUR PURE WHITE
	55Percentage) ASSAY
	55 Percentage MAX			BELGUARD
DMDMH)<br> <br>RA concerned may take further necessary action as per above decision of NC.	DMDMH)

Case No.			243 / NC/3/MEET/Sep/202223/8
Case Status			Case Approved

Case No.	243 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved

118

UDIN00232627AM23

Party Name<br>SYNTHO CHIRALS PRIVATE LIMITED	Party Name<br>SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00240653AM22
RA File Number<br>09AA04017004 AM22
Licence No and<br>Date<br>0911001811/03/11/2021
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.	Sl.	Import items		Qty.
		No.
Sodium(S)-4-oxo-4,6,7,8-tetrahydropyrrolo	1 kg	1	NORBORNADIENE TECH		1.73 kg
[1,2-a]pyrimidine-6- carboxylate
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.<br>244 / NC/3/MEET/Sep/202223/8	Case No.<br>244 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Approved
Party Name<br>SANDHYA ORGANIC CHEMICALS		PVT LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00240922AM22
RA File Number<br>03AA040114188 AM22
Licence No and<br>Date<br>0311008242/03/11/2021
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.8/82-ALC4/2018 dated 31.08.2018against advance authorization No.0310818751 dated
31.01.2018, 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.	Sl. No.		Import items	Qty.
2<br>ETHYLHEXYL<br>DIPHENYL 1 kg	1		PHENOL	0.604 kg

119

UDIN00232627AM23

PHOSPHITE((2EHDP))		2	2 ETHYL HEXANOL	0.386 kg
		3	YELLOW PHOSPHORUS	0.0966 kg

Case No.	Case No.	245 / NC/3/MEET/Sep/202223/8	245 / NC/3/MEET/Sep/202223/8	245 / NC/3/MEET/Sep/202223/8	245 / NC/3/MEET/Sep/202223/8	245 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		INDIA GLYCOLS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00244346AM22
RA File Number		05AA04093440 AM22
Licence No and<br>Date		0511005996/08/11/2021
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>Denatured Ethyl Alcohol<br>1.123 kg<br>2<br>Silver Catalyst (Activity 17% to 18%)<br>0.000228 kg<br>Mono Ethylene Glycol (MEG)<br>1 kg<br>3<br>Alumina Catalyst<br>0.000362 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Mono Ethylene Glycol (MEG)		1 kg	1	Denatured Ethyl Alcohol	1.123 kg
				2	Silver Catalyst (Activity 17% to 18%)	0.000228 kg
				3	Alumina Catalyst	0.000362 kg
				as per above decision of NC.

Case No.	246 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00245478AM22
RA File Number	03AA040118307 AM22

120

UDIN00232627AM23

Licence No and	Licence No and	Licence No and	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021
Date
Norms Committee			Decision:
Th Ci			idd h d d ki f li dii f d /
e ommttee co<br>import item in M			nsere te case as per agena an tang cue rom earer ecson or same export prouct<br>eeting NoNC/3/MEET/Jun/202223/5 dated 08072022against advance authorization No
<br>0311005056 dated<br>given below or as a			....<br>02.07.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>pplied by the firm, whichever is less:

	Sl. No.	Export product								Qty.

	1	Clobetasol Propionate Foam 0.05percent<br>		50gm(( Net		. wt. of		Net. wt. of Clobetasol Propionate USP		<br>1 Nu		mber
		(Micronized) is 5.00 Kgs)
	2	Clobetasol Propionate Foam 0.05per<br>(Micronized) is 10.00 Kgs.))		cent 100gm		((Net.		wt. of Clobetasol Propionate USP		<br>1 Nu		mber

	3	Clobetasol Propionate Cream USP 0.05percent (Pack Size 15gm)((Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.15 Kgs))								<br>1 Number

	4	Clobetasol Propionate Cream USP 0.05percent (Pack size 30gm)((Net Weight of Clobetasol								<br>1 Number
		<br>Propiona	<br>te USP (Micronized) 0.300 Kgs))


	5	Clobetas	ol Propionate Cream USP 0.05percent (Pack size 45 gm)((Net Weight of Clobetasol							<br>1 Number
		<br>Propiona	<br>te USP (Micronized) 1.125 Kgs))
	6	Clbt	l Pit C USP 005t Pk i 60Nt Wiht f Clbtl							<br>1 Nb
		oeas<br>Propiona	roponae ream .percen (ac sze gm)((e eg o oeaso<br>te USP (Micronized) 1.500 Kgs))							<br>umer

										<br>
	7	Clobetasol Propionate Ointment USP 0.05percent (Pack size 15gm)((Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.375 Kgs))								<br>1 Number
	8	Clobetasol Propionate Ointment USP 0.05percent (Pack size 30gm)((Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.750 Kgs))								<br>1 Number

	9	Clobetasol Propionate Ointment USP 0.05p<br>Propionate USP (Micronized) 0.900 Kgs))			ercent (Pack		size 45		gm)((Net Weight of Clobetasol	<br>1	Number

	10	Clobetasol Propionate Ointment USP 0.05p<br>Propionate USP (Micronized) 0.600 Kgs))			ercent (Pack		size 60		gm)((Net Weight of Clobetasol	<br>1	Number

	11	Clobetasol Propionate Spray 0.05percent (Pa			ck size 59m		l)((Net		Weight of Clobetasol Propionate	<br>1	Number

Licence No and	Licence No and	Licence No and	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021	0311008357/09/11/2021
Date
Norms Committee			Decision:
Th Ci			idd h d d ki f li dii f d /
e ommttee co<br>import item in M			nsere te case as per agena an tang cue rom earer ecson or same export prouct<br>eeting NoNC/3/MEET/Jun/202223/5 dated 08072022against advance authorization No
<br>0311005056 dated<br>given below or as a			....<br>02.07.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>pplied by the firm, whichever is less:

	Sl. No.	Export product								Qty.

	1	Clobetasol Propionate Foam 0.05percent<br>		50gm(( Net		. wt. of		Net. wt. of Clobetasol Propionate USP		<br>1 Nu		mber
		(Micronized) is 5.00 Kgs)
	2	Clobetasol Propionate Foam 0.05per<br>(Micronized) is 10.00 Kgs.))		cent 100gm		((Net.		wt. of Clobetasol Propionate USP		<br>1 Nu		mber

	3	Clobetasol Propionate Cream USP 0.05percent (Pack Size 15gm)((Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.15 Kgs))								<br>1 Number

	4	Clobetasol Propionate Cream USP 0.05percent (Pack size 30gm)((Net Weight of Clobetasol								<br>1 Number
		<br>Propiona	<br>te USP (Micronized) 0.300 Kgs))


	5	Clobetas	ol Propionate Cream USP 0.05percent (Pack size 45 gm)((Net Weight of Clobetasol							<br>1 Number
		<br>Propiona	<br>te USP (Micronized) 1.125 Kgs))
	6	Clbt	l Pit C USP 005t Pk i 60Nt Wiht f Clbtl							<br>1 Nb
		oeas<br>Propiona	roponae ream .percen (ac sze gm)((e eg o oeaso<br>te USP (Micronized) 1.500 Kgs))							<br>umer

										<br>
	7	Clobetasol Propionate Ointment USP 0.05percent (Pack size 15gm)((Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.375 Kgs))								<br>1 Number
	8	Clobetasol Propionate Ointment USP 0.05percent (Pack size 30gm)((Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.750 Kgs))								<br>1 Number

	9	Clobetasol Propionate Ointment USP 0.05p<br>Propionate USP (Micronized) 0.900 Kgs))			ercent (Pack		size 45		gm)((Net Weight of Clobetasol	<br>1	Number

	10	Clobetasol Propionate Ointment USP 0.05p<br>Propionate USP (Micronized) 0.600 Kgs))			ercent (Pack		size 60		gm)((Net Weight of Clobetasol	<br>1	Number

	11	Clobetasol Propionate Spray 0.05percent (Pa			ck size 59m		l)((Net		Weight of Clobetasol Propionate	<br>1	Number

121

UDIN00232627AM23

	USP (Micronized) 1.180 Kgs))
12	Clobetasol Propionate Spray 0.05percent (Pack size 125ml)((Net Weight of Clobetasol Propionate	<br>1 Number
	USP (Micronized) 2.500 Kgs))
13	Clobetasol Prop. Top Sol USP, 0.05percent 25ml((Net Weight of Clobetasol Propionate USP	<br>1 Number
	(Micronized) 0.625 Kgs))
14	Clobetasol Prop. Top Sol USP, 0.05percent 50ml((Net Weight of Clobetasol Propionate USP	<br>1 Number
	(Micronized) 1.000 Kgs))
15	Clobetasol Pro Shampoo, 0.05 percent 118ml((Net Weight of Clobetasol Propionate USP	<br>1 Number
	(Micronized) 2.360 Kgs))
16	Clobetasol Propionate Foam 0.05percent 100gm (Emulsion Formulation)(( Net. wt. of Clobetasol	<br>1 Number
	Propionate USP (Micronized) is 0.500 Kgs.))
17	Clobetasol Propionate Foam 0.05percent 50gm (Emulsion Formulation)(( Net. wt. of Clobetasol	<br>1 Number
	Propionate USP (Micronized) is 0.250 Kgs.))

Import Item	Import Item
	Import Item	Qty.
	CLOBETASOL PROPIONATE USP (MICRONIZED)	0.051 gram/ 100 gram pack
	(For other pack size from Sl. No. 1 to 10 and 16 and 17 of Export Products, the quantity of import item CLOBETASOL
	PROPIONATE USP (MICRONIZED) will be worked out on pro rata basis.

	Import Item	Qty.
	CLOBETASOL PROPIONATE USP (MICRONIZED)	0.051 gram/ 100 ml
	(For other pack size from Sl. No. 11 to 15 of Export Products, the quantity of import item CLOBETASOL PROPIONATE
	USP (MICRONIZED) will be worked out on pro rata basis.

122 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Case No.	247 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	NITIKA PHARMACEUTICAL SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00245623AM22
RA File Number	50AA04003867 AM22
Licence No and<br>Date	5011000294/09/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	248 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AARTI INDUSTRIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00246187AM22
RA File Number	03AA04078980 AM22
Licence No and<br>Date	0311008372/09/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	249 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	LUPIN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00246327AM22
RA File Number	03AA040117674 AM22
Licence No and<br>Date	0311008377/09/11/2021
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/Jun/202223/5 dated 08.07.2022against advance authorization No.<br>0311005020 dated 30.06.2021, 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:

123 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Export product	Qty.	Sl. No.	Import items	Qty.
QUININE SULFATE CAPS USP 324	<br>1 Number	1	QUININE SULFATE USP	330.48 mg /
MG(QUININE SULFATE CAPS USP				Capsule
324 MG (NET WT. 50.91 KGS, WEIGHT
OF DRUGS : 57.02 KGS))

Case No.	250 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	LUPIN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00246330AM22
RA File Number	03AA040117679 AM22
Licence No and<br>Date	0311008378/09/11/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	Case No.	251 / NC/3/MEET/Sep/202223/8	251 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		REYAANSH HEALTHCARE
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8	and 23/09/2022
HQ File Number		HQRNORM APPLY 00246356AM22
RA File Number		03AA040110381 AM22
Licence No and<br>Date		0311008381/09/11/2021
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.	Sl.	Import items	Qty.
			No.
	MAROPITANT	CITRATE 1 Number	1	MAROPITANT CITRATE (Monohydrate)	210 mg

124

UDIN00232627AM23

INJECTION 10 MG/ML, 20 ml Vial

Case No.	252 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00246932AM22
RA File Number	03AA040119771 AM22
Licence No and<br>Date	0311008387/10/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee.		Personal Hearing

Case No.	Case No.	253 / NC/3/MEET/Sep/202223/8	253 / NC/3/MEET/Sep/202223/8	253 / NC/3/MEET/Sep/202223/8	253 / NC/3/MEET/Sep/202223/8	253 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00248395AM22
RA File Number		03AA040113998 AM22
Licence No and<br>Date		0311008443/11/11/2021
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.<br>No.<br>Import items<br>Qty.<br>1<br>Ethylene Oxide<br>0.6453 kg<br>Methyl-Monoethanolamine<br>(MMEA)<br>1 kg<br>2<br>Monomethyl Amine 40%<br>0.4257 kg
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	Methyl-Monoethanolamine<br>(MMEA)		1 kg	1	Ethylene Oxide	0.6453 kg
				2	Monomethyl Amine 40%	0.4257 kg

125

UDIN00232627AM23

Case No.	Case No.	Case No.	254 / NC/3/MEET/Sep/202223/8	254 / NC/3/MEET/Sep/202223/8	254 / NC/3/MEET/Sep/202223/8	254 / NC/3/MEET/Sep/202223/8	254 / NC/3/MEET/Sep/202223/8
Case Status			Case Approved
Party Name			J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number			HQRNORM APPLY 00248392AM22
RA File Number			03AA040117919 AM22
Licence No and<br>Date			0311008437/11/11/2021
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/202223/3 dated 27.05.2022against advance authorization No.<br>0310814635 dated 14.07.2017, 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.<br>No.<br>Export product<br>Qty.<br>Sl. No<br>Import items<br>Qty.<br>1.<br>Benzydamine Hydrochloride 3.06 gram<br>2<br>Cetylpyridinium Chloride<br>1.356 gram<br>1<br>Benzydamine<br>Hydrochloride<br>And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory And Antiseptic Lozenges<br>Sugar Free and(all other flavours. Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride- 1.33mg (iii) Isomalt ST-M -<br>2586mg. Net content (i) 33.333 Kgs (ii)<br>14.778 Kgs (iii) 28733.356 Kgs.)<br>1000<br>Number<br>3<br>Isomalt ST-M<br>2586 gram<br>4<br>Benzydamine Hydrochloride 3.06 gram<br>2<br>Benzydamine<br>Hydrochloride,<br>2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine<br>Hydrochloride Anaesthetic, Anti-<br>Inflammatory,(Anti-Bacterial<br>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.)<br>1000<br>Number<br>5<br>Isomalt ST-M<br>2586 gram<br>6<br>Benzydamine Hydrochloride 3.06 gram<br>Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free. Each<br>1000<br>3
	Sl.<br>No.	Export product		Qty.	Sl. No	Import items	Qty.
	1	Benzydamine<br>Hydrochloride<br>And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory And Antiseptic Lozenges<br>Sugar Free and(all other flavours. Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride- 1.33mg (iii) Isomalt ST-M -<br>2586mg. Net content (i) 33.333 Kgs (ii)<br>14.778 Kgs (iii) 28733.356 Kgs.)		1000<br>Number	1.	Benzydamine Hydrochloride	3.06 gram
					2	Cetylpyridinium Chloride	1.356 gram
					3	Isomalt ST-M	2586 gram
	2	Benzydamine<br>Hydrochloride,<br>2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine<br>Hydrochloride Anaesthetic, Anti-<br>Inflammatory,(Anti-Bacterial<br>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.)		<br> <br> <br> <br> <br>1000<br>Number	4	Benzydamine Hydrochloride	3.06 gram
					5	Isomalt ST-M	2586 gram
	3	Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free. Each		<br>1000	6	Benzydamine Hydrochloride	3.06 gram

126

UDIN00232627AM23

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

Case No.	255 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	FREESIA CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00249915AM22
RA File Number	03AA040117893 AM22
Licence No and<br>Date	0311008508/12/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	256 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00250347AM22
RA File Number	32AA04026501 AM22
Licence No and<br>Date	3211001926/12/11/2021
Norms Committee Decision:

127

UDIN00232627AM23

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/202122/14 dated 21.02.2022 against advance authorization No. 3210079501 dated 05.05.2020 and also based on GST Production / Consumption data, 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 items	Qty.
Enamber / Kephalis / Tetrambrone	1 kg	1	Triethyl Orthoformate	2.400 kg
		2	Mesityl Oxide	2.700 kg

Case No.	Case No.	257 / NC/3/MEET/Sep/202223/8	257 / NC/3/MEET/Sep/202223/8	257 / NC/3/MEET/Sep/202223/8	257 / NC/3/MEET/Sep/202223/8	257 / NC/3/MEET/Sep/202223/8
Case Status		Case Approved
Party Name		KUSUMA PHARMA
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number		HQRNORM APPLY 00250919AM22
RA File Number		03AA040116489 AM22
Licence No and<br>Date		0311008529/13/11/2021
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/Apr/202223/1 dated 29.04.2022against advance<br>authorization No.0310822078 dated 02.07.2018, it was decided to ratify adoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>SACCHARIN POWDER<br>(PURE/AR) (DENTAL GRADE) (Not<br>less than 98% purity)<br>1 kg<br>1<br>SODIUM SACCHARIN<br>1.38 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	SACCHARIN POWDER<br>(PURE/AR) (DENTAL GRADE) (Not<br>less than 98% purity)		<br>1 kg	1	SODIUM SACCHARIN	1.38 kg

128

UDIN00232627AM23

Case No.<br>258 / NC/3/MEET/Sep/202223/8	Case No.<br>258 / NC/3/MEET/Sep/202223/8
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number<br>HQRNORM APPLY 00252656AM22
RA File Number<br>03AA040113394 AM22
Licence No and<br>Date<br>0311008534/15/11/2021
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.	259 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00253243AM22
RA File Number	34AA04009242 AM22
Licence No and<br>Date	3411001396/15/11/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No. 260 / NC/3/MEET/Sep/202223/8

129

UDIN00232627AM23

Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00253270AM22
RA File Number	05AA04099135 AM22
Licence No and<br>Date	0511006147/15/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	261 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	HELLA INFRA MARKET PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00255254AM22
RA File Number	03AA040120188 AM22
Licence No and<br>Date	0311008616/17/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	262 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00255297AM22
RA File Number	34AA04009240 AM22
Licence No and<br>Date	3411001409/17/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	263 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00255683AM22
RA File Number	09AA04016606 AM22
Licence No and	0911001869/17/11/2021

130 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Date Norms Committee Decision:

Deferred for comments of TE.

Case No.	264 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00255868AM22
RA File Number	03AA040112749 AM22
Licence No and<br>Date	0311008637/17/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	265 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	HELLA INFRA MARKET PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00255252AM22
RA File Number	03AA040117899 AM22
Licence No and<br>Date	0311008615/17/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	266 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00256672AM22
RA File Number	07AA04039164 AM22
Licence No and<br>Date	0711002363/18/11/2021
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:

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:

131 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:24.

UDIN00232627AM23

Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Prochlorperazine Edisylate Injection<br>USP<br>10mg/2mL(2mL<br>Vial<br>-<br>Prochlorperazine Edisylate Injection<br>USP 10mg/2mL and capped with<br>Rubber stopper 110010718)<br>1 Number<br>1<br>Rubber Stopper 110010718<br>Relevant as per<br>packing policy<br> <br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl.<br>No.	Import items	Qty.
	Prochlorperazine Edisylate Injection<br>USP<br>10mg/2mL(2mL<br>Vial<br>-<br>Prochlorperazine Edisylate Injection<br>USP 10mg/2mL and capped with<br>Rubber stopper 110010718)	<br> <br> <br> <br>1 Number	1	Rubber Stopper 110010718	Relevant as per<br>packing policy

Case No.	267 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	SARACA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00256800AM22
RA File Number	09AA04017459 AM22
Licence No and<br>Date	0911001876/18/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	268 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	ARKRAY HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00257390AM22
RA File Number	52AA04018127 AM22
Licence No and<br>Date	5211001587/18/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology<br>(DBT).

Case No.	269 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	ALTA LABORATORIES LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022

132

UDIN00232627AM23

and Date
HQ File Number	HQRNORM APPLY 00258363AM22
RA File Number	03AA040121922 AM22
Licence No and<br>Date	0311008684/19/11/2021
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.16/82-ALC4/2014 dated 23.01.2015against advance authorization No.0310763559<br>dated 27.12.2013, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:<br>Export Product<br>Qty<br>Sl. No.<br>Import Item Name.<br>Qty.<br>1<br>Salicylic Acid<br>0.955 kg<br>Methyl Salicylate<br>1 kg<br>2<br>Methanol<br>0.244 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	270 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00261092AM22
RA File Number	09AA04016734 AM22
Licence No and<br>Date	0911001888/22/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	271 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00262146AM22
RA File Number	03AA040119401 AM22
Licence No and	0311008754/23/11/2021

133

UDIN00232627AM23

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. 5/82-ALC4/2019 dated 02.08.2019 against advance authorization No. 0310829197 dated 22.05.2019 and SION A-1143 , 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.
TRIS TRIDECYL PHOSPHITE	1 kg	1	PHENOL	0.05 kg
		2	TRIDECYL ALCOHOL	0.975 kg
		3	YELLOW PHOSPHORUS	0.0522 kg

Case No.	272 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00262432AM22
RA File Number	05AA04098038 AM22
Licence No and<br>Date	0511006369/23/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	273 / NC/3/MEET/Sep/202223/8
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00262564AM22
RA File Number	03AA04013560 AM22
Licence No and<br>Date	0311008775/23/11/2021
Norms Committee Decision:

134

UDIN00232627AM23

Deferred for comments of TE.

Case No.	274 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	SYMED LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00262695AM22
RA File Number	09AA04017472 AM22
Licence No and<br>Date	0911001919/23/11/2021
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.<br>No.<br>Import items<br>Qty.<br>1<br>(S)-Ethyl 3-Cyano-5- methylhexanoate<br>1.438 kg<br>2<br>Methanol<br>1.00 kg<br>PREGABALIN<br>1 kg<br>3<br>Isopropyl Alcohol<br>2.00 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	275 / NC/3/MEET/Sep/202223/8
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00263425AM22
RA File Number	03AA040109731 AM22
Licence No and<br>Date	0311008810/24/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis GST data furnished by the firm and comparative

135

UDIN00232627AM23

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.	276 / NC/3/MEET/Sep/202223/8
Case Status	Case Rejected
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 8 and 23/09/2022
HQ File Number	HQRNORM APPLY 00272165AM22
RA File Number	03AA040124486 AM22
Licence No and<br>Date	0311009090/02/12/2021
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.

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