IN FORCE Advance Authorisation

DGFT Minutes

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Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग

Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली VANIJYA BHAWAN, AKBAR ROAD,NEW DELHI / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Dec/202223/15 DATED: 29/12/2022

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/Dec/202223/15 dated 29/12/2022 of Norms Committee - III for the year 2022-23 was held on 29/12/2022 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

	Name and Designation of Representatives
1	AJAY KUMAR,Deputy Director	DGFT(HQ)
2	NAND Lal,Technical Consultant	DPIIT
3	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT

Representatives**||Department| |---|---|---|---|---| |1||AJAY KUMAR,Deputy Director|DGFT(HQ)|| |2||NAND Lal,Technical Consultant|DPIIT|| |3||DINESHNARAIN MATHUR,Technical Consultant|DGFT||

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signe Name: Ajay Kumar( Deputy Director ) Name: Ajay Kumar( uty Director ) Date: 20-Jan-2023 16:13:36 Date: 20-Jan-2023 6:13:36 Reason: AJAY.DHIMAN88@GOV.IN Reason: AJAY. IAN88@GOV.IN Location: DGFT(HQ) Location: DGFTIHG)

This document has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 20-Jan-2023.

UDIN00314089AM23

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	BIO-GEN EXTRACTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00003012AM23
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was observed that as per COA, details of
import and export items are not different and also the process given is confusing.
Hence, it was decided to call the firm for attendingPersonal Hearing<br>		before Norms Committee to
explain its case.

Case No.<br>2 / NC/3/MEET/Dec/202223/15	Case No.<br>2 / NC/3/MEET/Dec/202223/15
Case Status<br>Case Approved
Party Name<br>INDIA GLYCOLS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>HQRNORM APPLY 00004452AM23
RA File Number<br>NA
Licence No and<br>Date<br>NA
Norms Committee Decision:
The Committee considered the case as per agenda and		taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Nov/202223/12 dated 18.11.2022against advance authorization No.
0511011991 dated 20.04.2022, it was decided to ratify		adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl.

20.04.2022**, it was decided to ratify||adhoc norms under Para 4.07 of HBP Vol. I as per details|||| |given below or as applied by the firm, whichever is less:|||||| |Export product Qty.|Sl. No.||Import items|Qty.|| |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||

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

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

Case No.	3 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	BIO-GEN EXTRACTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00003010AM23
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was observed that as per COA, details of
import and export items are not different and also the process given is confusing.
Hence, it was decided to call the firm for attendingPersonal Hearing<br>		before Norms Committee to
explain its case.

items are not different and also the process given is confusing.||| |Hence, it was decided to call the firm for attendingPersonal Hearing ||before Norms Committee to| |explain its case.|||

Case No.	4 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	BIO-GEN EXTRACTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00003011AM23
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was observed that as per COA, details of
import and export items are not different and also the process given is confusing.
Hence, it was decided to call the firm for attendingPersonal Hearing<br>		before Norms Committee to
explain its case.

Case No.	5 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	CORPORATE CHANNELS (INDIA) PVT. LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

HQ File Number	HQRNORM REVIW00002028AM23
RA File Number	132404000019 AM14
Licence No and<br>Date	1310044179/29/08/2013
Norms Committee Decision:
Deferred for comments of TE.

HQ File Number	HQRNORM REVIW00002028AM23
RA File Number	132404000019 AM14
Licence No and<br>Date	1310044179/29/08/2013
Norms Committee Decision:
Deferred for comments of TE.

Case No.	6 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00001869AM23
RA File Number	052404000399 AM17
Licence No and<br>Date	0510400599/02/12/2016
Norms Committee Decision:
Deferred for comments of TE.

Case No.	7 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	NATURAL HERBS & FORMULATIONS
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00004230AM23
RA File Number	612404000001 AM18
Licence No and<br>Date	6110001419/13/04/2017
Norms Committee Decision:
Deferred for comments of TE.

Case No.	8 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00001867AM23
RA File Number	052404000008 AM18
Licence No and<br>Date	0510402246/18/04/2017
Norms Committee Decision:
Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

ision:|| |Deferred for comments of TE.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case No.	9 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	NATURAL HERBS & FORMULATIONS
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00004226AM23
RA File Number	612404000002 AM18
Licence No and<br>Date	6110001452/18/08/2017
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	10 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00001870AM23
RA File Number	052404000297 AM18
Licence No and<br>Date	0510404439/31/10/2017
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	11 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	NATURAL HERBS & FORMULATIONS
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00004092AM23
RA File Number	612404000004 AM18
Licence No and<br>Date	6110001484/16/01/2018
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	12 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00160008AM22

Case No.	12 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00160008AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

RA File Number	039404000838 AM18
Licence No and<br>Date	0310818810/31/01/2018
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	13 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00001184AM23
RA File Number	092404000181 AM19
Licence No and<br>Date	0910066442/11/07/2018
Norms Committee Decision:<br>Deferred for comments of TE.

9/12/2022| |HQ File Number|HQRNORM REVIW00001184AM23| |RA File Number|092404000181 AM19| |Licence No and Date|0910066442/11/07/2018| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.		14 / NC/3/MEET/Dec/202223/15	14 / NC/3/MEET/Dec/202223/15	14 / NC/3/MEET/Dec/202223/15	14 / NC/3/MEET/Dec/202223/15	14 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			AUROBINDO PHARMA LTD
Meeting Number an<br>Date		d	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM REVIW00001185AM23
RA File Number			092404000345 AM19
Licence No and Da		te	0910066762/25/10/2018
Norms Committee		Decision:
The Committee considered the request of firm for fixation of adhoc norms and it wasdecided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:



	Export Product			Qty	Sl No	Import Items	Qty
				.	.

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| |||||.|. .||.| ||AMOXYCILLI |N AND || 80000000 |1|6-APA|23174.40 kg| ||CLAVULANAT |E POTASSIUM || Numbers|||| ||||||||| ||TABLETS Rlt Blk|25 MG([The D tt i|| |2|Methanol|1497.36 kg| ||eevan u the export produ Trihydrate 40|rug conen n ct is Amoxcillin 000 Kgs and|| |||| |||||||| | || Clavulanate Potasssium +Avicel 10000 KgA])||| |3|Methyl d-(-)-4-hydroxy-phenylglycinate OR D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester]| 19649.28 kg|

Case No.		14 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number an<br>Date	d	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM REVIW00001185AM23
RA File Number		092404000345 AM19
Licence No and Da	te	0910066762/25/10/2018
Norms Committee	Decision:
The Committee considered the request of firm for fixation of adhoc norms and it wasdecided to ratify adhoc norms<br>under Para 4.07 of HBP Vol.

62/25/10/2018||||| |Norms Committee||Decision:|||||| |The Committee considered the request of firm for fixation of adhoc norms and it wasdecided 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| |||||.|. .||.| ||AMOXYCILLI |N AND || 80000000 |1|6-APA|23174.40 kg| ||CLAVULANAT |E POTASSIUM || Numbers|||| ||||||||| ||TABLETS Rlt Blk|25 MG([The D tt i|| |2|Methanol|1497.36 kg| ||eevan u the export produ Trihydrate 40|rug conen n ct is Amoxcillin 000 Kgs and|| |||| |||||||| | || Clavulanate Potasssium +Avicel 10000 KgA])||| |3|Methyl d-(-)-4-hydroxy-phenylglycinate OR D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester]| 19649.28 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23


	4<br>Penicillin G Amidase (Particle size 250		-	<br>89.76 kg
	500 micron, Creamish to	Brown regularly
	shaped beads)
	5<br>Potassium<br>Clavulanate	<br>diluted<br>with		<br>10200	kg
	Microcrystalline<br>Cellulose<br>(1:1)		/	<br>Activity
	Clavulanate Potassium +Avicel [in Acitve
	Base]
A concerned may take further necessary action as	per above decision of NC.

ine Cellulose (1:1)||/| Activity||| ||||Clavulanate Potassium +Avicel [in Acitve|||||| ||||Base]|||||| ||A concerned may take further necessary action as||per above decision of NC.||||||


					4	Penicillin G Amidase (Particle size 250 -<br>	<br> <br>89.76 kg
						500 micron, Creamish to Brown regularly<br>hd bd
						sape eas)

					5	Potassium<br>Clavulanate<br>diluted<br>with	<br>10200<br>kg
						Microcrystalline<br>Cellulose<br>(1:1)<br>/<br>	<br> <br>Activity
						Clavulanate Potassium +Avicel [in Acitve<br>Base]
R
	A concerned may take further necessary action as				per above decision of NC.

Case No.			15 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			AUROBINDO PHARMA LTD

Meeting Number and<br>D			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
ate
H Fil Nb			HRNORM REVIW00001186AM23
Q e umer			Q
RA Fil Nb			092404000386 AM19
e umer
Li N d D			0910066874/20/11/2018
cence o an a		e
Norms Committee		Decision:
The Committee co		nsidered the request of firm for fixation of adhoc norms and it wasdecided 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.

asdecided 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.| ||||||||| ||AMOXYCILLIN AND||| 100000000|1|6-APA|50694.00 kg| || CLAVULANAT| E POTASSIUM|| Numbers|||| ||TABLETS 1|000 MG([The|||||| ||Relevant Bulk|Drug content in|||2|Methanol|3275.50 kg| ||the export Amoxycillin T |product is rihydrate 87500 || |||| ||||||3|Methyl d-(-)-4-hydroxy-phenylglycinate| 42982.80 kg| ||Kgs and Clavul |anate Potassium ||||OR D-(-)-4-hydroxyphenylglycine methyl|| ||+ Avicel 12500|gs)||||ester [PHPG Ester]|| ||||||||| ||||||4|Penicillin G Amidase (Particle size 250 -| 19635 kg| ||||||| 500 micron, Creamish to Brown regularly shaped beads)| .| ||||||Potassium Clavulanate diluted with 12750 kg 5|||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Microcrystalline Cellulose (1:1) / Activity Clavulanate Potassium +Avicel [in Acitve Base]

Case No.	16 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00001539AM23
RA File Number	342404000083 AM20
Licence No and<br>Date	3410045200/10/06/2019
Norms Committee Decision:
Deferred for comments of TE.

9/12/2022| |HQ File Number|HQRNORM REVIW00001539AM23| |RA File Number|342404000083 AM20| |Licence No and Date|3410045200/10/06/2019| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	17 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	JINDAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00405134AM22
RA File Number	039404000005 AM21
Licence No and<br>Date	0310835906/25/04/2020
Norms Committee Decision:
Deferred for comments of TE.

Case No.	18 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	JINDAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00405090AM22
RA File Number	039404000003 AM21
Licence No and<br>Date	0310835903/25/04/2020
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Deferred for comments of TE.

Case No.	19 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	KUMAR ORGANIC PRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00000645AM23
RA File Number	072404000030 AM21
Licence No and<br>Date	0710116410/01/05/2020
Norms Committee Decision:
Deferred for comments of TE.

9/12/2022| |HQ File Number|HQRNORM REVIW00000645AM23| |RA File Number|072404000030 AM21| |Licence No and Date|0710116410/01/05/2020| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	20 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00000568AM23
RA File Number	052404000295 AM21
Licence No and<br>Date	0510415273/21/09/2020
Norms Committee Decision:
Deferred for comments of TE.

Case No.	Case No.		21 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			ZYDUS LIFESCIENCES LIMITED
Meeting Number and<br>Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM REVIW00003412AM23
RA File Number			08AA04004845 AM21
Licence No and Date			0811000109/18/12/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it wasdecided to ratify adhoc norms under
Para 4.07		of HBP Vol. I	as per details given below or as applied by the firm, whichever is less:
	Sl. No.	Export product<br>Qty.<br>Sl. No.		Import items	Qty.

y adhoc norms under||||||| |Para 4.07||of HBP Vol. I|as per details given below or as applied by the firm, whichever is less:|||| ||Sl. No.|Export product Qty. Sl. No.||Import items|Qty.||

Case No.	Case No.		21 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			ZYDUS LIFESCIENCES LIMITED
Meeting Number and<br>Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM REVIW00003412AM23
RA File Number			08AA04004845 AM21
Licence No and Date			0811000109/18/12/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it wasdecided to ratify adhoc norms under
Para 4.07		of HBP Vol. I	as per details given below or as applied by the firm, whichever is less:
	Sl. No.	Export product<br>Qty.<br>Sl. No.		Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Qty. Sl. No.||Import items|Qty.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

1	ISOTRETINOIN<br>CAPSULES<br>USP<br>10<br>MG(ISOTRETINOIN<br>CAPSULES USP 10 MG<br>	ISOTRETINOIN<br>CAPSULES<br>USP<br>10<br>MG(ISOTRETINOIN<br>CAPSULES USP 10 MG<br>	ISOTRETINOIN<br>CAPSULES<br>USP<br>10<br>MG(ISOTRETINOIN<br>CAPSULES USP 10 MG<br>	<br> <br>1 Number	1	ISOTRETINOIN USP	10.2 mg /<br>10 mg capsule	10.2 mg /<br>10 mg capsule

	(ACTIVE INGREDIENT:<br>ISOTRETINOIN USP - N<br>		ET		2	GELATIN NF	375	mg

	WT. 11.249 KGS.))				3	GLYCERIN USP	191	mg
					4	ISOPROPYL ALCOHOL USP	200<br>10 m	mg /<br>g capsule
2	ISOTRETINOIN<br>CAPSULES<br>USP<br> <br>MG(ISOTRETINOIN<br>CAPSULES USP 20 M<br>(ACTIVE INGREDIENT:		20<br>G	<br> <br>1 Number	1	ISOTRETINOIN USP	20.4<br>20 m	mg /<br>g capsule

	<br>ISOTRETINOIN USP - NET<br>WT. 107.998 KGS.))				2	GELATIN NF	468 mg
					3	GLYCERIN USP	239 mg

					4	ISOPROPYL ALCOHOL USP	250 mg /
							20 mg capsule


3	ISOTRE<br>CAPSU	TINOIN<br>LES<br>USP<br>30		<br>1 Number	1	ISOTRETINOIN USP	30.6 mg /
	<br>MG(ISO	<br> <br> <br>TRETINOIN					30 mg capsule
	<br>CAPSU	<br>LES USP 30 MG

	(ACTIV<br>	E INGREDIENT:<br>			2	GELATIN NF	562 mg
	ISOTRETINOIN USP - NET<br>WT.

r>MG(ISO| TRETINOIN|||||||30 mg capsule|| ||| CAPSU| LES USP 30 MG||||||||| ||||||||||||| |||(ACTIV |E INGREDIENT: ||||2||GELATIN NF|562 mg|| |||ISOTRETINOIN USP - NET WT. 161.995 KGS.))|||||||||| ||||||||3||GLYCERIN USP|287 mg|| ||||||||||||| ||||||||4||ISOPROPYL ALCOHOL USP|300 mg /|| ||||||||||||| |||||||||||30 mg capsule|| ||||||||||||| ||||||||||||| ||4|ISOTRE CAPSU|TINOIN LES USP 40|| 1 Number||1||ISOTRETINOIN USP|40.8 mg / || |||MG(ISO |TRETINOIN |||||||40 mg capsule|| |||CAPSU |LES USP 40 MG ||||||||| ||||||||||||| |||(ACTIV|E INGREDIENT:||||2||GELATIN NF|562 mg|| |||||||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

3<br>GLYCERIN USP<br>287 mg<br>ISOTRETINOIN USP - NET<br>WT. 359.993 KGS.))<br>4<br>ISOPROPYL ALCOHOL USP<br>300 mg /<br>40 mg capsule<br>RA concerned may take further necessary action as per above decision of NC.		ISOTRETINOIN USP - NET<br>WT. 359.993 KGS.))		3	GLYCERIN USP	287 mg
				4	ISOPROPYL ALCOHOL USP	300 mg /<br>40 mg capsule

ary action as per above decision of NC.		ISOTRETINOIN USP - NET<br>WT. 359.993 KGS.))		3	GLYCERIN USP	287 mg
				4	ISOPROPYL ALCOHOL USP	300 mg /<br>40 mg capsule

Case No.	22 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00000419AM23
RA File Number	05AA04037727 AM21
Licence No and<br>Date	0511001580/08/03/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was observed that the details furnished by<br>the firm was incomplete and also the DML was not given for Approved Composition.<br> Hence, it was decided to call the firm for attendingPersonal Hearing<br> before Norms Committee to<br>explain its case.

Case No.	Case No.	23 / NC/3/MEET/Dec/202223/15	23 / NC/3/MEET/Dec/202223/15	23 / NC/3/MEET/Dec/202223/15	23 / NC/3/MEET/Dec/202223/15	23 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		INDOCO REMEDIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM REVIW00003465AM23
RA File Number		03AA04002955 AM22
Licence No and<br>Date		0311003171/20/04/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it wasdecided to ratify adhoc norms<br>under Para 4.07 of HBP Vol.

1003171/20/04/2021||||| |Norms Committee Decision: The Committee considered the request of firm for fixation of adhoc norms and it wasdecided 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.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Ketotifen Fumarate ophthalmic solution<br>(5ml<br>Bottle<br>)((Each<br>ml.<br>Contains:<br>Ketotifen(0.025<br>percentage)<br>Antihistamine) (Equivalent to Ketotifen<br>Fumarate 0.035 percentage ) = 1.750 mg<br>per bottle of 5ml.) (Net Weight in Export<br>Products is : 787.5 GRAM ))	1	Ketotifen Fumarate	1.785 mg
	2	Bottle	Relevant as per packing<br>policy
	3	Cap	Relevant as per packing<br>policy
	4	Dropper	Relevant as per packing<br>policy
A concerned may take further necessary action as per above decision of NC.

packing policy| ||||3|Cap|Relevant as per packing policy| ||||4|Dropper|Relevant as per packing policy| ||A concerned may take further necessary action as per above decision of NC.|||||

Case No.	Case No.	24 / NC/3/MEET/Dec/202223/15	24 / NC/3/MEET/Dec/202223/15	24 / NC/3/MEET/Dec/202223/15	24 / NC/3/MEET/Dec/202223/15	24 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM REVIW00003410AM23
RA File Number		08AA04001824 AM22
Licence No and Date		0811001352/28/04/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it wasdecided to revise adhoc norms as<br>under:<br>Sl. No. Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>BUSPIRONE<br>HYDROCHLORIDE<br>USP<br>23.454 kg<br>2<br>LACTOSE MONOHYDRATE NF/PH<br>EUR<br>224.573 kg<br>3<br>MICRO<br>CRYSTALLINE<br>CELLULOSE<br>NF/IP/BP/PH<br>EUR<br>(AVICEL PH102)<br>76.65 kg<br>4<br>SODIUM STARCH GLYCOLATE NF 13.80 kg<br>1<br>BUSPIRONE<br>HYDROCHLORIDE TABLETS<br>USP<br>5<br>MG((ACTIVE<br>INGREDIENT : BUSPIRONE<br>HYDROCHLORIDE<br>USP<br>-<br>NET WT. 22.994 KGS.))<br>4598800<br>Numbers
	Export Product		Qty.	Sl. No.	Import items	Qty.
	BUSPIRONE<br>HYDROCHLORIDE TABLETS<br>USP<br>5<br>MG((ACTIVE<br>INGREDIENT : BUSPIRONE<br>HYDROCHLORIDE<br>USP<br>-<br>NET WT.

00 Numbers||||||| ||Export Product||Qty.|Sl. No.|Import items|Qty.| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG((ACTIVE INGREDIENT : BUSPIRONE HYDROCHLORIDE USP - NET WT. 22.994 KGS.))|| 4598800 Numbers|1|BUSPIRONE HYDROCHLORIDE USP| 23.454 kg| |||||2|LACTOSE MONOHYDRATE NF/PH EUR| 224.573 kg| |||||3|MICRO CRYSTALLINE CELLULOSE NF/IP/BP/PH EUR (AVICEL PH102)|76.65 kg| |||||4|SODIUM STARCH GLYCOLATE NF|13.80 kg|

Case No.	Case No.	24 / NC/3/MEET/Dec/202223/15	24 / NC/3/MEET/Dec/202223/15	24 / NC/3/MEET/Dec/202223/15	24 / NC/3/MEET/Dec/202223/15	24 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM REVIW00003410AM23
RA File Number		08AA04001824 AM22
Licence No and Date		0811001352/28/04/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it wasdecided to revise adhoc norms as<br>under:<br>Sl. No. Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>BUSPIRONE<br>HYDROCHLORIDE<br>USP<br>23.454 kg<br>2<br>LACTOSE MONOHYDRATE NF/PH<br>EUR<br>224.573 kg<br>3<br>MICRO<br>CRYSTALLINE<br>CELLULOSE<br>NF/IP/BP/PH<br>EUR<br>(AVICEL PH102)<br>76.65 kg<br>4<br>SODIUM STARCH GLYCOLATE NF 13.80 kg<br>1<br>BUSPIRONE<br>HYDROCHLORIDE TABLETS<br>USP<br>5<br>MG((ACTIVE<br>INGREDIENT : BUSPIRONE<br>HYDROCHLORIDE<br>USP<br>-<br>NET WT.

L PH102) 76.65 kg 4 SODIUM STARCH GLYCOLATE NF 13.80 kg 1 BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG((ACTIVE INGREDIENT : BUSPIRONE HYDROCHLORIDE USP - NET WT. 22.994 KGS.)) 4598800 Numbers||||||| ||Export Product||Qty.|Sl. No.|Import items|Qty.| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG((ACTIVE INGREDIENT : BUSPIRONE HYDROCHLORIDE USP - NET WT. 22.994 KGS.))|| 4598800 Numbers|1|BUSPIRONE HYDROCHLORIDE USP| 23.454 kg| |||||2|LACTOSE MONOHYDRATE NF/PH EUR| 224.573 kg| |||||3|MICRO CRYSTALLINE CELLULOSE NF/IP/BP/PH EUR (AVICEL PH102)|76.65 kg| |||||4|SODIUM STARCH GLYCOLATE NF|13.80 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

				5	COLLOIDAL SILICON DIOXIDE NF	3.449 kg
				6	MAGNESIUM<br>STEARATE<br>PH<br>EUR/NF/JP	<br>3.449 kg
	2	BUSPIRONE<br>HYDROCHLORIDE TABLETS<br>USP<br>7.5<br>MG((ACTIVE<br>INGREDIENT : BUSPIRONE<br>HYDROCHLORIDE<br>USP<br>-<br>NET WT.

---| |||||6|MAGNESIUM STEARATE PH EUR/NF/JP| 3.449 kg| ||2|BUSPIRONE HYDROCHLORIDE TABLETS USP 7.5 MG((ACTIVE INGREDIENT : BUSPIRONE HYDROCHLORIDE USP - NET WT. 241.494 KGS.))| 32199200 Numbers|1|BUSPIRONE HYDROCHLORIDE USP| 246.324 kg| |||||2|LACTOSE MONOHYDRATE NF/PH EUR| 2358.60 kg| |||||3|MICRO CRYSTALLINE CELLULOSE NF/IP/BP/PH EUR (AVICEL PH102)|804.98 kg| |||||4|SODIUM STARCH GLYCOLATE NF|144.90 kg| |||||5|COLLOIDAL SILICON DIOXIDE NF|36.224 kg| |||||6|MAGNESIUM STEARATE PH EUR/NF/JP| 36.224 kg| ||3|BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG((ACTIVE INGREDIENT : BUSPIRONE HYDROCHLORIDE USP - NET WT. 206.956 KGS.))| 20695600 Numbers|1|BUSPIRONE HYDROCHLORIDE USP| 211.095 kg| |||||2|LACTOSE MONOHYDRATE NF/PH EUR| 2021.277 kg| |||||3|MICRO CRYSTALLINE CELLULOSE NF/IP/BP/PH EUR (AVICEL PH102)|699.784 kg| |||||4|SODIUM STARCH GLYCOLATE NF|124.174 kg| |||||5|COLLOIDAL SILICON DIOXIDE NF|31.043 kg| |||||6|MAGNESIUM STEARATE PH EUR/NF/JP| 31.043 kg| ||4|BUSPIRONE HYDROCHLORIDE TABLETS USP 15 MG((ACTIVE INGREDIENT : BUSPIRONE| 66692200 Numbers|1|BUSPIRONE HYDROCHLORIDE USP| 1020.39 kg| |||||2|LACTOSE MONOHYDRATE NF/PH| 9770.040 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

TOSE MONOHYDRATE NF/PH| 9770.040 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

		EUR

	3	MICRO<br>CRYSTALLINE<br> <br> <br>	3334.61 kg
		CELLULOSE<br>NF/IP/BP/PH<br>EUR<br>(AVICEL PH102)

	4	SODIUM STARCH GLYCOLATE NF	600.230 kg


	5	COLLOIDAL SILICON DIOXIDE NF	150.06 kg

	6	MAGNESIUM<br>STEARATE<br>PH	<br>15006 kg
<br> <br> <br>EUR/NF/JP<br>.<br>1<br>BUSPIRONE<br>HYDROCHLORIDE<br>USP<br>668.50 kg<br>2<br>LACTOSE MONOHYDRATE NF/PH<br>EUR<br>6401.02 kg<br>3<br>MICRO<br>CRYSTALLINE<br>CELLULOSE<br>NF/IP/BP/PH<br>EUR<br>(AVICEL PH102)<br>2184.65 kg<br>4<br>SODIUM STARCH GLYCOLATE NF 393.24 kg<br>5<br>COLLOIDAL SILICON DIOXIDE NF 103.552 kg<br>5<br>BUSPIRONE<br>HYDROCHLORIDE TABLETS<br>USP<br>30<br>MG((ACTIVE<br>INGREDIENT : BUSPIRONE<br>HYDROCHLORIDE<br>USP<br>-<br>NET WT.

TE NF 393.24 kg 5 COLLOIDAL SILICON DIOXIDE NF 103.552 kg 5 BUSPIRONE HYDROCHLORIDE TABLETS USP 30 MG((ACTIVE INGREDIENT : BUSPIRONE HYDROCHLORIDE USP - NET WT. 655.394 KGS.)) 21846480 Numbers 6 MAGNESIUM STEARATE PH EUR/NF/JP 98.309 kg RA concerned may take further necessary action as per above decision of NC.|5||||||| EUR/NF/JP| .|| |||BUSPIRONE HYDROCHLORIDE TABLETS USP 30 MG((ACTIVE INGREDIENT : BUSPIRONE||| 21846480 Numbers||1|BUSPIRONE HYDROCHLORIDE USP| 668.50 kg|| |||HYDROCHLORIDE NET WT. 655.394 KG||USP - S.))||||||| ||||||||2|LACTOSE MONOHYDRATE NF/PH | 6|401.02 kg| |||||||||EUR||| ||||||||3|MICRO CRYSTALLINE|2|18465 k| ||||||||| CELLULOSE NF/IP/BP/PH EUR (AVICEL PH102)||. g| |||||||||||| |||||||||||| ||||||||4|SODIUM STARCH GLYCOLATE NF|3|93.24 kg| |||||||||||| ||||||||5|COLLOIDAL SILICON DIOXIDE NF|1|03.552 kg| |||||||||||| ||||||||6|MAGNESIUM STEARATE PH EUR/NF/JP| 9|8.309 kg| |||||||||||| |||||||||||| |Case No.|||25 / NC/3/MEET/Dec/202223/15|||||||| |||||||||||| |Case Status|||Case Deferred|||||||| |||||||||||| |Party Name|||ASHISH LIFE SCIENCE PRIVATE LIMITED|||||||| |||||||||||| |Meeting Number||||||||||| | and Date|||NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022|||||||| |HQ File Number|||HQRNORM REVIW00001514AM23|||||||| |||||||||||| |RA File Number|||03AA04011100 AM22||||||||

Number||||||||||| | and Date|||NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022|||||||| |HQ File Number|||HQRNORM REVIW00001514AM23|||||||| |||||||||||| |RA File Number|||03AA04011100 AM22||||||||

Case No.	25 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00001514AM23
RA File Number	03AA04011100 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Licence No and 0311003600/06/05/2021 Date 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:

i. DML for each export product with Approved Composition.
ii. Master Batch Formula for each export product showing net content of inputs in export item.
iii. Wastage claimed in each export product.

Case No.	26 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM REVIW00001551AM23
RA File Number	13AA04002353 AM22
Licence No and<br>Date	1311000341/19/05/2021
Norms Committee Decision:
Deferred for comments of TE.

9/12/2022| |HQ File Number|HQRNORM REVIW00001551AM23| |RA File Number|13AA04002353 AM22| |Licence No and Date|1311000341/19/05/2021| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.<br>27 / NC/3/MEET/Dec/202223/15	Case No.<br>27 / NC/3/MEET/Dec/202223/15
Case Status<br>Case Approved
Party Name<br>KALKI HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>HQRNORM REVIW00001509AM23
RA File Number<br>34AA04002336 AM22
Licence No and<br>Date<br>3411000712/09/06/2021
Norms Committee Decision:
The Committee considered the request of firm for fixation of			adhoc norms and it wasdecided 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.
S-(+)-2-Aminobutyramide HCL	1 kg	1		Propionaldehyde	1.66 kg
		2		Acetone Cynohydrin	2.43 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

3 Tararic Acid 1.10 kg

Case No.	28 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	VARTIKA CHEMICALS AND PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00002099AM23
RA File Number	NA
Licence No and<br>Date	1311000462/22/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Copy of DML with Approved Composition of Export Product.<br>i.<br>Complete technical details as per Annexure to Appendix 4E.

Case No.	29 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001128AM23
RA File Number	52AX04000054 AM23
Licence No and<br>Date	5211002565/01/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	30 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001143AM23
RA File Number	07AX04000272 AM23
Licence No and<br>Date	0711004133/01/06/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

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/Jan/202122/13 dated 21/01/2022 against advance authorization No. 0711001669 dated 09.08.2021 , 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:

Sl.	Export product	Export product			Qty.	Sl. No.	Import items	Qty.
No.
1	Bumetanide	<br>Injection	0.25mg/mL,		90909	1	V-35 4031/45G DC SIL	Relevant as per
	4mL vial				Number		WesterSELECT RS P02(13mm Serum	packing policy
							Non laminated Bromobutyl R/S RFS)
2	Bumetanide	<br>Injection	0.25mg/mL,		<br>145454	2	V-35 4031/45G DC SIL	Relevant as per
	10mL vial				Number		WesterSELECT RS P02(13mm Serum	packing policy
							Non laminated Bromobutyl R/S RFS)
3	Famotidine	Injection 10mg/mL, 2mL			<br>127272	3	V-35 4031/45G DC SIL	Relevant as per
	vial				Number		WesterSELECT RS P02(13mm Serum	packing policy
							Non laminated Bromobutyl R/S RFS)
4	Diltiazem	Hydrochloride		Injection	<br>90909	4	V-35 4031/45G DC SIL	Relevant as per
	5mg/mL, 5mL vial				Number		WesterSELECT RS P02(13mm Serum	packing policy
							Non laminated Bromobutyl R/S RFS)
5	Diltiazem	Hydrochloride		Injection	<br>47619	5	V-35 4031/45G DC SIL	Relevant as per
	5mg/mL, 25mL vial				Number		WesterSELECT RS P02(13mm Serum	packing policy
							Non laminated Bromobutyl R/S RFS)

ydrochloride||Injection| 47619|5|V-35 4031/45G DC SIL|Relevant as per| ||5mg/mL, 25mL vial||||Number||WesterSELECT RS P02(13mm Serum|packing policy| ||||||||Non laminated Bromobutyl R/S RFS)||

Case No.	31 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001144AM23
RA File Number	03AX04000995 AM23
Licence No and<br>Date	0311015188/02/06/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case No.	Case No.	32 / NC/3/MEET/Dec/202223/15	32 / NC/3/MEET/Dec/202223/15	32 / NC/3/MEET/Dec/202223/15	32 / NC/3/MEET/Dec/202223/15	32 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001150AM23
RA File Number		03AX04000872 AM23
Licence No and<br>Date		0311015199/02/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Nov/202223/12dated18/11/2022 against advance authorization No.<br>0311013055dated17/03/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

port item in Meeting No.NC/3/MEET/Nov/202223/12dated18/11/2022 against advance authorization No. 0311013055dated17/03/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.240 kg Ciprofloxacin Hydrochloride USP 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin Hydrochloride USP||1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.240 kg| |||||2|Piperazine Anhydrous|0.390 kg| |||||s per above decision of NC|||

Case No.	33 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001158AM23
RA File Number	09AX04000093 AM23
Licence No and<br>Date	0911003095/02/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Nov/202223/14dated07/12/2022 against advance authorization No.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

2** against advance authorization No.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

0911002409 dated 28/01/2022 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
1	Nadroparin Calcium Injection (Low	1 Number	1	Nadroparin Calcium	26.125 mg
	Molecular<br>Weight<br>Heparin)<br>2850
	IU/0.3ml PFS (IU Condition: The firm
	should account for 7.125 Kgs of input at		2	Barrel Syringes	1.05 Numbers
	SL No. 1 and 3,00,000 Nos each of input
	at Sl No. 2,3,4,5 of the import list in the
	resultant product should be reflected in		3	Plunger Stoppers	1.1085 Numbers
	SBs. Export to : Kazakhstan Buyer
	Name & Address as per DML )
			4	Plunger Rods	1.0165 Numbers
			5	Preventis	1.05 Numbers
2	Nadroparin Calcium Injection (Low	1 Number	1	Nadroparin Calcium	52.25 mg
	Molecular<br>Weight<br>Heparin)<br>5700
	IU/0.6ml PFS(IU Condition: The firm
	should account for 18.857 Kgs of input		2	Barrel Syringes	1.05 Numbers
	at SL No. 6 and 3,97,000 Nos each of
	input at Sl No. 7,8,9,10 of the import
	list in the resultant product should be		3	Plunger Stoppers	1.1085 Numbers
	reflected in SBs. Export to : Kazakhstan
	Buyer Name & Address as per DML)		4	Plunger Rods	1.0165 Numbers
			5	Preventis	1.05 Numbers

duct should be||3|Plunger Stoppers|1.1085 Numbers| ||reflected in SBs. Export to : Kazakhstan||||| ||Buyer Name & Address as per DML)||4|Plunger Rods|1.0165 Numbers| ||||5|Preventis|1.05 Numbers|

Case No.	34 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001161AM23
RA File Number	05AX04000552 AM23
Licence No and<br>Date	0511012969/02/06/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

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.
Meropenem	Sodium	Sterile	<br>1 kg	1	Meropenem Trihydrate (Non Sterile)	0.8968 kg
((Meropenem for Injection))

port product			Qty.	Sl. No.	Import items	Qty.
Meropenem	Sodium	Sterile	<br>1 kg	1	Meropenem Trihydrate (Non Sterile)	0.8968 kg
((Meropenem for Injection))


The Committee co<br>Vol. I as per detai		nsidered the case as per agenda and it was decided t<br>ls given below or as applied by the firm, whichever i				o ratify adhoc norms under Para 4.07 of HBP<br>s less:
Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items		Qty.

	Meropenem<br>	Sodium<br>Sterile	<br>1 kg	1	Meropenem T	rihydrate (Non Sterile)	0.8968 kg
	((Meropenem for	Injection))


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



Case No.		35 / NC/3/MEET/Dec/202223/15

Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITE				D
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001163AM23

RA File Number		05AX04000658 AM23

Licence No and
<br>Date		0511012970/02/06/2022

Norms Committee		Decision:
The Committee co<br>		nsidered the case as per agenda and taking cue fr<br>				om earlier decision for same export product /<br>

22||||||||| ||||||||||||| |Norms Committee|||Decision:||||||||| |The Committee co |||nsidered the case as per agenda and taking cue fr ||||||om earlier decision for same export product / ||| |import item in Mee |||ting No.7/82-ALC4/2020 dated 04.12.2020against ||||||advance authorization No.0510414952 dated ||| |20.08.2020, it was lid b th fi|||decided to ratify adhoc norms under Para 4.07 of hih i l||||||HBP Vol. I as per details given below or as||| |appe y e rm|||, wcever s ess:||||||||| ||Sl. No. Export Product Qty.||||||||||| |||Export Product||||Qty.||Sl. No.|.|Import items|Qty.| ||||||||||||| ||||||||||||| ||1|Clarithromycin Carbomer Granules |||| 1500 kg||1||Carbopol 974 P|300 kg| |||27.5% /|28%||||||||| ||||||||||||| |||||||||2||Clarithromycin|416.55 kg| ||||||||||||| ||2|Clarithro |mycin Carbomer Granules ||| 1340 kg||1||Carbopol 974 P|495.8 kg| |||43.75%|44%||||||||| ||||||||||||| |||||||||2||Clarithromycin|588.796 kg| ||||||||||||| ||||||||||||| |||||||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

|||||||||| ||||||||||||| |||||||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case No.	36 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001164AM23
RA File Number	05AX04000638 AM23
Licence No and<br>Date	0511012971/02/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.<br>0510413989 dated 13.04.2020, 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. Import Items<br>Qty<br>Kombinil-DUO Eye/Ear Drops 5ml Vial<br>(5 mg / Vial)<br>1 Pack<br>1<br>Dexamethasone Micronised PH EUR<br>USP JP<br>5.10 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	37 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001173AM23
RA File Number	03AX04001017 AM23
Licence No and<br>Date	0311015227/03/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

29/12/2022| |HQ File Number|HQRNORM APPLY 00001173AM23| |RA File Number|03AX04001017 AM23| |Licence No and Date|0311015227/03/06/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	38 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	CONNEX PHARMA PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001182AM23
RA File Number	26AX04000017 AM23
Licence No and<br>Date	2611000608/03/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated29/04/2022 against advance authorization No.<br>2611000203dated26-07-2021, 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>CHLOROMETHYL<br>ISOPROPYL<br>CARBONATE (API)<br>1 kg<br>1<br>METHYLCHLORO FORMATE<br>0.943 kg<br>RA concerned may take further necessary action as per above decision of NC.

mport Items Qty CHLOROMETHYL ISOPROPYL CARBONATE (API) 1 kg 1 METHYLCHLORO FORMATE 0.943 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	39 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001183AM23
RA File Number	52AX04000220 AM23
Licence No and<br>Date	5211002594/03/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Complete chemistry, molecular weight, percentage yield on molar basis etc. as per Annexure to Appendix 4E.<br>i.<br>Indigenous item, if any.<br>ii.<br>Production / Consumption data duly certified by CA.<br>iii.

Case No.	40 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	OC SPECIALITIES PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001188AM23
RA File Number	03AX04001018 AM23
Licence No and<br>Date	0311015240/03/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

|---|---| |HQ File Number|HQRNORM APPLY 00001188AM23| |RA File Number|03AX04001018 AM23| |Licence No and Date|0311015240/03/06/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	41 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	MITHILA RASAYAN PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001167AM23
RA File Number	03AX04001036 AM23
Licence No and<br>Date	0311015222/03/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	Case No.	42 / NC/3/MEET/Dec/202223/15	42 / NC/3/MEET/Dec/202223/15	42 / NC/3/MEET/Dec/202223/15	42 / NC/3/MEET/Dec/202223/15	42 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			SANOFI INDIA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM APPLY 00001172AM23
RA File Number			03AX04000912 AM23
Licence No and<br>Date			0311015226/03/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/15 dated 17/03/2022 against 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.

10-03-2021**, 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: Sl. No. Export product Qty. Sl. No. Import items Qty. Festal Dragees (Tablets) Enterosoluble 10x10s((Total net Weight,Pancreatin 76800.00 Kgs Strength of Pancreatin 1 1 Number Tablet 1 PANCREATIN 195.84 mg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Festal Dragees (Tablets) Enterosoluble 10x10s((Total net Weight,Pancreatin 76800.00 Kgs Strength of Pancreatin|| 1 Number Tablet|1|PANCREATIN|195.84 mg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

	192mg/Tablet))
2	Festal N Dragees (Tablets) 2x10s((Total	<br>1 Number	2	PANCREATIN	216.75 mg
	net Weight, Pancreatin 5312.5 Kgs	<br>Tablet
	Strength of Pancreatin 212.50mg/Tablet))

---|---|---|---| |2|Festal N Dragees (Tablets) 2x10s((Total| 1 Number|2|PANCREATIN|216.75 mg| ||net Weight, Pancreatin 5312.5 Kgs| Tablet|||| ||Strength of Pancreatin 212.50mg/Tablet))|||||


		192mg/T	ablet))


	2	Festal N<br>net W	Dragees (Tablets) 2x10s((Total<br>eight, Pancreatin 5312.5 Kgs	<br> <br>1 Number<br>Tablet	2	PANCREATIN	216.75 mg
Strength of Pancreatin 212.50mg/Tablet))		Strength of Pancreatin 212.50mg/Tablet))

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



Case No.			43 / NC/3/MEET/Dec/202223/15

Case Status			Case Approved
Pt N			HONOUR LAB LIMITED
ary ame
Mti Nb
eeng umer<br>and Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022

HQ File Number			HQRNORM APPLY 00001225AM23
RA Fil Nb			09AX04000202 AM23
e umer
Licence No and<br>Date			0911003130/06/06/2022
Norms Committee Decision:

The Committee co<br>			nsidered the case as per agenda and taking cue from earlier decision for same export product /<br>
import item in M<br>			eeting No.NC/3/MEET/Nov/202223/12 dated 18/11/2022 against advance authorization No.<br>
0911002884 dated<br>i bl			21/04/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

ET/Nov/202223/12** dated 18/11/2022 against advance authorization No. ||||||||| |0911002884 dated i bl|||21/04/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details lid b h fi hih i l||||||||| |gven eow or as|||ppe y te rm, wcever s ess:||||||||| ||||||||||||| ||||||||||||| ||Export product|||Qty.||Sl. No.||Import items|||Qty.| ||||||||||||| ||1-(2,2-DIMETHOXYETHYL)-5-METHOXY- 6-(METHOXYCARBONYL)-4-OXO-1H- PYRIDINE-3-CARBOXYLIC ACID|||1 kg||1||Amino Acetyldehyde Di Methyl Acetal|||0.575 kg| |||||||2||Methyl-4-Methoxy Acetoacetate|||0.725 kg| |||||||3||Di Methyl Oxalate|||1.17 kg| ||||||||||||| |||||||4||Lithium Hydroxide|||0.300 kg| ||||||||||||| ||||||||||||| ||||||||||||| |RA concerned may|||take further necessary action as per above decision of NC.|||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

n as per above decision of NC.|||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case No.	Case No.	44 / NC/3/MEET/Dec/202223/15	44 / NC/3/MEET/Dec/202223/15	44 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001232AM23
RA File Number		03AX04001034 AM23
Licence No and<br>Date		0311015299/07/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Nov/202223/12dated18/11/2022 against advance authorization No.<br>0311013055dated17/03/2022, 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>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin HCL<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.

late 1.240 kg Ciprofloxacin HCL 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin HCL||1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.240 kg| |||||2|Piperazine Anhydrous|0.390 kg| |||||s per above decision of NC.|||

Case No.<br>	45 / NC/3/MEET/Dec/202223/15
Case Status<br>	Case Approved
Party Name<br>	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>	HQRNORM APPLY 00001234AM23
RA File Number<br>	03AX04001026 AM23
Licence No and<br>Date<br>	0311015302/07/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Oct/202223/11 dated 31/10/2022 against advance authorization No.<br>0311004402 dated 07/06/2021, 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:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

plied by the firm, whichever is less:||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

|Sl. No. Export Product Qty. Sl. No. Import items Qty. 1 OFLOMIL LAK NAIL 5 Percent (Pack size 2.5ml) (Oflomil Lacquer/Amorolfine Hydrochloride Nail Lacquer)((Each 1 ml contains Amorolfine hydrochloride 50 mg) (Net wt of Amorolfine Hydrochloride is 12.50 Kgs)) 100000 Number 1 Amorolfine Hydrochloride 12.75 kg 2 OFLOMIL LAK NAIL 5 Percent (Pack size 5ml) (Oflomil Lacquer/Amorolfine Hydrochloride Nail Lacquer)((Each 1 ml contains Amorolfine hydrochloride 50 mg) (Net wt of Amorolfine Hydrochloride is 25.00 Kgs)) 100000 Number 2 Amorolfine Hydrochloride 25.50 kg RA concerned may take further necessary action as per above decision of NC.|Sl. No. 1 2|Export Product|Qty.|Sl.

5.00 Kgs))<br>100000<br>Number<br>2<br>Amorolfine Hydrochloride<br>25.50 kg<br>RA concerned may take further necessary action as per above decision of NC.	Sl.<br>No.<br>1<br>2	Export Product	Qty.	Sl. No.	Import items	Qty.
		OFLOMIL LAK NAIL 5 Percent (Pack<br>size<br>2.5ml)<br>(Oflomil<br>Lacquer/Amorolfine<br>Hydrochloride<br>Nail Lacquer)((Each 1 ml contains<br>Amorolfine hydrochloride 50 mg) (Net<br>wt of Amorolfine Hydrochloride is<br>12.50 Kgs))	<br> <br> <br> <br> <br> <br>100000<br>Number	1	Amorolfine Hydrochloride	12.75 kg
		OFLOMIL LAK NAIL 5 Percent (Pack<br>size 5ml) (Oflomil Lacquer/Amorolfine<br>Hydrochloride Nail Lacquer)((Each 1<br>ml contains Amorolfine hydrochloride<br>50<br>mg)<br>(Net<br>wt<br>of<br>Amorolfine<br>Hydrochloride is 25.00 Kgs))	<br> <br> <br> <br> <br>100000<br>Number	2	Amorolfine Hydrochloride	25.50 kg

Case No.	Case No.	46 / NC/3/MEET/Dec/202223/15	46 / NC/3/MEET/Dec/202223/15	46 / NC/3/MEET/Dec/202223/15	46 / NC/3/MEET/Dec/202223/15	46 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		FDC LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001235AM23
RA File Number		03AX04000861 AM23
Licence No and<br>Date		0311015303/07/06/2022

and Date||NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022||||| |HQ File Number||HQRNORM APPLY 00001235AM23||||| |RA File Number||03AX04000861 AM23||||| |Licence No and Date||0311015303/07/06/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Jul/202122/4dated15/07/2021 against advance authorization No. 0311004667dated 16/06/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. BRIMONIDINE EYE DROPS 5ML AND IOBRIM EYE DROPS 5ML((Each vial contains 0.010 GM of 75000 Vials 1 BRIMONIDINE L TARTRATE 765 grams||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||BRIMONIDINE EYE DROPS 5ML AND IOBRIM EYE DROPS 5ML((Each vial contains 0.010 GM of|| 75000 Vials|1|BRIMONIDINE L TARTRATE|765 grams|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Brimonidine L Tartrate Net Wt of bulk drug is 750 gms))

d. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Brimonidine L Tartrate Net Wt of bulk drug is 750 gms))

Case No.	47 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001238AM23
RA File Number	03AX04000996 AM23
Licence No and<br>Date	0311015308/07/06/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	48 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001239AM23
RA File Number	03AX04000947 AM23
Licence No and<br>Date	0311015309/07/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents from the
firm:
DML.<br>i.
Master Batch Formula.<br>ii.

Case No.	49 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001229AM23
RA File Number	03AX04000530 AM23

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

M23| |RA File Number|03AX04000530 AM23|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Licence No and 0311015288/07/06/2022 Date 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 to explain its case.

Licence No and	Licence No and	Licence No and	0311015288/07/06/2022	0311015288/07/06/2022	0311015288/07/06/2022
Date
Norms Committee			Decision:
The Committee considered the case as per agenda and it was decided to callthe firm for attendingPersonal Hearing<br>before Norms Committee to explain its case.

C	ase No.		50 / NC/3/MEET/Dec/202223/	15
C	ase Status		Case Approved
P
	arty Name		DIAMINES AND CHEMICA	LS LIMITED
M<br>a	eeting Nu<br>nd Date	mber	NC/ 3/ MEET/ Dec/ 202223/ 1	5 and 29/12/20	22
H	Q File Nu	mber	HQRNORM APPLY 0000124	3AM23
R	A File Nu	ber	34AX04000188 AM23

L<br>D	icence No<br>ate	and	3411002347/07/06/2022

1||||5 and 29/12/20|22|||| |H|Q File Nu|mber|HQRNORM APPLY 0000124||||3AM23||||| |R|A File Nu|ber|34AX04000188 AM23||||||||| ||||||||||||| |L D|icence No ate|and|3411002347/07/06/2022||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Sep/202223/9 dated07/10/2022 against advance authorization No. 3411000643dated27/05/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:|orms Com |mittee Decision: |||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Export Product|||Qty|Sl. No|Import Item Name.||||Qty.|| ||||||.||||||| ||||||||||||| ||PIPERAZINE|||1 kg|1|PIPERAZINE CRUDE OR PIPERAZINE MIXTURE||||2.047 kg|| ||ANHYDROUS|||||(Percentae urit NMT 481%)|||||| |||||||g py .|||||| ||||||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||||||

Case No.	51 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001230AM23
RA File Number	03AX04000940 AM23
Licence No and<br>Date	0311015296/07/06/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

7/06/2022| |Norms Committee Decision:||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. 10/82-ALC4/2018 dated 16.10.2018 against advance authorization No. 0310821155 dated 22.05.2018 , 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	Qty.	Sl. No.	Import items	Qty.
STEARYL ERUCAMIDE	1 kg	1	ERUCIC ACID	0.592 kg
		2	STEARYL AMINE	0.471 kg

Case No.<br>52 / NC/3/MEET/Dec/202223/15
Case Status<br>Case Approved
Party Name<br>RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and	29/12/2022
HQ File Number<br>HQRNORM APPLY 00001250AM23
RA File Number<br>03AX04000906 AM23
Licence No and<br>Date<br>0311015328/07/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same		export product /
import item in Meeting No.NC/3/MEET/Nov/202223/12dated 18/11/2022 against advance authorization No.
0311014526dated 06/05/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:
Sl. No.

||| |0311014526dated 06/05/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details|||||| |given below or as applied by the firm, whichever is less:|||||| |Sl. No. Export product|Qty.|Sl. No.|Import items|Qty.|| |1 Maxigesic cold & flu Hot Drink| 1 Number|1|Ibuprofen Lysine Salt| 258.88 mg /|| |500mg/150mg Sachets (Paracetamol &|||IH|Sachet|| |Ibuprofen Sachets 500 mg & 150 mg)(No.|||||| |of Sachets 350,000 (Net content of|||||| |Ibuprofen Lysine Salt IH API 89.78 kg))|||||| |Maxigesic cold & flu Hot Drink 2| 1 Number|2|Ibuprofen Lysine Salt|517.77 mg /||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

	1000mg/300mg Sachets (Paracetamol &			IH	Sachet
	Ibuprofen Sachets 1000 mg & 300 mg)(No.
	of Sachets 350,000 (Net content of
	Ibuprofen Lysine Salt IH API 179.55 kg))

hets (Paracetamol &|||IH|Sachet| |---|---|---|---|---|---| ||Ibuprofen Sachets 1000 mg & 300 mg)(No.||||| ||of Sachets 350,000 (Net content of||||| ||Ibuprofen Lysine Salt IH API 179.55 kg))|||||

Case No.	Case No.	Case No.	53 / NC/3/MEET/Dec/202223/15	53 / NC/3/MEET/Dec/202223/15	53 / NC/3/MEET/Dec/202223/15	53 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM APPLY 00001231AM23
RA File Number			03AX04001050 AM23
Licence No and<br>Date			0311015297/07/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Dec/202122/9dated 15/10/2021 against advance authorization No.<br>0310837175dated 14/07/2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Import items<br>Qty.<br>1<br>Clobetasol Propionate Foam 0.05percent 50gm((<br>Net. wt. of Net. wt. of Clobetasol Propionate USP<br>(Micronized) is 5.00 Kgs)<br>200000<br>Packs<br>2<br>Clobetasol<br>Propionate<br>Foam<br>0.05percent<br>100gm((Net. wt.

Foam 0.05percent 50gm(( Net. wt. of Net. wt. of Clobetasol Propionate USP (Micronized) is 5.00 Kgs) 200000 Packs 2 Clobetasol Propionate Foam 0.05percent 100gm((Net. wt. of Clobetasol Propionate USP (Micronized) is 10.00 Kgs.)) 200000 Packs 3 Clobetasol Propionate Cream USP 0.05percent (Pack Size 15gm)((Net Weight of Clobetasol Propionate USP (Micronized) 0.15 Kgs)) 200000 Packs Clobetasol Propionate Cream USP 0.05percent (Pack size 30gm)((Net Weight of Clobetasol 4 200000 Packs CLOBETASOL PROPIONATE USP (MICRONIZED) 36.295 kg||||||| ||Sl. No. 1 2 3 4|Export Product||Qty.|Import items|Qty.| |||Clobetasol Propionate Foam 0.05percent 50gm(( Net. wt. of Net. wt. of Clobetasol Propionate USP (Micronized) is 5.00 Kgs)|| 200000 Packs|CLOBETASOL PROPIONATE USP (MICRONIZED)| 36.295 kg| |||Clobetasol Propionate Foam 0.05percent 100gm((Net. wt. of Clobetasol Propionate USP (Micronized) is 10.00 Kgs.))|| 200000 Packs||| |||Clobetasol Propionate Cream USP 0.05percent (Pack Size 15gm)((Net Weight of Clobetasol Propionate USP (Micronized) 0.15 Kgs))|| 200000 Packs||| |||Clobetasol Propionate Cream USP 0.05percent (Pack size 30gm)((Net Weight of Clobetasol|| 200000 Packs|||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Clobetasol|| 200000 Packs|||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

	Propionate USP (Micronized) 0.300 Kgs))	Propionate USP (Micronized) 0.300 Kgs))
5	Clobetasol Propionate Cream USP 0.05percent<br>(Pack size 45 gm)(( Net Weight of Clobetasol<br>Propionate USP (Micronized) 1.125 Kgs))		<br> <br>50000<br>Packs
6	Clobetasol Propionate Cream USP 0.05percent<br>(Pack size 60gm)((Net Weight of Clobetasol<br>i ii		<br> <br>50000<br>Packs
	Proponate USP (Mcronzed) 1.500 Kgs))


7	Clobetaso	l Propionate Ointment USP 0.05percent	<br>50000
	(Pack siz<br>	e 15gm)((Net Weight of Clobetasol<br>	<br>Packs
	Propionat	e USP (Micronized) 0.375 Kgs))

8	Clobetaso	l Propionate Ointment USP 0.05percent	<br>50000
	(Pack siz	e 30gm)((Net Weight of Clobetasol	<br>Packs
	Propionat	e USP (Micronized) 0.750 Kgs))

9	Clobetasol Propionate Ointment USP 0.05percent<br>(Pack size 45gm)((Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.900 Kgs))		<br> <br>40000<br>Packs


10	Clobetaso	l Propionate Ointment USP 0.05percent	<br>20000
	<br>(Pack siz	<br>e 60gm)((Net Weight of Clobetasol	<br> <br> <br>Packs
	<br>Propionat	<br>e USP (Micronized) 0.600 Kgs))

			<br>
11	Clobetaso<br>59ml)((N	Propionate Spray 0.05percent (Pack size<br>t Weiht of Clobetasol Proionate USP	<br> <br>40000<br>Packs

ionat| e USP (Micronized) 0.600 Kgs))|||| |||||||| ||||| ||| ||11|Clobetaso 59ml)((N|Propionate Spray 0.05percent (Pack size t Weiht of Clobetasol Proionate USP| 40000 Packs||| ||| (Microniz|g p ed) 1.180 Kgs))| ||| |||||||| |||||||| ||12|Clobetasol Propionate Spray 0.05percent (Pack size 125ml)((Net Weight of Clobetasol Propionate USP (Micronized) 2.500 Kgs))|| 40000 Packs||| ||||| ||| ||13|Clobetaso |l Prop. Top Sol USP, 0.05percent | 50000 ||| |||25ml((Net Mii|Weight of Clobetasol Propionate USP d 0625 K| Packs||| |||(cronz|) . gs))|||| ||14|Clobetasol|Prop. Top Sol USP, 0.05percent| 60000||| |||50ml((Net |Weight of Clobetasol Propionate USP | Packs||| |||(Microniz|ed) 1.50 Kgs))|||| |||||||| ||15|Clobetasol|Pro Shampoo, 0.05 percent 118ml((Net|60000||| ||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

	Weight of Clobetasol Propionate USP (Micronized)	<br>Packs
	3.54 Kgs))
16	Clobetasol Propionate Foam 0.05percent 100gm	<br>50000
	(Emulsion Formulation)(( Net. wt. of Clobetasol	<br>Packs
	Propionate USP (Micronized) is 2.50 Kgs.))
17	Clobetasol Propionate Foam 0.05percent 50gm	<br>50000
	(Emulsion Formulation)(( Net. wt. of Clobetasol	<br>Packs
	Propionate USP (Micronized) is 1.250 Kgs.))

d) is 2.50 Kgs.))|||| |17|Clobetasol Propionate Foam 0.05percent 50gm| 50000||| ||(Emulsion Formulation)(( Net. wt. of Clobetasol| Packs||| ||Propionate USP (Micronized) is 1.250 Kgs.))||||

Case No.<br>54 / NC/3/MEET/Dec/202223/15	Case No.<br>54 / NC/3/MEET/Dec/202223/15
Case Status<br>Case Approved
Party Name<br>WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>HQRNORM APPLY 00001257AM23
RA File Number<br>07AX04000289 AM23
Licence No and<br>Date<br>0711004250/08/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.<br>Sl. No.	Import items	Qty.
	Vancomycin<br>Hydrochloride<br>for<br>1 Number<br>1	Vancomycin HCL Sterile	539 mg / Vial
	Injection USP 500mg
RA concerned may take further necessary action as per above decision of NC.

Case No	55 / NC/3/MEET/Dec/202223/15
.
Case Status	Case Deferred

Part Name	EAST AFRICAN INDIA OVERSEAS
y
Meetin Number	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
g

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

ec/ 202223/ 15 and 29/12/2022| |g|| |||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

and Date
HQ File Number	HQRNORM APPLY 00001260AM23
RA File Number	05AX04000587 AM23
Licence No and<br>Date	0511013087/08/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	56 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001266AM23
RA File Number	03AX04001106 AM23
Licence No and<br>Date	0311015346/08/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	57 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001271AM23
RA File Number	09AX04000171 AM23
Licence No and<br>Date	0911003148/08/06/2022
Norms Committee Decision:
Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00001271AM23| |RA File Number|09AX04000171 AM23| |Licence No and Date|0911003148/08/06/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	58 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	NATCO PHARMA LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001280AM23
RA File Number	09AX04000174 AM23
Licence No and Date	0911003150/08/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

import item in Meeting No. NC/3/MEET/Feb/202122/14 dated 21/02/2022 against advance authorization No. 0911000714 dated 23-04-2021 , 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:

ance authorization No. 0911000714 dated 23-04-2021 , 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:

Sl.	Export product	Qty.	Sl. No.	Import items		Qty.
No.
1	NITROGLYCERIN	1 Number	1	DILUTED	NITROGLYCERIN	<br>15.70 mg
	SUBLINGUAL TABLETS USP			USP 1.95 %
	0.3 mg-Each Tablet contains
	Nitroglycerin USP 0.3 mg (1 x<br>1,80,000 = 1,80,000 Tabs)		2	Glyceryl Monosterate (Imwitor 491		<br>1.60 mg
				powder)
2	NITROGLYCERIN	1 Number	1	DILUTED NITROGLYCERIN		20.93 mg
	SUBLINGUAL TABLETS USP			USP 1.95 %
	0.4 mg-Each Tablet contains
	Nitroglycerin USP 0.4 mg (3<br>x12,00,000= 36,00,000 Tabs)		2	Glyceryl Monosterate (Imwitor 491		<br>1.60 mg
				powder)

Case No.<br>59 / NC/3/MEET/Dec/202223/15
Case Status<br>Case Approved
Party Name<br>UPL LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>HQRNORM APPLY 00001254AM23
RA File Number<br>03AX04000946 AM23
Licence No and<br>Date<br>0311015330/08/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.6/82-ALC4/2020 dated 13.11.2020against advance authorization No.0310831562 dated
16.09.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

port item in Meeting No.6/82-ALC4/2020 dated 13.11.2020against advance authorization No.0310831562 dated||||| |16.09.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as||per details given below or as||| |applied by the firm, whichever is less:||||| |Export product Qty. Sl. No.|Import items||Qty.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Triphenyl Phosphite	1	kg	1	Phenol	0.937 kg
			2	Yellow Phosphorus	0.1 kg

Case No.	60 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	NASENSE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001297AM23
RA File Number	09AX04000213 AM23
Licence No and<br>Date	0911003160/09/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00001297AM23| |RA File Number|09AX04000213 AM23| |Licence No and Date|0911003160/09/06/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.	61 / NC/3/MEET/Dec/202223/15	61 / NC/3/MEET/Dec/202223/15	61 / NC/3/MEET/Dec/202223/15	61 / NC/3/MEET/Dec/202223/15	61 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		GODAVARI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001293AM23
RA File Number		09AX04000117 AM23
Licence No and<br>Date		0911003154/09/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08/07/2022against advance authorization No.<br>0911002342 dated 20/01/2022, 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>ETHYL 3-CYCLOPROPYLAMINO-2-(2,4-<br>DICHLORO-5-FLUOROBENZOYL)<br>ACRYLATE<br>1.24 kg<br>CIPROFLOXACIN HCL / BASE 1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	CIPROFLOXACIN HCL / BASE		1 kg	1	ETHYL 3-CYCLOPROPYLAMINO-2-(2,4-<br>DICHLORO-5-FLUOROBENZOYL)<br>ACRYLATE	1.24 kg

XACIN HCL / BASE 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||CIPROFLOXACIN HCL / BASE||1 kg|1|ETHYL 3-CYCLOPROPYLAMINO-2-(2,4- DICHLORO-5-FLUOROBENZOYL) ACRYLATE|1.24 kg|

Case No.	Case No.	61 / NC/3/MEET/Dec/202223/15	61 / NC/3/MEET/Dec/202223/15	61 / NC/3/MEET/Dec/202223/15	61 / NC/3/MEET/Dec/202223/15	61 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		GODAVARI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001293AM23
RA File Number		09AX04000117 AM23
Licence No and<br>Date		0911003154/09/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08/07/2022against advance authorization No.<br>0911002342 dated 20/01/2022, 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>ETHYL 3-CYCLOPROPYLAMINO-2-(2,4-<br>DICHLORO-5-FLUOROBENZOYL)<br>ACRYLATE<br>1.24 kg<br>CIPROFLOXACIN HCL / BASE 1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	CIPROFLOXACIN HCL / BASE		1 kg	1	ETHYL 3-CYCLOPROPYLAMINO-2-(2,4-<br>DICHLORO-5-FLUOROBENZOYL)<br>ACRYLATE	1.24 kg

ACIN HCL / BASE 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||CIPROFLOXACIN HCL / BASE||1 kg|1|ETHYL 3-CYCLOPROPYLAMINO-2-(2,4- DICHLORO-5-FLUOROBENZOYL) ACRYLATE|1.24 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

2	CAUSTIC SODA FLAKES	0.35 kg
3	TOLUENE	0.123 kg
4	ANHYDROUS PIPERAZINE	0.39 kg
5	METHANOL	1.00 kg

Case No.	Case No.	62 / NC/3/MEET/Dec/202223/15	62 / NC/3/MEET/Dec/202223/15	62 / NC/3/MEET/Dec/202223/15	62 / NC/3/MEET/Dec/202223/15	62 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		GLAND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001295AM23
RA File Number		26AX04000021 AM23
Licence No and<br>Date		2611000614/09/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/7 dated 16/09/2022against advance authorization No.<br>0910067519 dated 14/05/2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

rt item in Meeting No.NC/3/MEET/Sep/202223/7 dated 16/09/2022against advance authorization No. 0910067519 dated 14/05/2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export Product Qty Sl. No. Import Items Qty 1 Heparin Sodium 79.466 mg 2 Barrel Syringes Net + 5% wastage 3 Plunger Stoppers Net + 11.55% wastage 4 Plunger Rods Net + 2.5% wastage 1 Low molecular weight Heparin Enoxaparin Sodium Injection USP, 40mg in 0.4ml Pre-filled Syringe(-) 1 Number 5 Preventis Needle Shielding System Net + 3% wastage||||||| ||Export Product||Qty|Sl. No.|Import Items|Qty| ||Low molecular weight Heparin Enoxaparin Sodium Injection USP, 40mg in 0.4ml Pre-filled Syringe(-)|| 1 Number|1|Heparin Sodium|79.466 mg| |||||2|Barrel Syringes|Net + 5% wastage| |||||3|Plunger Stoppers|Net + 11.55% wastage| |||||4|Plunger Rods|Net + 2.5% wastage| |||||5|Preventis Needle Shielding System|Net + 3% wastage|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

edle Shielding System|Net + 3% wastage|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

2	Low<br>molecular	Low<br>molecular	weight	<br>1 Number	1	Heparin Sodium	119.187 mg
	Heparin	Enoxaparin
	Sodium	Injection	USP,
	60mg in	0.6ml Pre-filled			2	Barrel Syringes	Net + 5% wastage
	Syringe(-)
					3	Plunger Stoppers	Net + 10.85% wastage
					4	Plunger Rods	Net + 1.65% wastage
					5	Preventis Needle Shielding System	Net + 3% wastage
3	Low<br>molecular		weight	<br>1 Number	1	Heparin Sodium	158.93 mg
	Heparin	Enoxaparin
	Sodium	Injection	USP,
	80mg in	0.8ml Pre-filled			2	Barrel Syringes	Net + 4.65% wastage
	Syringe(-)
					3	Plunger Stoppers	Net + 12% wastage
					4	Plunger Rods	Net + 2.5% wastage
					5	Preventis Needle Shielding System	Net + 3% wastage

Syringes|Net + 4.65% wastage| ||Syringe(-)||||||| ||||||3|Plunger Stoppers|Net + 12% wastage| ||||||4|Plunger Rods|Net + 2.5% wastage| ||||||5|Preventis Needle Shielding System|Net + 3% wastage|

Case No.<br>63 / NC/3/MEET/Dec/202223/15
Case Status<br>Case Approved
Party Name<br>GRAMEN BOTANICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>HQRNORM APPLY 00001296AM23
RA File Number<br>05AX04000728 AM23
Licence No and<br>Date<br>0511013111/09/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/May/202223/4dated17/06/2022 against advance authorization No.
0511002405dated04/05/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>BERBERINE HYDROCHLORIDE<br>(97 PERCENT)<br>1 kg<br>1<br>BERBERIS<br>ARISTATA<br>EXTRACT<br>(Assay 90% +/- 1%)<br>1.00 kg<br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl. No.	Import items	Qty.
	BERBERINE HYDROCHLORIDE<br>(97 PERCENT)	1 kg	1	BERBERIS<br>ARISTATA<br>EXTRACT<br>(Assay 90% +/- 1%)	<br>1.00 kg

of NC.	Export product	Qty.	Sl. No.	Import items	Qty.
	BERBERINE HYDROCHLORIDE<br>(97 PERCENT)	1 kg	1	BERBERIS<br>ARISTATA<br>EXTRACT<br>(Assay 90% +/- 1%)	<br>1.00 kg

Case No.	Case No.	64 / NC/3/MEET/Dec/202223/15	64 / NC/3/MEET/Dec/202223/15	64 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		HONOUR LAB LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001310AM23
RA File Number		09AX04000134 AM22
Licence No and<br>Date		0911003163/10/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/16dated08/04/2022 against advance authorization No.<br>0911001953dated26-11-2021, 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>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,7-DIHYDROXY FLUOREN-9-ONE<br>0.686 kg<br>2<br>2-DIETHYLE AMINO ETHYL CHLORIDE HCL<br>1.430 kg<br>3<br>TETRA BUTYL AMMONIUM BROMIDE<br>0.686 kg<br>TILORONE<br>DIHYDROCHLORIDE<br>1 kg<br>4<br>METHONOL<br>2.36 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

BROMIDE 0.686 kg TILORONE DIHYDROCHLORIDE 1 kg 4 METHONOL 2.36 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||TILORONE DIHYDROCHLORIDE||1 kg|1|2,7-DIHYDROXY FLUOREN-9-ONE|0.686 kg| |||||2|2-DIETHYLE AMINO ETHYL CHLORIDE HCL|1.430 kg| |||||3|TETRA BUTYL AMMONIUM BROMIDE|0.686 kg| |||||4|METHONOL|2.36 kg| |||||action as per above decision of NC.|||

Case No. 65 / NC/3/MEET/Dec/202223/15

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case Status	Case Deferred
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001312AM23
RA File Number	03AX04001057 AM23
Licence No and<br>Date	0311015409/10/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00001312AM23| |RA File Number|03AX04001057 AM23| |Licence No and Date|0311015409/10/06/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	66 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001321AM23
RA File Number	09AX04000211 AM23
Licence No and<br>Date	0911003166/11/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202223/12dated 18/11/2022 against advance authorization No.<br>0911002884dated21-04-2022, 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>Amino Acetyldehyde Di Methyl Acetal<br>0.575 kg<br>2<br>Methyl-4-Methoxy Acetoacetate<br>0.725 kg<br>3<br>Di Methyl Oxalate<br>1.17 kg<br>1-(2,2-DIMETHOXYETHYL)-5-<br>METHOXY-6-<br>(METHOXYCARBONYL)-4-OXO-1H-<br>PYRIDINE-3-CARBOXYLIC ACID<br>1 kg<br>4<br>Lithium Hydroxide<br>0.300 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 67 / NC/3/MEET/Dec/202223/15

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case No. 67 / NC/3/MEET/Dec/202223/15

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case Status	Case Status	Case Approved	Case Approved	Case Approved
Party Name		HONOUR LAB LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001322AM23
RA File Number		09AX04000212 AM23
Licence No and<br>Date		0911003167/11/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Nov/202223/12dated 18/11/2022 against advance authorization No.<br>0911002884dated 21-04-2022, 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>Amino Acetyldehyde Di Methyl Acetal<br>0.575 kg<br>2<br>Methyl-4-Methoxy Acetoacetate<br>0.725 kg<br>3<br>Di Methyl Oxalate<br>1.17 kg<br>1-(2,2-DIMETHOXYETHYL)-5-<br>METHOXY-6-<br>(METHOXYCARBONYL)-4-OXO-<br>1H-PYRIDINE-3-CARBOXYLIC<br>ACID<br>1 kg<br>4<br>Lithium Hydroxide<br>0.300 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

OXO- 1H-PYRIDINE-3-CARBOXYLIC ACID 1 kg 4 Lithium Hydroxide 0.300 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||1-(2,2-DIMETHOXYETHYL)-5- METHOXY-6- (METHOXYCARBONYL)-4-OXO- 1H-PYRIDINE-3-CARBOXYLIC ACID||1 kg|1|Amino Acetyldehyde Di Methyl Acetal|0.575 kg| |||||2|Methyl-4-Methoxy Acetoacetate|0.725 kg| |||||3|Di Methyl Oxalate|1.17 kg| |||||4|Lithium Hydroxide|0.300 kg| |||||per above decision of NC.|||

Case No.	68 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	MEGHMANI FINECHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001341AM23
RA File Number	34AX04000162 AM23
Licence No and<br>Date	3411002378/13/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No. 69 / NC/3/MEET/Dec/202223/15

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001355AM23
RA File Number	03AX04000821 AM23
Licence No and<br>Date	0311015467/13/06/2022
Norms Committee Decision:
Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00001355AM23| |RA File Number|03AX04000821 AM23| |Licence No and Date|0311015467/13/06/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	70 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	SATYADIVIS PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001343AM23
RA File Number	09AX04000118 AM23
Licence No and<br>Date	0911003170/13/06/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>71 / NC/3/MEET/Dec/202223/15
Case Status<br>Case Approved
Party Name<br>ALTA LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>HQRNORM APPLY 00001356AM23
RA File Number<br>03AX04001132 AM23
Licence No and<br>Date<br>0311015468/13/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.6/82-ALC4/2020 dated 13.11.2020against advance authorization No.0310836920 dated
29.06.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as
applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
SODIUM SALICYLATE<br>1 kg<br>1	SALICYLIC ACID	0.80 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case No.	72 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001344AM23
RA File Number	092404000405 AM21
Licence No and<br>Date	0911003173/13/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	73 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001357AM23
RA File Number	03AX04001138 AM23
Licence No and<br>Date	0311015469/13/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	74 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001345AM23
RA File Number	05AX04000761 AM23
Licence No and<br>Date	0511013170/13/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	75 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

| |---|---| |Case Status|Case Deferred|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001358AM23
RA File Number	03AX04001122 AM23
Licence No and<br>Date	0311015470/13/06/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	76 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001346AM23
RA File Number	05AX04000760 AM23
Licence No and<br>Date	0511013171/13/06/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.		77 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		ROYAL PHARMA
Meeting Number an<br>Date	d	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001359AM23
RA File Number		03AX04001263 AM23
Licence No and Da	te	0311015473/13/06/2022
Norms Committee	Decision:

/ 15 and 29/12/2022||||| |HQ File Number|||HQRNORM APPLY 00001359AM23||||| |RA File Number|||03AX04001263 AM23||||| |Licence No and Da||te|0311015473/13/06/2022||||| |Norms Committee||Decision:|||||| |The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.6/82-ALC4/2020 dated 13.11.2020against advance authorization No.0310838908 dated 15.10.2020it was decided to ratify adhoc norms under Para 407 of HBP Vol I as per details given below or as|||||||| |, . . applied by the firm, whichever is less:|||||||| ||||||||| ||||||||| ||||||||| ||||||||| ||Export produc|t||Qty.|Sl.|Import items|Qty.| ||||||No.||| ||||||||| ||||||||| ||BICALUTAM|IDE||1 kg|1|N - [4-CYANO-3- (TRIFLUOROMETHYL)| 0.709 kg|

Case No.		77 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		ROYAL PHARMA
Meeting Number an<br>Date	d	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001359AM23
RA File Number		03AX04001263 AM23
Licence No and Da	te	0311015473/13/06/2022
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

PHENYL] METHACRYLAMIDE<br>SULFIDE(CHEMICAL NAME:<br>N-[4-CYANO-3-(TRIFLUORO<br>METHYL)PHENYL]-3-[(4-<br>FLUOROPHENYL THIO)] -2-<br>HYDROXY-2-METHYL<br>PROPIONALIDE)<br>2<br>4- FLUOROTHIOPHENOL<br>0.30 kg<br>RA concerned may take further necessary action as per above decision of NC.	SULFIDE(CHEMICAL NAME:<br>N-[4-CYANO-3-(TRIFLUORO<br>METHYL)PHENYL]-3-[(4-<br>FLUOROPHENYL THIO)] -2-<br>HYDROXY-2-METHYL<br>PROPIONALIDE)			PHENYL] METHACRYLAMIDE
			2	4- FLUOROTHIOPHENOL	0.30 kg

CYANO-3-(TRIFLUORO METHYL)PHENYL]-3-[(4- FLUOROPHENYL THIO)] -2- HYDROXY-2-METHYL PROPIONALIDE)|||PHENYL] METHACRYLAMIDE|| |---|---|---|---|---|---| ||||2|4- FLUOROTHIOPHENOL|0.30 kg|

Case No.	78 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	AROCHEMA INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001332AM23
RA File Number	26AX04000018 AM23
Licence No and<br>Date	2611000615/13/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee for explaining its case alongwith following documents / information:<br> (i) Catalogue of foreign supplier for import items 3 to 5.<br>(ii) Bill of entry of import with invoice of foreign supplier.<br>(iii) Production / consumption data duly certified by a GST officer.<br>(iv) Application of Export item.		Personal Hearing

Case No.	79 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001347AM23
RA File Number	05AX04000669 AM23
Licence No and<br>Date	0511013173/13/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

sion: Deferred for comments of TE.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case No.	80 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001338AM23
RA File Number	08AX04000229 AM23
Licence No and<br>Date	0811005174/13/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Complete chemistry, molecular weight, percentage yield on molar basis etc. as per Annexure to Appendix 4E.<br>i.

Case No.	81 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001350AM23
RA File Number	03AX04001135 AM23
Licence No and<br>Date	0311015463/13/06/2022
Norms Committee Decision:
Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00001350AM23| |RA File Number|03AX04001135 AM23| |Licence No and Date|0311015463/13/06/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	82 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001340AM23
RA File Number	03AX04000749 AM23
Licence No and<br>Date	0311015456/13/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to callthe firm for attendingPersonal Hearing
before Norms Committee to explain its case.

Case No. 83 / NC/3/MEET/Dec/202223/15

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case Status	Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name			J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM APPLY 00001354AM23
RA File Number			03AX04001153 AM23
Licence No and<br>Date			0311015466/13/06/2022

Date|||NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022||||| |HQ File Number|||HQRNORM APPLY 00001354AM23||||| |RA File Number|||03AX04001153 AM23||||| |Licence No and Date|||0311015466/13/06/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Nov/202223/12 dated 18/11/2022against advance authorization No. 0311012790 dated 14/03/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No Import items Qty. 1. Benzydamine Hydrochloride 3.06 gram 2 Cetylpyridinium Chloride 1.356 gram 1 Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and(all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. Net content (i) 33.333 Kgs (ii) 14.778 Kgs (iii) 28733.356 Kgs.) 1000 Number 3 Isomalt ST-M 2586 gram 4 Benzydamine Hydrochloride 3.06 gram 2 Benzydamine Hydrochloride, 2,4- Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. Net content (i) 21.333 Kgs.

esthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. Net content (i) 21.333 Kgs. (ii) 18389.439 Kgs.) 1000 Number 5 Isomalt ST-M 2586 gram 6 Benzydamine Hydrochloride 3.06 gram 3 Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride-(3mg (ii) Isomalt ST-M - 2586mg. Net content (i) 12 Kgs. (ii) 10344 Kgs.) 1000 Number 7 Isomalt ST-M 2586 gram 8 Cetylpyridinium Chloride 1.356 gram Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) Isomalt ST-M - 2586 mg. Net 4 1000 Number 9 Isomalt ST-M 2586 gram|||||||| ||Sl. No.|Export product||Qty.|Sl. No|Import items|Qty.| ||1|Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and(all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg.

tiseptic Lozenges Sugar Free and(all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. Net content (i) 33.333 Kgs (ii) 14.778 Kgs (iii) 28733.356 Kgs.)||1000 Number|1.|Benzydamine Hydrochloride|3.06 gram| ||||||2|Cetylpyridinium Chloride|1.356 gram| ||||||3|Isomalt ST-M|2586 gram| ||2|Benzydamine Hydrochloride, 2,4- Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. Net content (i) 21.333 Kgs. (ii) 18389.439 Kgs.)|| 1000 Number|4|Benzydamine Hydrochloride|3.06 gram| ||||||5|Isomalt ST-M|2586 gram| ||3|Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride-(3mg (ii) Isomalt ST-M - 2586mg. Net content (i) 12 Kgs. (ii) 10344 Kgs.)|| 1000 Number|6|Benzydamine Hydrochloride|3.06 gram| ||||||7|Isomalt ST-M|2586 gram| ||4|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) Isomalt ST-M - 2586 mg. Net|| 1000 Number|8|Cetylpyridinium Chloride|1.356 gram| ||||||9|Isomalt ST-M|2586 gram|

ontains (i) Cetylpyridinium Chloride - 1.33mg (ii) Isomalt ST-M - 2586 mg. Net|| 1000 Number|8|Cetylpyridinium Chloride|1.356 gram| ||||||9|Isomalt ST-M|2586 gram|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

	content (i) 13.333 Kg (ii) 25924.878 Kg)	content (i) 13.333 Kg (ii) 25924.878 Kg)
5	Cetylpyridinium<br>Chloride	And	<br>1000	10	Cetylpyridinium	1.02 gram
	Benzydamine<br>Hydrochloride	Antiseptic			Chloride
	Lozenges<br>Suger<br>Free.<br>Each	<br>lozenge	<br>Number
	contains((i) Cetylpyridinium Chloride- 1mg
	(ii) Isomalt ST-M - 2586mg. Net	content (i)		11	Isomalt ST-M	2586 gram
	5.22 Kg (ii) 13498.92 Kg)

Case No.	Case No.	84 / NC/3/MEET/Dec/202223/15	84 / NC/3/MEET/Dec/202223/15	84 / NC/3/MEET/Dec/202223/15	84 / NC/3/MEET/Dec/202223/15	84 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001379AM23
RA File Number		09AX04000215 AM23
Licence No and<br>Date		0911003175/14/06/2022

and Date||NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022||||| |HQ File Number||HQRNORM APPLY 00001379AM23||||| |RA File Number||09AX04000215 AM23||||| |Licence No and Date||0911003175/14/06/2022||||| |Norms Committee Decision: T The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.1/82-ALC4/2018 dated 01.05.2018against advance authorization No.0910064911 dated 13.04.2017, 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 Qty. Sl. No. Import items Qty. 1 Gemfibrozil 0.707 kg 2 Pregelatinised Starch 0.083 kg 3 Maize Starch 0.1485 kg 4 Sodium Starch Glycollate 0.030 kg Compresso GEM 70(Compresso GEM 70 (Gemfibrozil Granules DC 70% )) 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Compresso GEM 70(Compresso GEM 70 (Gemfibrozil Granules DC 70% ))|| 1 kg|1|Gemfibrozil|0.707 kg| |||||2|Pregelatinised Starch|0.083 kg| |||||3|Maize Starch|0.1485 kg| |||||4|Sodium Starch Glycollate|0.030 kg|

ompresso GEM 70 (Gemfibrozil Granules DC 70% ))|| 1 kg|1|Gemfibrozil|0.707 kg| |||||2|Pregelatinised Starch|0.083 kg| |||||3|Maize Starch|0.1485 kg| |||||4|Sodium Starch Glycollate|0.030 kg|

Case No.	Case No.	84 / NC/3/MEET/Dec/202223/15	84 / NC/3/MEET/Dec/202223/15	84 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001379AM23
RA File Number		09AX04000215 AM23
Licence No and<br>Date		0911003175/14/06/2022
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.1/82-ALC4/2018 dated 01.05.2018against advance authorization No.0910064911<br>dated 13.04.2017, 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>Gemfibrozil<br>0.707 kg<br>2<br>Pregelatinised Starch<br>0.083 kg<br>3<br>Maize Starch<br>0.1485 kg<br>4<br>Sodium Starch Glycollate<br>0.030 kg<br>Compresso GEM 70(Compresso GEM 70<br>(Gemfibrozil Granules DC 70% ))<br>1 kg
	Export product		Qty.	Sl.

083 kg 3 Maize Starch 0.1485 kg 4 Sodium Starch Glycollate 0.030 kg Compresso GEM 70(Compresso GEM 70 (Gemfibrozil Granules DC 70% )) 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Compresso GEM 70(Compresso GEM 70 (Gemfibrozil Granules DC 70% ))|| 1 kg|1|Gemfibrozil|0.707 kg| |||||2|Pregelatinised Starch|0.083 kg| |||||3|Maize Starch|0.1485 kg| |||||4|Sodium Starch Glycollate|0.030 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

	5	Povidone K 30	0.0270 kg
	6	Sodium Lauryl Sulfate	0.00150 kg
	7	Stearic Acid	0.0100 kg

5<br>Povidone K 30<br>0.0270 kg<br>6<br>Sodium Lauryl Sulfate<br>0.00150 kg<br>7<br>Stearic Acid<br>0.0100 kg		5	Povido	ne K 30	0.027	0 kg
		6	Sodium	Lauryl Sulfate	0.001	50 kg

		7	Stearic Acid		0.0100 kg

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

Case No.	85 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number
and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001367AM23
RA File Number	05AX04000746 AM23
Licence No and<br>Date	0511013184/14/06/2022

Dec/ 202223/ 15 and 29/12/2022|||||||||| |HQ File Number|||HQRNORM APPLY 00001367AM23|||||||||| |RA File Number|||05AX04000746 AM23|||||||||| |Licence No and Date|||0511013184/14/06/2022|||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08/04/2022against advance authorization No. 0511005240 dated 06-10-2021, 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. 1 Moxifloxacin Hydrochloride 1547.09 gram Moxifloxacin HCL & Dexamethasone Sodium Phosphate Eye Drops 0.5%w/v, 0.1% w/v, 5ml (MILFLOX DM, MILFODOX, MIFLOCO DELTA)((Each ml contain Moxifloxacin Base 5mg. equi. to Moxifloxacin HCL 5.45mg. 54071 Numbers 2 Dexamethasone Sodium Phosphate 312.26 gram||||||||||||| ||511005240 dated 06-10-2021, it was decide ven below or as applied by the firm, whiche||||d to ratif ver is less||y adhoc :|norms under Para 4.07 of HBP Vol.|||I as per details|| |||||||||||||| ||Export product|||Qty.||||||||| ||||||||Sl. No.|Import items||Q|ty.|| ||Moxifloxacin HCL & Dexamethasone Sodium Phosphate Ee Dros 05%w/v 01% w/v 5ml|||5407 Num|1 bers|||||||| ||||||||1|Moxifloxacin Hydrochloride||1|547.09 gram|| |||||||||||||| ||y p ., .

oxifloxacin HCL & Dexamethasone Sodium Phosphate Ee Dros 05%w/v 01% w/v 5ml|||5407 Num|1 bers|||||||| ||||||||1|Moxifloxacin Hydrochloride||1|547.09 gram|| |||||||||||||| ||y p ., . , (MILFLOX DM, MILFODOX, MIFLOCO DELTA)((Each ml contain Moxifloxacin Base 5mg. equi. to Moxifloxacin HCL 5.45mg.||||||2|Dexamethasone Sodium Phosphate||312.26 gram||| ||& Dexamethasone Phosphate 1mg|||||||||||| ||equi. to Dex ||amethasone Sodium |||||||||| ||Phosphate ||1.1mg (Equi.to |||||||||| ||1473.435gm M 297391m De||oxifloxacin HCL & amethasone Sodium|||||||||| ||.g Phosphate)|||||||||||| |||||||||||||| |||||||||||||| ||||||||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case No.	86 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001371AM23
RA File Number	03AX04000956 AM23
Licence No and<br>Date	0311015488/14/06/2022
Norms Committee Decision:
Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00001371AM23| |RA File Number|03AX04000956 AM23| |Licence No and Date|0311015488/14/06/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

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


Case No.			86 / NC/3/MEET/Dec/202223/15
Case Status			Case Deferred
Party Name			MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM APPLY 00001371AM23
RA File Number			03AX04000956 AM23
Licence No and<br>Date			0311015488/14/06/2022

Norms Committee Decision:
Deferred for comm			ents of TE.


Case No.			87 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
and Date

/15||||||||| |Case Status|||Case Approved||||||||| |Party Name|||GLENMARK PHARMACEUTICALS LIMITED||||||||| |Meeting Number|||NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022||||||||| |and Date|||||||||||| |HQ File Number|||HQRNORM APPLY 00001372AM23||||||||| |RA File Number|||03AX04001157 AM23||||||||| |Licence No and Date|||0311015490/14/06/2022||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Oct/202122/9 dated 15/10/2021against advance authorization No. 0310838214 dated 11-09-2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Clindamycin Phosphate USP 262.50 mg / pack 1 Clindamycin & Benzoyl Peroxide Gel 1percent/5percent ( Pack Size 25gm )((Net Wt. of Import Item Sr. No. 1 is 25.00 Kgs. & Sr. No. 2 is 125.00 Kgs.)) 1 Number Pack 2 HYDROUS BENZOYL PEROXIDE USP 1312.50 mg / pack |||||||||||| ||310838214 dated 11-09-2020, it was decid iven below or as applied by the firm, whiche|||ed to ratif ver is less||y adhoc :||norms under Para 4.07 of HBP Vol.||I as per details|| ||||||||||||| ||Sl. No.|Export product|||Qty.||||||| ||||||||Sl|. No.|Import items||Qty.| ||1|Clindamycin & Benzoyl Peroxide G 1percent/5percent ( Pack Size 25g )((Net Wt. of Import Item Sr. No.

|||||||||||| ||Sl. No.|Export product|||Qty.||||||| ||||||||Sl|. No.|Import items||Qty.| ||1|Clindamycin & Benzoyl Peroxide G 1percent/5percent ( Pack Size 25g )((Net Wt. of Import Item Sr. No. 1||el m is| 1 Num Pack||||||| |||||||ber|1||Clindamycin Phosphate USP||262.50 mg / pack| |||25.00 Kgs. & Sr. No. 2 is 125.00 Kgs.))|||||2||HYDROUS BENZOYL PEROXIDE USP||1312.50 mg / pack| |||||| ||||||| ||2|Clindamycin & Benzoyl Peroxide Gel 1ercent/5ercent ( Pack Size 35m||| 1 Number Pack||1||Clindamycin Phosphate USP||367.50 mg / ack| |||p )((Net W|p g t. of Import Item Sr. No. 1 is|| ||||||p| |||35.00 Kg|s. & Sr. No. 2 is 175.00 Kgs.))||||||||| ||||||||||||| |||||||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

|2 HYDROUS BENZOYL PEROXIDE USP 1837.50 mg / pack 1 Clindamycin Phosphate USP 525.00 mg / pack 3 Clindamycin & Benzoyl Peroxide Gel 1percent/5percent ( Pack Size 50gm )((Net Wt. of Import Item Sr. No. 1 is 40.00 Kgs. & Sr. No. 2 is 200.00 Kgs.)) 1 Number Pack 2 HYDROUS BENZOYL PEROXIDE USP 2625.00 mg / pack 4 Adapalene & Benzoyl Peroxide Gel 0.1percent/2.5percent ( Pack Size 45gm )((Net Wt. of Import Item Sr. No.

		2	HYDROUS<br>BENZOYL<br>PEROXIDE USP	1837.50 mg /<br>pack
Clindamycin & Benzoyl Peroxide Gel<br>1percent/5percent ( Pack Size 50gm<br>)((Net Wt. of Import Item Sr. No. 1 is<br>40.00 Kgs. & Sr. No. 2 is 200.00 Kgs.))	<br> <br> <br>1 Number<br>Pack	1	Clindamycin Phosphate USP	525.00 mg /<br>pack
		2	HYDROUS<br>BENZOYL<br>PEROXIDE USP	2625.00 mg /<br>pack
Adapalene & Benzoyl Peroxide Gel<br>0.1percent/2.5percent ( Pack Size 45gm<br>)((Net Wt. of Import Item Sr. No. 2 is<br>67.50 Kgs.))	<br> <br>1 Number<br>Pack	1	HYDROUS<br>BENZOYL<br>PEROXIDE USP	1181.25 mg /<br>pack

Case No.	Case No.	Case No.	88 / NC/3/MEET/Dec/202223/15	88 / NC/3/MEET/Dec/202223/15	88 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM APPLY 00001386AM23
RA File Number			08AX04000368 AM23
Licence No and<br>Date			0811005222/15/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/16dated08/04/2022 against advance authorization No.<br>0811002920dated20-10-2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>(for 1 Number<br>Vial)<br>1<br>METHOTREXATE<br>INJECTION<br>BP<br>25MG/ML<br>[2ML<br>VIAL](EACH<br>ML<br>CONTAINS:<br>METHOTREXATE<br>PH.<br>EUR. 25MG)<br>1 Number<br>1<br>METHOTREXATE EP / BP /<br>IP / USP / PH. EUR.<br>55.00 mg
	Sl. No.	Export product		Qty.	Sl.

[2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. 55.00 mg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty. (for 1 Number Vial)| ||1|METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|| 1 Number|1|METHOTREXATE EP / BP / IP / USP / PH. EUR.| 55.00 mg|

Case No.	Case No.	Case No.	88 / NC/3/MEET/Dec/202223/15	88 / NC/3/MEET/Dec/202223/15	88 / NC/3/MEET/Dec/202223/15	88 / NC/3/MEET/Dec/202223/15	88 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM APPLY 00001386AM23
RA File Number			08AX04000368 AM23
Licence No and<br>Date			0811005222/15/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/16dated08/04/2022 against advance authorization No.<br>0811002920dated20-10-2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No.

plied by the firm, whichever is less:||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
1	MAGNESIUM<br>CITRATE<br>(USP/<br>NONAHYDRATE<br>Eur.Ph/<br>ANHYDROUS<br>Eur.Ph/<br>DODECAHYDRATE Eur.Ph)	<br> <br> <br>1 kg	1	CITRIC ACID - ANY GRADE	1.001 kg
			2	MAGNESIUM<br>CARBONATE<br>-<br>ANY GRADE	<br>0.730 kg
2	CALCIUM CITRATE(USP)	1 kg	1	CITRIC ACID - ANY GRADE	0.816 kg
			2	CALCIUM CARBONATE	0.708 kg
3	ZINC CITRATE(USP)	1 kg	1	CITRIC ACID - ANY GRADE	0.880 kg
4	POTASSIUM<br>CITRATE<br>(BP/Eur.Ph/ USP)	<br>1 kg	1	CITRIC ACID - ANY GRADE

GRADE|0.816 kg| |||||2|CALCIUM CARBONATE|0.708 kg| ||3|ZINC CITRATE(USP)|1 kg|1|CITRIC ACID - ANY GRADE|0.880 kg| ||4|POTASSIUM CITRATE (BP/Eur.Ph/ USP)| 1 kg|1|CITRIC ACID - ANY GRADE||

Case No.	103 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001459AM23
RA File Number	07AX04000281 AM23
Licence No and<br>Date	0711004347/17/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>COA report of Export Product and Import Item.<br>i.<br>Indigenous item to use in manufacturing export item and to fill the same in Appendix 4E.<br>ii.

Case No.	104 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	AROCHEMA INGREDIENTS PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

e|AROCHEMA INGREDIENTS PRIVATE LIMITED|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022	Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022	Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022	Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>HQRNORM APPLY 00001494AM23
RA File Number<br>26AX04000023 AM23
Licence No and<br>Date<br>2611000623/20/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.
	ORCANOX<br>1 kg	1	SCLAREOLIDE	1.1768 kg
		2	TERT - AMYL ALCOHOL	1.00 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	105 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001521AM23
RA File Number	03AX04001765 AM23
Licence No and<br>Date	0311015682/20/06/2022
Norms Committee Decision:
Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00001521AM23| |RA File Number|03AX04001765 AM23| |Licence No and Date|0311015682/20/06/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	106 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001522AM23
RA File Number	07AX04000389 AM23
Licence No and Date	0711004350/21/06/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

|T i 0 g R|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.NC/3/MEET/Nov/202223/12dated18/11/2022 against advance authorization No. 711003985dated19/05/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.NC/3/MEET/Nov/202223/12dated18/11/2022 against advance authorization No. 711003985dated19/05/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

mport item in Meeting No.NC/3/MEET/Nov/202223/12dated18/11/2022 against advance authorization No. 711003985dated19/05/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.NC/3/MEET/Nov/202223/12dated18/11/2022 against advance authorization No. 711003985dated19/05/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.NC/3/MEET/Nov/202223/12dated18/11/2022 against advance authorization No. 711003985dated19/05/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.NC/3/MEET/Nov/202223/12dated18/11/2022 against advance authorization No. 711003985dated19/05/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:| |---|---|---|---|---|---| ||Export product|Qty.|Sl.

**, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:| |---|---|---|---|---|---| ||Export product|Qty.|Sl. No.|Import items|Qty.| ||Prochlorperazine Edisylate Injection 10mg/2mL(Prochlorperazine Edisylate Injection 10mg, 2mL vial - 10 mg of bulk drug filled in 2 mL vial and capped with 13mm Rubber Stopper & 13mm Omniflexplus Coated(Dark Grey) Seals)| 307800 Numbers|1|110010718 V9239 FM259/0 FLCO 015 (13mm Omniflexplus Coated BB R/S-RFS V9239 FM259/0)| Relevant as per Packing Policy| ||A concerned may take further necessary action as per above decision of NC.|||||

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/Nov/202223/12 dated 18/11/2022 against advance authorization No. 0711003985 dated 19/05/2022 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

nce authorization No. 0711003985 dated 19/05/2022 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Case No.	Case No.	107 / NC/3/MEET/Dec/202223/15	107 / NC/3/MEET/Dec/202223/15	107 / NC/3/MEET/Dec/202223/15	107 / NC/3/MEET/Dec/202223/15	107 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001527AM23
RA File Number		09AX04000227 AM23
Licence No and<br>Date		0911003213/21/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/2022122/16dated 08/04/2022 against advance authorization No.<br>0911001704dated 11-10-2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>L Proline<br>0.855 kg<br>2<br>Amantadine HCL<br>0.904 kg<br>VILDAGLIPTIN<br>(Pharmaceutical product)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	VILDAGLIPTIN<br>(Pharmaceutical product)		1 kg	1	L Proline	0.855 kg
				2	Amantadine HCL	0.904 kg

br>(Pharmaceutical product) 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||VILDAGLIPTIN (Pharmaceutical product)||1 kg|1|L Proline|0.855 kg| |||||2|Amantadine HCL|0.904 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

3 Dimethylformamide 0.50 kg

Case No.	108 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001530AM23
RA File Number	03AX04001714 AM23
Licence No and<br>Date	0311015686/21/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/2022223/5dated 08/07/2022 against advance authorization No.<br>0311001236dated 28/01/2021, 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>Dimethyl Sulfoxide<br>0.932 kg<br>TRIMETHYL SULFOXONIUM BROMIDE<br>1 kg<br>2<br>Trimetyl Orthoformate<br>0.018 kg<br>RA concerned may take further necessary action as per above decision of NC.

r>Dimethyl Sulfoxide 0.932 kg TRIMETHYL SULFOXONIUM BROMIDE 1 kg 2 Trimetyl Orthoformate 0.018 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	109 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001548AM23
RA File Number	07AX04000277 AM23
Licence No and<br>Date	0711004391/21/06/2022
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Jun/2022122/2 dated 02/07/2021 against advance authorization No. 0711000943 dated 23/04/2021 , 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:

nce authorization No. 0711000943 dated 23/04/2021 , 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:

Sl. No.	EXPORT PRODUCT	QTY.	Sl. No.	IMPORT ITEMS	QTY.
1.	CALCIUM LACTOBIONATE	1 kg	1.	CALCIUM CARBONATE	0.172 kg
			2.	LACTOSE	1.16 kg
2.	CALCIUM BROMO<br>LACTOBIONATE	1 kg	1.	CALCIUM CARBONATE	0.360 kg
			2.	LACTOSE	1.021 kg
			3.	HYDROBROMIC ACID	0.510 kg
3.	CALCIUM GLUBIONATE	1 kg	1.	CALCIUM CARBONATE	0.140 kg
			2.	LACTOSE	0.829 kg
			3.	CALCIUM GLUCONATE	0.42 kg
4.	LACTOBIONIC ACID	1 kg	1.	CALCIUM CARBONATE	0.234 kg
			2.	LACTOSE	1.58 kg

Case No.	110 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	BRAWN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001556AM23
RA File Number	05AX04000865 AM23
Licence No and	0511013337/21/06/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Date

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Mar/2022122/15 dated 17/03/2022 against advance authorization No. 0311000200 dated 16/12/2020 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product			Qty.	Sl. No.	Import items	Qty.
DOXYCYCLINE	CAPSULES	100 MG((HARD	<br>1 Number	1	DOXYCYCLINE	117 mg
GELATINE	CAPSULES	CONTAINING			HYCLATE
YELLOW GRANULAR POWDER))

Case No.<br>111 / NC/3/MEET/Dec/202223/15
Case Status<br>Case Approved
Party Name<br>J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>HQRNORM APPLY 00001568AM23
RA File Number<br>03AX04001806 AM23
Licence No and<br>Date<br>0311015747/22/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking and		taking cue from earlier decision for same export
product / import item in Meeting No.NC/3/MEET/Nov/202223/12		dated	18/11/2022 against advance authorization
No.0311012790dated14/03/2022, it was decided to	ratify adhoc norms under Para 4.07 of HBP			Vol. I as per
details given below or as applied by the firm, whichever is less:
Sl. No. Export product	Qty.	Sl.

4/03/2022**, it was decided to|ratify adhoc norms under Para 4.07 of HBP|||Vol. I as per|| |details given below or as applied by the firm, whichever is less:|||||| |Sl. No. Export product|Qty.|Sl. No|Import items|Qty.|| |Benzydamine Hydrochloride And 1|1000|1.|Benzydamine|3.06 gram|| |Cetylpyridinium Chloride Anti-|||Hydrochloride||| |Inflammatory And Antiseptic Lozenges|Number||||| |Sugar Free and(all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii)||2|Cetylpyridinium Chloride|1.356 gram||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

|Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. Net content (i) 33.333 Kgs (ii) 14.778 Kgs (iii) 28733.356 Kgs.) 3 Isomalt ST-M 2586 gram 4 Benzydamine Hydrochloride 3.06 gram 2 Benzydamine Hydrochloride, 2,4- Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. Net content (i) 21.333 Kgs. (ii) 18389.439 Kgs.) 1000 Number 5 Isomalt ST-M 2586 grram 6 Benzydamine Hydrochloride 3.06 gram 3 Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride-(3mg (ii) Isomalt ST-M - 2586mg. Net content (i) 12 Kgs.

r>3<br>Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each lozenge contains (i) Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-M -<br>2586mg. Net content (i) 12 Kgs. (ii)<br>10344 Kgs.)<br>1000<br>Number<br>7<br>Isomalt ST-M<br>2586 gram<br>8<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>4<br>Cetylpyridinium<br>Chloride<br>And<br>Bromhexine Hydrochloride Antiseptic<br>Lozenges Sugar Free and all other<br>flavours.(Each lozenge contains (i)<br>Cetylpyridinium Chloride - 1.33mg (ii)<br>Isomalt ST-M - 2586 mg. Net content<br>(i) 13.333 Kg (ii) 25924.878 Kg)<br>1000<br>Number<br>9<br>Isomalt ST-M<br>2586 gram<br>9<br>Cetylpyridinium<br>Chloride<br>1.02 gram<br>5<br>Cetylpyridinium<br>Chloride<br>And<br>Benzydamine Hydrochloride Antiseptic<br>Lozenges Suger Free. Each lozenge<br>contains((i) Cetylpyridinium Chloride-<br>1mg (ii) Isomalt ST-M - 2586mg. Net<br>content (i) 5.22 Kg (ii) 13498.92 Kg)<br>1000<br>Number<br>10<br>Isomalt ST-M<br>2586 gram<br> <br>RA concerned may take further necessary action as per above decision of NC.		Cetylpyridinium Chloride- 1.33mg (iii)<br>Isomalt ST-M - 2586mg. Net content (i)<br>33.333 Kgs (ii) 14.778 Kgs (iii)<br>28733.356 Kgs.)		3	Isomalt ST-M	2586 gram
	2	Benzydamine<br>Hydrochloride,<br>2,4-<br>Dichlorobenzyl Alcohol And Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial Lozenges<br>Sugar Free. Each lozenge contains (i)<br>Benzydamine Hydrochloride - 3mg (ii)<br>Isomalt ST-M- 2586mg. Net content (i)<br>21.333 Kgs.

Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. Net content (i) 21.333 Kgs. (ii) 18389.439 Kgs.)|1000 Number|4|Benzydamine Hydrochloride|3.06 gram| |||||5|Isomalt ST-M|2586 grram| ||3|Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride-(3mg (ii) Isomalt ST-M - 2586mg. Net content (i) 12 Kgs. (ii) 10344 Kgs.)|1000 Number|6|Benzydamine Hydrochloride|3.06 gram| |||||7|Isomalt ST-M|2586 gram| ||4|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) Isomalt ST-M - 2586 mg. Net content (i) 13.333 Kg (ii) 25924.878 Kg)|1000 Number|8|Cetylpyridinium Chloride|1.356 gram| |||||9|Isomalt ST-M|2586 gram| ||5|Cetylpyridinium Chloride And Benzydamine Hydrochloride Antiseptic Lozenges Suger Free. Each lozenge contains((i) Cetylpyridinium Chloride- 1mg (ii) Isomalt ST-M - 2586mg. Net content (i) 5.22 Kg (ii) 13498.92 Kg)|1000 Number|9|Cetylpyridinium Chloride|1.02 gram| |||||10|Isomalt ST-M|2586 gram|

Case No.	112 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001597AM23

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

RA File Number<br>03AX04001819 AM23	RA File Number<br>03AX04001819 AM23
Licence No and<br>Date<br>0311015779/22/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the		firm, whichever is less:
Export Product	Qty.	Sl. No.	Import items	Qty.
CASPOFUNGIN ACETATE FOR	<br>1 Vial	1	CASPOFUNGIN ACETATE	55 mg / Vial
INJECTION 50MG. Net content of
CASPOFUNGIN ACETATE 650
GMS
RA concerned may take further necessary action as per above decision of NC.

ASPOFUNGIN ACETATE|55 mg / Vial|| |INJECTION 50MG. Net content of|||||| |CASPOFUNGIN ACETATE 650|||||| |GMS|||||| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.<br>113 / NC/3/MEET/Dec/202223/15
Case Status<br>Case Approved
Party Name<br>J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>HQRNORM APPLY 00001569AM23
RA File Number<br>03AX04001807 AM23
Licence No and<br>Date<br>0311015749/22/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking and		taking cue from earlier decision for same export
product / import item in Meeting No.NC/3/MEET/Nov/202223/12		dated	18/11/2022 against advance authorization
No.0311012790dated14/03/2022, it was decided to	ratify adhoc norms under Para 4.07 of HBP			Vol. I as per
details given below or as applied by the firm, whichever is less:
Sl. No. Export product	Qty.	Sl. No	Import items	Qty.
Benzydamine<br>Hydrochloride<br>And<br>1	<br>1000	1.	Benzydamine	3.06 gram
Cetylpyridinium<br>Chloride<br>Anti-			Hydrochloride
Inflammatory And Antiseptic Lozenges	<br>Number
Sugar Free and(other flavours. Each<br>lozenge<br>contains<br>(i)<br>Benzydamine	<br>	2	Cetylpyridinium	1.356 gram

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

ine| |2|Cetylpyridinium|1.356 gram||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

|Chloride Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. Net content (i) 31.034 Kgs (ii) 13.759 Kgs (iii) 26751.736 Kgs.) 3 Isomalt ST-M 2586 gram 4 Benzydamine Hydrochloride 3.06 gram 2 Benzydamine Hydrochloride, 2,4- Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Inflammatory, Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. Net content (i) 25.926 Kgs. (ii) 22348.129 Kgs.) 1000 Number 5 Isomalt ST-M 2586 grram 6 Benzydamine Hydrochloride 3.06 gram 3 Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free.(Each lozenge contains (i) Benzydamine Hydrochloride- 3mg (ii) Isomalt ST-M - 2586mg. Net content (i) 13.333 Kgs. (ii) 11493.343 Kgs.) 1000 Number 7 Isomalt ST-M 2586 gram 8 Cetylpyridinium Chloride 1.356 gram 4 Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg.

	Hydrochloride-3mg (ii) Cetylpyridinium<br>Chloride- 1.33mg (iii) Isomalt ST-M -<br>2586mg. Net content (i) 31.034 Kgs (ii)<br>13.759 Kgs (iii) 26751.736 Kgs.)	<br> <br>		Chloride
			3	Isomalt ST-M	2586 gram
2	Benzydamine<br>Hydrochloride,<br>2,4-<br>Dichlorobenzyl Alcohol And Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Inflammatory,<br>Anti-Bacterial Lozenges Sugar Free.<br>Each lozenge contains (i) Benzydamine<br>Hydrochloride - 3mg (ii) Isomalt ST-M-<br>2586mg. Net content (i) 25.926 Kgs. (ii)<br>22348.129 Kgs.)	1000<br>Number	4	Benzydamine<br>Hydrochloride	3.06 gram
			5	Isomalt ST-M	2586 grram
3	Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory<br>Lozenges<br>Sugar<br>Free.(Each<br>lozenge<br>contains<br>(i)<br>Benzydamine Hydrochloride- 3mg (ii)<br>Isomalt ST-M - 2586mg.

2586 grram| ||3|Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free.(Each lozenge contains (i) Benzydamine Hydrochloride- 3mg (ii) Isomalt ST-M - 2586mg. Net content (i) 13.333 Kgs. (ii) 11493.343 Kgs.)| 1000 Number|6|Benzydamine Hydrochloride|3.06 gram| |||||7|Isomalt ST-M|2586 gram| ||4|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii) 3825.997 Kg.)|1000 Number|8|Cetylpyridinium Chloride|1.356 gram| |||||9|Isomalt ST-M|2586 gram| ||5|Cetylpyridinium Chloride And Benzydamine Hydrochloride Antiseptic Lozenges Sugar Free.(Each lozenge contains (i) Cetylpyridinium Chloride- 1 mg (ii) lsomalt ST-M - 2586mg. Net content (i) 1.333 Kg (ii) 3448.028 Kg)| 1000 Number|9|Cetylpyridinium Chloride|1.02 gram| |||||10|Isomalt ST-M|2586 gram|

Case No.	114 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

/ MEET/ Dec/ 202223/ 15 and 29/12/2022|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

HQ File Number	HQRNORM APPLY 00001570AM23
RA File Number	05AX04000861 AM23
Licence No and<br>Date	0511013343/22/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export<br>product / import item in Meeting No.NC/3/MEET/Mar/202223/16dated 08/04/2022 against advance authorization<br>No.0511005404dated 13/10/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No Import items<br>Qty.<br>Brinzolamide Ophthalmic Suspension,<br>1% w/v 5ml (Sterile Eye Drops)<br>(BRINOLAR / BRAZTEC)((Each ml<br>contains Brinzolamide equivalent to<br>Brinzolamide Micronized Sterile 10 mg<br>(Equivalent to 1300 Gm of Bulk Drug),)<br>26000<br>Numbers<br>1<br>Brinzolamide Micronized<br>Sterile<br>1326 gram<br> <br>RA concerned may take further necessary action as per above decision of NC.

valent to 1300 Gm of Bulk Drug),) 26000 Numbers 1 Brinzolamide Micronized Sterile 1326 gram RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	115 / NC/3/MEET/Dec/202223/15	115 / NC/3/MEET/Dec/202223/15	115 / NC/3/MEET/Dec/202223/15	115 / NC/3/MEET/Dec/202223/15	115 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		SMS PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001577AM23
RA File Number		09AX04000241 AM23
Licence No and Date		0911003220/22/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export<br>product / import item in Meeting No.NC/3/MEET/Sep/202223/9dated 07/10/2022 against advance authorization No.<br>0911002637dated 08/03/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,4,5 TRIFLUOROPHENYLACETIC ACID<br>1.146 kg<br>SITAGLIPTIN<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	SITAGLIPTIN		1 kg	1	2,4,5 TRIFLUOROPHENYLACETIC ACID	1.146 kg

r>1 2,4,5 TRIFLUOROPHENYLACETIC ACID 1.146 kg SITAGLIPTIN 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||SITAGLIPTIN||1 kg|1|2,4,5 TRIFLUOROPHENYLACETIC ACID|1.146 kg|

Case No.	Case No.	115 / NC/3/MEET/Dec/202223/15	115 / NC/3/MEET/Dec/202223/15	115 / NC/3/MEET/Dec/202223/15	115 / NC/3/MEET/Dec/202223/15	115 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		SMS PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001577AM23
RA File Number		09AX04000241 AM23
Licence No and Date		0911003220/22/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export<br>product / import item in Meeting No.NC/3/MEET/Sep/202223/9dated 07/10/2022 against advance authorization No.<br>0911002637dated 08/03/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,4,5 TRIFLUOROPHENYLACETIC ACID<br>1.146 kg<br>SITAGLIPTIN<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	SITAGLIPTIN		1 kg	1	2,4,5 TRIFLUOROPHENYLACETIC ACID	1.146 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

,5 TRIFLUOROPHENYLACETIC ACID|1.146 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

2	MELDRUM ACID	0.88 kg
3	3-(TERIFLUOROMETHYL)-5,6,7,8-TETRAHYDRI-<br>[1,2,4]<br>TRIAZOLO[4,3-a]<br>PYRAZINE<br>HYDROCHLORIDE	0.75 kg
4	DI-TERTIARY BUTYL DICARBONATE (DIBOC)	1.50 kg
5	TETRAHYDROFURAN	1.50 kg
6	ISO PROPYL ALCOHOL	5.50 kg
7	METHYL DI CHLORIDE	12.18 kg
8	METHANOL	3.12 kg
9	N-HEPTANE	1.80 kg
10	TERTIARY BUTANOL (T-BUTANOL)	1.78 kg

| ||||5|TETRAHYDROFURAN|1.50 kg| ||||6|ISO PROPYL ALCOHOL|5.50 kg| ||||7|METHYL DI CHLORIDE|12.18 kg| ||||8|METHANOL|3.12 kg| ||||9|N-HEPTANE|1.80 kg| ||||10|TERTIARY BUTANOL (T-BUTANOL)|1.78 kg|

Case No.	116 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	SATYADIVIS PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001579AM23
RA File Number	09AX04000240 AM23
Licence No and<br>Date	0911003221/22/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export<br>product / import item in Meeting No.NC/3/MEET/Oct/202122/10dated 12/11/2021 against advance authorization<br>No.0910069294dated 01/10/2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Export product	Qty.	Sl. No.	Import items	Qty.
FLUOXETINE HCL	1 kg	1	BENZALDEHYDE	0.83 kg
		2	PALLADIUM	0.005 kg
		3	ACETOPHENONE	0.847 kg
		4	DIMETHYL SULPHOXIDE	2.29 kg
		5	PARAFORMALDEHYDE	0.253 kg
		6	PARA CHLORO BENZO TRIFLOURIDE	1.054 kg

CL|1 kg|1|BENZALDEHYDE|0.83 kg| |||2|PALLADIUM|0.005 kg| |||3|ACETOPHENONE|0.847 kg| |||4|DIMETHYL SULPHOXIDE|2.29 kg| |||5|PARAFORMALDEHYDE|0.253 kg| |||6|PARA CHLORO BENZO TRIFLOURIDE|1.054 kg|

Case No.<br>117 / NC/3/MEET/Dec/202223/15
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number<br>HQRNORM APPLY 00001585AM23
RA File Number<br>05AX04000883 AM23
Licence No and<br>Date<br>0511013369/22/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and	taking and taking cue from earlier decision for same export
product / import item in Meeting No.NC/3/MEET/May/202223/4dated 17/06/2022 against advance authorization
No.0511002009dated 31/03/2021, 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<br>Qty.		Sl. No.	Import items	Qty.
Brimonidine Tartrate 0.1% Eye Drops<br>157060 Vials		1	Brimonidine Tartrate	0.80 kg
Solution 5ml Santabrim

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

|Solution 5ml Santabrim|||||| |||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case No.	Case No.	118 / NC/3/MEET/Dec/202223/15
Case Status		Case Approved
Party Name		SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number		HQRNORM APPLY 00001586AM23
RA File Number		05AX04000882 AM23
Licence No and<br>Date		0511013370/22/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and			taking and taking cue from earlier			decision for same export
product / import item in Meeting No.NC/3/MEET/Apr/202223/1dated 29/04/2022 against advance authorization No.
0511006792dated		10/12/2021, it was decided to ratify	adhoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever			is less:
	Export product	Qty.		Sl. No.	Import items	Qty.
	Brinex / Brinex-M / Brinarga / Brinera<br>1 Vial			1	Brinzolamide	51.00 mg / Vial
	(Brinzolamide	Opthalmic<br>Suspension
	1%)- 5ml
<br>RA concerned may take further necessary action as per above decision of NC.

r>1 Vial|||1|Brinzolamide|51.00 mg / Vial|| ||(Brinzolamide|Opthalmic Suspension|||||| ||1%)- 5ml||||||| | RA concerned may take further necessary action as per above decision of NC.||||||||

Case No.	119 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001593AM23
RA File Number	03AX04001832 AM23
Licence No and<br>Date	0311015776/22/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export
product / import item in Meeting No.NC/3/MEET/Nov/202223/12dated 18/11/2022 against advance authorization
No.0311013612dated 05/04/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

plied by the firm, whichever is less:||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23


Sl. No.	Export Product	Qty.	Sl. No.	Import items	Qty.
1	Atorvastatin Calcium Tablets USP<br>10mg((Net wt. of Import Sr. No. 1<br>is 495.945kgs, Sr. No. 2 is<br>2746.71kg, Sr. No. 3 is 779.985kg,<br>Sr. No. 4 is 505000 Nos.))	<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	Silica Gel Dessicants - Packaged<br>Activated Carbon (Strippax Sorbent)	<br>Relevant as per<br>packing policy
2	Atorvastatin Calcium Tablets USP<br>20mg((Net wt. of Import Sr. No. 1<br>is 198.378kgs, Sr. No. 2 is<br>1102.572kg, Sr. No. 3 is 312.93kg,<br>Sr. No. 4 is 101000 Nos.))	<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	Silica Gel Dessicants - Packaged<br>Activated Carbon (Strippax Sorbent)	<br>Relevant as per<br>packing policy
3	Atorvastatin Calcium Tablets USP<br>40mg((Net wt. of Import Sr. No. 1<br>is 4364.316kgs, Sr. No.

essicants - Packaged Activated Carbon (Strippax Sorbent)| Relevant as per packing policy| ||3|Atorvastatin Calcium Tablets USP 40mg((Net wt. of Import Sr. No. 1 is 4364.316kgs, Sr. No. 2 is 24172.83kg, Sr. No. 3 is 6864.264.24kg, Sr. No. 4 is 1111000 Nos.))| 1 Number Tablet|1|Atorvastatin Calcium Propylene Glycol Solvate USP| 45.595 mg| |||||2|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)| 258.08 mg| |||||3|Calcium Acetate|71.963 mg| |||||4|Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent)| Relevant as per packing policy| ||4|Atorvastatin Calcium Tablets USP 80mg((Net wt. of Import Sr. No. 1 is 2063.131kgs, Sr. No. 2 is 11482.123kg, Sr. No. 3 is 3258.146kg, Sr. No. 4 is 262600| 1 Number Tablet|1|Atorvastatin Calcium Propylene Glycol Solvate USP| 91.20 mg| |||||2|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)| 518.206 mg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

) NF (Avicel PH 102)| 518.206 mg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

	3<br>Nos.))	Calcium Acetate	144.929 mg
	4	Silica Gel Dessicants - Packaged	<br>Relevant as per
		Activated Carbon (Strippax Sorbent)	packing policy
Note:	The above norms are valid only for subject to fulfillment of following conditions:
1.	Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex<br>
	Corp, US. Agent for Apotex Inc., Candada.
2.	Export to USA only.<br>
3.	Firm holding Certificate of Manufacturing Exclusivity.<br>

Case No.	120 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001604AM23
RA File Number	08AX04000401 AM23
Licence No and<br>Date	0811005305/23/06/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	121 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001605AM23
RA File Number	08AX04000497 AM23
Licence No and<br>Date	0811005314/23/06/2022
Norms Committee Decision:
Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00001605AM23| |RA File Number|08AX04000497 AM23| |Licence No and Date|0811005314/23/06/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	122 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	CIPLA LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Meeting Number	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
and Date
H Fil Nb	HRNORM APPLY 00001629AM23
Q e umer	Q

RA File Number	03AX04001871 AM23

Licence No and	0311015826/24/06/2022
Date

Norms Committee	Decision:
<br>The Committee co	<br>nsidered the case as per agenda and taking and tak	ing cue from earlier decisi	on for same export
product / import it	em in Meeting No.NC/3/MEET/Jan/202122/13da	ted 21/01/2022 against ad	vance authorization

aking and tak|||||ing cue from earlier decisi||on for same export|||| |product / import it||||em in Meeting No.NC/3/MEET/Jan/202122/13da|||||ted 21/01/2022 against ad||vance authorization|||| |No.**0311005772d ** ||||ated 30/07/2021, it was decided to ratify adhoc no |||||rms under Para 4.07 of HB||P Vol. I as|||| |per details given be||||low or as applied by the firm, whichever is less:||||||||||| |||||||||||||||| ||Sl. No.||Export product |||Qty.||Sl. No.||||Qty.||| |||||||||||Import items||||| |||||||||||||||| |||| |||||||||||| ||1||Telmis|artan and Amlodipine Tablets ||1 Number||1||Amlodipine Besilate||10.20 mg||| |||||||||||||||| ||||40/10|g / Each uncoated tablets||||||||||| ||||contai|s : Telmisartan 40||||||||||| |||| | ||||||||||| ||||mg(Te|lmisartan 40 mg equivalent to||||||||||| |||| | ||||||||||| ||||Telmis Amlod|artan granules 67.36mg ipine Besilate equivalent to||||||||||| |||| Ald| ii USP 10 N f||||||||||| ||||mo|pne mg et wt o||||||||||| ||||Telmis|artan Granules is||||||||||| |||||||||||||||| |||||||||||||||| ||||2020.8 Bilt|00 Kgs. Net wt of Amlodipine i 300000 K||||||||||| ||||esa|s .

|||||| ||||mo|pne mg et wt o||||||||||| ||||Telmis|artan Granules is||||||||||| |||||||||||||||| |||||||||||||||| ||||2020.8 Bilt|00 Kgs. Net wt of Amlodipine i 300000 K||||||||||| ||||esa|s . gs.)||||||||||| |||||||||||||||| ||2||Telmisartan and Amlodipine Tablets 80/10mg / Each uncoated tablets contains : Telmisartan 80 |||1 Number||2||Amlodipine Besilate||10.20 mg||| |||||||||||||||| ||||mg(Telmisartan 80 mg equivalent to |||||||||||| ||||Telmis |artan granules 134.72mg ||||||||||| ||||Amlod |ipine Besilate equivalent to ||||||||||| ||||Amlod Telmis|ipine USP 10mg artan Granules is|Net wt of|||||||||| |||| | ||||||||||| ||||10777.|600 Kgs. Net wt of|Amlodipine|||||||||| ||||Besilat|e is 800.000 Kgs.)||||||||||| |||||||||||||||| |||||||||||||||| ||3||Telmis 40/5m|artan and Amlodi / Each unco|pine Tablets ated tablets |1 Numb|er|3||Amlodipine Besilate||5.|10 mg|| |||| contains : Telmi mg(Telmisartan 40 mg Telmisartan granules Amlodipine Besilate e lii||sartan 40 equivalent to 67.36mg quivalent to f|||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| ||||Amodpne USP 5mg Telmisartan Granules is 6||Net wt o 286933 Ks|||||||||| |||||. g.|||||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

86933 Ks|||||||||| |||||. g.|||||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

	Net wt of	Amlodipine Besilate is
	466.667 Kgs.)
4	Telmisartan	and Amlodipine Tablets	1 Number	4	Amlodipine Besilate	5.10 mg
	80/5mg<br>/	Each<br>uncoated<br>tablets
	contains	:<br>Telmisartan<br>80
	mg(Telmisartan 80 mg equivalent to
	Telmisartan	granules<br>134.72mg
	Amlodipine	Besilate equivalent to
	Amlodipine	USP 5mg Net wt of
	Telmisartan	Granules is 10777.600
	Kgs. Net wt	of Amlodipine Besilate is
	400.000 Kgs.)


	Net w<br>	t of Amlodipine<br>	Besilate is
	466.66	7 Kgs.)


4	Telmis	artan and Amlodi	pine Tablets<br>	1 Numb	er	4	Amlodipine Besilate	5.	10 mg
	<br>80/5m	<br>g<br>/<br>Each<br>unco	<br>ated<br>tablets
	contain<br>mg(Te<br>	s<br>:<br>Telmis<br>lmisartan 80 mg e<br> <br>	artan<br>80<br>quivalent to

	Telmisartan<br>granules<br>Amlodipine Besilate eq<br>		134.72mg<br>uivalent to<br>
	Amlodipine USP 5mg<br>Telmisartan Granules is<br>Kgs.

quivalent to||||||||||| |||||||||||||||||| ||||Telmisartan granules Amlodipine Besilate eq |||134.72mg uivalent to ||||||||||| ||||Amlodipine USP 5mg Telmisartan Granules is Kgs. Net wt of Amlodipin|||Net wt of 10777.600 e Besilate is||||||||||| |||||||||||||||||| |||| 400.000 Kgs.)|||||||||||||| |||||||||||||||||| |R|A conce|rned may||take further necess||ary action as p||er above|decision of NC.|||||||| |||||||||||||||||| |||||||||||||||||| |||||||||||||||||| |C|ase No.|||123 / NC/3/MEET/||Dec/202223/15||||||||||| ||S|||C Ad||||||||||||| |||||||||||||||||| ||ase tat|s||ase pprove||||||||||||| |||||BALAI SPECIAL||TY CHEMIC||LS LI|ITED|||||||| ||arty Nam|e||J||||||||||||| ||i|b||||||||||||||| | a|eetng nd Date|umer||NC/ 3/ MEET/ Dec/||202223/ 15 an||d 29/12/|2022|||||||| |||||||||||||||||| ||Fil|b||HRORM APPL||00001636A||23||||||||| ||Q e|umer||QN||||||||||||| |R|A File N|umber||31AX04000064 AM||23||||||||||| |L D|icence N ate|o and||3111001476/24/06/||2022||||||||||| |N|orms Co|mmittee Decision:||||||||||||||| |||||||||||||||||| |||||||||||||||||| |T |he Com |mittee co ||nsidered the case a ||s per agenda ||and takin |g and taking cue from earlier decision for ||||||same export || |p |roduct / |import it ||em in Meeting No. ||NC/3/MEET ||/Jan/202 |122/15dated 17/03/2022 against advance ||||||authorization ||

on for ||||||same export || |p |roduct / |import it ||em in Meeting No. ||NC/3/MEET ||/Jan/202 |122/15dated 17/03/2022 against advance ||||||authorization || |N p|o.3111 er details|**00148 d ** given be||ated 09/02/2021, i low or as applied b||t was decided y the firm, wh||to ratify ichever i|adhoc norms under Para 4.07 of HBP s less:||||||Vol. I as|| |||||||||||||||||| |||||||||||||||||| |||||||||||||||||| ||Export|product|||Q|ty.|Sl. No.|||||||||| |||||||||Import|items||||Qty.|||| |||||||||||||||||| ||ETHYL (ORGA|ENE DI AMINE NIC PRODUCT)|||1|kg|1|||||||||| |||||||||MONO|ETHANOL AMINE||||1.0374 kg|||| |||||||||||||||||| ||||||||2|AMM|ONIA ANHYDROUS||||Not allow||ed, as it is|| |||||||||||||| shown indi|| genous|| |||||||||||||||||| |||||||||||||||||| |||||||||||||||||| | R| A conce| rned may||take further necess||ary action as p||er above|decision of NC.|||||||| |||||||||||||||||| |||||||||||||||||| ||||||||||||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Case No.	124 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	MITHILA RASAYAN PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001652AM23
RA File Number	03AX04001866 AM23
Licence No and<br>Date	0311015853/24/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00001652AM23| |RA File Number|03AX04001866 AM23| |Licence No and Date|0311015853/24/06/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	125 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	SHREYANS CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001660AM23
RA File Number	03AX04001924 AM23
Licence No and<br>Date	0311015858/25/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	126 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	SMS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001683AM23
RA File Number	09AX04000288 AM23
Licence No and<br>Date	0911003239/27/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	127 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001673AM23
RA File Number	03AX04001934 AM23

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Licence No and 0311015879/27/06/2022 Date Norms Committee Decision:

y Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Licence No and 0311015879/27/06/2022 Date Norms Committee Decision:

Case No.	128 / NC/3/MEET/Dec/202223/15
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001720AM23
RA File Number	33AX04000021 AM23
Licence No and<br>Date	3311000772/28/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	Case No.	129 / NC/3/MEET/Dec/202223/15	129 / NC/3/MEET/Dec/202223/15	129 / NC/3/MEET/Dec/202223/15	129 / NC/3/MEET/Dec/202223/15	129 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM APPLY 00001695AM23
RA File Number			03AX04001892 AM23
Licence No and<br>Date			0311015922/28/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export<br>product / import item in Meeting No.NC/3/MEET/Jan/202223/11dated 31/10/2022 against advance authorization<br>No.0311009414 dated 13/12/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl.

*, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Maxigesic cold & flu Hot Drink 500mg/150mg Sachets (Paracetamol & Ibuprofen Sachets 500 mg & 150 mg)(No. of Sachets 2,00,000 (Net content of Ibuprofen Lysine Salt IH API 51.30 kg)) 1 Number 1 Ibuprofen Lysine Salt IH 258.88 mg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Maxigesic cold & flu Hot Drink 500mg/150mg Sachets (Paracetamol & Ibuprofen Sachets 500 mg & 150 mg)(No. of Sachets 2,00,000 (Net content of Ibuprofen Lysine Salt IH API 51.30 kg))|| 1 Number|1|Ibuprofen Lysine Salt IH|258.88 mg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

r|1|Ibuprofen Lysine Salt IH|258.88 mg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

| |2|Maxigesic cold & flu Hot Drink 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg)(No. of Sachets 2,00,000 (Net content of Ibuprofen Lysine Salt IH API |Maxigesic cold & flu Hot Drink 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg)(No. of Sachets 2,00,000 (Net content of Ibuprofen Lysine Salt IH API |Maxigesic cold & flu Hot Drink 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg)(No. of Sachets 2,00,000 (Net content of Ibuprofen Lysine Salt IH API |Maxigesic cold & flu Hot Drink 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg)(No. of Sachets 2,00,000 (Net content of Ibuprofen Lysine Salt IH API |Maxigesic cold & flu Hot Drink 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg)(No.

mg)(No. of Sachets 2,00,000 (Net content of Ibuprofen Lysine Salt IH API |Maxigesic cold & flu Hot Drink 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg)(No. of Sachets 2,00,000 (Net content of Ibuprofen Lysine Salt IH API | 1 Numbe| 1 Numbe| 1 Numbe|r|2|2|Ibuprof|en Lysine Salt IH|en Lysine Salt IH|en Lysine Salt IH|517.77 mg| |---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---| |||102.60 kg))|||||||||||||||| || ||||||||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| |Case No.|||130 / NC/3/MEET/Dec/202223/15||||||||||||||| ||||||||||||||||||| |Case Status|||Case Approved||||||||||||||| ||||||||||||||||||| |Party Name|||BIOXERA PHARMA PRIVATE LIMITED||||||||||||||| |Mti Nb|||||||||||||||||| |eeng umer and Date|||NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022||||||||||||||| ||||||||||||||||||| |HQ File Number|||HQRNORM APPLY 00001697AM23||||||||||||||| ||||||||||||||||||| |RA File Number|||03AX04001885 AM23||||||||||||||| |Li N d|||||||||||||||||| |cence o an Date|||0311015929/28/06/2022|||||||||||||||

||HQRNORM APPLY 00001697AM23||||||||||||||| ||||||||||||||||||| |RA File Number|||03AX04001885 AM23||||||||||||||| |Li N d|||||||||||||||||| |cence o an Date|||0311015929/28/06/2022||||||||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Apr/202223/1dated 29/04/2022 against advance authorization No. 0311009297 dated 08/12/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. BENFOTIAMINE 1 kg 1 THIAMINE HYDROCHLORIDE 0.922 kg RA concerned may take further necessary action as per above decision of NC.|||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||Export p|roduct||Qty.||Sl. No.||Im|port item|||s||||Qty.|| ||BENFO|TIAMINE||1 kg||1||T|HIAMINE|||HYDROCHLORIDE||||0.922 kg|| ||||||||||||||||||| || A conce| rned may take further necessary a|||ction as per ab||||ove decisi|||on of NC.|||||| ||||||||||||||||||| |C|ase No.||131 / NC/3/MEET/Dec/2||02223/15||||||||||||| |C|||||||||||||||||| ||ase Status||Case Approved||||||||||||||| |P|arty Name||MAIVA PHARMA PRIVATE LIMITED||||||||||||||| |Meeting Number and Date|||NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022||||||||||||||| ||||||||||||||||||| |HQ File Number|||HQRNORM APPLY 00001702AM23||||||||||||||| |||||||||||||||||||

|||||||||| |Meeting Number and Date|||NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022||||||||||||||| ||||||||||||||||||| |HQ File Number|||HQRNORM APPLY 00001702AM23||||||||||||||| ||||||||||||||||||| |RA File Number|||07AX04000446 AM23||||||||||||||| ||||||||||||||||||| |Licence No and|||0711004428/28/06/2022||||||||||||||| |||||||||||||||||||

Case No.	131 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001702AM23
RA File Number	07AX04000446 AM23
Licence No and	0711004428/28/06/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

Norms Committee Decision:

The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Aug/202223/6 dated 09/09/2022 against advance authorization No. 0711002764 dated 30/12/2021 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Sl. No.	Export product	Qty.	Sl. No.	Import items			Qty.
1	Furosemide Injection 10mg/mL -	<br>1 Number	1	V-35 4432/50/GREY		Westar?	<br>Relevant as
	2mL Vial(2mL Vial - filled with			RS SIL 1 (13mm Chlorobutyl			<br>per packing
	20mg of furosemide as bulk drug			R/S V- 35	4432/50 Grey -		<br>policy
	mixed in water for injection and			RFS)
	filled in 2mL Vial and capped with
	13mm chlorobutyle Rubber Stopper)
2	Furosemide Injection 10mg/mL -	<br>1 Number	2	V-35	4432/50/GREY		Relevant as
	4mL Vial(4mL Vial - filled with			Westar? RS	SIL 1	(13mm	per packing
	40mg of furosemide as bulk drug			Chlorobutyl	R/S	V-<br>35	policy
	mixed in water for injection and			4432/50 Grey - RFS)
	filled in 4mL Vial and capped with
	13mm chlorobutyle Rubber Stopper)

as bulk drug|||Chlorobutyl|R/S|V- 35|policy| ||mixed in water for injection and|||4432/50 Grey - RFS)|||| ||filled in 4mL Vial and capped with||||||| ||13mm chlorobutyle Rubber Stopper)|||||||

Case No.	132 / NC/3/MEET/Dec/202223/15
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number	HQRNORM APPLY 00001703AM23
RA File Number	07AX04000445 AM23
Licence No and<br>Date	0711004432/28/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09/09/2022against advance authorization No.0711002764
dated 30/12/2021,	it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as
applied by the firm,	whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

pplied by the firm,|whichever is less:|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

|Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Furosemide Injection 10mg/mL - 2mL Vial(2mL Vial - filled with 20mg of furosemide as bulk drug mixed in water for injection and filled in 2mL Vial and capped with 13mm chlorobutyle Rubber Stopper) 1 Number 1 V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS) Relevant as per packing policy 2 Furosemide Injection 10mg/mL - 4mL Vial(4mL Vial - filled with 40mg of furosemide as bulk drug mixed in water for injection and filled in 4mL Vial and capped with 13mm chlorobutyle Rubber Stopper) 1 Number 2 V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS) Relevant as per packing policy 3 Prochlorperazine Edisylate Injection USP 10mg/2mL(2mL Vial - Prochlorperazine Edisylate Injection USP 10mg/2mL and capped with 13mm chlorobutyle Rubber Stopper) 1 Number 3 V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS) Relevant as per packing policy RA concerned may take further necessary action as per above decision of NC.|Sl. No.|Export product|Qty.|Sl.

Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
1	Furosemide Injection 10mg/mL - 2mL<br>Vial(2mL Vial - filled with 20mg of<br>furosemide as bulk drug mixed in<br>water for injection and filled in 2mL<br>Vial<br>and<br>capped<br>with<br>13mm<br>chlorobutyle Rubber Stopper)	<br> <br> <br> <br> <br>1 Number	1	V-35 4432/50/GREY Westar?<br>RS SIL 1 (13mm Chlorobutyl<br>R/S V-35 4432/50 Grey - RFS)	<br> <br>Relevant as per<br>packing policy
2	Furosemide Injection 10mg/mL - 4mL<br>Vial(4mL Vial - filled with 40mg of<br>furosemide as bulk drug mixed in<br>water for injection and filled in 4mL<br>Vial<br>and<br>capped<br>with<br>13mm<br>chlorobutyle Rubber Stopper)	<br> <br> <br> <br> <br>1 Number	2	V-35 4432/50/GREY Westar?<br>RS SIL 1 (13mm Chlorobutyl<br>R/S V-35 4432/50 Grey -<br>RFS)	Relevant as per<br>packing policy
3	Prochlorperazine Edisylate Injection<br>USP<br>10mg/2mL(2mL<br>Vial<br>-<br>Prochlorperazine Edisylate Injection<br>USP 10mg/2mL and capped with<br>13mm chlorobutyle Rubber Stopper)	<br> <br> <br> <br>1 Number	3	V-35 4432/50/GREY Westar?<br>RS SIL 1 (13mm Chlorobutyl<br>R/S V-35 4432/50 Grey -<br>RFS)	Relevant as per<br>packing policy

Case No.	Case No.	Case No.	133 / NC/3/MEET/Dec/202223/15	133 / NC/3/MEET/Dec/202223/15	133 / NC/3/MEET/Dec/202223/15	133 / NC/3/MEET/Dec/202223/15	133 / NC/3/MEET/Dec/202223/15
Case Status			Case Approved
Party Name			MICRO LABS LIMITED
Meeting Number and<br>Date			NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022
HQ File Number			HQRNORM APPLY 00001705AM23
RA File Number			07AX04000436 AM23
Licence No and Date			0711004457/28/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export<br>product / import item in Meeting No.5/82-ALC4/2020 dated 09.10.2020against advance authorization No.<br>0710116125 dated 17.02.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>AMOXICILLIN<br>125<br>MG<br>+ 80000<br>1<br>1<br>AMOXICILLIN TRIHYDRATE<br>1704.42 kg
	Sl. No.<br>1	Export product		Qty.	Sl. No.	Import items	Qty.
		AMOXICILLIN<br>125<br>MG<br>+		80000	1<br>	AMOXICILLIN TRIHYDRATE	1704.42 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

br>MG +||80000|1 |AMOXICILLIN TRIHYDRATE|1704.42 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jan-2023 16:13:36 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00314089AM23

==> picture [472 x 174] intentionally omitted <==

----- Start of picture text ----- FLUCLOXACILLIN 125 MG / 5 ML Bottles ORAL SUSPENSION 100ML BOTTLES(AMOXICILLIN 125 MG + FLUCLOXACILLIN 125 MG / 5 ML ORAL SUSPENSION 100ML BOTTLES BP/EP/USP/IP 400.00 KG) 2 AMOXICILLIN 250 MG + 4999960 2 FLUCLOXACILLIN SODIUM BP/ 1615.85 kg FLUCLOXACILLIN 250 MG EP / USP/ IP CAPSULES(AMOXICILLIN 250 MG + Bottles FLUCLOXACILLIN 250 MG CAPSULES BP/EP/USP/IP 3000.00 KG) ----- End of picture text -----

	FLUCLO<br>	XACILLIN 125 MG / 5 ML<br> <br>	<br> <br>Bottles
	ORAL<br>BOTTLE	SUSPENSION<br>100ML<br>S(AMOXICILLIN 125 MG +	<br>
	<br>FLUCLO	<br>XACILLIN 125 MG / 5 ML	<br>
	ORAL S<br>BP/EP/U	USPENSION 100ML BOTTLES<br>SP/IP 400.00 KG)

2	AMOXICILLIN<br>250<br>MG<br>+<br>FLUCLOXACILLIN<br>250<br>MG<br>CAPSULES(AMOXICILLIN 250 MG +<br>FLUCLOXACILLIN<br>250<br>MG<br>CAPSULES BP/EP/USP/IP 3000.00 KG)		<br> <br> <br> <br>4999960<br>Bottles	2	FLUCLOXACILLIN SODIUM BP/<br>EP / USP/ IP	<br>1615.85 kg

N 250 MG CAPSULES BP/EP/USP/IP 3000.00 KG)|||||| 4999960 Bottles||2||FLUCLOXACILLIN SODIUM BP/ EP / USP/ IP||| 1615.85 kg|| ||||||||||||||||||| ||||||||||||||||||| |R|A concerned may take|||||further n|ecessary|action as per above decision of NC.|||||||||| ||||||||||||||||||| |C|ase No.||||134 /|NC/3/ME|ET/Dec|/202223/15|||||||||| ||ase Status||||Case|Approved|||||||||||| |C|||||||||||||||||| |P|arty Name||||MAIVA PHARMA PRIVATE LIMITED||||||||||||| |Meeting Number and Date|||||NC/ 3/ MEET/ Dec/ 202223/ 15 and 29/12/2022||||||||||||| |HQ File Number|||||HQRNORM APPLY 00001708AM23||||||||||||| |RA File Number|||||07AX04000458 AM23||||||||||||| |Licence No and |||||0711004447/28/06/2022||||||||||||| |Date|||||||||||||||||| ||||||||||||||||||| |Norms Committee|||||Decision:||||||||||||| |The Committee co import item in M|||||nsidered the case as per agenda and taking cue from earlier decision for sam eeting No.NC/3/MEET/Aug/202223/6 dated 09/09/2022 against advance||||||||||e export product / authorization No.||| | 0711002867 dated||||| 20/01/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP V|||||||||| ol. I as per details||| |given below or as a||||

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