IN FORCE Advance Authorisation

DGFT Minutes

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Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय

Department of Commerce / वािणज्य िवभाग

Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Jan/202223/18 DATED: 23/01/2023

Please Note

I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in
II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.
III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.

Meeting No. NC/3/MEET/Jan/202223/18 dated 23/01/2023 of Norms Committee - III for the year 2022-23 was held on 23/01/2023 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

	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||

This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

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Case Details and Decision(s):

Case Details and Decision(s):
Case No.<br>1 / NC/3/MEET/Jan/202223/18
Case Status<br>Case Approved
Party Name<br>S.M. HERBALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number<br>HQRNORM REVIW00004282AM23
RA File Number<br>052404000147 AM13
Licence No and<br>Date<br>0510330512/25/07/2012
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as
under:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Camptothecin (CHEMICAL) HPLC Purity NLT<br>1 kg	1	Crude Camptothecin (CHEMICAL)	<br>1.10 kg
98.5% (Average purity as per COA, NLT 99%)		HPLC Purity NLT 90% (Average
		purity as per COA, NMT 91.1%)
Note: Above revised norms are for regularization and	closure	purpose only.
RA concerned may take further necessary action as per above decision of NC.

er COA, NMT 91.1%)||| |Note: Above revised norms are for regularization and|closure|purpose only.||| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	2 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00001497AM23
RA File Number	039504000262 AM13
Licence No and<br>Date	0310705888/22/08/2012
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was observed that the firm still has not
furnished its reply.	Hence, the Committee decided torejectthe case.

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


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


Case No		3 / NC/3/MEET/Jan/202223/18
.
Case Status		Case Aroved
		pp
Party Name		S.M.

action as per above decision of NC.||||||||| |||||||||||| |||||||||||| |Case No||3 / NC/3/MEET/Jan/202223/18||||||||| |.||||||||||| |Case Status||Case Aroved||||||||| |||pp||||||||| |Party Name||S.M. HERBALS PRIVATE LIMITED||||||||| |||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023||||||||| |HQ File Number||HQRNORM REVIW00004283AM23||||||||| |RA File Number||052404000239 AM14||||||||| |Licence No and Date||0510367886/08/10/2013||||||||| |N T u|orms Committee Decision: h Citt idd th t f fi f i f dh d it didd t i dh|||||||||| ||e ommee consere e reques o nder:||rm or reve||o aoc n|||rms an was ece o r|vse aoc norms as|| |||||||||||| |||||||||||| ||Export product|||Qty.||Sl. No.|Import items|||Qty.| ||Quinoline Based Alkoliod - Camptothecin Chil HPLC Pi NLT 985% A||| 1 kg||1|Quinoline Based Alkaloid- Camptothecin (Chemical) HPLC ||| 1.085 kg| ||(emca) urty . (verage purity as per COA, NLT 99%)||||||Purity NLT 90% (Average purity as per COA, NMT 90.55%)|||| ||Note: Above revised norms are for regularization and closure purpose only.|||||||||| |||||||||||| |||||||||||| |||||||||||| |||||||||||| ||RA concerned ma|y take further necessary action as per above decision of NC.||||||||| |||||||||||| |||||||||||| |C||4 / C/3/MEET//202223/18||||||||| |ase No.||NJan||||||||| |C S||C Ad||||||||| |ase tatus||ase pprove||||||||| |Party Name||S.M.

tion as per above decision of NC.||||||||| |||||||||||| |||||||||||| |C||4 / C/3/MEET//202223/18||||||||| |ase No.||NJan||||||||| |C S||C Ad||||||||| |ase tatus||ase pprove||||||||| |Party Name||S.M. HERBALS PRIVATE LIMITED||||||||| |||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023||||||||| |HQ File Number||HQRNORM REVIW00004285AM23||||||||| |RA File Number||052404000321 AM14||||||||| |||||||||||| |Licence No and Date||0510374573/27/12/2013||||||||| |Norms Committee Decision: ||||||||||| |The Committee co ||nsidered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as||||||||| |under:||||||||||| |||||||||||| ||||||||||||

Case No.	4 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	S.M. HERBALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00004285AM23
RA File Number	052404000321 AM14
Licence No and<br>Date	0510374573/27/12/2013
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as
under:

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573/27/12/2013| |Norms Committee Decision:|| |The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as|| |under:||

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Export product	Qty.	Sl. No.	Import items	Qty.
10 Deacetyl Baccatin III HPLC Purity NLT	<br>1 kg	1	Ketones in Carbonyl Group 10	<br>1.05 kg
98.5% (Average purity as per COA, NLT			Deacetyl Baccatin - III HPLC
99.4%)			Purity NLT 95% (Average purity as
			per COA, NMT 95.11%)
Note: Above revised norms are for regularization and		closure	purpose only.

Case No.<br>5 / NC/3/MEET/Jan/202223/18
Case Status<br>Case Approved
Party Name<br>VENKATA NARAYANA ACTIVE INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number<br>HQRNORM REVIW00004193AM23
RA File Number<br>042404000248 AM15
Licence No and<br>Date<br>0410159986/07/01/2015
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Sitagliptin Phosphate<br>1 kg	1	2,4,5 – Trifluorophenylacetic Acid	1.167 kg
(APIs / Bulk Drugs)
	2	Meldrum Acid	0.77 kg
RA concerned may take further necessary action as per above decision of NC.

phate 1 kg|1|2,4,5 – Trifluorophenylacetic Acid|1.167 kg|| |(APIs / Bulk Drugs)||||| ||2|Meldrum Acid|0.77 kg|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	6 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred

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Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00004183AM23
RA File Number	522404000058 AM15
Licence No and<br>Date	5210041428/13/02/2015
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information / documents from the firm:
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>i.
stage wise percentage yields on molar basis.
Stepwise justification for wastage.<br>ii.

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

ise justification for wastage.** ii.||

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

Case No.<br>7 / NC/3/MEET/Jan/202223/18
Case Status<br>Case Approved
Party Name<br>VENKATA NARAYANA ACTIVE INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number<br>HQRNORM REVIW00004194AM23
RA File Number<br>042404000003 AM16
Licence No and<br>Date<br>0410160438/24/04/2015
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Sitagliptin Phosphate<br>1 kg	1	2,4,5 – Trifluorophenylacetic Acid	1.167 kg
(APIs / Bulk Drugs)
	2	Meldrum Acid	0.77 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	8 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED

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

Case No.	8 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED

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M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Jan	/ 202223/	18 and 23
H	Q File Number	HQRNORM REVI	W000041	82AM23

R	A File Number	522404000034 AM	16
L<br>D	icence No and<br>ate	5210041610/14/08	/2015

Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information / documents from the firm:	orms Committee Decision:
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>i.<br>Stepwise justification for wastage.<br>ii.

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

ustification for wastage.** ii.|||||||

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


Case No		9 / NC/3/MEET/Jan/202223/18
.
Case Status		Case Approved

Party Name		PAYAL POLYPLAST PRIVATE LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

HQ File Number		HQRNORM REVIW00004098AM23

RA File Number		052404000418 AM16

Licence No and<br>Date		0510396612/14/12/2015

Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms andtaking cue from earlier decision for same<br>export product / import item in Meeting No NC/3/MEET/Nov/202223/12 dated 18/11/2022against advance<br>authorization No.0510408806 dated 06/12/2018, it was decidedto revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

	Di-Octyl Tere Phthalate (DOTP)		1 kg	1	Pure Terephthalic Acid	0.447 kg
				2	2 Ethyl Hexanol	0.680 kg



RA d		tk fth ti		b dii f NC
concerne ma		y ae urer necessary acon as per aove ecson o .


Case No.		10 / NC/3/MEET/Jan/202223/18

Case Status		Case Approved

Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED

cson o .||||| |||||||| |||||||| |Case No.||10 / NC/3/MEET/Jan/202223/18||||| |||||||| |Case Status||Case Approved||||| |||||||| |Party Name||J B CHEMICALS AND PHARMACEUTICALS LIMITED||||| ||||||||

Case No.	10 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED

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Meeting Number<br>and Date	Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number			HQRNORM REVIW00004145AM23
RA File Number			039404001096 AM16
Licence No and<br>Date			0310803709/01/04/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms andtaking cue from earlier decision for same<br>export product / import item in Meeting No NC/3/MEET/May/202223/3 dated 27/05/2022against advance<br>authorization No.0310801629 dated 07.01.2016, 0310801603 dated 06.01.2016, 0310801571 dated 05.01.2016 and<br>0310801604 dated 06.01.2016, it was decidedto revise adhoc norms as under:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl. No.

16, 0310801603 dated 06.01.2016, 0310801571 dated 05.01.2016 and** 0310801604 dated 06.01.2016, it was decidedto revise adhoc norms as under: Sl. No. Export product Qty. Sl. No. Import items Qty. (in gm for 100 lozenges) 1 Benzydamine Hydrochloride 0.306 gram 2 Cetylpyridinium Chloride 0.1356 gram 1 Difflam Sugar Free Lozenges Flavours Raspberry/Eucalyptus & Menthol/Honey & Lemon/ Orange/ Double Mint.(Each lozenge contains Benzydamine Hydrchloride 3.00 mg, Cetylpyridinium Chloride 1.33 mg, Isomalt ST-M 2591.86 mg. Net Content Benzydamine Hydrchloride 73.001 Kgs, Cetylpyridinium Chloride 32.364 Kgs, Isomalt ST-M 63069.284 Kgs.) 100 lozenges 3 Isomalt ST-M 259.186 gram 4 Benzydamine Hydrochloride 0.306 gram 2 Difflam AAA Sugar Free Lozenges Flavours Eucalyptus & Menthol/Honey & Lemon/Black Currant/Berry.(Each lozenge contains Benzydamine Hydrchloride 3.00 mg, Isomalt ST-M 2591.86 mg. Net Content Benzydamine Hydrchloride 98.546 Kgs, Isomalt ST-M 85139.491 Kgs) 100 lozenges 5 Isomalt ST-M 259.186 gram 6 Benzydamine Hydrochloride 0.306 gram 3 Difflam Sugar Free Lozenges Mint Fresh Flavour.(Each lozenge contains Benzydamine Hydrchloride 3.00 mg, Isomalt ST-M 2591.86 mg.

r>Benzydamine Hydrochloride 0.306 gram 3 Difflam Sugar Free Lozenges Mint Fresh Flavour.(Each lozenge contains Benzydamine Hydrchloride 3.00 mg, Isomalt ST-M 2591.86 mg. Net Content Benzydamine Hydrchloride 47.446 Kgs, Isomalt ST-M 40991.365 Kgs) 100 lozenges 7 Isomalt ST-M 259.186 gram 8 Cetylpyridinium Chloride 0.102 gram Septolete Lozenges/ Septolete Extra Lozenges /Septolete Ultra Lozenges / Septolete Omni Lozenges /(Septolete Total Lozenges / Septolete Duo Lozenges/ Septabene Lozenges. Each lozenge contains Cetylpyridinium Chloride EP 1.00 MG,, 4 100 lozenges 9 Isomalt ST-M 259.186 gram|||||||| ||Sl. No.| Export product||Qty.|Sl. No.|Import items|Qty. (in gm for 100 lozenges)| ||1|Difflam Sugar Free Lozenges Flavours Raspberry/Eucalyptus & Menthol/Honey & Lemon/ Orange/ Double Mint.(Each lozenge contains Benzydamine Hydrchloride 3.00 mg, Cetylpyridinium Chloride 1.33 mg, Isomalt ST-M 2591.86 mg. Net Content Benzydamine Hydrchloride 73.001 Kgs, Cetylpyridinium Chloride 32.364 Kgs, Isomalt ST-M 63069.284 Kgs.)|| 100 lozenges|1|Benzydamine Hydrochloride|0.306 gram| ||||||2|Cetylpyridinium Chloride|0.1356 gram| ||||||3|Isomalt ST-M|259.186 gram| ||2|Difflam AAA Sugar Free Lozenges Flavours Eucalyptus & Menthol/Honey & Lemon/Black Currant/Berry.(Each lozenge contains Benzydamine Hydrchloride 3.00 mg, Isomalt ST-M 2591.86 mg.

|Difflam AAA Sugar Free Lozenges Flavours Eucalyptus & Menthol/Honey & Lemon/Black Currant/Berry.(Each lozenge contains Benzydamine Hydrchloride 3.00 mg, Isomalt ST-M 2591.86 mg. Net Content Benzydamine Hydrchloride 98.546 Kgs, Isomalt ST-M 85139.491 Kgs)|| 100 lozenges|4|Benzydamine Hydrochloride|0.306 gram| ||||||5|Isomalt ST-M|259.186 gram| ||3|Difflam Sugar Free Lozenges Mint Fresh Flavour.(Each lozenge contains Benzydamine Hydrchloride 3.00 mg, Isomalt ST-M 2591.86 mg. Net Content Benzydamine Hydrchloride 47.446 Kgs, Isomalt ST-M 40991.365 Kgs)|| 100 lozenges|6|Benzydamine Hydrochloride|0.306 gram| ||||||7|Isomalt ST-M|259.186 gram| ||4|Septolete Lozenges/ Septolete Extra Lozenges /Septolete Ultra Lozenges / Septolete Omni Lozenges /(Septolete Total Lozenges / Septolete Duo Lozenges/ Septabene Lozenges. Each lozenge contains Cetylpyridinium Chloride EP 1.00 MG,,||100 lozenges|8|Cetylpyridinium Chloride|0.102 gram| ||||||9|Isomalt ST-M|259.186 gram|

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Isomalt ST-M 2591.86 MG. Net Content Cetylpyridinium Chloride 40.876 Kgs, Isomalt ST-M 105944.70 Kgs.)

pyridinium Chloride|0.102 gram| ||||||9|Isomalt ST-M|259.186 gram|

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Isomalt ST-M 2591.86 MG. Net Content Cetylpyridinium Chloride 40.876 Kgs, Isomalt ST-M 105944.70 Kgs.)

Case No.	11 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00004184AM23
RA File Number	522404000042 AM17
Licence No and<br>Date	5210042032/30/09/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information / documents from the firm:<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>i.<br>Stepwise justification for wastage.<br>ii.

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

ise justification for wastage.** ii.||

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

Case No.	Case No.	12 / NC/3/MEET/Jan/202223/18	12 / NC/3/MEET/Jan/202223/18	12 / NC/3/MEET/Jan/202223/18	12 / NC/3/MEET/Jan/202223/18	12 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00004110AM23
RA File Number		318304000187 AM17
Licence No and<br>Date		3110066649/31/03/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as<br>under:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

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2,3,6-Trimethyl Phenol (TMP)	1	kg	1	Meta Cresol (MC99)	0.982 kg
			2	Methanol	0.575 kg
			3	Catalyst (Katalco 71-5)	0.027 kg

items|Qty.|

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2,3,6-Trimethyl Phenol (TMP)	1	kg	1	Meta Cresol (MC99)	0.982 kg
			2	Methanol	0.575 kg
			3	Catalyst (Katalco 71-5)	0.027 kg

Case No.	13 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00004113AM23
RA File Number	318304000010 AM18
Licence No and<br>Date	3110066712/01/05/2017
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to revise			adhoc norms as
under:
Export product<br>Qty.<br>Sl. No.		Import items	Qty.
2,6 Xylidine	1<br>500 MT	2,6 xylenol	700.00 MT
	2	Catalyst [PD on Alumina Catalyst (Pd	<br>0.805 MT
		content 0.4% -0.5%)]
RA concerned may take further necessary action as per above decision of NC.

Case No.	14 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00002092AM23
RA File Number	342404000340 AM18

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Licence No and 3410043947/09/03/2018 Date Norms Committee Decision: The Committee considered the request of firm for review of adhoc norms and it was observed that the firm still has not furnished its reply. Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.	15 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00002113AM23
RA File Number	342404000399 AM19
Licence No and<br>Date	3410045006/28/03/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was observed that the firm still has not<br>furnished its reply. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

s observed that the firm still has not furnished its reply. Hence, the Committee decided torejectthe case. RA concerned may take further necessary action as per above decision of NC.||

Case No.	16 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SYMBIOSIS PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00000804AM23
RA File Number	332404000002 AM20
Licence No and<br>Date	3310030527/16/04/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to call the firm for<br>attendingPersonal Hearing<br> before Norms Committee for explaining its case alongwith following documents /<br>information:<br>DML / Approved Composition of export product.<br>i.<br>Detail of Gelatin is confusing. Please clarify it.<br>ii.

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Case No.	17 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	018205001022AM20
RA File Number	052404000669 AM20
Licence No and<br>Date	0510413373/17/01/2020
Norms Committee Decision:<br>Deferred for comments of TE.

18 and 23/01/2023| |HQ File Number|018205001022AM20| |RA File Number|052404000669 AM20| |Licence No and Date|0510413373/17/01/2020| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.	18 / NC/3/MEET/Jan/202223/18	18 / NC/3/MEET/Jan/202223/18	18 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00004128AM23
RA File Number		039504000985 AM20
Licence No and<br>Date		0310834682/06/02/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc normsand taking cue from earlier decision for same<br>export product / import item in Meeting No NC/3/MEET/Sep/202223/8 dated 23/09/2022 against advance<br>authorization No.0311008242 dated 03/11/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PHENOL<br>0.604 kg<br>2<br>ETHYLHEXANOL<br>0.386 kg<br>2 ETHYLHEXYL DIPHENYL PHSOPHITE (2<br>EHDP)<br>1 kg<br>3<br>YELLOW PHOSPHORUS<br>0.0966 kg<br> <br> RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

L DIPHENYL PHSOPHITE (2 EHDP) 1 kg 3 YELLOW PHOSPHORUS 0.0966 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||2 ETHYLHEXYL DIPHENYL PHSOPHITE (2 EHDP)|| 1 kg|1|PHENOL|0.604 kg| |||||2|ETHYLHEXANOL|0.386 kg| |||||3|YELLOW PHOSPHORUS|0.0966 kg| || RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	19 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved

UDIN00346384AM23

Party Name	Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD	SANDHYA ORGANIC CHEMICALS PVT LTD	SANDHYA ORGANIC CHEMICALS PVT LTD	SANDHYA ORGANIC CHEMICALS PVT LTD	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00004129AM23
RA File Number		039504001128 AM20
Licence No and<br>Date		0310835301/09/03/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc normsand taking cue from earlier decision for same<br>export product / import item in Meeting No NC/3/MEET/Dec/202223/15 dated 29/12/2022 against advance<br>authorization No.0311015330 dated 08/06/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

ted 08/06/2022**, 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 PHENOL 0.937 kg TRIPHENYL PHOSPHITE 1 kg 2 YELLOW PHOSPHORUS 0.10 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||TRIPHENYL PHOSPHITE||1 kg|1|PHENOL|0.937 kg| |||||2|YELLOW PHOSPHORUS|0.10 kg| || RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	20 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	018205001136AM20
RA File Number	052404000749 AM20
Licence No and<br>Date	0510413850/12/03/2020
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	21 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00002534AM23
RA File Number	072404000046 AM21

UDIN00346384AM23

UDIN00346384AM23

Licence No and 0710116483/22/05/2020 Date Norms Committee Decision: The Committee considered the request of firm for fixation of adhoc norms and it was observed that the reply furnished by the firm is not proper as they have attached papers of other licences / export products. Hence, it was decided to reject the case maintain the status quo. RA concerned may take further necessary action as per above decision of NC.

Case No.	22 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00002538AM23
RA File Number	072404000053 AM21
Licence No and<br>Date	0710116510/27/05/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was observed that the reply furnished by<br>the firm is incomplete. Hence, it was decided torejectthe case maintaining the status quo.<br> RA concerned may take further necessary action as per above decision of NC.

ly furnished by the firm is incomplete. Hence, it was decided torejectthe case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	23 / NC/3/MEET/Jan/202223/18	23 / NC/3/MEET/Jan/202223/18	23 / NC/3/MEET/Jan/202223/18	23 / NC/3/MEET/Jan/202223/18	23 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		AMI ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00004268AM23
RA File Number		522404000013 AM21
Licence No and<br>Date		5210043424/08/06/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

l. I as per details given below or as applied by the firm, whichever is less: Export Product Qty. Sl. No. Import Items Qty.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.|

Case No.	Case No.	23 / NC/3/MEET/Jan/202223/18	23 / NC/3/MEET/Jan/202223/18	23 / NC/3/MEET/Jan/202223/18	23 / NC/3/MEET/Jan/202223/18	23 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		AMI ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00004268AM23
RA File Number		522404000013 AM21
Licence No and<br>Date		5210043424/08/06/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00346384AM23

4-HYDROXY COUMARIN	1 kg	1	Acetyl Salicylic Acid	1.56 kg
(by Acetyl Salicylic Acid route)			(For Industrial Use)
		2	Ethyl Aceto Acetate	1.147 kg

UDIN00346384AM23

4-HYDROXY COUMARIN	1 kg	1	Acetyl Salicylic Acid	1.56 kg
(by Acetyl Salicylic Acid route)			(For Industrial Use)
		2	Ethyl Aceto Acetate	1.147 kg

Case No.	24 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	018205001409AM21
RA File Number	522404000018 AM21
Licence No and<br>Date	5210043446/23/06/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>25 / NC/3/MEET/Jan/202223/18	Case No.<br>25 / NC/3/MEET/Jan/202223/18	Case No.<br>25 / NC/3/MEET/Jan/202223/18
Case Status<br>Case Approved
Party Name<br>VIBRANT PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202223/ 18		and 23/01/2023
HQ File Number<br>018205001663AM21
RA File Number<br>072404000163 AM21
Licence No and<br>Date<br>0710117014/15/09/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.

ded 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.||

Case No.<br>25 / NC/3/MEET/Jan/202223/18	Case No.<br>25 / NC/3/MEET/Jan/202223/18	Case No.<br>25 / NC/3/MEET/Jan/202223/18
Case Status<br>Case Approved
Party Name<br>VIBRANT PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202223/ 18		and 23/01/2023
HQ File Number<br>018205001663AM21
RA File Number<br>072404000163 AM21
Licence No and<br>Date<br>0710117014/15/09/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.

UDIN00346384AM23

CIS TOSYLATE	1	kg	1	p-TOLUENESULFONYL CHLORIDE	2.066	kg
			2	IMIDAZOLE	1.380	kg

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

UDIN00346384AM23

CIS TOSYLATE	1	kg	1	p-TOLUENESULFONYL CHLORIDE	2.066	kg
			2	IMIDAZOLE	1.380	kg

Case No.	Case No.	26 / NC/3/MEET/Jan/202223/18	26 / NC/3/MEET/Jan/202223/18	26 / NC/3/MEET/Jan/202223/18	26 / NC/3/MEET/Jan/202223/18	26 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00004093AM23
RA File Number		039404000283 AM21
Licence No and<br>Date		0310838453/24/09/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as<br>under:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>PHENOL<br>1.15 kg<br>2<br>XYLENE<br>0.50 kg<br>3<br>MAGNESIUM TURNINGS<br>0.148 kg<br>4<br>PARAFORMALDEHYDE<br>0.9177 kg<br>COUMARIN<br>1 kg<br>5<br>ACETIC ANHYDRIDE<br>0.7356 kg<br> RA concerned may take further necessary action as per above decision of NC.				review of adhoc norms and it was decided to revise adhoc norms as
	Export product		Qty.	Sl. No.	Import items	Qty.
	COUMARIN		1 kg	1	PHENOL	1.15 kg
				2	XYLENE	0.50 kg
				3	MAGNESIUM TURNINGS	0.148 kg
				4	PARAFORMALDEHYDE	0.9177 kg
				5	ACETIC ANHYDRIDE	0.7356 kg
	RA concerned may take further necessary action as per above decision of NC.

50 kg| |||||3|MAGNESIUM TURNINGS|0.148 kg| |||||4|PARAFORMALDEHYDE|0.9177 kg| |||||5|ACETIC ANHYDRIDE|0.7356 kg| ||RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	27 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED

UDIN00346384AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	018205001832AM21
RA File Number	052404000405 AM21
Licence No and<br>Date	0510415761/06/11/2020
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	28 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	018205001853AM21
RA File Number	342404000223 AM21
Licence No and<br>Date	3410046549/13/11/2020
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	29 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	018205001869AM21
RA File Number	052404000441 AM21
Licence No and<br>Date	0510415972/24/11/2020
Norms Committee Decision:<br>Deferred for comments of TE.

18 and 23/01/2023| |HQ File Number|018205001869AM21| |RA File Number|052404000441 AM21| |Licence No and Date|0510415972/24/11/2020| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	30 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00001578AM23
RA File Number	03AA04021189 AM21
Licence No and Date	0311001372/01/02/2021
Norms Committee Decision:

16 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

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

Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
1	ASHOXY<br>20%<br>LA<br>(OXYTETRACYCLINE<br>INJECTABLE<br>SOLUTION 20% LONG ACTING) Pack<br>100ML vial (EACH VIAL CONTAINS<br>38ML<br>2-pyrrolid(VETERINARY<br>FORMULATION-INJECTION)	<br> <br> <br> <br> <br>200000<br>Numbers	1	2 PYRROLIDONE	8000 kg
2	ASHOXY<br>20%<br>LA<br>(OXYTETRACYCLINE<br>INJECTABLE<br>SOLUTION 20% LONG ACTING) Pack<br>50ML vial (EACH VIAL CONTAINS<br>19ML<br>2-pyrrolido(VETERINARY<br>FORMULATION-INJECTION)	<br> <br> <br> <br> <br>323000<br>Numbers	2	2 PYRROLIDONE	6460 kg

Case No.	Case No.	31 / NC/3/MEET/Jan/202223/18	31 / NC/3/MEET/Jan/202223/18	31 / NC/3/MEET/Jan/202223/18	31 / NC/3/MEET/Jan/202223/18	31 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		CHIRAG ENTERPRISE
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00076610AM21
RA File Number		24AA04002562 AM21
Licence No and<br>Date		2411000202/04/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09/09/2022against advance authorization No.<br>2410042868 dated 27.09.2019 and 2410042947 dated 12.12.2019, it was decided to ratify adhoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

UDIN00346384AM23

CRUDE	METHYL	METHACRYLATE	<br>1 kg	1	ACRYLIC PLASTIC STRIPS /	<br>1.23 kg
MONOMER					OFFCUTS
Note: No repeat licence		will be issued on the basis of above decision.

LATE| 1 kg|1|ACRYLIC PLASTIC STRIPS /| 1.23 kg| |---|---|---|---|---|---|---| |MONOMER|||||OFFCUTS|| |Note: No repeat licence||will be issued on the basis of above decision.|||||

Case No.	32 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00094103AM21
RA File Number	34AA04002716 AM21
Licence No and<br>Date	3411000254/01/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	33 / NC/3/MEET/Jan/202223/18	33 / NC/3/MEET/Jan/202223/18	33 / NC/3/MEET/Jan/202223/18	33 / NC/3/MEET/Jan/202223/18	33 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		VIBRANT PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00000295AM22
RA File Number		07AA04011201 AM21
Licence No and<br>Date		0711000825/01/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.

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

UDIN00346384AM23

CIS TOSYLATE	1 kg	1	p-TOLUENESULFONYL CHLORIDE	2.066 kg
(DRUG INTERMEDIATE)
		2	IMIDAZOLE	1.380 kg

Case No.	34 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00004824AM22
RA File Number	05AA04000952 AM22
Licence No and<br>Date	0511002092/06/04/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	35 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00023689AM22
RA File Number	07AA04002023 AM22
Licence No and<br>Date	0711000922/21/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Production / Consumption data duly certified by GST.

The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: Production / Consumption data duly certified by GST.||

Case No.	36 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00027802AM22

UDIN00346384AM23

RA File Number	07AA04002553 AM22
Licence No and<br>Date	0711000992/27/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Production / Consumption data duly certified by GST.

Case No.	37 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00027804AM22
RA File Number	07AA04002549 AM22
Licence No and<br>Date	0711000993/27/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Production / Consumption data duly certified by GST.

The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: Production / Consumption data duly certified by GST.||

Case No.	38 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00027780AM22
RA File Number	07AA04000758 AM22
Licence No and<br>Date	0711000991/27/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No. NC/3/MEET/Dec/202223/15 dated 29/12/2022against advance authorization No.<br>0711004325 dated 16/06/2022, 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:

20 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>GLYCINE<br>0.97 kg<br>MAGNESIUM<br>BISGLYCINATE<br>/<br>MAGNESIUM GLYCINE COMPLEX<br>1 kg<br>2<br>MAGNESIUM OXIDE<br>0.26 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl. No.	Import items	Qty.
	MAGNESIUM<br>BISGLYCINATE<br>/<br>MAGNESIUM GLYCINE COMPLEX	<br>1 kg	1	GLYCINE	0.97 kg
			2	MAGNESIUM OXIDE	0.26 kg

.	Export product	Qty.	Sl. No.	Import items	Qty.
	MAGNESIUM<br>BISGLYCINATE<br>/<br>MAGNESIUM GLYCINE COMPLEX	<br>1 kg	1	GLYCINE	0.97 kg
			2	MAGNESIUM OXIDE	0.26 kg

Case No.	39 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00032203AM22
RA File Number	03AA04009823 AM22
Licence No and<br>Date	0311003530/04/05/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	40 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00032203AM22
RA File Number	03AA04009823 AM22
Licence No and<br>Date	0311003530/04/05/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	41 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00036355AM22
RA File Number	03AA04007493 AM22
Licence No and	0311003675/09/05/2021

UDIN00346384AM23

Date

Norms Committee Decision:

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

i. Complete chemistry with molecular weight of reactant and Product.
ii. Percentage of Yield.

By-Product and its value availing invoice.

Date	Date
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:
Complete chemistry with molecular weight of reactant and Product.<br>i.
Percentage<br>ii.		of Yield.
BPdt d i		l ili ii
y-rouc an		s vaue avang nvoce.

Case No.			42 / NC/3/MEET/Jan/202223/18

Case Status			Case Approved

Party Name			MACLEODS PHARMACEUTICALS LTD

Meeting Number an<br>Date		d	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

HQ File Number			HQRNORM APPLY 00038818AM22
RA File Number			03AA04005126 AM22
Licence No and Date			0311003736/12/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No NC/3/MEET/Nov/202223/14 dated 07/12/2022against advance authorization No.<br>0311001091dated 20/01/2021, 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:


					l	i
	Export product			Qty.	S.

fy adhoc norms under Para 4.07 of HBP Vol. I as per details |||||||| |given below or as applied by the firm, whichever is less:|||||||| ||||||||| ||||||||| ||||||l|i|| ||Export product|||Qty.|S. No.|Import tems|Qty.| ||||||||| ||Lamivudine 3|00mg + Tenofovir|| 1 Number|1|(R)-3-AMINO-1-BUTANOL|19.635 mg| ||disoproxil Fu |marate 300mg + || |||| ||||||||| ||Dolutegravir tablets(Lamivudi |Sodium 50mg ne 300mg + Tenofovir || |2|1-(2,2-dimethoxyethyl)-5- methoxy-6(methoxycarbonyl) 4-|Indigenously procured| ||disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets (Net content: 3080.240 kgs Dolutegravir Sodium + 18481.440 kgs Tenofovir||| || oxo-1,4-dihydropyridine-3- carboxylic acid|| ||||||||| ||Disoproxil Fumarate + 18481.440 kgs||||3|Lithium bromide anhydrous|Indigenously| ||Lamivudine))|||||| procured| ||||||||| ||||||||| ||||||4|(R)-9-(2-phosphonomethoxy propyl)-adenine|205.02 mg| ||||||||| ||||||||| ||||||5|LAMIVUDINE|Indigenously| ||||||||| |||||||||

UDIN00346384AM23

procured

d| ||||||||| ||||||||| ||||||4|(R)-9-(2-phosphonomethoxy propyl)-adenine|205.02 mg| ||||||||| ||||||||| ||||||5|LAMIVUDINE|Indigenously| ||||||||| |||||||||

UDIN00346384AM23

procured

Case No.<br>43 / NC/3/MEET/Jan/202223/18
Case Status<br>Case Approved
Party Name<br>EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number<br>HQRNORM APPLY 00039055AM22
RA File Number<br>05AA04009662 AM22
Licence No and<br>Date<br>0511002560/12/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
NIPARIN<br>5ML(HEPARIN<br>SODIUM<br>33783	1	HEPARIN SODIUM USP	900 MIU
INJECTION 5000 UNITS/ML)<br>Numbers
RA concerned may take further necessary action as per above decision of NC.

NIPARIN 5ML(HEPARIN SODIUM 33783|1|HEPARIN SODIUM USP|900 MIU|| |INJECTION 5000 UNITS/ML) Numbers||||| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	44 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00045345AM22
RA File Number	30AA04001247 AM22
Licence No and<br>Date	3011000633/18/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:

UDIN00346384AM23

Export product	Qty.	Sl. No.	Import items	Qty.
DEXKETOPROFFEN TROMETAMOL	1 kg	1	KETOPROFEN	1.00 kg
		2	N OCTYL D GLUCAMINE	0.36 kg
		3	TRIS<br>AMINO<br>BUFFER<br>TROMETHAMINE	<br>0.36 kg

|Sl. No.|Import items|Qty.| |---|---|---|---|---| |DEXKETOPROFFEN TROMETAMOL|1 kg|1|KETOPROFEN|1.00 kg| |||2|N OCTYL D GLUCAMINE|0.36 kg| |||3|TRIS AMINO BUFFER TROMETHAMINE| 0.36 kg|

Case No.	Case No.	45 / NC/3/MEET/Jan/202223/18	45 / NC/3/MEET/Jan/202223/18	45 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		ATUL LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00104366AM22
RA File Number		08AA04004876 AM22
Licence No and Date		0811001618/01/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda andit was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Phenol<br>0.3728 kg<br>2<br>Methanol<br>0.434 kg<br>Lapox<br>AC-14<br>[2,4,6-<br>tris(dimethylaminomethyl)phenol](Slight yellow<br>liquid, accelerator for epoxy resin)<br>1 kg<br>3<br>40 PCT Dimethylamine<br>1.339 kg<br> <br> RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

, accelerator for epoxy resin) 1 kg 3 40 PCT Dimethylamine 1.339 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Lapox AC-14 [2,4,6- tris(dimethylaminomethyl)phenol](Slight yellow liquid, accelerator for epoxy resin)|| 1 kg|1 2 3|Phenol|0.3728 kg| ||||||Methanol|0.434 kg| ||||||40 PCT Dimethylamine|1.339 kg| || RA concerned may take further necessary action as per above decision of NC.||||||

Case No. 46 / NC/3/MEET/Jan/202223/18

UDIN00346384AM23

Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00108212AM22
RA File Number	05AA04019922 AM22
Licence No and<br>Date	0511002989/05/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee for explaining its case alongwith following documents / information:<br>COA of Export Product.<br>i.<br>COA of import item from foreign supplier.<br>ii.<br>Copy of Master Batch Formula.<br>iii.		Personal Hearing

h following documents / information: COA of Export Product. i. COA of import item from foreign supplier. ii. Copy of Master Batch Formula. iii.||Personal Hearing|

Case No.	47 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00109428AM22
RA File Number	34AA04002141 AM22
Licence No and<br>Date	3411000701/08/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agendaand it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee for explaining its case alongwith following documents / information:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis<br>ii.<br>Stoichiometric balance between import and export on molar basis<br>iii.<br>Complete justification of wastage of raw materials for the manufacturing of export product.<br>iv.

Case No.	48 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00004186AM23
RA File Number	03AA04019330 AM22
Licence No and	0311004745/19/06/2021

UDIN00346384AM23

Date

Deferred for comments of TE.

Case No.	49 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00122419AM22
RA File Number	34AA04003768 AM22
Licence No and<br>Date	3411000762/23/06/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	50 / NC/3/MEET/Jan/202223/18	50 / NC/3/MEET/Jan/202223/18	50 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		ALKALOIDS CORPORATION
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00004945AM23
RA File Number		02AA04012158 AM22
Licence No and<br>Date		0211000889/05/07/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms andtaking cue from earlier decision for same<br>export product / import item in Meeting No. NC/3/MEET/Jun/202223/5 dated 08/07/2022against advance<br>authorization No.0210207287 dated 27/01/2017, it was decidedto revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Digoxin<br>1 kg<br>1<br>Digitalis Lanata Leaves (Dried)<br>(Digoxin content NMT 0.3%)<br>436.525 kg<br> RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

g 1 Digitalis Lanata Leaves (Dried) (Digoxin content NMT 0.3%) 436.525 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Digoxin||1 kg|1|Digitalis Lanata Leaves (Dried) (Digoxin content NMT 0.3%)|436.525 kg| ||RA concerned may take further necessary action as per above decision of NC.||||||

UDIN00346384AM23

Case No.	51 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00135125AM22
RA File Number	30AA04009718 AM22
Licence No and<br>Date	3011000867/09/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	Case No.	52 / NC/3/MEET/Jan/202223/18	52 / NC/3/MEET/Jan/202223/18	52 / NC/3/MEET/Jan/202223/18	52 / NC/3/MEET/Jan/202223/18	52 / NC/3/MEET/Jan/202223/18
Case Status			Case Approved
Party Name			CERIGO ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number			HQRNORM APPLY 00135220AM22
RA File Number			03AA04027670 AM22
Licence No and<br>Date			0311005241/09/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda andit was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl.

per agenda andit 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 CAP ADP-85 (2,2 Dithiobis N- Methylbenzamide) 1 kg 1 2 2 DITHIODIBENZOIC ACID 1.022 kg 2 CA Protect-100 (N-n-Butyl-1,2- Benzisothiazolin-3-one) 1 kg 2 2 2 DITHIODIBENZOIC ACID 1.329 kg RA concerned may take further necessary action as per above decision of NC.|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|CAP ADP-85 (2,2 Dithiobis N- Methylbenzamide)||1 kg|1|2 2 DITHIODIBENZOIC ACID| 1.022 kg| ||2|CA Protect-100 (N-n-Butyl-1,2- Benzisothiazolin-3-one)||1 kg|2|2 2 DITHIODIBENZOIC ACID| 1.329 kg| || RA concerned may take further necessary action as per above decision of NC.|||||||

Case No.	53 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

UDIN00346384AM23

ET/Jan/202223/18| |---|---| |Case Status|Case Rejected| |Party Name|SUDEEP PHARMA PRIVATE LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023|

UDIN00346384AM23

HQ File Number	HQRNORM APPLY 00136846AM22
RA File Number	34AA04005040 AM22
Licence No and<br>Date	3411000829/12/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	54 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00137048AM22
RA File Number	34AA04005105 AM22
Licence No and<br>Date	3411000838/12/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br> Copy of DML for export item.<br>i.<br>Complete chemistry, molecular weight, percentage yield on molar basis etc. as per Annexure to<br>Appendix 4E.<br>ii.

ments from the firm: Copy of DML for export item. i. Complete chemistry, molecular weight, percentage yield on molar basis etc. as per Annexure to Appendix 4E. ii.||

Case No.	55 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00137172AM22
RA File Number	08AA04014354 AM22
Licence No and<br>Date	0811001969/12/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:

28 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

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Sl. No.	Export Product	Qty.	Sl. No.	Import Items	Qty.
1	Q PARIN 5000 IU/ML (Heparin	<br>1 Number	1	HEPARIN SODIUM BP (580 MEGA)	<br>175.944 mg
	Sodium) 5ML			(Potency 156.3 IU / mg)
2	Q PARIN 1000 IU/ML (Heparin	<br>1 Number	2	HEPARIN SODIUM BP (580 MEGA)	<br>35.189 mg
	Sodium) 5ML			(Potency 156.3 IU / mg)

MEGA)| 175.944 mg| ||Sodium) 5ML|||(Potency 156.3 IU / mg)|| |2|Q PARIN 1000 IU/ML (Heparin| 1 Number|2|HEPARIN SODIUM BP (580 MEGA)| 35.189 mg| ||Sodium) 5ML|||(Potency 156.3 IU / mg)||

Case No.	56 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00138116AM22
RA File Number	26AA04002063 AM22
Licence No and<br>Date	2611000198/13/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	57 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00143924AM22
RA File Number	07AA04016516 AM22
Licence No and<br>Date	0711001521/21/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Production / Consumption data duly certified by GST.

Case No.	58 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	R.L.FINE CHEM PRIVATE LIMITED

UDIN00346384AM23

n / Consumption data duly certified by GST.**||

Case No.	58 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	R.L.FINE CHEM PRIVATE LIMITED

UDIN00346384AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00144695AM22
RA File Number	07AA04016662 AM22
Licence No and<br>Date	0711001530/22/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	59 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00145203AM22
RA File Number	34AA04005573 AM22
Licence No and<br>Date	3411000885/22/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee for explaining its case alongwith following documents / information:
(i) COA report of both import and export items giving clearly percentage of it purity.
(ii) Production of export item vis-à-vis Consumption of all the raw materials (both imported and
indigenous)) for last three years duly certified by GST / CA.

age of it purity.|| |(ii) Production of export item vis-à-vis Consumption of all the raw materials (both imported and**|| |indigenous)) for last three years duly certified by GST / CA.|| |(iii) Total sales value of By-Product per kg of export item, giving evidence and also to subtract the|| |quantity of import item per kg of export from this value.||

Case No.	60 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SYNOKEM PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00147457AM22
RA File Number	05AA04059070 AM22
Licence No and<br>Date	0511003826/26/07/2021
Norms Committee Decision:

30 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

D	eferred for comments of TE.	eferred for comments of TE.

C	ase No.	61 / NC/3/MEET/Jan/2022	23/18
C	ase Status	Case Approved

P	arty Name	R.L.FINE CHEM PRIVAT	E LIMIT	ED
M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Jan/ 202223	/ 18 and
				3/01/20	3
H	Q File Number	HQRNORM APPLY 0014	8635AM2	2
RA File Number
		07AA04017973 AM22
Licence No and<br>Date		0711001565/27/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in M		eeting No.

21|||||||| |Norms Committee Decision:|||||||||| |The Committee considered the case as per agenda and taking cue from earlier decision for same export product /|||||||||| |import item in M||eeting No. **10/82-ALC4/2018 dated 16/10/2018 **against advance authorization No.0710112770|||||||| |dated 02/02/2018,||it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or|||||||| |a|s applied by the f|irm, whichever is less:|||||||| ||||||||||| ||||||||||| ||||||||||| ||Export product|||Qty.||Sl. No.||Import items|Qty.| ||||||||||| ||DOXYLAMINE|SUCCINATE (USP/EP)||1 kg||1||2 ACETYL PYRIDINE|058 kg| ||||||||||.| |||||||2||TETRA HYDRO FURAN|1.03 kg| |||||||3||TOLUENE|1.10 kg| |||||||4||ACETONE|0.83 kg| ||||||||||| ||||||||||| |RA concerned may||take further necessary action as per above decision of NC.|||||||| ||||||||||| ||||||||||| |Case No.||62 / NC/3/MEET/Jan/202223/18|||||||| |Case Status||Case Rejected|||||||| |Party Name||ZEE LABORATORIES LIMITED|||||||| |Meeting Number and Date||NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023|||||||| |HQ File Number||HQRNORM APPLY 00149067AM22|||||||| |RA File Number||05AA04057371 AM22|||||||| |Licence No and Date||0511003868/28/07/2021|||||||| |Norms Committee Decision:||||||||||

3|||||||| |HQ File Number||HQRNORM APPLY 00149067AM22|||||||| |RA File Number||05AA04057371 AM22|||||||| |Licence No and Date||0511003868/28/07/2021|||||||| |Norms Committee Decision:||||||||||

Case No.	62 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	ZEE LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00149067AM22
RA File Number	05AA04057371 AM22
Licence No and<br>Date	0511003868/28/07/2021
Norms Committee Decision:

UDIN00346384AM23

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

Case No.	63 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00150875AM22
RA File Number	05AA04055660 AM22
Licence No and<br>Date	0511003910/30/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee for explaining its case alongwith following documents / information:
(i)	Copy of DML for export item showing Approved Composition.
(ii)	COA of the export item.
(iii)	Process details with wastage claimed.

wing documents / information:|| |(i)|Copy of DML for export item showing Approved Composition.| |(ii)|COA of the export item.| |(iii)|Process details with wastage claimed.|

Case No.	64 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00004039AM23
RA File Number	34AA04005924 AM22
Licence No and<br>Date	3411000924/02/08/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc normsand it was decided to call the firm for attending
Personal Hearing<br>	before Norms Committee for explaining its case alongwith following documents / information:
Complete<br>i.	justification for low yield giving chemistry.
Production / Consumption data duly certified by GST.<br>ii.

Case No. 65 / NC/3/MEET/Jan/202223/18

32 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

ta duly certified by GST.** ii.||

Case No. 65 / NC/3/MEET/Jan/202223/18

32 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00004041AM23
RA File Number	34AA04005925 AM22
Licence No and<br>Date	3411000923/02/08/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc normsand it was decided to call the firm for<br>attendingPersonal Hearing<br> before Norms Committee for explaining its case alongwith following documents /<br>information:<br> Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.

lar basis.** ii. Complete technical details as per Annexure to Appendix 4E for chemical products. iii. Stoichiometric balance between import and export on molar basis. iv.||

Case No.	66 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00397057AM22
RA File Number	08AA04017921 AM22
Licence No and<br>Date	0811002234/04/08/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as per the following details furnished by the<br>firm:<br>As per the COA furnished by the firm from foreign supplier, content of Triflow Acetic Acid varies from 8% to 12%<br>besides 1.7% water and other Residual solvents to compensate 12.34% excess API is used. Bivaludin Free Base is<br>otherwise unstable as an API. 11.71%.<br>i.<br>11.71% wastage is shown for manufacturing Process Loss.<br>ii.<br>Since the export product is Freeze Dried Powder, 12% excess volume is added as per regulatory requirement.<br>iii.

UDIN00346384AM23

(iv) Export to USA and Canada only.

Considering 12.34% Potency loss, 10% standard manufacturing loss as per SION and 2% notional extra-filling, it was decided to revise adhoc norms as under:

iv) Export to USA and Canada only.

Considering 12.34% Potency loss, 10% standard manufacturing loss as per SION and 2% notional extra-filling, it was decided to revise adhoc norms as under:

Export product	Qty.	Sl. No.	Import items	Qty.
BIVALIRUDIN FOR INJECTION	<br>1 Number	1	Bivalirudin (containing 8% to 12%	<br>315.114 mg/
250<br>MG/VIAL<br>(5ML<br>VIAL)			Triflow Acetic Acid as per COA)	Vial
(Freeze Dried Powder for Injection
250 mg / Vial) (EACH VIAL
CONTAINS: BIVALIRUDIN 250
MG

Case No.	Case No.	67 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00397079AM22
RA File Number		08AA04018916 AM22
Licence No and<br>Date		0811002280/09/08/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and considering potency correction due to all
Alcoholic Solvents		and water content not less than 1.86% as per COA furnished by the firm, it was decided to revise adhoc
norms as under:
	Export product	Qty.	Sl. No.	Import items	Qty.
	NALTREXONE	<br>1 Number	1	NALTREXONE HYDROCHLORIDE EP	<br>51.93 mg /
	HYDROCHLORIDE<br>TABLETS			/ BP / IP / USP / PH. EUR (All Alcoholic	<br>Tablet
	50 MG(EACH	FILM COATED		Solvents and water content NLT 1.86% as
	TABLET	CONTAINS:		per COA of import item)
	NALTREXONE

BLETS|||/ BP / IP / USP / PH. EUR (All Alcoholic| Tablet|| ||50 MG(EACH|FILM COATED||Solvents and water content NLT 1.86% as||| ||TABLET|CONTAINS:||per COA of import item)||| ||NALTREXONE||||||

Case No.	Case No.	67 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00397079AM22
RA File Number		08AA04018916 AM22
Licence No and<br>Date		0811002280/09/08/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and considering potency correction due to all
Alcoholic Solvents		and water content not less than 1.86% as per COA furnished by the firm, it was decided to revise adhoc
norms as under:
	Export product	Qty.	Sl. No.	Import items	Qty.
	NALTREXONE	<br>1 Number	1	NALTREXONE HYDROCHLORIDE EP	<br>51.93 mg /
	HYDROCHLORIDE<br>TABLETS			/ BP / IP / USP / PH. EUR (All Alcoholic	<br>Tablet
	50 MG(EACH	FILM COATED		Solvents and water content NLT 1.86% as
	TABLET	CONTAINS:		per COA of import item)
	NALTREXONE

UDIN00346384AM23

HYDROCHLORIDE PH. EUR. 50 MG [IN WHICH ACTIVE INGREDIENT NALTREXONE HYDROCHLORIDE USED IS 135.000 KGS.])

TABLET|CONTAINS:||per COA of import item)||| ||NALTREXONE||||||

UDIN00346384AM23

HYDROCHLORIDE PH. EUR. 50 MG [IN WHICH ACTIVE INGREDIENT NALTREXONE HYDROCHLORIDE USED IS 135.000 KGS.])

Case No.	68 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00170502AM22
RA File Number	08AA04022482 AM22
Licence No and<br>Date	0811002393/25/08/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	Case No.	69 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00397092AM22
RA File Number		08AA04023464 AM22
Licence No and<br>Date		0811002450/31/08/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and considering potency correction due to all
Alcoholic Solvents		and water content not less than 1.86% as per COA furnished by the firm, it was decided to revise adhoc
norms as under:
	Export product	Qty.	Sl. No.	Import items	Qty.
	NALTREXONE	<br>1 Number	1	NALTREXONE HYDROCHLORID E EP	<br>51.93 mg /
	HYDROCHLORIDE<br>TABLETS			/ BP / IP / USP / PH. EUR (All Alcoholic	<br>Tablet
	50 MG(EACH	FILM COATED		Solvents and water content NLT 1.86% as

UDIN00346384AM23

EP| 51.93 mg /|| ||HYDROCHLORIDE TABLETS|||/ BP / IP / USP / PH. EUR (All Alcoholic| Tablet|| ||50 MG(EACH|FILM COATED||Solvents and water content NLT 1.86% as|||

UDIN00346384AM23

TABLET CONTAINS: per COA of import item) NALTREXONE HYDROCHLORIDE PH. EUR. 50 MG [IN WHICH ACTIVE INGREDIENT NALTREXONE HYDROCHLORIDE USED IS 135.000 KGS.])

Case No.	70 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00001475AM23
RA File Number	08AA04022429 AM22
Licence No and<br>Date	0811002501/06/09/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as per the following details furnished by the<br>firm:<br>As per the COA furnished by the firm from foreign supplier, content of Triflow Acetic Acid varies from 8% to 12%<br>besides 1.7% water and other Residual solvents to compensate 12.34% excess API is used. Bivaludin Free Base is<br>otherwise unstable as an API. 11.71%.<br>i.<br>11.71% wastage is shown for manufacturing Process Loss.<br>ii.<br>Since the export product is Freeze Dried Powder, 12% excess volume is added as per regulatory requirement.<br>iii.<br>(iv) Export to USA and Canada only.<br>Considering 12.34% Potency loss, 10% standard manufacturing loss as per SION and 2% notional extra-filling, it was<br>decided to revise adhoc norms as under:

UDIN00346384AM23

da only. Considering 12.34% Potency loss, 10% standard manufacturing loss as per SION and 2% notional extra-filling, it was decided to revise adhoc norms as under:||

UDIN00346384AM23

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

BIVALIRUDIN<br>FOR<br>INJECTION 250 MG/VIAL (5ML<br>VIAL) (Freeze Dried Powder for<br>Injection 250 mg / Vial) (EACH<br>VIAL<br>CONTAINS:<br>BIVALIRUDIN 250 MG	<br> <br> <br>1 Numb	er	1	Biv<br>Trif	alirudin (containing 8% to 12<br>low Acetic Acid as per COA)	%	<br>315.114 mg/<br>Vial
	<br> <br>

: BIVALIRUDIN 250 MG| 1 Numb|er|1||Biv Trif|alirudin (containing 8% to 12 low Acetic Acid as per COA)|%| 315.114 mg/ Vial| ||| |||||||| ||||||||||| |||||||||||


Case No	71 / NC/3/MEET/Jan/202223/18
.
Case Status	Case Deferred

Part Name	ZYDUS LIFESCIENCES LIMITED
y
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

HQ File Number	HQRNORM APPLY 00177562AM22

RA File Number	08AA04023793 AM22

Licence No and<br>Date	0811002515/06/09/2021

Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>DML<br>i.<br>Master Batch Formula.<br>ii.


C N	72 / NC/3/MEET/J/202223/18
ase o.	an
C Stt	C Ad
ase aus	ase pprove
Pt N	INTAS PHARMACEUTICALS LIMITED
ary ame
Meeting Number<br>d Dt	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
an ae
H Fil Nb	HRNORM REVIW00397104AM22
Q e umer	Q
RA Fil Nb	08AA04025507 AM22
e umer
Licence No and<br>Dt	0811002517/06/09/2021
ae
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as per the following details furnished by the<br>firm:

UDIN00346384AM23

i. As per the COA furnished by the firm from foreign supplier, content of Triflow Acetic Acid varies from 8% to 12% besides 1.7% water and other Residual solvents to compensate 12.34% excess API is used. Bivaludin Free Base is otherwise unstable as an API. 11.71%.

t of Triflow Acetic Acid varies from 8% to 12% besides 1.7% water and other Residual solvents to compensate 12.34% excess API is used. Bivaludin Free Base is otherwise unstable as an API. 11.71%.

ii. 11.71% wastage is shown for manufacturing Process Loss.
iii. Since the export product is Freeze Dried Powder, 12% excess volume is added as per regulatory requirement.
(iv) Export to USA and Canada only.

Considering 12.34% Potency loss, 10% standard manufacturing loss as per SION and 2% notional extra-filling, it was decided to revise adhoc norms as under:

Export product	Qty.	Sl. No.	Import items	Qty.
BIVALIRUDIN FOR INJECTION<br>250<br>MG/VIAL<br>(5ML<br>VIAL)<br>(Freeze Dried Powder for Injection<br>250 mg / Vial) (EACH VIAL<br>CONTAINS: BIVALIRUDIN 250<br>MG	<br> <br> <br> <br> <br>1 Number	1	Bivalirudin (containing 8% to 12%<br>Triflow Acetic Acid as per COA)	<br>315.114 mg/<br>Vial

Case No.	73 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00177945AM22
RA File Number	05AA04070230 AM22
Licence No and<br>Date	0511004557/06/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.

UDIN00346384AM23

Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence, the Committee decided torejectthe case.||

UDIN00346384AM23

Case No.	74 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00178977AM22
RA File Number	08AA04026034 AM22
Licence No and<br>Date	0811002528/07/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	75 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00179705AM22
RA File Number	05AA04071036 AM22
Licence No and<br>Date	0511004601/08/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	76 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00181385AM22
RA File Number	08AA04024263 AM22
Licence No and<br>Date	0811002550/10/09/2021
Norms Committee Decision:

3/ MEET/ Jan/ 202223/ 18 and 23/01/2023| |HQ File Number|HQRNORM APPLY 00181385AM22| |RA File Number|08AA04024263 AM22| |Licence No and Date|0811002550/10/09/2021| |Norms Committee Decision:||

39 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

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

i. DML.

ii. Master Batch Formula.

iii. COA of import item from foreign supplier. iv. Composition of import item.

Case No.	77 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00181607AM22
RA File Number	05AA04061713 AM22
Licence No and<br>Date	0511004657/10/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence,|| |the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>78 / NC/3/MEET/Jan/202223/18
Case Status<br>Case Deferred
Party Name<br>DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number<br>HQRNORM APPLY 00184161AM22
RA File Number<br>34AA04007354 AM22
Licence No and<br>Date<br>3411001111/15/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee for explaining its case alongwith following documents / information:
COA report of both import and export items giving clearly percentage of it purity.<br>i.
Production of export item vis-à-vis Consumption of all the raw materials (both imported and<br>ii.
indigenous)) for last three years duly certified by GST / CA.
Total sales value of By-Product per kg of export item, giving evidence and also to subtract the quantity<br>iii.
of import item per kg of export from this value.

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

UDIN00346384AM23

e.**|

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

UDIN00346384AM23

Case No.	79 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00184484AM22
RA File Number	05AA04076999 AM22
Licence No and<br>Date	0511004742/15/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	80 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SANOFI INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00185047AM22
RA File Number	03AA04082679 AM22
Licence No and<br>Date	0311007007/16/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	81 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00185767AM22
RA File Number	03AA04011760 AM22
Licence No and<br>Date	0311007030/16/09/2021

|Meeting Number and Date|NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023| |HQ File Number|HQRNORM APPLY 00185767AM22| |RA File Number|03AA04011760 AM22| |Licence No and Date|0311007030/16/09/2021| |Norms Committee Decision: The Committee considered the case as per agendaand 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:||

41 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

Export product	Qty.	Sl. No.	Import items	Qty.
Atorvastatin Calcium USP / BP / EP	1 kg	1	(4R-CIS)-1,<br>1-<br>Dimethylethyl-6-<br>Cyanomethyl-2, 2-Dimethyl-1-3-Dioxane-<br>4-Acetate	0.708 kg
		2	Iso Propyl Alcohol	2.56 kg
		3	Methanol	4.285 kg

Case No.	82 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00187904AM22
RA File Number	08AA04029099 AM22
Licence No and<br>Date	0811002644/20/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2023| |HQ File Number|HQRNORM APPLY 00187904AM22| |RA File Number|08AA04029099 AM22| |Licence No and Date|0811002644/20/09/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	83 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00187990AM22
RA File Number	07AA04024759 AM22
Licence No and<br>Date	0711001935/20/09/2021
Norms Committee Decision:<br>The firm vide its e-mail dated10.02.2023has requested to grant them time to submit its reply.<br>The Committee considered the request of firm and it was decided to grant them 15 days time to firm to furnish its<br>reply.

UDIN00346384AM23

Case No.	84 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00001473AM23
RA File Number	08AA04029213 AM22
Licence No and<br>Date	0811002696/27/09/2021
Norms Committee Decision:
Deferred for comments of TE.

3/01/2023| |HQ File Number|HQRNORM REVIW00001473AM23| |RA File Number|08AA04029213 AM22| |Licence No and Date|0811002696/27/09/2021| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	85 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00195372AM22
RA File Number	34AA04006808 AM22
Licence No and<br>Date	3411001180/27/09/2021
Norms Committee Decision:
The Committee considered the case as per agendaand it was decided to call the firm for attendingPersonal Hearing
before Norms Committee for explaining its case.

Case No.	86 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00201651AM22
RA File Number	07AA04031322 AM22
Licence No and<br>Date	0711002073/04/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Complete technical details as per Annexure to Appendix 4E.

Case No.	87 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred

UDIN00346384AM23

ents from the|| |firm:|| |Complete technical details as per Annexure to Appendix 4E.||

Case No.	87 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred

UDIN00346384AM23

Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00201659AM22
RA File Number	07AA04034939 AM22
Licence No and<br>Date	0711002076/04/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Complete technical details as per Annexure to Appendix 4E.<br>i.<br>Technical literature in support of yield.<br>ii.<br>Production / Consumption data duly certified by GST.<br>iii.

Case No.	Case No.	88 / NC/3/MEET/Jan/202223/18	88 / NC/3/MEET/Jan/202223/18	88 / NC/3/MEET/Jan/202223/18	88 / NC/3/MEET/Jan/202223/18	88 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM REVIW00397111AM22
RA File Number		08AA04030678 AM22
Licence No and<br>Date		0811002770/04/10/2021

and Date||NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023||||| |HQ File Number||HQRNORM REVIW00397111AM22||||| |RA File Number||08AA04030678 AM22||||| |Licence No and Date||0811002770/04/10/2021||||| |Norms Committee Decision: The Committee considered the request of firm for review of adhoc norms and considering potency correction due to all Alcoholic Solvents and water content not less than 1.86% as per COA furnished by the firm, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. NALTREXONE HYDROCHLORIDE TABLETS 50 MG(EACH FILM COATED TABLET CONTAINS: NALTREXONE HYDROCHLORIDE PH. EUR. 50 MG [IN WHICH ACTIVE INGREDIENT NALTREXONE HYDROCHLORIDE USED IS 135.000 KGS.]) 1 Number 1 NALTREXONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR (All Alcoholic Solvents and water content NLT 1.86% as per COA of import item) 51.93 mg / Tablet||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||NALTREXONE HYDROCHLORIDE TABLETS 50 MG(EACH FILM COATED TABLET CONTAINS: NALTREXONE HYDROCHLORIDE PH. EUR. 50 MG [IN WHICH ACTIVE INGREDIENT NALTREXONE HYDROCHLORIDE USED IS 135.000 KGS.])|| 1 Number|1|NALTREXONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR (All Alcoholic Solvents and water content NLT 1.86% as per COA of import item)| 51.93 mg / Tablet|

UDIN00346384AM23

NE HYDROCHLORID E EP / BP / IP / USP / PH. EUR (All Alcoholic Solvents and water content NLT 1.86% as per COA of import item)| 51.93 mg / Tablet|

UDIN00346384AM23

Case No.	89 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00210670AM22
RA File Number	56AA04005794 AM22
Licence No and<br>Date	5611000556/12/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee for explaining its case alongwith following documents / information:<br>(i) Complete specification and COA of import item from foreign supplier.<br>(ii) Point out the difference in specification of import and export.<br>(iii) Production / Consumption data for last two years duly certified by GST.		Personal Hearing

er. (ii) Point out the difference in specification of import and export. (iii) Production / Consumption data for last two years duly certified by GST.**||Personal Hearing|

Case No.	90 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00210670AM22
RA File Number	56AA04005794 AM22
Licence No and<br>Date	5611000556/12/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee for explaining its case alongwith following documents / information:<br>(i) Complete specification and COA of import item from foreign supplier.<br>(ii) Point out the difference in specification of import and export.<br>(iii) Production / Consumption data for last two years duly certified by GST		Personal Hearing

Case No. 91 / NC/3/MEET/Jan/202223/18

45 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

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fied by GST**||Personal Hearing|

Case No. 91 / NC/3/MEET/Jan/202223/18

45 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

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Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00211526AM22
RA File Number	03AA040110500 AM22
Licence No and<br>Date	0311007683/13/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No NC/3/MEET/Sep/202223/9 dated 07/10/2022against advance authorization No.<br>0311012331 dated 07/03/2022, 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.<br>Import items<br>Qty.<br>1<br>PROPIOPHENONE<br>0.922 kg<br>2-AMINO<br>-2-PHENYLBUTYRIC<br>ACID SODIUM SALT<br>1 kg<br>2<br>SODIUM CYANIDE (NaCN)<br>0.337 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

0.922 kg 2-AMINO -2-PHENYLBUTYRIC ACID SODIUM SALT 1 kg 2 SODIUM CYANIDE (NaCN) 0.337 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	92 / NC/3/MEET/Jan/202223/18	92 / NC/3/MEET/Jan/202223/18	92 / NC/3/MEET/Jan/202223/18	92 / NC/3/MEET/Jan/202223/18	92 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00211838AM22
RA File Number		05AA04081672 AM22
Licence No and<br>Date		0511005408/13/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

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Aziriv Tablet 500 mg	1 Number	1	AZITHROMYCIN	Dihydrate	<br>534.512 mg
			USP
(AZITHROMYCIN TABLETS 500 MG)

Case No.	93 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00001474AM23
RA File Number	08AA04033170 AM22
Licence No and<br>Date	0811002920/20/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

3/01/2023| |HQ File Number|HQRNORM REVIW00001474AM23| |RA File Number|08AA04033170 AM22| |Licence No and Date|0811002920/20/10/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	94 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00001209AM23
RA File Number	08AA04033169 AM22
Licence No and<br>Date	0811002929/20/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	95 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00001519AM23
RA File Number	31AA04028264 AM22
Licence No and<br>Date	3111000632/21/10/2021
Norms Committee Decision:

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

Case No.	96 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00221594AM22
RA File Number	08AA04033661 AM22
Licence No and<br>Date	0811002958/22/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2023| |HQ File Number|HQRNORM APPLY 00221594AM22| |RA File Number|08AA04033661 AM22| |Licence No and Date|0811002958/22/10/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	97 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	METROPOLITAN EXIMCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00225235AM22
RA File Number	03AA040108347 AM22
Licence No and<br>Date	0311007901/25/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	98 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	METROPOLITAN EXIMCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00225235AM22
RA File Number	03AA040108347 AM22
Licence No and	0311007901/25/10/2021

48 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

Date

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

Case No.	99 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00000529AM23
RA File Number	08AA04033768 AM22
Licence No and<br>Date	0811002982/26/10/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and considering potency correction due to all<br>Alcoholic Solvents and water content not less than 1.86% as per COA furnished by the firm, it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>NALTREXONE<br>HYDROCHLORIDE<br>TABLETS<br>50 MG(EACH FILM COATED<br>TABLET<br>CONTAINS:<br>NALTREXONE<br>HYDROCHLORIDE PH. EUR. 50<br>MG<br>[IN<br>WHICH<br>ACTIVE<br>INGREDIENT<br>NALTREXONE<br>HYDROCHLORIDE USED IS<br>135.000 KGS.])<br>1 Number<br>1<br>NALTREXONE HYDROCHLORID E EP<br>/ BP / IP / USP / PH. EUR (All Alcoholic<br>Solvents and water content NLT 1.86% as<br>per COA of import item)<br>51.93 mg /<br>Tablet<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	100 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED

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ecessary action as per above decision of NC.||

Case No.	100 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00000528AM23
RA File Number	08AA04034748 AM22
Licence No and<br>Date	0811003137/15/11/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and considering potency correction due to all<br>Alcoholic Solvents and water content not less than 1.86% as per COA furnished by the firm, it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>NALTREXONE<br>HYDROCHLORIDE<br>TABLETS<br>50 MG(EACH FILM COATED<br>TABLET<br>CONTAINS:<br>NALTREXONE<br>HYDROCHLORIDE PH. EUR. 50<br>MG<br>[IN<br>WHICH<br>ACTIVE<br>INGREDIENT<br>NALTREXONE<br>HYDROCHLORIDE USED IS<br>135.000 KGS.])<br>1 Number<br>1<br>NALTREXONE HYDROCHLORID E EP<br>/ BP / IP / USP / PH. EUR (All Alcoholic<br>Solvents and water content NLT 1.86% as<br>per COA of import item)<br>51.93 mg /<br>Tablet<br>RA concerned may take further necessary action as per above decision of NC.

H. EUR (All Alcoholic Solvents and water content NLT 1.86% as per COA of import item) 51.93 mg / Tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	101 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00000530AM23
RA File Number	08AA04034735 AM22
Licence No and<br>Date	0811003139/15/11/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as per the following details furnished by the<br>firm:<br>As per the COA furnished by the firm from foreign supplier, content of Triflow Acetic Acid varies from 8% to 12%<br>i.

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besides 1.7% water and other Residual solvents to compensate 12.34% excess API is used. Bivaludin Free Base is otherwise unstable as an API. 11.71%.

ii. 11.71% wastage is shown for manufacturing Process Loss.

iii. Since the export product is Freeze Dried Powder, 12% excess volume is added as per regulatory requirement.

(iv) Export to USA and Canada only.

Considering 12.34% Potency loss, 10% standard manufacturing loss as per SION and 2% notional extra-filling, it was decided to revise adhoc norms as under:

iv) Export to USA and Canada only.

Considering 12.34% Potency loss, 10% standard manufacturing loss as per SION and 2% notional extra-filling, it was decided to revise adhoc norms as under:

Export product	Qty.	Sl. No.	Import items	Qty.
BIVALIRUDIN FOR INJECTION<br>250<br>MG/VIAL<br>(5ML<br>VIAL)<br>(Freeze Dried Powder for Injection<br>250 mg / Vial) (EACH VIAL<br>CONTAINS: BIVALIRUDIN 250<br>MG	<br> <br> <br> <br> <br>1 Number	1	Bivalirudin (containing 8% to 12%<br>Triflow Acetic Acid as per COA)	<br>315.114 mg/<br>Vial

Case No.	102 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00262416AM22
RA File Number	34AA04008408 AM22
Licence No and<br>Date	3411001440/23/11/2021
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:

UDIN00346384AM23

Actual quantity with its value of each By-Product produced per MT of Export Product manufacturing.

to call for following information / documents from the firm:||

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Actual quantity with its value of each By-Product produced per MT of Export Product manufacturing.

Case No.	103 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00262416AM22
RA File Number	34AA04008408 AM22
Licence No and<br>Date	3411001440/23/11/2021
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>Actual quantity with its value of each By-Product produced per MT of Export Product manufacturing.

Case No.	104 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00263488AM22
RA File Number	03AA04014060 AM22
Licence No and<br>Date	0311008817/24/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence, the Committee decided torejectthe case. RA concerned may take further necessary action as per above decision of NC.||

Case No.	105 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00263488AM22
RA File Number	03AA04014060 AM22
Licence No and<br>Date	0311008817/24/11/2021

52 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

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Norms Committee Decision:

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

Case No.	106 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00263483AM22
RA File Number	03AA04003343 AM22
Licence No and<br>Date	0311008815/24/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	107 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00263483AM22
RA File Number	03AA04003343 AM22
Licence No and<br>Date	0311008815/24/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

s observed that the firm still has not furnished its reply. Hence, the Committee decided torejectthe case. RA concerned may take further necessary action as per above decision of NC.||

Case No.	108 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

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and Date
HQ File Number	HQRNORM APPLY 00263486AM22
RA File Number	03AA04009051 AM22
Licence No and<br>Date	0311008816/24/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	109 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00263486AM22
RA File Number	03AA04009051 AM22
Licence No and<br>Date	0311008816/24/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

s observed that the firm still has not furnished its reply. Hence, the Committee decided torejectthe case. RA concerned may take further necessary action as per above decision of NC.||

Case No.	110 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00266181AM22
RA File Number	08AA04035102 AM22
Licence No and<br>Date	0811003242/26/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	111 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SUDEEP PHARMA PRIVATE LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00270155AM22
RA File Number	342404000285 AM20
Licence No and<br>Date	3411001477/30/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

s observed that the firm still has not furnished its reply. Hence, the Committee decided torejectthe case. RA concerned may take further necessary action as per above decision of NC.||

Case No.	112 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00270155AM22
RA File Number	342404000285 AM20
Licence No and<br>Date	3411001477/30/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	113 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00271633AM22
RA File Number	342404000080 AM21
Licence No and<br>Date	3411001485/01/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.

55 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

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rnished its reply. Hence, the Committee decided torejectthe case.||

55 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

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Case No.	114 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	UPL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00271160AM22
RA File Number	03AA040125862 AM22
Licence No and<br>Date	0311009068/01/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Dec/202223/15 dated 29/12/2022against advance authorization No.<br>03110015330 dated 08/06/2022, 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>Phenol<br>0.937 kg<br>Tri phenyl Phosphite<br>1 kg<br>2<br>Yellow Phosphorus<br>0.10 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

items Qty. 1 Phenol 0.937 kg Tri phenyl Phosphite 1 kg 2 Yellow Phosphorus 0.10 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	115 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00271471AM22
RA File Number	342404000079 AM21
Licence No and<br>Date	3411001482/01/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.

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Case No.	116 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00271583AM22
RA File Number	342404000002 AM21
Licence No and<br>Date	3411001484/01/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence,|| |the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.	117 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	PMC RUBBER CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00272783AM22
RA File Number	02AA04035173 AM22
Licence No and<br>Date	0211001583/02/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	118 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00272834AM22
RA File Number	03AA04014502 AM22
Licence No and<br>Date	0311009117/02/12/2021

57 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

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Norms Committee Decision:

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

Case No.	119 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00272951AM22
RA File Number	03AA04014150 AM22
Licence No and<br>Date	0311009127/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	120 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00276162AM22
RA File Number	03AA040123869 AM22
Licence No and<br>Date	0311009212/06/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	121 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM REVIW00001552AM23
RA File Number	13AX04000009 AM22
Licence No and	1311000821/15/12/2021

58 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

Date

The Committee considered the request of firm for fixation of adhoc norms and it was observed that the firm still has not furnished its reply. Hence, the Committee decided to reject the case.

Case No.	122 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00289566AM22
RA File Number	34AX04000036 AM22
Licence No and<br>Date	3411001553/17/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agendaand it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee for explaining its case alongwith following documents / information:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis<br>ii.<br>Stoichiometric balance between import and export on molar basis<br>iii.<br>Complete justification of wastage of raw materials for the manufacturing of export product.<br>iv.

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

ufacturing of export product.** iv.|||

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

Case No.	123 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00289569AM22
RA File Number	34AX04000035 AM22
Licence No and<br>Date	3411001554/17/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agendaand it was decided to call the firm for attending<br>before Norms Committee for explaining its case alongwith following documents / information:<br>Step wise manufacturing process.<br>i.		Personal Hearing

UDIN00346384AM23

ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis
iii. Stoichiometric balance between import and export on molar basis.
iv. Complete justification of wastage of raw materials for the manufacturing of export product.

n molar basis**

iii. Stoichiometric balance between import and export on molar basis.
iv. Complete justification of wastage of raw materials for the manufacturing of export product.

Case No.	124 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00291533AM22
RA File Number	34AX04000052 AM22
Licence No and<br>Date	3411001560/20/12/2021
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>DML for each export Product<br>i.<br>Master Batch Formula for each export product.<br>ii.

Case No.	125 / NC/3/MEET/Jan/202223/18
Case Status	Case Rejected
Party Name	MELZER CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00291926AM22
RA File Number	31AA04030064 AM22
Licence No and<br>Date	3111000802/20/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	126 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

S 187000|1|GENTAMICIN SULPHATE|5.722 kg||

UDIN00346384AM23

10ML(GENTAMICIN EYE/EAR DROPS 10ML Vials (EACH VIAL CONTAINS GENTAMICIN SULPHATE 0.030 GM NET WT OF A BULK DRUG IS 5.610 KGS))

Case No.	155 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002638AM23
RA File Number	31AX04000146 AM23
Licence No and<br>Date	3111001620/12/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Gliclazide BP<br>1 kg<br>1<br>N-Amino-3-azabicyclo (3,3.0) Octane HCL<br>0.577 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	156 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002625AM23
RA File Number	34AX04000448 AM23
Licence No and<br>Date	3411002646/12/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agendaand it was decided to call the firm for attending<br>before Norms Committee for explaining its case.		Personal Hearing

UDIN00346384AM23

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

UDIN00346384AM23

Case No.	157 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002634AM23
RA File Number	03AX04002522 AM23
Licence No and<br>Date	0311017151/12/08/2022
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>Chemical name and complete COA of import and export item.<br>i.<br>Quantity of By-Products obtained and their commercial value.<br>ii.<br>Production / Consumption data for last two years duly certified by GST.<br>iii.

Case No.	158 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	MEGHMANI FINECHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002655AM23
RA File Number	34AX04000449 AM23
Licence No and<br>Date	3411002647/16/08/2022

|Meeting Number and Date|NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023| |HQ File Number|HQRNORM APPLY 00002655AM23| |RA File Number|34AX04000449 AM23| |Licence No and Date|3411002647/16/08/2022| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: Stoichiometric balance on molar basis between import and export. i. Complete chemical reaction with molecular and structural formula and molecular weight alongwith stage wise percentage yield on molar basis. ii.||

Case No.	159 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002656AM23
RA File Number	09AX04000230 AM23
Licence No and	0911003485/16/08/2022

76 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

Date

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.
LEVETIRACETAM	1 kg	1	S(+)-2-Amino butyramide hydrochloride	0.95 kg
		2	Methylene Chloride	2.26 kg
		3	Acetone	0.40 kg

Export product	Qty.	Sl. No.	Import items	Qty.
LEVETIRACETAM	1 kg	1	S(+)-2-Amino butyramide hydrochloride	0.95 kg
		2	Methylene Chloride	2.26 kg
		3	Acetone	0.40 kg

Case No.	160 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002645AM23
RA File Number	03AX04002727 AM23
Licence No and<br>Date	0311017254/16/08/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	161 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002657AM23
RA File Number	05AX04001367 AM23
Licence No and<br>Date	0511014295/16/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import

UDIN00346384AM23

item in Meeting No. NC/3/MEET/Apr/202223/1 dated 29/04/2022 against advance authorization No. 0511006792 dated 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>(Brinzolamide Opthalmic Suspension 1%)- 5ml	<br>1 Vial	1	Brinzolamide	51.00 mg / Vial

ort product	Qty.	Sl. No.	Import items	Qty.
Brinex / Brinex-M / Brinarga / Brinera<br>(Brinzolamide Opthalmic Suspension 1%)- 5ml	<br>1 Vial	1	Brinzolamide	51.00 mg / Vial

Case No.	Case No.	Case No.	162 / NC/3/MEET/Jan/202223/18	162 / NC/3/MEET/Jan/202223/18	162 / NC/3/MEET/Jan/202223/18	162 / NC/3/MEET/Jan/202223/18	162 / NC/3/MEET/Jan/202223/18
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number			HQRNORM APPLY 00002646AM23
RA File Number			03AX04002728 AM23
Licence No and<br>Date			0311017256/16/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import<br>item in Meeting No.NC/3/MEET/Oct/202122/9 dated 15/10/2021against advance authorization No.0310838214 dated<br>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<br>by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Clindamycin Phosphate USP<br>262.50 mg /<br>pack<br>1<br>Clindamycin & Benzoyl Peroxide Gel<br>1percent/5percent ( Pack Size 25gm<br>)((Net Wt. of Import Item Sr. No. 1 is<br>25.00 Kgs. & Sr. No.

r>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 1 Clindamycin Phosphate USP 367.50 mg / pack HYDROUS BENZOYL 1837.50 mg / 2 Clindamycin & Benzoyl Peroxide Gel 1percent/5percent ( Pack Size 35gm )((Net Wt. of Import Item Sr. No. 1 is 35.00 Kgs. & Sr. No. 2 is 175.00 Kgs.)) 1 Number Pack 2|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||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|1|Clindamycin Phosphate USP|262.50 mg / pack| ||||||2|HYDROUS BENZOYL PEROXIDE USP|1312.50 mg / pack| ||2|Clindamycin & Benzoyl Peroxide Gel 1percent/5percent ( Pack Size 35gm )((Net Wt. of Import Item Sr. No. 1 is 35.00 Kgs. & Sr. No. 2 is 175.00 Kgs.))|| 1 Number Pack|1|Clindamycin Phosphate USP|367.50 mg / pack| ||||||2|HYDROUS BENZOYL|1837.50 mg /|

UDIN00346384AM23

. 1 is 35.00 Kgs. & Sr. No. 2 is 175.00 Kgs.))|| 1 Number Pack|1|Clindamycin Phosphate USP|367.50 mg / pack| ||||||2|HYDROUS BENZOYL|1837.50 mg /|

UDIN00346384AM23

						PEROXIDE USP	PEROXIDE USP	pack

	3	Clindamycin & Benzoyl Peroxide Gel<br>		<br> <br>1 Number<br>	1	Clindamycin Phosphate USP		525.00 mg /<br>
		1percent/<br>)((Net W	5percent ( Pack Size 50gm<br>t of Import Item Sr No 1 is	<br> <br>Pack				pack
		<br>50.00 Kg	. . .<br>s. & Sr. No. 2 is 250.00 Kgs.))

					2	H<br>	YDROUS<br>BENZOYL<br>	2625.00 mg /<br>
						P	EROXIDE USP	pack

	4	Adapalen	e & Benzoyl Peroxide Gel	<br>1 Number	2	H	YDROUS<br>BENZOYL	1181.25 mg /
		0.1percen<br>	t/2.5percent ( Pack Size 45gm<br>	<br> <br>Pack		P	EROXIDE USP	pack
		)((Net W<br>112.50 K	t. of Import Item Sr. No. 2 is<br>gs.))
<br>RA concerned may take further necessary action as per above decision of NC.

| Pack||P|EROXIDE USP|pack| |||)((Net W 112.50 K|t. of Import Item Sr. No. 2 is gs.))|||||| | RA concerned may take further necessary action as per above decision of NC.|||||||||

Case No.	Case No.	Case No.	163 / NC/3/MEET/Jan/202223/18	163 / NC/3/MEET/Jan/202223/18	163 / NC/3/MEET/Jan/202223/18
Case Status			Case Approved
Party Name			INDOCO REMEDIES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number			HQRNORM APPLY 00002649AM23
RA File Number			03AX04002620 AM23
Licence No and<br>Date			0311017259/16/08/2022
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/202223/17dated 13/01/2023 against advance authorization No.<br>0311007392dated 01/10/2021, 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:


(A)



	Sl. No.	Export	Product	Qty.	S	l. No.	Import Items	Qty.

	1	ALLO	URINOL TABLETS 100MG (Eh	1 Nb	1		Allil	10200 / 100
		ac<br>Allopurinol<br>Tablet<br>of<br>100mg<br>contains<br>Allopurinol<br>100mg)(Equivalent<br>to:-Cyano<br>Acetamide 0.0001mg,Triethyl Ortho formate<br>0.00021mg,<br>Formamide<br>0.00015<br>mg,<br>Morpholine 0.00013mg Hydrazine Hydrate		umer			opurno	.

s Allopurinol 100mg)(Equivalent to:-Cyano Acetamide 0.0001mg,Triethyl Ortho formate 0.00021mg, Formamide 0.00015 mg, Morpholine 0.00013mg Hydrazine Hydrate||umer|||opurno|. mg mg Tablet| |||||||||| |||,|||||||

UDIN00346384AM23

	0.00006 mg) Net wt of Allopurinol 15000 kgs
	(Cross Norms of Allopurinol SION No.A2321
	& Tablets/Capsules A412))
2	ALLOPURINOL TABLETS 300MG (Each	<br>1 Number	2	Allopurinol	306.00 mg / 300
	Allopurinol<br>Tablet<br>of<br>300mg<br>contains				mg Tablet
	Allopurinol 300 mg)(Equivalent to:-Cyano
	Acetamide 0.0003mg ,Triethyl Ortho-formate
	0.00063mg,<br>Formamide<br>0.00045<br>mg,
	Morpholine 0.00039mg , Hydrazine Hydrate
	0.00018 mg) Net wt of Allopurinol 15000 kgs.
	(Cross Norms of Allopurinol SION No.A2321
	& Tablets/Capsules A412))

(B)

Export product	Qty.	Sl. No.	Import items	Qty.
ALLOPURINOL	1 kg	1	Cyano Acetamide	1.00 kg
		2	Triethyl Ortho formate	2.10 kg
		3	Formamide	1.50 kg
		4	Morpholine	1.30 kg
		5	Hydrazine Hydrate	0.60 kg

Case No.	164 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	SUVEN PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002650AM23

80 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

RA File Number	09AX04000426 AM23
Licence No and<br>Date	0911003473/16/08/2022
Norms Committee Decision:
Deferred for comments of TE.

RA File Number	09AX04000426 AM23	09AX04000426 AM23
Licence No and	0911003473/16/08/2022
Date
Norms Committee	Decision:
Deferred for comme	nts of TE.


Case No.	165 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	MICRO LABS LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002651AM23
RA File Number	07AX04000712 AM23
Licence No and
Date	0711005013/16/08/2022
Norms Committee	Decision:
h i	idd h d d ki f	li dii f d

PLY 00002651AM23|||||| |RA File Number||07AX04000712 AM23|||||| |Licence No and|||||||| |Date||0711005013/16/08/2022|||||| |Norms Committee||Decision:|||||| |h i||idd h d d ki f||||li dii f d|| |Te Commttee co import item in Mee 13/03/2018i||nsere te case as per agena an tang cue r ting No.15/82-ALC4/2018dated 22/03/2019 agains didd if dh d P 407 f||||m earer ecson or same export prouct / t advance authorization No.0710112960dated HBP Vl I dil i bl|| |, t wa alied b the firm||ece to raty aoc norms uner ara . o whichever is less:||||o. as per etas gven eow or as|| |pp y||,|||||| ||||||||| ||Export Product||Qty.|Sl. No.|Im|port items|Qty.| ||OLOPATADINE HYDROCHLORIDE || 120000|1|OLOPATADINE || 679.32 gram| ||OPTHALMIC SOLUTION 0.1% w/v 5ml(Eh ml ntin 111 m f Oltdin|| Numbers||HYDROCHLORIDE USP / PhEr||| ||ac co Hydrochloride) (|as . g o opaae Net Content 666.00 grams ))||||.u.|| ||||||||| ||||||||| |RA concerned may||take further necessary action as per above decision||||of NC|| ||||||||| ||||||||| |Case No.||166 / NC/3/MEET/Jan/202223/18|||||| |Case Status||Case Approved|||||| |Party Name||MICRO LABS LIMITED|||||| |Meeting Number and Date||NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023|||||| |HQ File Number||HQRNORM APPLY 00002652AM23|||||| ||||||||| |RA File Number||07AX04000627 AM23|||||| |Licence No and ||0711005017/16/08/2022|||||| |Date|||||||| ||||||||| |Norms Committee||Decision:|||||| |||||||||

ORM APPLY 00002652AM23|||||| ||||||||| |RA File Number||07AX04000627 AM23|||||| |Licence No and ||0711005017/16/08/2022|||||| |Date|||||||| ||||||||| |Norms Committee||Decision:|||||| |||||||||

Case No.	166 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002652AM23
RA File Number	07AX04000627 AM23
Licence No and<br>Date	0711005017/16/08/2022
Norms Committee Decision:

UDIN00346384AM23

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:

The Committee co<br>	The Committee co<br>	The Committee co<br>	nsidered the case as per agenda and it was decided t<br>	nsidered the case as per agenda and it was decided t<br>	nsidered the case as per agenda and it was decided t<br>	o ratify adhoc norms under Para 4.07 of HBP<br>	o ratify adhoc norms under Para 4.07 of HBP<br>	o ratify adhoc norms under Para 4.07 of HBP<br>
Vol. I as per detail			s given below or as applied by the firm, whichever is			less:



	Sl. No.	Export Product		Qty.	Sl. No	.	Import items	Qty.
	1	LISINOPRIL<br>2.5<br>MG<br>TABLETS(BP/EP/IP/USP 7.50 Kg)		<br>1 Number	1			2.55 mg /<br>Tablet
							Lisinopril Dihydrate Ph.

||||||| ||Sl. No.|Export Product||Qty.|Sl. No|.|Import items|Qty.| ||1|LISINOPRIL 2.5 MG TABLETS(BP/EP/IP/USP 7.50 Kg)|| 1 Number|1|||2.55 mg / Tablet| ||||||||Lisinopril Dihydrate Ph. Eur.|| |||||||||| |||||||||| ||2|LISINO|PRIL 5 MG| 1 Number|2||Lisinopril Dihydrate Ph Eur|510 mg /| ||| TABLE| TS(BP/EP/IP/USP 15.00 Kg)| |||. .|. Tablet| |||||||||| ||3|LISINO |PRIL 10 MG | 1 Number|3||Lisinopril Dihydrate Ph. Eur.|10.20 mg / | |||TABLE|S(BP/EP/IP/USP 90.00 Kg)|||||Tablet| |||||||||| |||||||||| ||4|LISINO TABLE|PRIL 20 MG TS(BP/EP/IP/USP 180.00 Kg)| 1 Number|4||Lisinopril Dihydrate Ph. Eur.|20.40 mg / Tablet| |RA concerned may take further necessary action as per above decision of NC.||||||||| ||||||||||


Case No		167 / NC/3/MEET/Jan/202223/18
.
Case Status		Case Approved

Party Name		MICRO LABS LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

HQ File Number		HQRNORM APPLY 00002662AM23

RA File Number		07AX04000714 AM23

Licence No and<br>Date		0711005023/17/08/2022

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



	Export Product		Qty.	Sl.

ided 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.| ||||||||| ||Azelastine Hyd|rochloride Eye Drops,| 38000|1|AZELASTINE||193.8 gram| || Solution 0.5| % w/v (Azelastine| Numbers||HYDROCHLORIDE Ph. Eur.||| |||||||||

UDIN00346384AM23

Hydrochloride 0.5mg / ml Eye Drops, Solution) 10ml( { Net Content 190.00 gm})

Case No.	168 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002668AM23
RA File Number	05AX04001382 AM23
Licence No and<br>Date	0511014320/17/08/2022
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>Molecular weight of import and export item.<br>i.<br>Stoichiometric balance on the basis of molecular weight and yield.<br>ii.<br>Percentage purity of Export Product.<br>iii.

irm: Molecular weight of import and export item. i. Stoichiometric balance on the basis of molecular weight and yield. ii. Percentage purity of Export Product. iii.||

Case No.	169 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002678AM23
RA File Number	31AX04000141 AM23
Licence No and<br>Date	3111001623/17/08/2022
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/202223/12 dated 18/11/2022against advance authorization No.<br>3111001358 dated 17/05/2022, 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:

UDIN00346384AM23

1358 dated 17/05/2022**, 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:||

UDIN00346384AM23

Export product	Qty.	Sl. No.	Import items	Qty.
DNOVO BP818 (Powder)<br>(Tetra Methyl Bisphenol F)	1 kg	1	OCP 50 (O-Cresol and Phenol)	0.23136 kg
		2	Paraformaldehyde	0.14090 kg
		3	Methanol	Not allowed
		4	Katalco 71 5	0.004 kg

Case No.	170 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002680AM23
RA File Number	05AX04001361 AM23
Licence No and<br>Date	0511014334/17/08/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2023| |HQ File Number|HQRNORM APPLY 00002680AM23| |RA File Number|05AX04001361 AM23| |Licence No and Date|0511014334/17/08/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	171 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	ASMEE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002687AM23
RA File Number	03AX04002781 AM23
Licence No and<br>Date	0311017314/18/08/2022
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 chemical reactions with molecular and structural formula and molecular weights along with<br>i.

i. Complete chemical reactions with molecular and structural formula and molecular weights along with

UDIN00346384AM23

stage wise percentage yields on molar basis.

ii. Production / Consumption data duly certified by GST.

Case No.	172 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002693AM23
RA File Number	07AX04000739 AM23
Licence No and<br>Date	0711005063/19/08/2022
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>DML.<br>i.<br>Master Batch Formula.<br>ii.

Case No.	Case No.	173 / NC/3/MEET/Jan/202223/18	173 / NC/3/MEET/Jan/202223/18	173 / NC/3/MEET/Jan/202223/18	173 / NC/3/MEET/Jan/202223/18	173 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00002695AM23
RA File Number		03AX04002817 AM23
Licence No and<br>Date		0311017348/21/08/2022
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 6/82-ALC4/2018 dated26/07/2018against advance authorization No.0310814211dated<br>22/06/2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.

** 22/06/2017, 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 DIPHENYLAMINE 0.50 kg 2 DI-ISOBUTYLENE 0.64 kg DI-OCTYLATED DIPHENYLAMINE (YALUB DODPA) 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||DI-OCTYLATED DIPHENYLAMINE (YALUB DODPA)||1 kg|1|DIPHENYLAMINE|0.50 kg| |||||2|DI-ISOBUTYLENE|0.64 kg|

UDIN00346384AM23

3 ACTIVATED CLAY 0.10 kg


		3	A	CTIVATED CLAY	0.10 kg


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

Case No.	174 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved

Part Name	PIRAMAL PHARMA LIMITED
y
Meeting Number
<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

HQ File Number	HQRNORM APPLY 00002696AM23

RA File Number	03AX04002836 AM23
Licence No and
<br>Date	0311017351/22/08/2022

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>

|||||||| |||||||||||||| |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 Meeting No.NC/3/MEET/Nov/202223/14 dated 07/12/2022against advance authorization No. 0311010308 dated 10/01/2022, 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 Pr|oduct|Qty.||Sl. No.||Impor||t items|Qty.|| |||||||||||||| ||||| |||||| | || ||1|Atorvasta 10mg((N is 495.9|tin Calcium Tablets USP et wt. of Import Sr. No. 1 45kgs, Sr. No. 2 is| 1 Number Tablet||1||Atorv Glyco||astatin Calcium Propylene l Solvate USP| 11.415 mg|| ||| 2746.71k| g, Sr. No. 3 is 779.985kg,| ||||||||| |||Sr. No. 4|is 505000 Nos.))|||2||Micro ||crystalline Cellulose (MCC) NF | 64.578 mg|| |||||||||(Avic||el PH 102)||| |||||||||||||| |||||||3||Calci||um Acetate|18.049 mg|| |||||||4||Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent)||| Relevant as per packing policy|| |||||||||||||| |||||||||||||| ||2|Atorvasta|tin Calcium Tablets USP| 1 Number||1||Atorvastatin Calcium Propylene||| 22.830 mg|| |||20mg((N|et wt. of Import Sr. No. 1| Tablet|||| Glycol Solvate USP||| || |||is 59.5 |13kgs, Sr. No. 2 is | ||||||||| |||||||||||||| |||330.772k Sr. No. 4|g, Sr. No.

20mg((N|et wt. of Import Sr. No. 1| Tablet|||| Glycol Solvate USP||| || |||is 59.5 |13kgs, Sr. No. 2 is | ||||||||| |||||||||||||| |||330.772k Sr. No. 4|g, Sr. No. 3 is 93.879kg, is 30300 Nos.))|||2||Microcrystalline Cellulose (MCC) NF (Avicel PH 102)||| 129.427 mg|| |||||||||||||| |||||||||||||| |||||||3||Calcium Acetate|||36090 m|| ||||||||||||. g||

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							<br>
				4	Silica Gel Dessicants - Packaged<br>Activated Carbon (Strippax Sorbent)		<br>Relevant as per<br>packing policy
3	Atorvastatin Calcium Tablets USP<br>40Nt t f It S N 1		<br> <br>1 Number<br>Tblt	1	Atorvastatin<br>Calcium<br>Propylene<br>Gll Slt USP		<br>45.595 mg
	mg((e w. o mpor r. o.<br>is 3570.804kgs, Sr. No. 2 is		<br> <br>ae		yco ovae
	<br>19777.77	<br>kg,<br>Sr.<br>No.<br>3<br>is	<br>
	5616.216<br>	kg, Sr. No. 4 is 909000		2	Micro<br>	crystalline Cellulose (MCC) NF<br>	<br>258.08 mg
	Nos.))				(Avic	el PH 102)
				3	Calci	um Acetate	71.963 mg


				4	Silica	Gel Dessicants - Packaged	<br>Relevant as per
					<br>Activ	<br>ated Carbon (Strippax Sorbent)	<br> <br>packing policy

4	Atorvastatin Calcium Tablets USP<br>80mg((Net wt. of Import Sr. No. 1<br>is 2063.131kgs, Sr. No.

nt as per| ||||||| Activ| ated Carbon (Strippax Sorbent)| 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 3258146k Sr No 4 is 262600|| 1 Number Tablet|1|Atorv Glyco|astatin Calcium Propylene l Solvate USP| 91.20 mg| |||||||||| ||||||2|Microcrystalline Cellulose (MCC) NF|| 518.206 mg| |||.g, . . Nos.))|||| (Avicel PH 102)|| | |||||||||| ||||||3|Calci|m Acetate|144929 m| |||||||||. g| ||||||4|Silica |Gel Dessicants - Packaged | Relevant as per | |||||||Activ|ated Carbon (Strippax Sorbent)|packing policy| |||||||||| |||||||||| ||Note: The abo||ve norms are valid only for subject to fulfillment of foll||||owing conditions:|| ||Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex Corp, US. Agent for Apotex Inc., Candada. 1. Export to USA only. 2. Firm holding Certificate of Manufacturing Exclusivity. 3.|||||||| |||||||||| |||||||||| |||||||||| |RA concerned may|||take further necessary action as per above decision||||of NC.|| |||||||||| |||||||||| |Case No.|||175 / NC/3/MEET/Jan/202223/18|||||| |Case Status|||Case Deferred|||||| |Party Name|||TORRENT PHARMACEUTICALS LTD|||||| |Meeting Number|||NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023|||||| |and Date||||||||| |HQ File Number|||HQRNORM APPLY 00002697AM23|||||| |RA File Number|||08AX04000846 AM23|||||| ||||||||||

|||| |Meeting Number|||NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023|||||| |and Date||||||||| |HQ File Number|||HQRNORM APPLY 00002697AM23|||||| |RA File Number|||08AX04000846 AM23|||||| ||||||||||

Case No.	175 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002697AM23
RA File Number	08AX04000846 AM23

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Licence No and 0811005777/22/08/2022 Date Norms Committee Decision:

Case No.	176 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002706AM23
RA File Number	03AX04002788 AM23
Licence No and<br>Date	0311017379/22/08/2022
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/202223/12 dated 18/11/2022against advance authorization No.<br>0311013460dated30/03/2022, 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.<br>Import items<br>Qty.<br>Colesevelam HCL for oral suspension<br>3.75 GM ( Per Pack 30 Pouchs) (<br>Total 35000 Packs)((Net.

lied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. Colesevelam HCL for oral suspension 3.75 GM ( Per Pack 30 Pouchs) ( Total 35000 Packs)((Net. Content of Colesevelam Hydrochloride is 3937.500 kgs)) 35000 Packs 1 Colesevelam Hydrochloride 4134.375 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	177 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002714AM23
RA File Number	09AX04000432 AM23
Licence No and<br>Date	0911003510/22/08/2022
Norms Committee Decision:

UDIN00346384AM23

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.
Valganciclovir Tablets USP 450 mg	1 Number	1	Valganciclovir<br>Hcl<br>(USP<br>Amorphous)	<br>506.24 mg

whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Valganciclovir Tablets USP 450 mg	1 Number	1	Valganciclovir<br>Hcl<br>(USP<br>Amorphous)	<br>506.24 mg

Case No.	178 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002737AM23
RA File Number	07AX04000747 AM23
Licence No and<br>Date	0711005078/23/08/2022
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>DML.<br>i.<br>Master Batch Formula.<br>ii.

Case No.	179 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002742AM23
RA File Number	34AX04000462 AM23
Licence No and<br>Date	3411002662/23/08/2022
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:

UDIN00346384AM23

i. DML.
ii. Master Batch Formula.

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

UDIN00346384AM23

i. DML.
ii. Master Batch Formula.

Case No.	180 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002755AM23
RA File Number	34AX04000497 AM23
Licence No and<br>Date	3411002675/24/08/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.
Production / Consumption data for last two years duly certified by GST.<br>vi.

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

years duly certified by GST.** vi.||

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

Case No.	181 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002758AM23
RA File Number	08AX04000605 AM23
Licence No and<br>Date	0811005824/24/08/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	182 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

90 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

HQ File Number	HQRNORM APPLY 00002763AM23
RA File Number	09AX04000349 AM23
Licence No and<br>Date	0911003525/24/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jul/202122/4 dated 15/07/2021against advance authorization No.<br>0911000447dated 26/02/2021, 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.

02/2021**, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. Daptomycin for Injection 500mg/vial 400000 Numbers 1 Daptomycin 220.00 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	183 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	EUGIA PHARMA SPECIALITIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002764AM23
RA File Number	09AX04000315 AM23
Licence No and<br>Date	0911003526/24/08/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	184 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002765AM23
RA File Number	02AX04000280 AM23
Licence No and<br>Date	0211002902/24/08/2022
Norms Committee Decision:

UDIN00346384AM23

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

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

Case No.	185 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002772AM23
RA File Number	03AX04002827 AM23
Licence No and<br>Date	0311017461/25/08/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	186 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002776AM23
RA File Number	03AX04002881 AM23
Licence No and<br>Date	0311017468/25/08/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	187 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	KREATIVE ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002807AM23
RA File Number	09AX04000474 AM23
Licence No and	0911003550/26/08/2022

92 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

Date

92 This document has been digitally signed by AJAY KUMAR, Deputy Director on 23-02-2023 17:51:11.

UDIN00346384AM23

Date

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:

Date

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 2-ETHYL ANILINE / 2-ETHYL BENZENEAMINE 1.058 kg 2 2,3-DIHYDROFURANE 0.330 kg 3 METHYL 3 OXO PENTONOATE 0.455 kg 4 Methanol 1.133 kg 5 Toluene Not shown in the process 6 Sodium Nitrite 0.40 kg ETODOLAC METHYL ESTER 1 kg 7 Sodium Sulfite 2.20 kg RA concerned may take further necessary action as per above decision of NC.

process 6 Sodium Nitrite 0.40 kg ETODOLAC METHYL ESTER 1 kg 7 Sodium Sulfite 2.20 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	188 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002809AM23
RA File Number	34AX04000499 AM23
Licence No and<br>Date	3411002686/26/08/2022
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/202223/12 dated 18/11/2022against advance authorization No.<br>3411002081 dated 31/03/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details

UDIN00346384AM23

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

Export product	Qty.	Sl. No.	Import items	Qty.
Phenol	1 MT	1	Cumene	0.84466 MT

s||

UDIN00346384AM23

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

Export product	Qty.	Sl. No.	Import items	Qty.
Phenol	1 MT	1	Cumene	0.84466 MT

Case No.<br>189 / NC/3/MEET/Jan/202223/18	Case No.<br>189 / NC/3/MEET/Jan/202223/18
Case Status<br>Case Approved
Party Name<br>DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number<br>HQRNORM APPLY 00002810AM23
RA File Number<br>34AX04000500 AM23
Licence No and<br>Date<br>3411002689/26/08/2022
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.
3411002081 dated 31/03/2022, 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<br>Qty.	Sl. No.	Import items	Qty.
Phenol<br>1 MT	1	Cumene	0.84466 MT
<br>RA concerned may take further necessary action as per above		decision of NC.

Case No.	190 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002813AM23
RA File Number	07AX04000768 AM23

UDIN00346384AM23

UDIN00346384AM23

Licence No and 0711005110/26/08/2022 Date Norms Committee Decision:

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

i. Specify the grade of Citric Acid and Magnesium Carbonate.
ii. Manufacturing process indicating the grade of chemicals to use.
iii. Use of Potassium Carbonate Granular.
iv. Reason for using Granular form of Potassium Carbonate.

Case No.	191 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002801AM23
RA File Number	09AX04000470 AM23
Licence No and<br>Date	0911003541/26/08/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2023| |HQ File Number|HQRNORM APPLY 00002801AM23| |RA File Number|09AX04000470 AM23| |Licence No and Date|0911003541/26/08/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.	192 / NC/3/MEET/Jan/202223/18	192 / NC/3/MEET/Jan/202223/18	192 / NC/3/MEET/Jan/202223/18	192 / NC/3/MEET/Jan/202223/18	192 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00002826AM23
RA File Number		03AX04002925 AM23
Licence No and<br>Date		0311017549/29/08/2022
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/202223/15 dated 29/12/2022against advance authorization No.<br>0311016722dated 29/07/2022, 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.<br>Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.|

Case No.	Case No.	192 / NC/3/MEET/Jan/202223/18	192 / NC/3/MEET/Jan/202223/18	192 / NC/3/MEET/Jan/202223/18	192 / NC/3/MEET/Jan/202223/18	192 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00002826AM23
RA File Number		03AX04002925 AM23
Licence No and<br>Date		0311017549/29/08/2022
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/202223/15 dated 29/12/2022against advance authorization No.<br>0311016722dated 29/07/2022, 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.<br>Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

UDIN00346384AM23

AMANTADINE HYDRCHLORIDE	100MG	<br>1	Number	1	AMANTADINE	102	mg
CAPSULES					HYDROCHLORIDE

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

UDIN00346384AM23

AMANTADINE HYDRCHLORIDE	100MG	<br>1	Number	1	AMANTADINE	102	mg
CAPSULES					HYDROCHLORIDE

Case No.	193 / NC/3/MEET/Jan/202223/18
Case Status	Case Approved
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002835AM23
RA File Number	05AX04001515 AM23
Licence No and<br>Date	0511014526/29/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethylene Oxide<br>0.197 kg<br>Choline Chloride 60% Aqueous<br>1 kg<br>2<br>Trimethyl Amine<br>0.261 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	194 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002838AM23
RA File Number	34AX04000490 AM23
Licence No and<br>Date	3411002712/29/08/2022
Norms Committee Decision:

UDIN00346384AM23

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

i. DML. ii. Master Batch Formula.

UDIN00346384AM23

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

i. DML. ii. Master Batch Formula.

Case No.	195 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	GODAVARI BIOREFINERIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002842AM23
RA File Number	03AX04002739 AM23
Licence No and<br>Date	0311017558/29/08/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	Case No.	195 / NC/3/MEET/Jan/202223/18	195 / NC/3/MEET/Jan/202223/18	195 / NC/3/MEET/Jan/202223/18	195 / NC/3/MEET/Jan/202223/18

Case Status		Case Deferred

Party Name		GODAVARI BIOREFINERIES LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

HQ File Number		HQRNORM APPLY 00002842AM23

RA File Number		03AX04002739 AM23

Licence No and<br>Date		0311017558/29/08/2022

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

Case No.		196 / NC/3/MEET/Jan/202223/18

Case Status		Case Approved

Party Name		YASHO INDUSTRIES LIMITED

Meeting Number
<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00002846AM23

RA File Number		03AX04002941 AM23

Licence No and

| and Date||NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023|||||| |HQ File Number||HQRNORM APPLY 00002846AM23|||||| ||||||||| |RA File Number||03AX04002941 AM23|||||| ||||||||| |Licence No and|||||||| |Date||0311017563/30/08/2022|||||| |Norms Committee||Decision:|||||| |The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No 5/82-ALC4/2018 dated25/07/2018against advance authorization No.0310811041dated 08/02/2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as alied b the firm whichever is less:|||||||| |pp y ,|||||||| ||||||||| ||||||||| ||||||||| ||Exort roduct||Qt|Sl No|Imort items||Qt| ||p p||y.|. .|p||y.| ||||||||| ||BUTYLATED |OCTYLATED | 1 kg|1|DIPHENYLAMINE||0.405 kg| ||DIPHENYLAM|INE (YALUB BODPA)|||||| ||||||||| |||||2|DIISOBUTYLENE||0.62 kg| |||||||||

Case No.	Case No.	195 / NC/3/MEET/Jan/202223/18	195 / NC/3/MEET/Jan/202223/18	195 / NC/3/MEET/Jan/202223/18	195 / NC/3/MEET/Jan/202223/18

Case Status		Case Deferred

Party Name		GODAVARI BIOREFINERIES LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

HQ File Number		HQRNORM APPLY 00002842AM23

RA File Number		03AX04002739 AM23

Licence No and<br>Date		0311017558/29/08/2022

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

|||||||| |RA File Number||03AX04002739 AM23|||||| ||||||||| |Licence No and Date||0311017558/29/08/2022|||||| ||||||||| |Norms Committee Decision: Deferred for comments of TE.|||||||| ||||||||| |Case No.||196 / NC/3/MEET/Jan/202223/18|||||| ||||||||| |Case Status||Case Approved|||||| ||||||||| |Party Name||YASHO INDUSTRIES LIMITED|||||| ||||||||| |Meeting Number|||||||| | and Date||NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023|||||| |HQ File Number||HQRNORM APPLY 00002846AM23|||||| ||||||||| |RA File Number||03AX04002941 AM23|||||| ||||||||| |Licence No and|||||||| |Date||0311017563/30/08/2022|||||| |Norms Committee||Decision:|||||| |The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No 5/82-ALC4/2018 dated25/07/2018against advance authorization No.0310811041dated 08/02/2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as alied b the firm whichever is less:|||||||| |pp y ,|||||||| ||||||||| ||||||||| ||||||||| ||Exort roduct||Qt|Sl No|Imort items||Qt| ||p p||y.|. .|p||y.| ||||||||| ||BUTYLATED |OCTYLATED | 1 kg|1|DIPHENYLAMINE||0.405 kg| ||DIPHENYLAM|INE (YALUB BODPA)|||||| ||||||||| |||||2|DIISOBUTYLENE||0.62 kg| |||||||||

UDIN00346384AM23

3 ACTIVATED CLAY 0.20 kg

D |OCTYLATED | 1 kg|1|DIPHENYLAMINE||0.405 kg| ||DIPHENYLAM|INE (YALUB BODPA)|||||| ||||||||| |||||2|DIISOBUTYLENE||0.62 kg| |||||||||

UDIN00346384AM23

3 ACTIVATED CLAY 0.20 kg

Case No.<br>197 / NC/3/MEET/Jan/202223/18
Case Status<br>Case Rejected
Party Name<br>HONOUR LAB LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number<br>HQRNORM APPLY 00002854AM23
RA File Number<br>09AX04000430 AM23
Licence No and<br>Date<br>0911003559/30/08/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the details furnished by the firm are misleading
as they have applied for import of raw material and the intermediate manufactured from these raw material.
In view of above, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	198 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002857AM23
RA File Number	09AX04000483 AM23
Licence No and<br>Date	0911003562/30/08/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	199 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002871AM23
RA File Number	08AX04000919 AM23

UDIN00346384AM23

Licence No and 0811005862/01/09/2022 Date Norms Committee Decision:

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

i. DML.
ii. Master Batch Formula.

iii. COA of import item showing Actual Potency.

Case No.	Case No.	200 / NC/3/MEET/Jan/202223/18	200 / NC/3/MEET/Jan/202223/18	200 / NC/3/MEET/Jan/202223/18	200 / NC/3/MEET/Jan/202223/18	200 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		AMI ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00002873AM23
RA File Number		52AX04001623 AM23
Licence No and<br>Date		5211003147/01/09/2022
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 13/AM19 dated 14/01/2019against advance authorization No.5210041615 dated<br>21.08.2015 and 5210042176 dated 10.02.2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>VANILLINE- 99.5 % min<br>(Tech.

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 VANILLINE- 99.5 % min (Tech. spec :powder) 1.588 kg 2 DI METHYL FORMAMIDE - 99.5% (Tech. spec :Liquid) 2.40 kg 3,4 DI HYDROXY 5 NITRO BENZAL DEHYDE-99% min 1 kg 3 METHYLENE CHLORIDE (Tech. spec :Liquid) 3.17 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||3,4 DI HYDROXY 5 NITRO BENZAL DEHYDE-99% min|| 1 kg|1|VANILLINE- 99.5 % min (Tech. spec :powder)|1.588 kg| |||||2|DI METHYL FORMAMIDE - 99.5% (Tech. spec :Liquid)|2.40 kg| |||||3|METHYLENE CHLORIDE (Tech. spec :Liquid)|3.17 kg| |||||per above decision of NC.|||

UDIN00346384AM23

Case No.	201 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	HI-PURITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number	HQRNORM APPLY 00002877AM23
RA File Number	03AX04002948 AM23
Licence No and<br>Date	0311017592/01/09/2022
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 chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>i.

/ documents from the firm: Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis. i.||

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

Case No.	Case No.	202 / NC/3/MEET/Jan/202223/18	202 / NC/3/MEET/Jan/202223/18	202 / NC/3/MEET/Jan/202223/18	202 / NC/3/MEET/Jan/202223/18	202 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		BIODEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00002909AM23
RA File Number		05AX04001425 AM23
Licence No and<br>Date		0511014609/02/09/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09/09/2022against advance authorization No.<br>0511008526 dated 03/02/2022, 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.

02/2022**, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 NASAL ADAPTOR FOR MFG OF NASAL SPRAY Relevant, on Net to Net basis with accountability NASAL SPRAY(SNAP-ON, S20 WHITE SMOOTH, NASAL ADAPTOR AT PAG136, AM TL 17 ML, 14-0388-004, WHITE, BOTTLE WITH CHEMICALS AS PER THE DRUG LICENSE) 99000 Numbers 2 NASAL BOTTLE Relevant, on Net to Net basis with accountability||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||NASAL SPRAY(SNAP-ON, S20 WHITE SMOOTH, NASAL ADAPTOR AT PAG136, AM TL 17 ML, 14-0388-004, WHITE, BOTTLE WITH CHEMICALS AS PER THE DRUG LICENSE)|| 99000 Numbers|1|NASAL ADAPTOR FOR MFG OF NASAL SPRAY| Relevant, on Net to Net basis with accountability| |||||2|NASAL BOTTLE|Relevant, on Net to Net basis with accountability|

100

UDIN00346384AM23

FOR MFG OF NASAL SPRAY| Relevant, on Net to Net basis with accountability| |||||2|NASAL BOTTLE|Relevant, on Net to Net basis with accountability|

100

UDIN00346384AM23

Case No.	Case No.	203 / NC/3/MEET/Jan/202223/18	203 / NC/3/MEET/Jan/202223/18	203 / NC/3/MEET/Jan/202223/18
Case Status		Case Approved
Party Name		BALAJI AMINES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number		HQRNORM APPLY 00002916AM23
RA File Number		31AX04000160 AM23
Licence No and<br>Date		3111001669/02/09/2022
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/202223/14 dated 07/12/2022against advance authorization No.<br>3111000158dated08/03/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>DIETHYLENE GLYCOL<br>1.279 kg<br>2<br>AMMONIA ANHYDROUS<br>0.217 kg<br>3<br>HYDROGEN<br>Not allowed, as it is<br>procured<br>indigenously.<br>MORPHOLINE<br>(ORGANIC CHEMICAL)<br>1 kg<br>4<br>MORPHOLINE CATALYST<br>Not allowed as no<br>catalogue<br>is<br>available.<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

r>4 MORPHOLINE CATALYST Not allowed as no catalogue is available. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||MORPHOLINE (ORGANIC CHEMICAL)||1 kg|1|DIETHYLENE GLYCOL|1.279 kg| |||||2|AMMONIA ANHYDROUS|0.217 kg| |||||3|HYDROGEN|Not allowed, as it is procured indigenously.| |||||4|MORPHOLINE CATALYST|Not allowed as no catalogue is available.| |||||per above decision of NC.|||

Case No.	204 / NC/3/MEET/Jan/202223/18
Case Status	Case Deferred
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number	NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023

101

UDIN00346384AM23

and Date
HQ File Number	HQRNORM APPLY 00002917AM23
RA File Number	34AX04000464 AM23
Licence No and<br>Date	3411002727/02/09/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee for explaining its case alongwith following documents / information:<br> COA report of both import and export items giving clearly percentage of it purity.<br>i.<br>Production of export item vis-à-vis Consumption of all the raw materials (both imported and<br>indigenous)) for last three years duly certified by GST / CA.<br>ii.<br>Total sales value of By-Product per kg of export item, giving evidence and also to subtract the quantity<br>of import item per kg of export from this value.<br>iii.

ST / CA.** ii. Total sales value of By-Product per kg of export item, giving evidence and also to subtract the quantity of import item per kg of export from this value. iii.|||

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

Case No.	Case No.	Case No.	205 / NC/3/MEET/Jan/202223/18	205 / NC/3/MEET/Jan/202223/18	205 / NC/3/MEET/Jan/202223/18	205 / NC/3/MEET/Jan/202223/18	205 / NC/3/MEET/Jan/202223/18
Case Status			Case Approved
Party Name			ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jan/ 202223/ 18 and 23/01/2023
HQ File Number			HQRNORM APPLY 00002918AM23
RA File Number			34AX04000542 AM23
Licence No and<br>Date			3411002728/02/09/2022
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/202223/14 dated 07/12/2022against advance authorization No.<br>3411001604 dated 29/12/2021, 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>Sl. No. Export product<br>Qty.<br>Sl. No.

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 Duloxetine Hydrochloride Ph,Eur. 22.88 mg 2 Sugar Spheres (30-35 PHARM-A- SPHERES) 20.33 mg 3 Hypromellose (Pharmacoat 606) 20.00 mg Talc (Luzenac Pharma Ultra Micronised 1 Duloxetine Caps.20 mg (Duloxetine Caps.20 mg (Net content of active ingredients 54.000 kgs ) ) 1 Number Capsule 4 12.63 mg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Duloxetine Caps.20 mg (Duloxetine Caps.20 mg (Net content of active ingredients 54.000 kgs ) )|| 1 Number Capsule|1|Duloxetine Hydrochloride Ph,Eur.|22.88 mg| ||||||2|Sugar Spheres (30-35 PHARM-A- SPHERES)|20.33 mg| ||||||3|Hypromellose (Pharmacoat 606)|20.00 mg| ||||||4|Talc (Luzenac Pharma Ultra Micronised|12.63 mg|

102

UDIN00346384AM23

||||2|Sugar Spheres (30-35 PHARM-A- SPHERES)|20.33 mg| ||||||3|Hypromellose (Pharmacoat 606)|20.00 mg| ||||||4|Talc (Luzenac Pharma Ultra Micronised|12.63 mg|

102

UDIN00346384AM23

				grade)
			5	Sucrose (Compressuc PS)	15.67 mg
			6	Hypromellose Phthalate (HP 55)	12.07 mg
			7	Triethyl Citrate	1.21 mg
2	Duloxetine<br>Caps.<br>30<br>mg(Duloxetine Caps. 30<br>mg (Net content of active<br>ingredients 210.00 kgs ) )	<br> <br> <br>1 Number<br>Capsule	1	Duloxetine Hydrochloride Ph,Eur.	34.36 mg
			2	Sugar<br>Spheres<br>(30-35<br>PHARM-A-<br>SPHERES)	30.50 mg
			3	Hypromellose (Pharmacoat 606)	30.00 mg
			4	Talc (Luzenac Pharma Ultra Micronised<br>grade)	18.94 mg
			5	Sucrose (Compressuc PS)	23.50 mg
			6	Hypromellose Phthalate (HP 55)	18.10 mg
			7	Triethyl Citrate	1.81 mg
3	Duloxetine<br>Caps.<br>40<br>mg(Duloxetine Caps. 40<br>mg (Net content of active<br>ingredients 120.000 kgs ) )	<br> <br> <br>1 Number<br>Capsule	1	Duloxetine Hydrochloride Ph,Eur.	45.76 mg
			2	Sugar<br>Spheres<br>(30-35<br>PHARM-A-<br>SPHERES)	40.67 mg
			3	Hypromellose (Pharmacoat 606)	40.00 mg
			4	Talc (Luzenac Pharma Ultra Micronised<br>grade)	25.26 mg
			5	Sucrose (Compressuc PS)	31.34 mg
			6	Hypromellose Phthalate (HP 55)	24.14 mg
			7	Triethyl Citrate	2.41 mg

103

UDIN00346384AM23

enac Pharma Ultra Micronised grade)|25.26 mg| |||||5|Sucrose (Compressuc PS)|31.34 mg| |||||6|Hypromellose Phthalate (HP 55)|24.14 mg| |||||7|Triethyl Citrate|2.41 mg|

103

UDIN00346384AM23

1	Duloxetine Hydrochloride Ph,Eur.	68.71 mg
2	Sugar<br>Spheres<br>(30-35<br>PHARM-A-<br>SPHERES)	61.00 mg
3	Hypromellose (Pharmacoat 606)	60.00 mg
4	Talc (Luzenac Pharma Ultra Micronised<br>grade)	37.88 mg
5	Sucrose (Compressuc PS)	47.00 mg
6	Hypromellose Phthalate (HP 55)	36.20 mg
7	Triethyl Citrate	3.62 mg

Case No.	206 / NC/3/MEET/Jan/202223/18
Case Status	Case

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