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/Feb/202223/20 DATED: 24/02/2023

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/Feb/202223/20 dated 24/02/2023 of Norms Committee - III for the year 2022-23 was held on 24/02/2023 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:-

S.No.	Name and Designation of Representatives	Department
1	AJAY KUMAR,Deputy Director	DGFT(HQ)
2	NAND Lal,Technical Consultant	DGFT
3	SHAISH KUMAR,Technical Consultant	DGFT
4	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT

ment**| |---|---|---| |1|AJAY KUMAR,Deputy Director|DGFT(HQ)| |2|NAND Lal,Technical Consultant|DGFT| |3|SHAISH KUMAR,Technical Consultant|DGFT| |4|DINESHNARAIN MATHUR,Technical Consultant|DGFT|

This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	CORPORATE CHANNELS (INDIA) PVT. LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00002028AM23
RA File Number	132404000019 AM14
Licence No and<br>Date	1310044179/29/08/2013
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was observed that the firm is going
for Backward Integration to make Cu Sleeve from Copper Tube, which is used for manufacturing of Export Product.
Earlier while ratifying adhoc norms, the quantity of import item No. 4 – Copper Tube was wrongly given as 0.00029
kg. Taking into recovery of 50% Copper, the Committee decided to revise the quantity of import item No. 4 –
COPPER TUBE (Purity 99.99% minimum) from 0.00029 kg to 0.026 kg.
Rest of the earlier Minutes would remain the same.
RA may take appropriate action as per the decision of Norms Committee.

|COPPER TUBE (Purity 99.99% minimum) from 0.00029 kg to 0.026 kg.|| |Rest of the earlier Minutes would remain the same.|| |RA may take appropriate action as per the decision of Norms Committee.||

Case No.	2 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00001869AM23
RA File Number	052404000399 AM17
Licence No and<br>Date	0510400599/02/12/2016
Norms Committee Decision:
The Committee considered the request of firm for review of of adhoc norms and it was decided to call for following
information / documents from the firm:
COA of import item does not indicate net content of Limonene. Please furnish Revised COA, since<br>i.
Linonene content ranges from 20% - 50%.
Value of By-Product Alpha Terpinene etc. obtained during recovery of Limenone from import.<br>ii.

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COA, since** i.|| |Linonene content ranges from 20% - 50%.|| |Value of By-Product Alpha Terpinene etc. obtained during recovery of Limenone from import. ii.||

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Case No.	3 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	NATURAL HERBS & FORMULATIONS
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00004230AM23
RA File Number	612404000001 AM18
Licence No and<br>Date	6110001419/13/04/2017
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was observed that the<br>applied for change in the export product / import items. Hence, it was decided to call the firm to attend <br>Hearing<br>before Norms Committee to explain its case.		firm has<br> Personal

Case No.	4 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00001867AM23
RA File Number	052404000008 AM18
Licence No and<br>Date	0510402246/18/04/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information / documents from the firm:<br>COA of import item does not indicate net content of Limonene. Please furnish Revised COA, since<br>Linonene content ranges from 20% - 50%.<br>i.<br>**Value of By-Product Alpha Terpinene etc.

COA of import item does not indicate net content of Limonene. Please furnish Revised COA, since Linonene content ranges from 20% - 50%. i. Value of By-Product Alpha Terpinene etc. obtained during recovery of Limenone from import. ii.||

Case No.	5 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred

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Party Name	NATURAL HERBS & FORMULATIONS
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00004226AM23
RA File Number	612404000002 AM18
Licence No and<br>Date	6110001452/18/08/2017
Norms Committee Decision:
The Committee the request of firm for fixation of adhoc norms and it was decided to call for following information /
documents from the firm:
Copy of Shipping Bill for entire export.<br>i.
Index of Shipping Bill with date and Number.<br>ii.
Copy of Bill of Entry for entire import with index indicating Bill of Entry No. and Date.<br>iii.
Packaging<br>iv.	details of Export Product.

Bill with date and Number.** ii.|| |Copy of Bill of Entry for entire import with index indicating Bill of Entry No. and Date. iii.|| |Packaging iv.|details of Export Product.|

Case No.	6 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00001870AM23
RA File Number	052404000297 AM18
Licence No and<br>Date	0510404439/31/10/2017
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information / documents from the firm:
COA of import item does not indicate net content of Limonene. Please furnish Revised COA, since<br>i.
Linonene content ranges from 20% - 50%.
Value of By-Product Alpha Terpinene etc. obtained during recovery of Limenone from import.<br>ii.

Case No.	7 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	NATURAL HERBS & FORMULATIONS

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uring recovery of Limenone from import.** ii.||

Case No.	7 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	NATURAL HERBS & FORMULATIONS

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M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/	Feb/ 202223/ 2	0 and 24	/02/2023
H	Q File Number	HQRNORM R	EVIW0000409	2AM23

R	A File Number	612404000004	AM18
L<br>D	icence No and<br>ate	6110001484/16	/01/2018

Norms Committee Decision:<br>The Committee the request of firm for fixation of adhoc norms and it was decided to call for following information /<br>documents from the firm:<br>Copy of Shipping Bill for entire export.<br>i.<br>Index of Shipping Bill with date and Number.<br>ii.<br>Copy of Bill of Entry for entire import with index indicating Bill of Entry No. and Date.<br>iii.<br>Packaging details of Export Product.<br>iv.	orms Committee Decision:<br>he Committee the request of fir<br>ocuments from the firm:<br>Copy of Shipping Bill for<br>i.		m for fixation<br>entire export
				of adhoc	norms and it was decided to call for fol	lowing information /
				.

s from the firm: Copy of Shipping Bill for i.||m for fixation entire export|||| |||||of adhoc|norms and it was decided to call for fol|lowing information /| |||||.||| ||||||||





Case No.		8 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
and Date
HQ File Number		HQRNORM REVIW00160008AM22
RA File Number		039404000838 AM18
Licence No and<br>Date		0310818810/31/01/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as<br>under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>N-Methyl Pyrrolidone (Purity minimum<br>99.8%, Moisture less than 1000 PPM)<br>240 MT<br>1<br>N-Methyl Pyrrolidone<br>(Purity not more than minimum<br>86.27%. water 5% to 7%)<br> 295.2 MT<br>RA may take appropriate action as per the decision of Norms Committee.
	ner:
	Export product<br>N-Methyl Pyrrolidone (Purit<br>99.8%, Moisture less than 1000<br>A may take appropriate action as pe
					Qty.		Sl. No.	Import items		Qty.

			y minimum<br>PPM)	<br>2	40 MT		1	N-Methyl Pyrrolidone		295.2 MT
								(Purity not more than mi<br>86.27%. water 5% to 7%)	nimum

			r the decision of		Norms C	ommittee.

PM)| 2|40 MT||1|N-Methyl Pyrrolidone||295.2 MT| |||||||||(Purity not more than mi 86.27%. water 5% to 7%)|nimum|| |||||||||||| ||||r the decision of||Norms C|ommittee.||||| ||||||||||||

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Case No.	9 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00002756AM23
RA File Number	522404000085 AM18
Licence No and<br>Date	5210042570/20/03/2018
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	10 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00003008AM23
RA File Number	318304000171 AM18
Licence No and<br>Date	3110067030/12/04/2018
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,6 xylenol<br>1.06 MT<br>DNOVO BP818 (Tetra Methyl Bisphenol F)<br>1 MT<br>2<br>Methanol<br>0.103 MT<br>RA may take appropriate action as per the decision of Norms Committee.

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ylenol 1.06 MT DNOVO BP818 (Tetra Methyl Bisphenol F) 1 MT 2 Methanol 0.103 MT RA may take appropriate action as per the decision of Norms Committee.||

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Case No.	11 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00003137AM23
RA File Number	318304000005 AM19
Licence No and<br>Date	3110067060/23/05/2018
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,6 xylenol<br>1.06 MT<br>2<br>Paraformaldehyde<br>0.1302 MT<br>DNOVO BP818 (Tetra Methyl Bisphenol F)<br>1 MT<br>3<br>Methanol<br>0.10 MT<br>RA may take appropriate action as per the decision of Norms Committee

Case No.	12 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00001184AM23
RA File Number	092404000181 AM19
Licence No and<br>Date	0910066442/11/07/2018
Norms Committee Decision:

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Deferred for comments of TE.

ber|HQRNORM REVIW00001184AM23| |RA File Number|092404000181 AM19| |Licence No and Date|0910066442/11/07/2018| |Norms Committee Decision:||

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Deferred for comments of TE.

Case No.	13 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00003005AM23
RA File Number	318304000081 AM19
Licence No and<br>Date	3110067162/24/08/2018
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>OCP 50<br>1.00 MT<br>ORTHO CRESOL<br>1 MT<br>2<br>Methanol<br>0.998 MT<br>RA may take appropriate action as per the decision of Norms Committee

Case No.	14 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00002987AM23
RA File Number	318304000157 AM19
Licence No and<br>Date	3110067278/09/01/2019
Norms Committee Decision:

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

considered the request of firm for fixation of adhoc norms and it was decided to ratify 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.
ORTHO CRESOL	1 MT	1	OCP 50	1.00 MT
		2	Methanol	0.998 MT

RA may take appropriate action as per the decision of Norms Committee.

Case No.	Case No.	15 / NC/3/MEET/Feb/202223/20	15 / NC/3/MEET/Feb/202223/20	15 / NC/3/MEET/Feb/202223/20	15 / NC/3/MEET/Feb/202223/20	15 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		TIDE INDUSTRIES
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM REVIW00001539AM23
RA File Number		342404000083 AM20
Licence No and<br>Date		3410045200/10/06/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as<br>under:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Hexyl Alcohol or N-Hexanol<br>1.36 kg<br>2<br>Acrylic Acid<br>0.96 kg<br>Gamma Nonalactone or Aldehyde C18<br>1 kg<br>3<br>Di-tert Butyl Peroxide<br>0.229 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Gamma Nonalactone or Aldehyde C18		1 kg	1	Hexyl Alcohol or N-Hexanol	1.36 kg
				2	Acrylic Acid	0.96 kg
				3	Di-tert Butyl Peroxide	0.229 kg

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RA may take appropriate action as per the decision of Norms Committee.

r N-Hexanol|1.36 kg| |||||2|Acrylic Acid|0.96 kg| |||||3|Di-tert Butyl Peroxide|0.229 kg| ||||||||

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RA may take appropriate action as per the decision of Norms Committee.

Case No.	16 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	JINDAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00405090AM22
RA File Number	039404000003 AM21
Licence No and<br>Date	0310835903/25/04/2020
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	17 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	JINDAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00405134AM22
RA File Number	039404000005 AM21
Licence No and<br>Date	0310835906/25/04/2020
Norms Committee Decision:<br>Deferred for comments of TE

Case No.	18 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	KUMAR ORGANIC PRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00000645AM23
RA File Number	072404000030 AM21

11 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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11 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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Licence No and<br>Date	0710116410/01/05/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>ZINC PYRITHIONE (ASSAY 50%)<br>1 kg<br>1<br>2, CHLOROPYRIDINE<br>0.50 kg<br>RA may take appropriate action as per the decision of Norms Committee.

Licence No and Date

0710116410/01/05/2020

Norms Committee Decision: The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. ZINC PYRITHIONE (ASSAY 50%) 1 kg 1 2, CHLOROPYRIDINE 0.50 kg RA may take appropriate action as per the decision of Norms Committee.

Case No.	19 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	018205001343AM21
RA File Number	039404000110 AM21
Licence No and<br>Date	0310836469/01/06/2020
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	20 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00085836AM21
RA File Number	34AA04001557 AM21
Licence No and<br>Date	3411000043/17/02/2021
Norms Committee Decision:

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and 24/02/2023| |HQ File Number|HQRNORM APPLY 00085836AM21| |RA File Number|34AA04001557 AM21| |Licence No and Date|3411000043/17/02/2021| |Norms Committee Decision:||

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|T i 1 t|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.7/82-ALC4/2020 dated04/12/2020 against advance authorization No.3410044685 dt. 3.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by he firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.7/82-ALC4/2020 dated04/12/2020 against advance authorization No.3410044685 dt. 3.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by he firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.7/82-ALC4/2020 dated04/12/2020 against advance authorization No.3410044685 dt. 3.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol.

t / mport item in Meeting No.7/82-ALC4/2020 dated04/12/2020 against advance authorization No.3410044685 dt. 3.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by he firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.7/82-ALC4/2020 dated04/12/2020 against advance authorization No.3410044685 dt. 3.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by he firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.7/82-ALC4/2020 dated04/12/2020 against advance authorization No.3410044685 dt. 3.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by he firm, whichever is less:| |---|---|---|---|---|---| ||Export product|Qty.|Sl.

1.2018**, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by he firm, whichever is less:| |---|---|---|---|---|---| ||Export product|Qty.|Sl. No.|Import items|Qty.| ||3-TRIFLUOROMETHYL ACETO PHENONE (LIQUID)| 1 kg|1|Benzo Trifluoride|1.26 kg| ||||2|Sodium Nitrite|0.50 kg| ||||3|Toluene|0.150 kg| ||||4|Caustic Soda Lye|0.50 kg| ||||5|Acetaldoxime 50 percent Min Solution in Water| 0.951 kg| ||||6|Copper Sulphate|Not allowed, since it is shown indigenous| ||||7|Acetic Acid|Not allowed, since it is shown indigenous| ||||8|Sulphuric Acid|Not allowed, since it is shown indigenous| ||||9|Soda Ash|0.005 kg| ||||10|Nitric Acid|Not allowed| ||||11|Catalyst|Not allowed| ||||12|Hydrogen|Not allowed| ||||13|Hydrochloric Acid|Not allowed| |||||||

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. 7/82-ALC4/2020 dated 04/12/2020 against advance authorization No. 3410044685 dt. 13.11.2018 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

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

a 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

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

Case No.<br>21 / NC/3/MEET/Feb/202223/20
Case Status<br>Case Approved
Party Name<br>SCOTT EDIL PHARMACIA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number<br>HQRNORM REVIW00002997AM23
RA File Number<br>30AA04004572 AM21
Licence No and<br>Date<br>3011000300/24/02/2021
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and on the basis of written comments
furnished by Department of Biotechnology vide D.O. Letter No.PID-13011(15)/1/2021-PPB-DBT dated 28.02.2023
, it was decided to ratify 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.
Erythropoietin Injection 2000IU/ml (Each<br>1 Vial	1	Recombinant Human Erythropoietin	1.1 ml
ml contains : Erythropoietin Concentrated		2000IU ready to fill bulk
Solution BP 2000 IU)
RA concerned may take further necessary action as per above decision of NC.

ietin|1.1 ml|| |ml contains : Erythropoietin Concentrated||2000IU ready to fill bulk||| |Solution BP 2000 IU)||||| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	22 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00092003AM21
RA File Number	038504000144 AM21
Licence No and<br>Date	0311000450/25/02/2021

UDIN00366605AM23

Norms Committee Decision:

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

Percentage yield in conversion of Acetic Acid to Diketene.

Case No.	23 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00107278AM21
RA File Number	03AA04022151 AM21
Licence No and<br>Date	0311002655/19/03/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	24 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00020260AM22
RA File Number	34AA04000021 AM22
Licence No and<br>Date	3411000455/16/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>As per details of import, quantity asked is Net to Net. Please clarify it.<br>i.<br>Any indigenous Sorbic Acid is being used for maintaining 10% wastage (as asked in Appendix 4E).<br>Please clarify it.<br>ii.

15 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

UDIN00366605AM23

10% wastage (as asked in Appendix 4E).** Please clarify it. ii.||

15 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

UDIN00366605AM23

Case No.	25 / NC/3/MEET/Feb/202223/20
Case Status	Case Rejected
Party Name	SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM REVIW00001551AM23
RA File Number	13AA04002353 AM22
Licence No and<br>Date	1311000341/19/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was observed that the firm is using<br>only Pulvarised Process for manufacturing of Export Product, for which the wastage given by NC in its earlier<br>Meeting is quite enough.<br> Hence, the Committee decided torejectthe case maintaining the status quo.<br>RA may take appropriate action as per the decision of Norms Committee.

ts earlier Meeting is quite enough. Hence, the Committee decided torejectthe case maintaining the status quo. RA may take appropriate action as per the decision of Norms Committee.||

Case No.	Case No.	26 / NC/3/MEET/Feb/202223/20	26 / NC/3/MEET/Feb/202223/20	26 / NC/3/MEET/Feb/202223/20	26 / NC/3/MEET/Feb/202223/20	26 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		TIDE INDUSTRIES
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00126124AM22
RA File Number		34AA04004372 AM22
Licence No and<br>Date		3411000778/28/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking into consideration yield of 75.28%, it was decided to<br>ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Aldehyde C 9 (Purity 98%)<br>1 kg<br>1<br>N Nonanal (90% to 94% purity)<br>1.24 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Aldehyde C 9 (Purity 98%)		1 kg	1	N Nonanal (90% to 94% purity)	1.24 kg

UDIN00366605AM23

nanal (90% to 94% purity) 1.24 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Aldehyde C 9 (Purity 98%)||1 kg|1|N Nonanal (90% to 94% purity)|1.24 kg|

UDIN00366605AM23

Case No.	27 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00164102AM22
RA File Number	03AA04065031 AM22
Licence No and<br>Date	0311006216/17/08/2021
Norms Committee Decision:<br>Deferred for comments of TE

Case No.	Case No.	28 / NC/3/MEET/Feb/202223/20	28 / NC/3/MEET/Feb/202223/20	28 / NC/3/MEET/Feb/202223/20	28 / NC/3/MEET/Feb/202223/20	28 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00168909AM22
RA File Number		31AA04024928 AM22
Licence No and<br>Date		3111000540/23/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Dec/202223/17dated13/01/2023 against advance authorization No.<br>3111000564dt.03/09/2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.

3111000564dt.03/09/2021, it was decided to ratify 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 TIN INGOTS 0.496 kg MONO BUTYL TIN OXIDE (MBTO) 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||MONO BUTYL TIN OXIDE (MBTO)||1 kg|1|TIN INGOTS|0.496 kg|

UDIN00366605AM23

2 TETRA BUTYL TIN TBT 0.487 kg


C N		29 / NC/3/MEET/Fb/202223/20
ase o.		e
C S		C Ad
ase tatus		ase pprove
P N		MANGALAM ORGANICS LIMITED
arty ame
Meeting Number<br>d D		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
an ate
H Fil Nb		HRNORM APPLY 00169050AM22
Q e umer		Q
RA Fil Nb		03AA04027384 AM22
e umer
Licence No and<br>D		0311006375/23/08/2021
ate
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 dated18/11/2022against advance authorization No.<br>
0311014302dt.02/<br>lid b th		05/2022, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>fi hih i l
o	r as appe y	rm, wcever s ess:



	Export product		Qty.	Sl.

it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below fi hih i l||||| |o|r as appe y|rm, wcever s ess:||||| |||||||| |||||||| |||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| |||||||| |||||||| ||DIPENTENE||1 kg|1|GUM TURPENTINE OIL|1.03 kg| |||||||| |RA concerned may take further necessary action as per above decision of NC.||||||| ||||||||





Case No.	30 / NC/3/MEET/Feb/202223/20

Case Status	Case Deferred

Party Name	SI GROUP - INDIA PRIVATE LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

HQ File Number	HQRNORM APPLY 00170117AM22

UDIN00366605AM23

RA File Number	03AA04063156 AM22
Licence No and<br>Date	0311006435/25/08/2021
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>Molecular weight of import item.<br>i.<br>Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.<br>ii.

g information / documents from the firm: Molecular weight of import item. i. Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for. ii.||

Case No.	31 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00170350AM22
RA File Number	03AA04069090 AM22
Licence No and<br>Date	0311006443/25/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify 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>FENOFIBRATE PELLETS<br>(Each gram Pellets contains 662.5 mg Fenofibrate)<br>1 kg<br>1<br>FENOFIBRATE<br>0.669 kg<br>RA may take appropriate action as per the decision of Norms Committee.

Case No.	32 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved

UDIN00366605AM23

TE 0.669 kg RA may take appropriate action as per the decision of Norms Committee.||

Case No.	32 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved

UDIN00366605AM23

Party Name	Party Name	ATHENA DRUG DELIVER	Y SOLUTION	Y SOLUTION	S PRIVAT	S PRIVAT	E LIMITED	E LIMITED	E LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/	20 and 24/02/2		023

HQ File Number		HQRNORM APPLY 001703	57AM22
RA File Number		03AA04069088 AM22
Licence No and<br>Date		0311006444/25/08/2021

Norms Committee Decision:<br>The Committee considered the case as per age<br>as per details given below or as applied by the<br>Export product<br>FENOFIBRATE PELLETS<br>(Each gram Pellets contains 662.5 mg Fenofi<br>RA may take appropriate action as per the decision o			nda and it was<br>firm, whicheve		decided t<br>r is less:		o ratify norms under Para 4.07 of			HBP Vol. I

	Export product			Qty.		Sl No		Import items	Qt
						.	.			.
	FENOFIBRATE PELLETS<br>Eh Pllt ti 6625 Ffi		bt	1 kg		1		FENOFIBRATE	0.6	69 kg
	(ac gram ees conans . mg eno		rae)
			f Norms Commit
					tee.

|||.|.|||.| ||FENOFIBRATE PELLETS Eh Pllt ti 6625 Ffi||bt|1 kg||1||FENOFIBRATE|0.6|69 kg| ||(ac gram ees conans . mg eno||rae)|||||||| ||||f Norms Commit|||||||| ||||||tee.|||||| ||||||||||||

Case No.	33 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred

Party Name	HARMONY ORGANICS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00171602AM22
RA File Number	31AA04024595 AM22
Licence No and<br>Date	3111000549/26/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	34 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED

UDIN00366605AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00175852AM22
RA File Number	34AA04006370 AM22
Licence No and<br>Date	3411000952/02/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Dec/202223/17 dated13/01/2023 against advance authorization No.<br>3411000793dt.22/07/2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Phenol<br>1 kg<br>1<br>Propylene<br>0.329 kg<br>RA concerned may take further necessary action as per above decision of NC.

less: Export product Qty. Sl. No. Import items Qty. Phenol 1 kg 1 Propylene 0.329 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	35 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	KRUNAL INDUSTRIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00301989AM22
RA File Number	08AX04000162 AM22
Licence No and<br>Date	0811003592/30/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	36 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

UDIN00366605AM23

a	nd Date
H	Q File Number	HQRNORM APPLY 003		15825AM22
R	A File Number	09AX04000108 AM22
L<br>D	icence No and<br>ate
		0911002281/12/01/2022
N<br>T<br>a	orms Committee Decision:<br>he Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I<br>s per details given below or as applied by the firm, whichever is less:			enda and it wa		s decided	to ratif norms under Para 40	of HBP Vol I


	Export product		Qty.		Sl.

br>s per details given below or as applied by the firm, whichever is less:|||enda and it wa||s decided||to ratif norms under Para 40|of HBP Vol I| ||||||||||| ||||||||||| ||Export product||Qty.||Sl. No.||Import items||Qty.| ||||||||||| ||||||||||| ||AMOXYCILLIN CLAVULANAT| AND E POTASSIUM| 1 Number||1||6-Amino penicillanic acid||581.77 mg| ||TABLETS 100|0 MG (Each tablet|||||(6-APA)||| ||contains am |oxicillin Trihydrate | ||||||| ||||||||||| ||equivalent to A Clauvalanate Po |moxycillin 875 mg and ttasium equivalent to | ||2||D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester]||502.40 mg| ||Clauvanic Acid 125 mg)||||||||| ||||||3||Penicillin G Amidase||2.25 mg| ||||||4||Diluted Clavulanate Potassium (1:1) / Potassium Clavulanate Diluted with Microcrystalline Cellulose (1:1)|| 303.773 mg| ||||||||||| ||||||||||| ||||||||||| |RA concerned ma||take further necessary action as per above decision of NC|||||||| |||.|||||||| ||||||||||| ||||||||||| ||||||||||| ||||||||||| |Case No.||37 / NC/3/MEET/Feb/202223/20|||||||| ||||||||||| |Case Status||Case Approved|||||||| |Party Name||VISWAAT CHEMICALS LIMITED|||||||| |Meeting Number and Date||NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023|||||||| |HQ File Number||HQRNORM APPLY 00318314AM22|||||||| |RA File Number||03AX04000704 AM22|||||||| |Licence No and|||||||||| |Date||0311010518/14/01/2022|||||||| |Norms Committee||Decision:|||||||| |||||||||||

Number||HQRNORM APPLY 00318314AM22|||||||| |RA File Number||03AX04000704 AM22|||||||| |Licence No and|||||||||| |Date||0311010518/14/01/2022|||||||| |Norms Committee||Decision:|||||||| |||||||||||

Case No.	37 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	VISWAAT CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00318314AM22
RA File Number	03AX04000704 AM22
Licence No and<br>Date	0311010518/14/01/2022
Norms Committee Decision:

UDIN00366605AM23

The Committee considered the case as per agenda and it was decided to ratify 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.
VICASOL-MV-07<br>[POLYOXYPROPYLENE MIXED<br>TERPENES AND TERPENOIDS<br>ETHER]	<br> <br>600 MT	1	MIXED TERPENES AND TERPENOIDS<br>IN AROMATIC SOLVENT [AS/01/31]<br>(Mixed Terpene & Terpenoids – 30% and<br>solvent 70%)	<br> <br> <br>226.7 MT
		2	PROPYLENE OXIDE	376.3 MT

]| 600 MT|1|MIXED TERPENES AND TERPENOIDS IN AROMATIC SOLVENT [AS/01/31] (Mixed Terpene & Terpenoids – 30% and solvent 70%)| 226.7 MT| |||2|PROPYLENE OXIDE|376.3 MT|

Case No.	Case No.	38 / NC/3/MEET/Feb/202223/20	38 / NC/3/MEET/Feb/202223/20	38 / NC/3/MEET/Feb/202223/20	38 / NC/3/MEET/Feb/202223/20	38 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00320688AM22
RA File Number		31AX04000045 AM22
Licence No and<br>Date		3111000884/17/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08/07/2022 against advance authorization No.<br>3111000308 dt. 05/05/2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Cyclohexylamine (CHA)<br>1.41 kg<br>2<br>Methanol<br>0.08 kg<br>1,3-Dicyclo Hexyl Carbodimide (DCC)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	1,3-Dicyclo Hexyl Carbodimide (DCC)		1 kg	1	Cyclohexylamine (CHA)	1.41 kg
				2	Methanol	0.08 kg

UDIN00366605AM23

	3	Phosphorus Qxy Chloride	1.49	kg
	4	Ammonia	0.72	kg

Hexyl Carbodimide (DCC)||1 kg|1|Cyclohexylamine (CHA)|1.41 kg| |||||2|Methanol|0.08 kg|

UDIN00366605AM23

	3	Phosphorus Qxy Chloride	1.49	kg
	4	Ammonia	0.72	kg

Case No.	39 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00323538AM22
RA File Number	09AX04000097 AM22
Licence No and<br>Date	0911002338/19/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify 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>6 Amino Penicillanic Acid<br>166.22 mg<br>2<br>D-(-)-4-hydroxyphenylglycine<br>methyl<br>Ester [PHPG Ester]<br>143.54 mg<br>Amoxicillin<br>and<br>Clavulanate<br>Potassium<br>Tablets<br>375<br>mg((Each<br>tablet<br>contains<br>Amoxicillin<br>Trihydrate<br>equivalent<br>to<br>Amoxycillin<br>250<br>mg<br>and<br>Calvulanate<br>Potassium equivalent to Clavulanic Acid 125<br>mg))<br>1 Number<br>3<br>Diluted Clavulanate Potassium (1:1)/<br>potassium clavulanate diluted with<br>Microcrystalline cellulose (1 :1)<br>303.773 mg<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00366605AM23

/ potassium clavulanate diluted with Microcrystalline cellulose (1 :1) 303.773 mg RA concerned may take further necessary action as per above decision of NC.||

UDIN00366605AM23


Case No.		40 / NC/3/MEET/Feb/202223/20
Case Status		Case Deferred

Party Name		AUROBINDO PHARMA LTD

Meeting Number<br>		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
and Date

HQ File Number		HQRNORM APPLY 00326841AM22

RA File Number		09AA04016329 AM22
Licence No and<br>		0911002348/21/01/2022
Date

Norms Committee		ecision:
Deferred for comm		ents of TE.

Case No.	Case No.	41 / NC/3/MEET/Feb/202223/20	41 / NC/3/MEET/Feb/202223/20	41 / NC/3/MEET/Feb/202223/20	41 / NC/3/MEET/Feb/202223/20	41 / NC/3/MEET/Feb/202223/20

Case Status		Case Approved

Party Name		BEST VALUE CHEM PRIVATE LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

HQ File Number		HQRNORM APPLY 00343056AM22

RA File Number		34AX04000212 AM22

Licence No and<br>Date		3411001750/04/02/2022

Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.1/82-ALC4/2018 dated 01/05/2018 against advance authorization No.3410043482 dt.

r agenda and taking cue from earlier decision for same export product / import item in Meeting No.1/82-ALC4/2018 dated 01/05/2018 against advance authorization No.3410043482 dt.||||||| |18/09/2017, it was decided to ratify norms under Para||||4.07 of HBP Vol. I as per details given below or as applied by||| |the firm, whicheve||r is less:||||| |||||||| |||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| |||||||| |||||||| ||Undecavertol|(Kakdinol)((4-Methyl-3-|1 kg|1|Propionaldehyde|0.842 kg| ||decen- 5-ol))|||||| |||||||| |||||2|1-Pentanol / N Amyl Alcohol|0.639 kg| |||||3|Magnesium Turning|0.142 kg| ||||||||

Case No.	41 / NC/3/MEET/Feb/202223/20	41 / NC/3/MEET/Feb/202223/20

Case Status	Case Approved

Party Name	BEST VALUE CHEM PRIVATE LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

HQ File Number	HQRNORM APPLY 00343056AM22

RA File Number	34AX04000212 AM22

Licence No and<br>Date	3411001750/04/02/2022

Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.1/82-ALC4/2018 dated 01/05/2018 against advance authorization No.3410043482 dt.
18/09/2017, it was decided to ratify norms under Para		4.07 of HBP Vol.

rt item in Meeting No.1/82-ALC4/2018 dated 01/05/2018 against advance authorization No.3410043482 dt.||||||| |18/09/2017, it was decided to ratify norms under Para||||4.07 of HBP Vol. I as per details given below or as applied by||| |the firm, whicheve||r is less:||||| |||||||| |||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| |||||||| |||||||| ||Undecavertol|(Kakdinol)((4-Methyl-3-|1 kg|1|Propionaldehyde|0.842 kg| ||decen- 5-ol))|||||| |||||||| |||||2|1-Pentanol / N Amyl Alcohol|0.639 kg| |||||3|Magnesium Turning|0.142 kg| ||||||||

UDIN00366605AM23

Case No.	42 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00343395AM22
RA File Number	03AX04001061 AM22
Licence No and<br>Date	0311011086/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete Chemistry giving molecular weight of both reactants and product with calculation indicating<br>full chemical name of Export Product PDSH.<br>i.<br>Yield of the reactant.<br>ii.<br>Justification for low yield, if any.<br>iii.

actants and product with calculation indicating** full chemical name of Export Product PDSH. i. Yield of the reactant. ii. Justification for low yield, if any. iii.||

Case No.	43 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00343443AM22
RA File Number	03AX04000895 AM22
Licence No and<br>Date	0311011115/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:

26 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

UDIN00366605AM23

Export product	Qty.	Sl. No. Import items	Qty.
5'-ODMT-2'-Fluoro Uridine (Solid)	1 kg	1<br>2'-Fluoro-2'-Deoxyuridine	0.587 kg

RA may take appropriate action as per the decision of Norms Committee.

. No. Import items|Qty.| |---|---|---|---| |5'-ODMT-2'-Fluoro Uridine (Solid)|1 kg|1 2'-Fluoro-2'-Deoxyuridine|0.587 kg|

RA may take appropriate action as per the decision of Norms Committee.

Case No.	44 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00343444AM22
RA File Number	03AX04000893 AM22
Licence No and<br>Date	0311011116/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify 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>5'-ODMT-NAc-2'-Fluoro Cytidine (Solid)<br>1 kg<br>1<br>2'-Fluoro-2'-Deoxyuridine<br>0.900 kg<br>RA may take appropriate action as per the decision of Norms Committee.

Case No.	45 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00343445AM22

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RA File Number

03AX04000892 AM22

Licence No and Date

0311011117/04/02/2022

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify 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. 5'-ODMT N-Bz 2'-Fluoro Adenosine (Solid) 1 kg 1 2'-DEOXY 2'-FLUOROADENOSINE 0.490 kg RA may take appropriate action as per the decision of Norms Committee.

Case No.	Case No.	46 / NC/3/MEET/Feb/202223/20	46 / NC/3/MEET/Feb/202223/20	46 / NC/3/MEET/Feb/202223/20	46 / NC/3/MEET/Feb/202223/20	46 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00343548AM22
RA File Number		31AX04000047 AM22
Licence No and<br>Date		3111000999/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08/07/2022 against advance authorization No.<br>3111000308 dt. 05/05/2021, it was decided to ratify norms under Para 4.07 of HBP Vol.

br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08/07/2022 against advance authorization No. 3111000308 dt. 05/05/2021, it was decided to ratify 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 Cyclohexylamine (CHA) 1.41 kg 2 Methanol 0.08 kg 1,3-Dicyclo Hexyl Carbodimide (DCC) 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||1,3-Dicyclo Hexyl Carbodimide (DCC)||1 kg|1|Cyclohexylamine (CHA)|1.41 kg| |||||2|Methanol|0.08 kg|

UDIN00366605AM23

	3	Phosphorus Qxy Chloride	1.49	kg
	4	Ammonia	0.72	kg

Case No.	47 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00345730AM22
RA File Number	03AX04000898 AM22
Licence No and<br>Date	0311011149/07/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify 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>5'-ODMT NiBu 2'-Fluoro Guanosine<br>(Solid)<br>1 kg<br>1<br>2'-DEOXY 2'-FLUOROGUANOSINE<br>0.638 kg<br>RA may take appropriate action as per the decision of Norms Committee.

ort items Qty. 5'-ODMT NiBu 2'-Fluoro Guanosine (Solid) 1 kg 1 2'-DEOXY 2'-FLUOROGUANOSINE 0.638 kg RA may take appropriate action as per the decision of Norms Committee.||

Case No.	48 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	VENKATA NARAYANA ACTIVE INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

UDIN00366605AM23

HQ File Number	HQRNORM APPLY 00348986AM22
RA File Number	04AX04000023 AM22
Licence No and<br>Date	0411002608/09/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm to attendPersonal Hearing<br>before Norms Committee to explain its case alongwith following documents / information:<br>The firm has shown Export Quantity in Kgs Activity without showing its Assay / Potency in the<br>manufacturing process.<br>i.<br>Similarly, all import quantities are in KG Activity including that of Solvents.<br>ii.<br>All details and even the CA Certificate on Production / Consumption data is given in Kgs. Please clarify it.<br>iii.

Case No.	49 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	GANGWAL HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00356909AM22
RA File Number	03AX04001205 AM22
Licence No and<br>Date	0311011422/16/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/02/2023| |HQ File Number|HQRNORM APPLY 00356909AM22| |RA File Number|03AX04001205 AM22| |Licence No and Date|0311011422/16/02/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	50 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00390551AM22
RA File Number	03AX04001792 AM22
Licence No and<br>Date	0311013033/17/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /

UDIN00366605AM23

import item in Meeting No. NC/3/MEET/Jan/202021/4 dated 12/02/2021 against advance authorization No. 0310838661 dt. 05/10/2020 , it was decided to ratify 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.
DEXTRINOL	1 kg	1	CROTONIC ACID	0.849 kg
		2	BUTADIENE	0.629 kg

Case No.	51 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00401252AM22
RA File Number	03AX04001906 AM22
Licence No and<br>Date	0311013320/25/03/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/02/2023| |HQ File Number|HQRNORM APPLY 00401252AM22| |RA File Number|03AX04001906 AM22| |Licence No and Date|0311013320/25/03/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	52 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00408410AM22
RA File Number	56AX04000134 AM22
Licence No and<br>Date	5611000874/30/03/2022

UDIN00366605AM23

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to call the firm to attend Personal Hearing before Norms Committee to explain its case alongwith following documents / information:

(i) Complete specification and COA of import item from foreign supplier.

(ii) Point out the difference in specification of import and export.

(iii) Production / Consumption data for last two years duly certified by GST.

Case No.	53 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00408949AM22
RA File Number	52AX04000101 AM22
Licence No and<br>Date	5211002273/30/03/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/02/2023| |HQ File Number|HQRNORM APPLY 00408949AM22| |RA File Number|52AX04000101 AM22| |Licence No and Date|5211002273/30/03/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	54 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00409480AM22
RA File Number	34AX04000458 AM22
Licence No and<br>Date	3411002061/31/03/2022
Norms Committee Decision:<br>Deferred for comments of TE.

32 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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Case No.	Case No.	55 / NC/3/MEET/Feb/202223/20	55 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

HQ	File Number	HQRNORM APPLY 00410	005AM22
RA	File Number	09AX04000194 AM22
Lic<br>Dat	ence No and<br>e	0911002814/31/03/2022

||||||||||| |HQ||File Number|HQRNORM APPLY 00410|||005AM22|||||||||| |RA||File Number|09AX04000194 AM22||||||||||||| |Lic Dat||ence No and e|0911002814/31/03/2022||||||||||||| ||||||||||||||||| |N T |or h|ms Committee Decision: Committee considered the case as er a|||en|da and|it was d||ecided t||ratif norms under Para 407||of||HBP Vol I as| ||p per details given below or as applied by the|p details given below or as applied by the||| fir| m, whi| chever i|| s less:||y .||||.| ||||||||||||||||| ||Export product|||Q|ty.|||l||i|||||| |||||||||S.|o.|Import tems||||Qty.|| ||||||||||||||||| ||AMOXYCILLIN AND||| 1|Number|||1||6-APA||||58177 m|| || CLAVULANAT|| E POTASSIUM| ||||||||||. g|| ||TABLETS 100||0 MG (Each tablet||||||||||||| ||contains amo||xicillin Trihydrate|||||2||D-(-)-4-hydroxyphenylglycine hl PHPG E||||502.40 mg|| ||equivalent to Am||oxycillin 875 mg and|||||||mety ester [ ster]|||||| ||Clauvalanate Po||ttasium equivalent to||||||||||||| ||||||||||||||||| ||||||||||||||||| ||Clauvanic Acid||25 mg)|||||3||Penicillin G Amidase (Particl||e size|| 2.25 mg|| ||||||||||||||| || |||||||||||250 - 500 micron, Creami||sh to|||| ||||||||||||||||| |||||||||||Brown regularly shaped beads||)|||| ||||||||||||||||| ||||||||||||||||| |||||||||4||Diluted Clavulanate Pot||ssium|| 303773 m|| ||||||||||| (1:1) / Potassium Clavu|| lanate|| .

ped beads||)|||| ||||||||||||||||| ||||||||||||||||| |||||||||4||Diluted Clavulanate Pot||ssium|| 303773 m|| ||||||||||| (1:1) / Potassium Clavu|| lanate|| . g|| ||||||||||| Diluted with Microcrys|||||| |||||||||||||talline|||| |||||||||||Cellulose (1:1)|||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| |Case No.|||56 / NC/3/MEET/Feb/202223/20||||||||||||| |Case Status|||Case Deferred||||||||||||| |Party Name|||AUROBINDO PHARMA LTD||||||||||||| |Meeting Number|||||||||||||||| | and Date|||NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023||||||||||||| |HQ File Number|||HQRNORM APPLY 00410013AM22|||||||||||||

Case No.	56 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00410013AM22

UDIN00366605AM23

RA File Number	09AX04000193 AM22
Licence No and<br>Date	0911002816/31/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Y 00410013AM22|

UDIN00366605AM23

RA File Number	09AX04000193 AM22
Licence No and<br>Date	0911002816/31/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>57 / NC/3/MEET/Feb/202223/20	Case No.<br>57 / NC/3/MEET/Feb/202223/20
Case Status<br>Case Approved
Party Name<br>OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number<br>HQRNORM APPLY 00000064AM23
RA File Number<br>09AX04000330 AM22
Licence No and Date<br>0911002827/05/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07		of HBP Vol. I
as	per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.<br>Sl. No. Import items		Qty.
	1<br>(4-(Phenylthio)Phenyl)Methanol<br>FENTICONAZOLE NITRATE<br>1 kg		0.526 kg
	2<br>1-(2,4-Dichlorophenyl)-2-(1H-Imidazol-		0.680 kg
	1-yl)Ethanol (or) SM-01
RA may take appropriate action as per the decision of Norms Committee.

Case No.	58 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000150AM23

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RA File Number	03AX04000018 AM23
Licence No and<br>Date	0311013747/08/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify 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.
TRI POTASSIUM CITRATE (PURE)		1 MT	1	Citric Acid Anhydrous	0.604 kg
			2	Potassium Carbonate	0.65 kg
RA may take appropriate action as per the decision of Norms Committee.

Case No.	59 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	SUNSHIELD CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000186AM23
RA File Number	03AX04000112 AM23
Licence No and<br>Date	0311013797/11/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Molecular<br>i.	weight of raw material and finished product.
Percentage yield of reaction.<br>ii.

Case No. 60 / NC/3/MEET/Feb/202223/20

UDIN00366605AM23

from the firm:|| |Molecular i.|weight of raw material and finished product.| |Percentage yield of reaction. ii.||

Case No. 60 / NC/3/MEET/Feb/202223/20

UDIN00366605AM23

Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00000199AM23
RA File Number		09AX04000304 AM22
Licence No and<br>Date		0911002851/12/04/2022
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/202223/17 dated13/01/2023against advance authorization No.<br>0911002118dt.21/12/2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.

0911002118dt.21/12/2021, it was decided to ratify 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 Methyl L-pyroglutamate 2.70 kg 2 Triethyl amine 2.27 kg 3 2,5-Norbornadiene 1.73 kg 4 Chloro sulfonyl isocyanate 2.778 kg 5 Isopropyl alcohol 4.02 kg 6 Methyl tert butyl ether 5.91 kg 7 Toluene 5.72 Litre 8 Ethyl acetate 2.95 Litre 9 N-Heptane 1.82 kg 10 Ethyl benzene 1.00 kg 11 Methanol 1.50 kg sodium (S)-4-oxo-4,6,7,8- tetrahydropyrrolo [1,2-a]pyrimidine-6- carboxylate((Pyrimidinone acid, sodium salt)) 1 kg 12 Methylene chloride 3.25 Litre||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||sodium (S)-4-oxo-4,6,7,8- tetrahydropyrrolo [1,2-a]pyrimidine-6- carboxylate((Pyrimidinone acid, sodium salt))|| 1 kg|1|Methyl L-pyroglutamate|2.70 kg| |||||2|Triethyl amine|2.27 kg| |||||3|2,5-Norbornadiene|1.73 kg| |||||4|Chloro sulfonyl isocyanate|2.778 kg| |||||5|Isopropyl alcohol|4.02 kg| |||||6|Methyl tert butyl ether|5.91 kg| |||||7|Toluene|5.72 Litre| |||||8|Ethyl acetate|2.95 Litre| |||||9|N-Heptane|1.82 kg| |||||10|Ethyl benzene|1.00 kg| |||||11|Methanol|1.50 kg| |||||12|Methylene chloride|3.25 Litre|

UDIN00366605AM23

ene|5.72 Litre| |||||8|Ethyl acetate|2.95 Litre| |||||9|N-Heptane|1.82 kg| |||||10|Ethyl benzene|1.00 kg| |||||11|Methanol|1.50 kg| |||||12|Methylene chloride|3.25 Litre|

UDIN00366605AM23

Case No.	61 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000256AM23
RA File Number	09AX04000404 AM22
Licence No and<br>Date	0911002859/18/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	62 / NC/3/MEET/Feb/202223/20	62 / NC/3/MEET/Feb/202223/20	62 / NC/3/MEET/Feb/202223/20	62 / NC/3/MEET/Feb/202223/20	62 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		ANUH PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00000257AM23
RA File Number		03AX04001828 AM22
Licence No and<br>Date		0311013920/18/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify 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>Prednisolone Acetate IP/BP/USP/EP<br>1 kg<br>1<br>Prednisolone IP/BP/USP/EP<br>0.90 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Prednisolone Acetate IP/BP/USP/EP		1 kg	1	Prednisolone IP/BP/USP/EP	0.90 kg

1 Prednisolone IP/BP/USP/EP 0.90 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Prednisolone Acetate IP/BP/USP/EP||1 kg|1|Prednisolone IP/BP/USP/EP|0.90 kg| ||||||||

UDIN00366605AM23

Case No.	63 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000274AM23
RA File Number	30AX04000006 AM23
Licence No and<br>Date	3011002023/18/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify 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>KETOPROFEN<br>1.00 kg<br>2<br>N OCTYL D GLUCAMINE<br>0.36 kg<br>DEXKETOPROFEN TROMETAMOL<br>1 kg<br>3<br>TRIS<br>AMINO<br>BUFFER<br>TROMETHAMINE<br>0.36 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	64 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	MITHILA RASAYAN PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000290AM23
RA File Number	03AX04000086 AM23

UDIN00366605AM23

Licence No and 0311013960/19/04/2022 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:

Licence No and 0311013960/19/04/2022 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. Percentage of Zinc Diacrylate in Export Product.
ii. How the export is modified

iii. The name of Modifying Agent and its content in export.

Case No.	65 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	AMANTA HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000291AM23
RA File Number	08AX04000760 AM22
Licence No and<br>Date	0811004729/19/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08/07/2022 against advance authorization No.<br>0811001728dt.14/06/2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>SODIUM HYALURONATE EYE DROPS<br>0.2 W/V (XAILIN HA / XILIN HA / 1A1<br>AQAEYE HA / OPTAVID ADVANCED<br>EYE DROPS)((EACH 10ML EYE DROPS<br>CONTAINING<br>SODIUM<br>HYALURONATE 20MG + WASTAGE<br>29.81 PERCENTAGE = 25.961 MG))<br>1 Number<br>1<br>SODIUM HYALURONATE<br>20 mg /<br>Vial<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00366605AM23

r>29.81 PERCENTAGE = 25.961 MG)) 1 Number 1 SODIUM HYALURONATE 20 mg / Vial RA concerned may take further necessary action as per above decision of NC.||

UDIN00366605AM23

Case No.	66 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000298AM23
RA File Number	03AX04002053 AM22
Licence No and<br>Date	0311013980/19/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>67 / NC/3/MEET/Feb/202223/20
Case Status<br>Case Approved
Party Name<br>YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number<br>HQRNORM APPLY 00000374AM23
RA File Number<br>03AX04000319 AM23
Licence No and<br>Date<br>0311014080/22/04/2022
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/Apr/202223/1 dated 29/04/2022 against advance authorization No.
0310834867 dt. 14/02/2020, it was decided to ratify 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.

0834867 dt. 14/02/2020**, it was decided to ratify 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.|| |HYDROQUINONE BIS (2 Hydroxy 1 kg|1|HYDROQUINONE|0.579 kg|| |Ethyl Ether) (YAPOX LM 30/10)||||| ||2|ETHYLENE CARBONATE|0.934 kg|| |RA concerned may take further necessary action as per above decision of NC.|||||

UDIN00366605AM23

Case No.	68 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000403AM23
RA File Number	31AX04000003 AM23
Licence No and<br>Date	3111001301/25/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08/07/2022 against advance authorization No.<br>3111000308 dt. 05/05/2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Cyclohexylamine (CHA)<br>1.41 kg<br>2<br>Methanol<br>0.08 kg<br>3<br>Phosphorus Qxy Chloride<br>1.49 kg<br>1,3-Dicyclo Hexyl Carbodimide (DCC)<br>1 kg<br>4<br>Ammonia<br>0.72 kg<br>RA concerned may take further necessary action as per above decision of NC.

r>3 Phosphorus Qxy Chloride 1.49 kg 1,3-Dicyclo Hexyl Carbodimide (DCC) 1 kg 4 Ammonia 0.72 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	69 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000432AM23

UDIN00366605AM23

RA File Number

09AX04000029 AM23

Licence No and Date

0911002905/26/04/2022

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify 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 5-(2-Fluorophenyl)-1H-Pyrrole-3-Carbaldehyde 0.757 kg 2 3-Pyridinesulfonyl Chloride 0.856 kg 3 Acetonitrile 1.00 kg 4 Methanol 2.80 kg Vonoprazan Fumarate 1 kg 5 Acetone 3.29 kg RA may take appropriate action as per the decision of Norms Committee.

Case No.	70 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000438AM23
RA File Number	03AX04001990 AM22
Licence No and<br>Date	0311014190/26/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

UDIN00366605AM23

|HQRNORM APPLY 00000438AM23| |RA File Number|03AX04001990 AM22| |Licence No and Date|0311014190/26/04/2022| |Norms Committee Decision: Deferred for comments of TE.||

UDIN00366605AM23

Case No.	71 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	UNITED BIOCEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000479AM23
RA File Number	05AX04000238 AM23
Licence No and<br>Date	0511012150/28/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	72 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000485AM23
RA File Number	03AX04000399 AM23
Licence No and<br>Date	0311014263/29/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	73 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	GRANULES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000531AM23
RA File Number	26AX04000006 AM23
Licence No and<br>Date	2611000569/02/05/2022
Norms Committee Decision:

43 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

UDIN00366605AM23

|Licence No and Date|2611000569/02/05/2022| |Norms Committee Decision:||

43 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

UDIN00366605AM23

The Committee considered the case as per agenda and it was decided to ratify 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.
Tamoxifen<br>20	mg	<br>1 Number	1	Tamoxifen citrate	30.4 mg
(Tamoxifen 20 mg	(Each
uncoated tablets contains:
Tamoxifen	Citrate		2	Calcium hydrogen phosphate dihydrate	281.6 mg
Equivalent to Tamoxifen 20
mg)			3	Povidone K 25	8.00 mg
			4	Sodium starch glycolate, type A	20.00 mg
			5	Mangnesium stearate	5.00 mg
			6	Cellulose, microcrystalline	33.00 mg
			7	Silica, colloidal anhydrous	2.00 mg

RA may take appropriate action as per the decision of Norms Committee.

| ||||5|Mangnesium stearate|5.00 mg| ||||6|Cellulose, microcrystalline|33.00 mg| ||||7|Silica, colloidal anhydrous|2.00 mg|

RA may take appropriate action as per the decision of Norms Committee.

Case No.	74 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	SHREYANS CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000593AM23
RA File Number	03AX04000546 AM23
Licence No and<br>Date	0311014500/05/05/2022
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/Jun/202223/5 dated 08/07/2022against advance authorization No.
0311000702dt.06/01/2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or
as applied by the firm, whichever is less:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Jun/202223/5 dated 08/07/2022 against advance authorization No. 0311000702 dt. 06/01/2021 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

UDIN00366605AM23

Export product	Qty.	Sl. No.	Import items	Qty.
Ethyl Chloro Acetate (CAS- 105-39-5)<br>(Purity Min. 99.70%)	1 kg	1	Mono Chloro Acetic Acid<br>(CAS- 79-11-8)	1.22 kg

M23

Export product	Qty.	Sl. No.	Import items	Qty.
Ethyl Chloro Acetate (CAS- 105-39-5)<br>(Purity Min. 99.70%)	1 kg	1	Mono Chloro Acetic Acid<br>(CAS- 79-11-8)	1.22 kg

Case No.	75 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000633AM23
RA File Number	07AX04000046 AM23
Licence No and<br>Date	0711003906/06/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>As per COA report, the Assay of Technical grade (import) is 99.9% and assay of Pure grade is 99.5%,<br>please clarify it.<br>i.<br>Production / Consumption data certified by GST for the export product L-ORNITHINE-L-<br>ASPARTATE (Pure-pharma) having import item L-ORNITHINE-L-ASPARTATE (TECHNICAL<br>GRADE).<br>ii.

i. As per COA report, the Assay of Technical grade (import) is 99.9% and assay of Pure grade is 99.5%, please clarify it.

Case No.	76 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000708AM23

UDIN00366605AM23

RA File Number	26AX04000007 AM23
Licence No and<br>Date	2611000574/11/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Y 00000708AM23|

UDIN00366605AM23

RA File Number	26AX04000007 AM23
Licence No and<br>Date	2611000574/11/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	77 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000711AM23
RA File Number	31AX04000042 AM23
Licence No and<br>Date	3111001345/11/05/2022
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 09/09/2022 against advance authorization No.<br>3111000964 dt. 08/02/2022, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Phenol<br>0.90 kg<br>Anisole<br>1 kg<br>2<br>Methanol<br>0.350 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	78 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

UDIN00366605AM23

o.	78 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

UDIN00366605AM23

and Date	and Date
HQ File Number		HQRNORM APPLY 00000715AM23
RA	File Number	03AX04000356 AM23
Lic<br>Dat	ence No and<br>e	0311014646/11/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete Chemistry giving molecular weight of both reactants and product with calculation indicating<br>full chemical name of Export Product PDSH..<br>i.<br>Yield of the reactant.<br>ii.<br>Justification for low yield, if any.<br>iii.	ms Committee Decision:<br>Committee considered the case as per<br>m the firm:<br>Complete Chemistry giving mole<br>full chemical name of Export Pro<br>i.		agenda and i<br>cular weight<br>duct PDSH..	t was decided	to call for following infor	mation / documents

				of both reac	tants and product with ca	lculation indicating

Case No.	79 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000716AM23
RA File Number	52AX04000029 AM23
Licence No and<br>Date	5211002458/11/05/2022
Norms Committee Decision:
Deferred for comments of TE.

/02/2023| |HQ File Number|HQRNORM APPLY 00000716AM23| |RA File Number|52AX04000029 AM23| |Licence No and Date|5211002458/11/05/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	80 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000720AM23
RA File Number	08AX04000212 AM23
Licence No and<br>Date	0811004914/11/05/2022
Norms Committee Decision:

47 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

UDIN00366605AM23

he Committee considered the case as per agenda and it was decided to ratify norms under	he Committee considered the case as per agenda and it was decided to ratify norms under	he Committee considered the case as per agenda and it was decided to ratify norms under	he Committee considered the case as per agenda and it was decided to ratify norms under	he Committee considered the case as per agenda and it was decided to ratify norms under	Para 4.07 of HBP Vol. I	Para 4.07 of HBP Vol. I
per details given	below or as applied by the firm, whichever is less:
Export product		Qty.	Sl. No.	Import items		Qty.
ORPHENADRINE	CITRATE INJECTION	<br>1 Number	1	ORPHENADRINE	CITRATE	<br>66.00 mg
USP<br>30MG/ML	(2ML<br>VIAL)((ACTIVE			USP
INGREDIENT: ORPHENADRINE CITRATE
USP - NET WT.

ems||Qty.|| |ORPHENADRINE|CITRATE INJECTION| 1 Number|1|ORPHENADRINE|CITRATE| 66.00 mg|| |USP 30MG/ML|(2ML VIAL)((ACTIVE|||USP|||| |INGREDIENT: ORPHENADRINE CITRATE|||||||| |USP - NET WT. 18.000 KGS.))|||||||| ||||2|2 ML AMBER USP TYPE-I|| Relevant as per|| |||||TUBULAR GLASS VIAL||packing|| ||||3|13 MM RFS BROMOBUTYL|| Relevant as per|| |||||OMNIFLEX PLUS|COATED| packing|| |||||RUBBER STOPPER|||| |A may take appropriate action as per the decision||of Norms Committee.||||||

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

RA may take appropriate action as per the decision of Norms Committee.

Case No.	81 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000727AM23
RA File Number	03AX04000667 AM23
Licence No and<br>Date	0311014663/12/05/2022
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.2/82-ALC4/2018 dated 16/05/2018against advance authorization No.0310812137 dt.
27/03/2017, it was	decided to ratify norms under Para 4.07 of		HBP Vol.

port item in Meeting No.2/82-ALC4/2018 dated 16/05/2018against advance authorization No.0310812137 dt.||||||| |27/03/2017, it was||decided to ratify norms under Para 4.07 of||HBP Vol. I as per details given below or as applied by||| |the firm, whichever is less:||||||| ||Export product|Qty.|Sl.|Import items|Qty.|| ||||No.||||

UDIN00366605AM23

1<br>DIPHENYLAMINE<br>0.447 kg<br>2<br>ALPHA METHYL STYRENE<br>1.230 kg<br>AROMATIC DERIVATIVE OF<br>DIPHENYLAMINE (ADA)<br>1 kg<br>3<br>ACTIVATED CLAY<br>0.150 kg<br>RA concerned may take further necessary action as per above decision of NC.	AROMATIC DERIVATIVE OF<br>DIPHENYLAMINE (ADA)	1 kg	1	DIPHENYLAMINE	0.447 kg
			2	ALPHA METHYL STYRENE	1.230 kg
			3	ACTIVATED CLAY	0.150 kg

Case No.	82 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000750AM23
RA File Number	34AX04000127 AM23
Licence No and<br>Date	3411002246/13/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	83 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000753AM23
RA File Number	52AX04000039 AM23
Licence No and<br>Date	5211002485/13/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

UDIN00366605AM23

|HQRNORM APPLY 00000753AM23| |RA File Number|52AX04000039 AM23| |Licence No and Date|5211002485/13/05/2022| |Norms Committee Decision: Deferred for comments of TE.||

UDIN00366605AM23


Cas		e No.	84 / NC/3/MEET/Feb/202223/20
Cas		e Status	Case Approved
Part		y Name	ETERNIS FINE CHEMICALS LIM			ITED
Meeting Number<br>and Date
			NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number			HQRNORM APPLY 00000797AM23
RA File Number			03AX04000463 AM23
Licence No and<br>Date			0311014744/17/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and tak<br>import item in Meeting No.NC/3/MEET/Jan/202223/18<br>0310838453 dt. 24/09/2020, it was decided to ratify norms<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>1<br>2<br>3<br><br>COUMARIN<br>1 kg	orms Committee Decision:<br>he Committee considered the case as pe			r agenda	and tak		ing cue from earlier decision for same ex	port product /
	mport item in Meeting No.NC/3/MEE<br>310838453 dt. 24/09/2020, it was decide<br>r as applied by the firm, whichever is less<br>Export product<br>Qty<br>COUMARIN<br>1 k			T/Jan/2<br>d to ratify<br>:	02223/18<br>norms		dated 23/01/2023 against advance auth<br>under Para 4.07 of HBP Vol.

irm, whichever is less Export product Qty COUMARIN 1 k|||||T/Jan/2 d to ratify :||02223/18 norms||dated 23/01/2023 against advance auth under Para 4.07 of HBP Vol. I as per detail|||||orization No. s given below| ||||||||||||||||| ||||||||||||||||| |||Export product|||Qty|.|S|l. No.||Import items|||Qty.||| ||||||||||||||||| |||COUMARIN|||1 k|g|1|||PHENOL|||1.15 k||g| ||||||||||||||||| ||||||||2|||XYLENE|||0.50 k||g| ||||||||||||||||| ||||||||3|||MAGNESIUM TURNINGS|||0.148 kg||| ||||||||||||||||| ||||||||4|||PARAFORMALDEHYDE|||0.9177 kg||| ||||||||||||||||| ||||||||||||||||| ||||||||5|||ACETIC ANHYDRIDE|||0.7356 kg||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| |RA concerned may||||take further necessary action a|||s per above decision of NC.||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| |Case No.||||85 / NC/3/MEET/Feb/202223/20|||||||||||| ||||||||||||||||| |Case Status||||Case Approved|||||||||||| ||||||||||||||||| |Party Name||||KUMAR ORGANIC PRODUCTS LIMITED|||||||||||| ||||||||||||||||| |Meeting Number d Dt||||NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023|||||||||||| |an ae||||||||||||||||

Case No.	85 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	KUMAR ORGANIC PRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

UDIN00366605AM23

T/Feb/202223/20| |---|---| |Case Status|Case Approved| |Party Name|KUMAR ORGANIC PRODUCTS LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023|

UDIN00366605AM23

HQ File Number<br>HQRNORM APPLY 00000865AM23
RA File Number<br>07AX04000056 AM23
Licence No and<br>Date<br>0711004017/19/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of	HBP Vol. I
as per details given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No. Import items	Qty.
ZINC PYRITHIONE (ASSAY 50%)<br>1 kg<br>1<br>2, CHLOROPYRIDINE ASSAY 99%	0.50 kg
RA may take appropriate action as per the decision of Norms Committee.

Case No.	86 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	METROPOLITAN EXIMCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000920AM23
RA File Number	03AX04000550 AM23
Licence No and<br>Date	0311014915/22/05/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	87 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00000937AM23
RA File Number	30AX04000065 AM23
Licence No and	3011002150/23/05/2022

UDIN00366605AM23

Date

Norms Committee Decision:

UDIN00366605AM23

Date

Norms Committee Decision:

The Committee considered the case as per agenda and on the basis of written comments furnished by Department of Biotechnology vide D.O. Letter No. PID-13011(15)/1/2021-PPB-DBT dated 02.01.2023 , it was decided to call for following information / documents from the firm:

i. Justification for claiming 20% wastage.
ii. Import input, that is, Urokinase in terms of IU/mg.
iii. DML (Drug Manufacturing Licnese).

Case No.	Case No.	88 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00000992AM23
RA File Number		09AX04000139 AM23
Licence No and<br>Date		0911003051/26/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para				4.07 of HBP Vol. I
as	per details given below or as applied by the firm, whichever is less:
	Export product	Qty.<br>Sl. No.	Import items		Qty.
	Obeticholic Acid<br>1 kg<br>1		(4R)-4-((3R,6R,10S,13R)-6-Ethyl-3-		1.47 kg
			Hydroxy-10,13-Dimethyl-7-
			Oxohexadecahydro-1H-Cyclopenta[a]
			Phenanthren-17-yl)Pentanoic acid
RA may take appropriate action as per the decision of Norms Committee.

||||Hydroxy-10,13-Dimethyl-7-|||| ||||Oxohexadecahydro-1H-Cyclopenta[a]|||| ||||Phenanthren-17-yl)Pentanoic acid|||| |RA may take appropriate action as per the decision of Norms Committee.|||||||

Case No. 89 / NC/3/MEET/Feb/202223/20

UDIN00366605AM23

Case Status	Case Approved
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001015AM23
RA File Number	03AX04000924 AM23
Licence No and<br>Date	0311015041/27/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking into 90% yield, it was decided to ratify norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>1-HEXANOL<br>0.763 kg<br>N-HEXYL BROMIDE<br>1 kg<br>2<br>HYDROBROMIC ACID 48%<br>1.260 kg<br>RA may take appropriate action as per the decision of Norms Committee.

. Import items Qty. 1 1-HEXANOL 0.763 kg N-HEXYL BROMIDE 1 kg 2 HYDROBROMIC ACID 48% 1.260 kg RA may take appropriate action as per the decision of Norms Committee.||

Case No.	90 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001065AM23
RA File Number	03AX04000506 AM23
Licence No and<br>Date	0311015097/30/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>To indicate the chemical name with details and catalogue of import item No. 5 - Marlon AS3.<br>i.<br>Indigenous items to use in the process and whether Acetic Acid is indigenously procured.<br>ii.<br>Production / Consumption data is Nil. Therefore to indicate whether the product is manufacturing for<br>iii.

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the first time.

Case No.	91 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001068AM23
RA File Number	03AX04000845 AM23
Licence No and<br>Date	0311015100/30/05/2022
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>0311006419 dt. 25/08/2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>2 4 DICHLORO BENZYL CHLORIDE<br>1.154 kg<br>2,4-DICHLOROBENZYL<br>CYANIDE<br>1 kg<br>2<br>SODIUM CYANIDE<br>0.286 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	92 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001082AM23
RA File Number	04AX04000075 AM23
Licence No and	0411003399/31/05/2022

UDIN00366605AM23

Date

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Mar/202122/16 dated 08/04/2022 against advance authorization No. 0410165628 dt. 18/05/2019 , it was decided to ratify 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.
4-(2-Aminoethyl)-2-methoxyphenol [AE<br>Phenol]	<br>1 kg	1	Vanillin<br>[4-<br>hydroxy-3-methoxy-<br>benzaldehyde]	1.124 kg
		2	Sodium Cyanide	0.416 kg
		3	Methyl Tetr Butyl Ether	0.25 kg
		4	Palladium Metal	0.000132 kg

Case No.	93 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATELIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001090AM23
RA File Number	09AX04000132 AM23
Licence No and<br>Date	0911003083/31/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

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|HQRNORM APPLY 00001090AM23| |RA File Number|09AX04000132 AM23| |Licence No and Date|0911003083/31/05/2022| |Norms Committee Decision: Deferred for comments of TE.||

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Cas	e No.	94 / NC/3/MEET/Fe	b/202223/20
Cas	e Status	Case Deferred
Part	Name	AMI ORGANICS L	IMITED
	y
Mee<br>and	ting Number<br>Date	NC/ 3/ MEET/ Feb/	202223/ 20 and 2	4/02/2023
HQ	File Number	HQRNORM APPL	Y 00001128AM2	3
RA	File Number	52AX04000054 AM	23
Lice<br>Date	nce No and<br>	5211002565/01/06/	2022
Norms Committee Decision:<br>Deferred for comments of TE.	ms Committee Decision:

Case No.<br>	95 / NC/3/MEET/Feb/202223/20
Case Status<br>	Case Approved
Party Name<br>	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number<br>	HQRNORM APPLY 00001144AM23
RA File Number<br>	03AX04000995 AM23
Licence No and<br>Date<br>	0311015188/02/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202122/8 dated 24/09/2021against advance authorization No.<br>0310834867 dt. 14-02-2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

834867 dt. 14-02-2020**, it was decided to ratify 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 HYDROQUINONE 0.579 kg HYDROQUINONE BIS (2 Hydroxy Ethyl Ether) YAPOX LM 30/10 1 kg 2 ETHYLENE CARBONATE 0.934 kg RA may take appropriate action as per the decision of Norms Committee.||

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Case No.	96 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	MITHILA RASAYAN PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001167AM23
RA File Number	03AX04001036 AM23
Licence No and<br>Date	0311015222/03/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Export Product is stated to be modified. Please explain what modification has been done in the Export<br>Molecules.<br>i.

call for following information / documents from the firm: Export Product is stated to be modified. Please explain what modification has been done in the Export Molecules. i.||

Case No.	97 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001173AM23
RA File Number	03AX04001017 AM23
Licence No and<br>Date	0311015227/03/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Percentage yield at every stage of reaction.<br>i.<br>Production / Consumption data duly certified by GST.<br>ii.

Case No.	98 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved

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Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001188AM23
RA File Number	03AX04001018 AM23
Licence No and<br>Date	0311015240/03/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking into 73% yield, it was decided to ratify norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

d taking into 73% yield, it was decided to ratify 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. Dimethyl-2-methyl glutarate (MGDM) 1 kg 1 2-methyl glutaronitrile Crude (Purity 86% to 87%) 0.85 kg RA may take appropriate action as per the decision of Norms Committee.||

Case No.	99 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001260AM23
RA File Number	05AX04000587 AM23
Licence No and<br>Date	0511013087/08/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm to attend<br>before Norms Committee to explain its case alongwith following documents / information:<br>Documentary evidence of import item and its quantity.<br>i.<br>DML.<br>ii.		Personal Hearing

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explain its case alongwith following documents / information: Documentary evidence of import item and its quantity. i. DML. ii.||Personal Hearing|

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Case No.	100 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001266AM23
RA File Number	03AX04001106 AM23
Licence No and<br>Date	0311015346/08/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>DIPHENYLAMINE<br>0.50 kg<br>2<br>DI-ISOBUTYLENE<br>0.64 kg<br>DI-OCTYLATED<br>DIPHENYLAMINE<br>(YALUB DODPA)<br>1 kg<br>3<br>ACTIVATED CLAY<br>0.10 kg<br>RA may take appropriate action as per the decision of Norms Committee

Case No.	101 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	MEGHMANI FINECHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001341AM23
RA File Number	34AX04000162 AM23
Licence No and<br>Date	3411002378/13/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents

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from the firm:

/06/2022| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents||

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from the firm:

i. Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.
ii. Percentage yield of reactant.

Case No.	102 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001347AM23
RA File Number	05AX04000669 AM23
Licence No and<br>Date	0511013173/13/06/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	103 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001355AM23
RA File Number	03AX04000821 AM23
Licence No and<br>Date	0311015467/13/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<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.||

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

60 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

UDIN00366605AM23

v. Details of indigenous input with quantity.

Case No.	104 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001357AM23
RA File Number	03AX04001138 AM23
Licence No and<br>Date	0311015469/13/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Difference between Import and Export.<br>i.<br>COA of Import item and Export Product.<br>ii.<br>Process of manufacturing in detail and justification for wastage.<br>iii.

Case No.	105 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001371AM23
RA File Number	03AX04000956 AM23
Licence No and<br>Date	0311015488/14/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1dated29/04/2022against advance authorization No.<br>0311005286dt.11-07-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:

61 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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

61 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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Export Product	Qty.	Sl. No. Import items	Qty.
CAMPHENE	1 kg	1<br>ALPHA PINENE	1.140 kg

Case No.	106 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001399AM23
RA File Number	03AX04001167 AM23
Licence No and<br>Date	0311015523/15/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
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.

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

ndigenous input with quantity.** v.||

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

Case No.	107 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001521AM23
RA File Number	03AX04001765 AM23
Licence No and Date	0311015682/20/06/2022
Norms Committee Decision:

UDIN00366605AM23

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Nov/202223/12 dated 18/11/2022 against advance authorization No. 0311015038 dt. 27/05/2022 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Qty.	Sl. No.	Import items	Qty.
1 kg	1	DIPHENYLAMINE	0.459 kg
	2	DI-ISOBUTYLENE	0.60 kg
	3	ACTIVATED CLAY	0.10 kg

Qty.	Sl. No.	Import items	Qty.
1 kg	1	DIPHENYLAMINE	0.459 kg
	2	DI-ISOBUTYLENE	0.60 kg
	3	ACTIVATED CLAY	0.10 kg

Case No.	Case No.	108 / NC/3/MEET/Feb/202223/20	108 / NC/3/MEET/Feb/202223/20	108 / NC/3/MEET/Feb/202223/20	108 / NC/3/MEET/Feb/202223/20	108 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		MITHILA RASAYAN PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00001652AM23
RA File Number		03AX04001866 AM23
Licence No and<br>Date		0311015853/24/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking into consideration yield of 95%, it was decided to ratify<br>norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>BFR<br>-<br>1<br>(BROMINATED<br>FIRE<br>RETARDANT)(VERY FINE POWDER, GREYISH<br>IN COLOUR)<br>1 kg<br>1<br>TBP<br>(TRI<br>BROMO<br>PHENOL)<br>1.393 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	BFR<br>-<br>1<br>(BROMINATED<br>FIRE<br>RETARDANT)(VERY FINE POWDER, GREYISH<br>IN COLOUR)		<br> <br>1 kg	1	TBP<br>(TRI<br>BROMO<br>PHENOL)	<br>1.393 kg

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rt items|Qty.| ||BFR - 1 (BROMINATED FIRE RETARDANT)(VERY FINE POWDER, GREYISH IN COLOUR)|| 1 kg|1|TBP (TRI BROMO PHENOL)| 1.393 kg|

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Case No.	109 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	SHREYANS CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001660AM23
RA File Number	03AX04001924 AM23
Licence No and<br>Date	0311015858/25/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08/07/2022against advance authorization No.<br>0311000702dt.06/01/2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Ethyl Chloro Acetate (CAS- 105-39-5)<br>(Purity Min. 99.70%)<br>1 kg<br>1<br>Mono Chloro Acetic Acid<br>(CAS- 79-11-8)<br>1.22 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	110 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	ALCHEMIE FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001739AM23
RA File Number	03AX04001857 AM23

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Licence No and Date

0311015970/29/06/2022

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify 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 ORTHOTOLUIDINE 0.834 kg N,ETHYL-ORTHO -TOLUIDINE 1 kg 2 Denatured ethyl alcohol 0.358 kg RA may take appropriate action as per the decision of Norms Committee.

Case No.	111 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001773AM23
RA File Number	05AX04000689 AM23
Licence No and<br>Date	0511013507/30/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete chemistry giving molecular weight of both reactants and product with yield.<br>i.<br>Complete calculation for the requirement of raw material and water to be added in making 60%<br>Aqueous solution of export product.<br>ii.

Case No.	112 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved

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and water to be added in making 60%** Aqueous solution of export product. ii.||

Case No.	112 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved

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Party Name	Party Name	Party Name	YASHO INDUSTRIES LIMITED	YASHO INDUSTRIES LIMITED	YASHO INDUSTRIES LIMITED	YASHO INDUSTRIES LIMITED	YASHO INDUSTRIES LIMITED	YASHO INDUSTRIES LIMITED	YASHO INDUSTRIES LIMITED	YASHO INDUSTRIES LIMITED	YASHO INDUSTRIES LIMITED	YASHO INDUSTRIES LIMITED	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number			HQRNORM APPLY 00001814AM23
RA File Number			03AX04002032 AM23
Licence No and<br>Date			0311016038/03/07/2022
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 dated 26.07.2018 against advance authorization No.0310814211 dt.<br>22.06.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No.

dt. 22.06.2017, it was decided to ratify 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 3 ACTIVATED CLAY 0.10 kg|||||||||||||| ||orms Committee Decision: he Committee considered the case as per agenda and ||||taking ||cue from e ||arlier decision for same exp |||ort product / || ||mport item in Meeting No.6/82-ALC4/2018 dated 26 2.06.2017, it was decided to ratify norms under Para 4. e firm, whichever is less: Export Product Qty. DI-OCTYLATED DIPHENYLAMINE (YALUB DODPA) 1 kg||||.07.201** 07 of H||against ad BP Vol. I as||vance authorization No.03 per details given below or|||10814211 dt. as applied by|| ||||||||||||||| |||||Qty.||Sl.

DODPA) 1 kg||||.07.201 07 of H||against ad BP Vol. I as||vance authorization No.03 per details given below or|||10814211 dt. as applied by|| ||||||||||||||| |||||Qty.||Sl. N|o.|Import it|ems||Q|ty.|| ||||| 1 kg||1||DIPHEN|YLAMINE||0.|50 kg|| |||||||2||DI-ISOBUTYLENE|||0.64 kg||| ||||||||||||||| |||||||3||ACTIVAT||ED CLAY|0.10 kg||| ||||||||||||||| ||||||||||||||| ||||||||||||||| ||||||||||||||| |RA concerne||d may|take further necessary action as per above decision of NC.||||||||||| ||||||||||||||| ||||||||||||||| ||||||||||||||| ||||||||||||||| ||||||||||||||| ||||||||||||||| |Case No.|||113 / NC/3/MEET/Feb/202223/20||||||||||| ||||||||||||||| |Case Status|||Case Approved||||||||||| |Party Name|||YASHO INDUSTRIES LIMITED||||||||||| |Meeting Number|||NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023||||||||||| |and Date|||||||||||||| |HQ File Number|||HQRNORM APPLY 00001815AM23||||||||||| |RA File Number|||03AX04002034 AM23||||||||||| |Licence No and|||0311016039/03/07/2022||||||||||| |Date|||||||||||||| |Norms Committee|||Decision:||||||||||| |The Committee c|||nsidered the case as er aenda and takin cue from earlier decision for same exort roduct /||||||||||| | import item in Me|||p g g p p eting No8/82-ALC4/2018dated 31082018against advance authorization No0310817953 dt||||||||||| | 20.12.2017, it was|||. .. .. decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by|||||||||||

zation No0310817953 dt||||||||||| | 20.12.2017, it was|||. .. .. decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by|||||||||||

Case No.	113 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001815AM23
RA File Number	03AX04002034 AM23
Licence No and<br>Date	0311016039/03/07/2022
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.8/82-ALC4/2018 dated 31.08.2018 against advance authorization No.0310817953 dt.
20.12.2017, it was	decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by

UDIN00366605AM23

the firm, whichever is less:

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


			<br>
	TETRA BENZYL THIURAM DISU<br>	FIDE	<br>1 kg	1	DIBENZYLAMINE	0.74 kg
	(QUREACC TBZTD)

				2	CARBON DISULPHIDE	0285 k
						. g


RA concerned may take further necessary

DE| 1 kg|1|DIBENZYLAMINE|0.74 kg|| |||(QUREACC TBZTD)||||||| |||||||||| ||||||2|CARBON DISULPHIDE|0285 k|| ||||||||. g|| |||||||||| |||||||||| ||RA concerned may take further necessary||||||||


C
	ase No.	114 / NC/3/MEET/Feb/202	23/20
C	ase Status	Case Deferred

Party Name		SAGA LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00001849AM23
RA File Number		08AX04000569 AM23
Licence No and<br>Date		0811005433/05/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>COA of import item (105 kg) from foreign supplier to show Actual Potency and LoD.<br>i.

Case No.	115 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001879AM23
RA File Number	09AX04000318 AM23

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Licence No and Date

0911003277/06/07/2022

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify 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. Dapagliflozin Propanediol Monohydrate 1 kg 1 [(2R,3R,4R,5S,6S)-3,4,5-Triacetyloxy-6-[4-Chloro- 3-[(4-Ethoxyphenyl) Methyl]Phenyl]Oxan-2- yl]Methyl Acetate 1.53 kg RA may take appropriate action as per the decision of Norms Committee.

Case No.	Case No.	116 / NC/3/MEET/Feb/202223/20	116 / NC/3/MEET/Feb/202223/20	116 / NC/3/MEET/Feb/202223/20	116 / NC/3/MEET/Feb/202223/20	116 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00001881AM23
RA File Number		09AX04000311 AM23
Licence No and<br>Date		0911003280/06/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify 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.

e case as per agenda and it was decided to ratify 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. Eltrombopag Olamine 1 kg 1 (Z)-2'-(Benzyloxy)-3'-(2-(1-(3,4-Dimethylphenyl)-3- Methyl-5-oxo-1H-Pyrazol-4(5H)-Ylidene) Hydrazinyl)-[1,1'-Biphenyl]-3- Carboxylic Acid 1.68 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Eltrombopag Olamine||1 kg|1|(Z)-2'-(Benzyloxy)-3'-(2-(1-(3,4-Dimethylphenyl)-3- Methyl-5-oxo-1H-Pyrazol-4(5H)-Ylidene) Hydrazinyl)-[1,1'-Biphenyl]-3- Carboxylic Acid|1.68 kg|

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RA may take appropriate action as per the decision of Norms Committee.

Case No.	117 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001892AM23
RA File Number	09AX04000308 AM23
Licence No and<br>Date	0911003285/07/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify 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.

e case as per agenda and it was decided to ratify 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 5-(2-Fluorophenyl)-1H-Pyrrole-3-Carbaldehyde 0.757 kg 2 3-Pyridinesulfonyl Chloride 0.856 kg 3 Acetonitrile 1.00 kg 4 Methanol 2.80 kg Vonoprazan Fumarate 1 kg 5 Acetone 3.29 kg RA may take appropriate action as per the decision of Norms Committee.||

Case No. 118 / NC/3/MEET/Feb/202223/20

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Case Status	Case Status	Case Approved
Party Name		SHIVAM ADDITIVES PRIVATE LIMITED

Meeting Number an	d Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

HQ File Number		HQRNORM APPLY 00001907AM23

RA File Number		05AX04000961 AM23

Licence No and Da	te	0511013644/07/07/2022
Norms Committee	Decision:
The Committee co	nsidered the case as per agenda and taking cue from earlier decision for same export product /
<br>import item in M	<br>eeting No.NC/3/MEET/Apr/202223/1 dated29/04/2022 against advance authorization No.
<br>1311000821 dt.15-<br>or as applied by the	<br>12-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>firm, whichever is less:
<br>Export Product<br>Qty.<br>Sl. No.

as applied by the|| 12-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below firm, whichever is less:||||||| | Export Product Qty. Sl. No. Import items Qty. AZODICARBONAMIDE (BLOWING AGENT), PURITY MINIMUM 99.50 PERCENT, PARTICLE SIZE 4.5 TO 5.5 PERCENT MICRON 200000 kg 1 AZODICARBONAMIDE CRUDE PURITY MINIMUM 97 PERCENT PARTICLE SIZE 13 TO 15 PERCENT MICRON 201000 kg RA concerned may take further necessary action as per above decision of NC||||||||| ||Export Product|||Qty.|Sl. No.|Import items|Qty.|| ||AZODICARBONAMIDE (BLOWING AGENT), PURITY MINIMUM 99.50 PERCENT, PARTICLE SIZE 4.5 TO 5.5 PERCENT MICRON||| 200000 kg|1|AZODICARBONAMIDE CRUDE PURITY MINIMUM 97 PERCENT PARTICLE SIZE 13 TO 15 PERCENT MICRON| 201000 kg|| ||||||||||


Case No.	119 / NC/3/MEET/Feb/202223/20

Case Status	Case Deferred

Party Name	SRF LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

HQ File Number	HQRNORM APPLY 00001911AM23

RA File Number	05AX04001017 AM23

Licence No and<br>Date	0511013648/07/07/2022

Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>End use of export product.<br>i.<br>Clt d bl hit ll iht d t ild l bi f h t f<br>ii
ompee an aance cemsry, moecuar weg an percenage ye on moar ass or eac sep o<br>.

m the firm: End use of export product. i. Clt d bl hit ll iht d t ild l bi f h t f ii|| |ompee an aance cemsry, moecuar weg an percenage ye on moar ass or eac sep o .||

i. End use of export product. ii. Complete and balance chemistry, molecular weight and percentage yield on molar basis for each step of

UDIN00366605AM23

manufacturing process.

iii. Past Production / Consumption of raw material certified by GST Authorities.

Case No.	120 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001938AM23
RA File Number	03AX04001943 AM23
Licence No and<br>Date	0311016208/08/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete and balanced chemistry, percentage yield on molar basis and material balance to show the<br>requirement of Soda Ash as it is not a raw material in the process for manufacturing of HALQUINOL BP 80,<br>the export product.

Case No.	121 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001947AM23
RA File Number	03AX04002171 AM23
Licence No and<br>Date	0311016221/10/07/2022
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 dated 26.07.2018 against advance authorization No.0310814211 dt.<br>22.06.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:

e authorization No.0310814211 dt. 22.06.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:||

71 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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Export product	Qty.	Sl. No.	Import items	Qty.
DI-OCTYLATED<br>DIPHENYLAMINE<br>(YALUB DODPA)	<br>1 kg	1	DIPHENYLAMINE	0.50 kg
		2	DI-ISOBUTYLENE	0.64 kg
		3	ACTIVATED CLAY	0.10 kg

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

Case No.	122 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	VIPPY INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001956AM23
RA File Number	56AX04000008 AM23
Licence No and<br>Date	5611001042/11/07/2022

eting Number and Date|NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023|| |HQ File Number|HQRNORM APPLY 00001956AM23|| |RA File Number|56AX04000008 AM23|| |Licence No and Date|5611001042/11/07/2022|| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call the firm to attendPersonal Hearing before Norms Committee to explain its case alongwith following documents / information: Step wise manufacturing process. i. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis. ii. Complete technical details as per Annexure to Appendix 4E for chemical products. iii. Stoichiometric balance between import and export on molar basis. iv. Details of indigenous input with quantity. v. COA of import item from foreign supplier. vi. Purity of import item. vii. Impurity profile of export and import. viii.|||

Case No. 123 / NC/3/MEET/Feb/202223/20

UDIN00366605AM23

Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001959AM23
RA File Number	03AX04002151 AM23
Licence No and<br>Date	0311016241/11/07/2022
Norms Committee Decision:
Deferred for comments of TE.

/02/2023| |HQ File Number|HQRNORM APPLY 00001959AM23| |RA File Number|03AX04002151 AM23| |Licence No and Date|0311016241/11/07/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	124 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001972AM23
RA File Number	03AX04002163 AM23
Licence No and<br>Date	0311016269/11/07/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	125 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00001986AM23
RA File Number	03AX04002093 AM23
Licence No and<br>Date	0311016291/12/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Feb/202122/14dated21/02/2022 against advance authorization No.
0311003998dt.23-05-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or
as applied by the firm, whichever is less:

73 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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Export product	Qty.	Sl. No.	Import items	Qty.
E.D.T.A. DI SODIUM(PURE/AR)	1 kg	1	EDTA ACID	0.659 kg

KUMAR, Deputy Director on 14-03-2023 18:52:38.

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Export product	Qty.	Sl. No.	Import items	Qty.
E.D.T.A. DI SODIUM(PURE/AR)	1 kg	1	EDTA ACID	0.659 kg

Case No.	126 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002011AM23
RA File Number	52AX04001578 AM23
Licence No and<br>Date	5211002817/13/07/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	127 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002026AM23
RA File Number	05AX04001011 AM23
Licence No and<br>Date	0511013749/13/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:

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i. End use of export product.
ii. Complete and balance chemistry, molecular weight and percentage yield on molar basis for each step of manufacturing process.
iii. Past Production / Consumption of raw material certified by GST Authorities.

ce chemistry, molecular weight and percentage yield on molar basis for each step of manufacturing process.**

iii. Past Production / Consumption of raw material certified by GST Authorities.

Case No.	128 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002027AM23
RA File Number	34AX04000357 AM23
Licence No and<br>Date	3411002528/13/07/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.		129 / NC/3/MEET/Feb/202223/20
Case Status		Case Deferred
Party Name		FREESIA CHEMICALS
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00002037AM23
RA File Number		03AX04002018 AM23
Licence No and<br>Date		0311016342/14/07/2022
Norms Committee	Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from
the firm:
Complete<br>i.		chemistry, molecular weight and percentage yield on molar basis as per Annexure to
Appendix	4E.
Justification for low yield.<br>ii.

i. Complete chemistry, molecular weight and percentage yield on molar basis as per Annexure to Appendix 4E.

75 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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weight and percentage yield on molar basis as per Annexure to Appendix 4E.**

75 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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Case No.	130 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002045AM23
RA File Number	31AX04000111 AM23
Licence No and<br>Date	3111001563/14/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08/07/2022 against advance authorization No.<br>3111000308 dt. 05/05/2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Cyclohexylamine (CHA)<br>1.41 kg<br>2<br>Methanol<br>0.08 kg<br>3<br>Phosphorus Qxy Chloride<br>1.49 kg<br>1,3-Dicyclo Hexyl Carbodimide (DCC)<br>1 kg<br>4<br>Ammonia<br>0.72 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	131 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002130AM23

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RA File Number<br>03AX04002326 AM23
Licence No and<br>Date<br>0311016439/19/07/2022
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.8/82-ALC4/2018 dated 31.08.2018 against advance authorization No.0310817953 dt.
20.12.2017, it was decided to ratify 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.
TETRA BENZYL THIURAM DISULFIDE	<br>1 kg	1	DIBENZYLAMINE	0.74 kg
(QUREACC TBZTD)
		2	CARBON DISULPHIDE	0.285 kg
RA concerned may take further necessary action as per above decision of NC.

ZYL THIURAM DISULFIDE| 1 kg|1|DIBENZYLAMINE|0.74 kg|| |(QUREACC TBZTD)|||||| |||2|CARBON DISULPHIDE|0.285 kg|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	132 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002179AM23
RA File Number	05AX04001164 AM23
Licence No and<br>Date	0511013888/21/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Complete chemistry giving molecular weight of both reactants and product with yield.<br>i.
Complete calculation for the requirement of raw material based on the chemistry and yield giving<br>ii.
wastage and its justification.

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Case No.<br>133 / NC/3/MEET/Feb/202223/20
Case Status<br>Case Deferred
Party Name<br>SRF LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number<br>HQRNORM APPLY 00002213AM23
RA File Number<br>05AX04001131 AM23
Licence No and<br>Date<br>0511013929/22/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
End use of export product.<br>i.
Complete and balance chemistry, molecular weight and percentage yield on molar basis for each step of<br>ii.

ing information / documents| |from the firm:| |End use of export product. i.| |Complete and balance chemistry, molecular weight and percentage yield on molar basis for each step of ii.| |manufacturing process.| |Past Production / Consumption of raw material certified by GST Authorities. iii.|

ii. Complete and balance chemistry, molecular weight and percentage yield on molar basis for each step of manufacturing process.

Case No.	134 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	CANPEX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002216AM23
RA File Number	31AX04000115 AM23
Licence No and<br>Date	3111001583/22/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Complete<br>i.	chemistry, molecular weight and percentage yield on molar basis as per Annexure to
Appendix 4E.
Yield.<br>ii.
Calculation with meaning of Cyanamide 50% Solution.<br>iii.

i. Complete chemistry, molecular weight and percentage yield on molar basis as per Annexure to Appendix 4E.

78 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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weight and percentage yield on molar basis as per Annexure to Appendix 4E.**

78 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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Case No.	135 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002221AM23
RA File Number	07AX04000559 AM23
Licence No and<br>Date	0711004755/23/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete chemistry, molecular weight and percentage yield on molar basis as per Annexure to<br>Appendix 4E.<br>i.<br>Production / Consumption data duly certified by GST.<br>ii.<br>Use / Application of Export Product.<br>iii.

i. Complete chemistry, molecular weight and percentage yield on molar basis as per Annexure to Appendix 4E.

Case No.	136 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002228AM23
RA File Number	03AX04002208 AM23
Licence No and<br>Date	0311016558/25/07/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/02/2023| |HQ File Number|HQRNORM APPLY 00002228AM23| |RA File Number|03AX04002208 AM23| |Licence No and Date|0311016558/25/07/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	137 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023

79 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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HQ File Number	HQRNORM APPLY 00002265AM23
RA File Number	03AX04002336 AM23
Licence No and<br>Date	0311016601/26/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Difference<br>i.	between Import and Export.
COA of Import and Export.<br>ii.
Process of manufacturing in detail and justification for wastage.<br>iii.

s|| |from the firm:|| |Difference i.|between Import and Export.| |COA of Import and Export. ii.|| |Process of manufacturing in detail and justification for wastage. iii.||

Case No.	138 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002286AM23
RA File Number	08AX04000679 AM23
Licence No and<br>Date	0811005628/26/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Complete<br>i.	chemistry, molecular weight and percentage yield on molar basis as per Annexure to
Appendix 4E.
Details of indigenous items, if any.<br>ii.
Application / Use of Export Product.<br>iii.

i. Complete chemistry, molecular weight and percentage yield on molar basis as per Annexure to Appendix 4E.

Case No.	139 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ASMEE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002335AM23

80 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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Feb/ 202223/ 20 and 24/02/2023| |HQ File Number|HQRNORM APPLY 00002335AM23|

80 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-03-2023 18:52:38.

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RA File Number	03AX04002471 AM23
Licence No and<br>Date	0311016692/29/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete chemistry, molecular weight and percentage yield on molar basis as per Annexure to<br>Appendix 4E.<br>i.<br>Application / Use of Export Product.<br>ii.<br>By Product, if any and its Commercial Value.<br>iii.

i. Complete chemistry, molecular weight and percentage yield on molar basis as per Annexure to Appendix 4E.

Case No.	140 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002352AM23
RA File Number	03AX04002033 AM23
Licence No and<br>Date	0311016713/29/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/4 dated 17/06/2022against advance authorization No.<br>0310835280 dt. 06/03/2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

835280 dt. 06/03/2020**, it was decided to ratify 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. ISOBORNEOL ACETATE 1 kg 1 GUM TURPENTINE OIL 0.9529 kg RA concerned may take further necessary action as per above decision of NC.||

UDIN00366605AM23

Case No.	141 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	GUJARAT FLUOROCHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00002374AM23
RA File Number	34AX04000340 AM23
Licence No and<br>Date	3411002592/29/07/2022
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.
Stage wise manufacturing process starting from raw material imported.<br>vi.

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

g from raw material imported.** vi.||

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

Case No.<br>142 / NC/3/MEET/Feb/202223/20
Case Status<br>Case Approved
Party Name<br>GLENMARK PHARMACEUTICALS		LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number<br>HQRNORM APPLY 00003495AM23
RA File Number<br>03AX04003287 AM23
Licence No and<br>Date<br>0311018310/01/10/2022
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/202223/14 dated07/12/2022 against				advance authorization No.
0311010878dt.25/01/2022, it was decided to ratify 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.

UDIN00366605AM23

FLUTICASONE LOTION 0.05 Percent	<br>50000	1	Fluticasone Propionate USP	1.53 kg
(Pack 60 ML) (Net wt. of Fluticasone	<br>Numbers
Propionate USP is 1.50 Kgs.)

FLUTICASONE LOTION 0.05 Percent	<br>50000	1	Fluticasone Propionate USP	1.53 kg
(Pack 60 ML) (Net wt. of Fluticasone	<br>Numbers
Propionate USP is 1.50 Kgs.)

Case No.	143 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003501AM23
RA File Number	03AX04003199 AM23
Licence No and<br>Date	0311018319/03/10/2022
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.12/82-ALC4/2018dated 12.12.2018against advance authorization No.0310816656 dt.<br>31.10.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>NAS-5<br>(2-DIAZO-1-NAPHTHOL-5-<br>SULFONIC ACID, SODIUM SALT)<br>1 kg<br>1<br>TOBIAS ACID<br>(PURITY MIN.97%.)<br>1.20 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	144 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED

UDIN00366605AM23

ary action as per above decision of NC.||

Case No.	144 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED

UDIN00366605AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003514AM23
RA File Number	03AX04003421 AM23
Licence No and<br>Date	0311018336/03/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.<br>Percentage purity of Export Product with COA.<br>vi.

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

y of Export Product with COA.** vi.||

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

Case No.	Case No.	145 / NC/3/MEET/Feb/202223/20	145 / NC/3/MEET/Feb/202223/20	145 / NC/3/MEET/Feb/202223/20	145 / NC/3/MEET/Feb/202223/20	145 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00003515AM23
RA File Number		07AX04000970 AM23
Licence No and<br>Date		0711005403/03/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/3 dated27/05/2022 against advance authorization No.<br>0711001720dt.16-08-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>1 BROMO 3 CHLORO PROPANE<br>0.720 kg<br>2<br>TETRA HYDRO FURAN<br>0.530 kg<br>AMITRIPTYLINE HCL(EP/USP/BP)<br>1 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	AMITRIPTYLINE HCL(EP/USP/BP)		1 kg	1	1 BROMO 3 CHLORO PROPANE	0.720 kg
				2	TETRA HYDRO FURAN	0.530 kg

PTYLINE HCL(EP/USP/BP) 1 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||AMITRIPTYLINE HCL(EP/USP/BP)||1 kg|1|1 BROMO 3 CHLORO PROPANE|0.720 kg| |||||2|TETRA HYDRO FURAN|0.530 kg|

Case No.	Case No.	145 / NC/3/MEET/Feb/202223/20	145 / NC/3/MEET/Feb/202223/20	145 / NC/3/MEET/Feb/202223/20	145 / NC/3/MEET/Feb/202223/20	145 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00003515AM23
RA File Number		07AX04000970 AM23
Licence No and<br>Date		0711005403/03/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/3 dated27/05/2022 against advance authorization No.<br>0711001720dt.16-08-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>1 BROMO 3 CHLORO PROPANE<br>0.720 kg<br>2<br>TETRA HYDRO FURAN<br>0.530 kg<br>AMITRIPTYLINE HCL(EP/USP/BP)<br>1 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	AMITRIPTYLINE HCL(EP/USP/BP)		1 kg	1	1 BROMO 3 CHLORO PROPANE	0.720 kg
				2	TETRA HYDRO FURAN	0.530 kg

UDIN00366605AM23

1 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||AMITRIPTYLINE HCL(EP/USP/BP)||1 kg|1|1 BROMO 3 CHLORO PROPANE|0.720 kg| |||||2|TETRA HYDRO FURAN|0.530 kg|

UDIN00366605AM23

3<br>SODIUM BOROHYDRIDE<br>4<br>ACETONE<br>5<br>METHANOL<br>6<br>TOLUENE<br>Not allowed as not<br>shown<br>in<br>the<br>process reaction<br>RA concerned may take further necessary action as per above decision of NC.			3	SODIUM BOROHYDRIDE	Not allowed as not<br>shown<br>in<br>the<br>process reaction
			4	ACETONE
			5	METHANOL
			6	TOLUENE

Case No.	146 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003517AM23
RA File Number	08AX04001120 AM23
Licence No and<br>Date	0811006189/03/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jan/202223/18dated23/01/2023against advance authorization No.<br>0811002234dt.04/08/2021, and as per following documents furnished by the 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.

ontent 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%. i. 11.71% wastage is shown for manufacturing Process Loss. ii. Since the export product is Freeze Dried Powder, 12% excess volume is added as per regulatory requirement. iii. (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 ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:||

UDIN00366605AM23

Export product		Qty.	Sl. No.	Import items	Qty.
BIVALIRUDIN	FOR	<br>1 Number	1	Bivalirudin (containing 8% to 12%	<br>315.114 mg/
INJECTION 250 MG/VIAL	(5ML			Triflow Acetic Acid as per COA)	Vial
VIAL)(EACH VIAL CONTAINS:
BIVALIRUDIN 250 MG	[IN
WHICH ACTIVE INGREDIENT
BIVALIRUDIN<br>USED	IS
370.000 GRAMS])

/VIAL|(5ML|||Triflow Acetic Acid as per COA)|Vial| |VIAL)(EACH VIAL CONTAINS:|||||| |BIVALIRUDIN 250 MG|[IN||||| |WHICH ACTIVE INGREDIENT|||||| |BIVALIRUDIN USED|IS||||| |370.000 GRAMS])||||||

Case No.	147 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	SHREE MAHADEV INTERMEDIATE
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003525AM23
RA File Number	34AX04000640 AM23
Licence No and<br>Date	3411002862/04/10/2022
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.
End use of<br>vi.	Export Product.

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

Case No.	148 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved

UDIN00366605AM23

al formula and molecular weights along with stage wise percentage yields on molar basis.**

Case No.	148 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved

UDIN00366605AM23

Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003532AM23
RA File Number	34AX04000617 AM23
Licence No and<br>Date	3411002863/04/10/2022
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>3411001256dated 12/10/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Phenol<br>1 MT<br>1<br>Cumene<br>0.84466 MT<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	149 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003540AM23
RA File Number	03AX04003155 AM23
Licence No and<br>Date	0311018363/05/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	150 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	GEM AROMATICS PRIVATE LIMITED

UDIN00366605AM23

ee Decision: Deferred for comments of TE.||

Case No.	150 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	GEM AROMATICS PRIVATE LIMITED

UDIN00366605AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003541AM23
RA File Number	03AX04003363 AM23
Licence No and<br>Date	0311018364/05/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	151 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003542AM23
RA File Number	08AX04001117 AM23
Licence No and<br>Date	0811006202/06/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jan/202122/13 dated21/01/2022 against advance authorization No.<br>0811002277dt.09-08-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Taxus Baccata<br>1340.00 kg<br>Docetaxel<br>1 kg<br>2<br>1,5-Bis[diisopropyl-(+)-(3R,4S)-1-tert-butoxycarbonyl-4-<br>phenyl-2-azetidinone-3- hydroxyl-silyl] pentane<br>0.888 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 152 / NC/3/MEET/Feb/202223/20

yl-4- phenyl-2-azetidinone-3- hydroxyl-silyl] pentane 0.888 kg RA concerned may take further necessary action as per above decision of NC.||

Case No. 152 / NC/3/MEET/Feb/202223/20

UDIN00366605AM23

Case Status	Case Deferred
Party Name	CORAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003543AM23
RA File Number	05AX04001818 AM23
Licence No and<br>Date	0511015160/06/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	153 / NC/3/MEET/Feb/202223/20	153 / NC/3/MEET/Feb/202223/20	153 / NC/3/MEET/Feb/202223/20	153 / NC/3/MEET/Feb/202223/20	153 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00003547AM23
RA File Number		09AA04017855 AM22
Licence No and<br>Date		0911003746/06/10/2022
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>0911003192dt. 17/06/2022, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.

0911003192dt. 17/06/2022*, it was decided to ratify 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 Di-Tert-Butyl Dicarbonate (Boc Anhydride) 3.16 kg 2 CDX-034 Lyophilized Enzyme Powder 0.012 kg 3 Beta-Nicotinamide Adenine dinucleotide phosphate Sodium salt (beta-NADP-Na) 0.008 kg 4 N-Heptane 3.00 kg (1R,2R)-2-Amino-6-(4- Nitrophenyl)-1-Phenylhex-5-yn-1- ol Hydrochloride 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||(1R,2R)-2-Amino-6-(4- Nitrophenyl)-1-Phenylhex-5-yn-1- ol Hydrochloride||1 kg|1|Di-Tert-Butyl Dicarbonate (Boc Anhydride)|3.16 kg| |||||2|CDX-034 Lyophilized Enzyme Powder|0.012 kg| |||||3|Beta-Nicotinamide Adenine dinucleotide phosphate Sodium salt (beta-NADP-Na)|0.008 kg| |||||4|N-Heptane|3.00 kg|

UDIN00366605AM23

5<br>Tetra Hydro Furan<br>5.00 kg<br>6<br>Iso Propyl Alcohol (IPA)<br>10.00 kg<br>7<br>Methyl Tertiary-Butyl Ether (MTBE)<br>3.50 kg<br>RA concerned may take further necessary action as per above decision of NC.			5	Tetra Hydro Furan	5.00 kg
			6	Iso Propyl Alcohol (IPA)	10.00 kg
			7	Methyl Tertiary-Butyl Ether (MTBE)	3.50 kg

r necessary action as per above decision of NC.			5	Tetra Hydro Furan	5.00 kg
			6	Iso Propyl Alcohol (IPA)	10.00 kg
			7	Methyl Tertiary-Butyl Ether (MTBE)	3.50 kg

Case No.	154 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003551AM23
RA File Number	03AX04003473 AM23
Licence No and<br>Date	0311018382/06/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete Chemistry giving molecular weight of both reactants and product with calculation indicating<br>full chemical name of Export Product PDSH.<br>i.<br>Yield of the reactant.<br>ii.<br>Justification for low yield, if any.<br>iii.

Case No.	155 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003555AM23
RA File Number	52AX04001659 AM23
Licence No and	5211003386/06/10/2022

UDIN00366605AM23

Date Norms Committee Decision:

Deferred for comments of TE.

UDIN00366605AM23

Date Norms Committee Decision:

Deferred for comments of TE.

Case No.	156 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003558AM23
RA File Number	03AX04003496 AM23
Licence No and<br>Date	0311018391/06/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.<br>Percentage yield at every stage of reaction.<br>vi.

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

d at every stage of reaction.** vi.||

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

Case No.	157 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003559AM23
RA File Number	07AX04000989 AM23
Licence No and<br>Date	0711005409/06/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /

UDIN00366605AM23

import item in Meeting No. 12/82-ALC4/2018 dated 12.12.2018 against advance authorization No. 0710111682 dt. 30.05.2017 , it was decided to ratify 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.
PREMIX OF NIFUROXAZIDE(( Each	<br>6300 kg	1	NIFUROXAZIDE BP / EP	3512.376 kg
gm of Premix Contains Nifuroxazide BP
0.552 gm) {Nifuroxazide Net
Content is 3477.60kg })

---|---| |PREMIX OF NIFUROXAZIDE(( Each| 6300 kg|1|NIFUROXAZIDE BP / EP|3512.376 kg| |gm of Premix Contains Nifuroxazide BP||||| |0.552 gm) {Nifuroxazide Net||||| |Content is 3477.60kg })|||||

Case No.<br>158 / NC/3/MEET/Feb/202223/20
Case Status<br>Case Approved
Party Name<br>OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number<br>HQRNORM APPLY 00003574AM23
RA File Number<br>09AX04000597 AM23
Licence No and<br>Date<br>0911003759/07/10/2022
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/Dec/202223/15 dated 29/12/2022against advance authorization No.
0911003192dt. 17/06/2022, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
1<br>(1R,2R)-2-Amino-6-(4-<br>Nitrophenyl)-1-Phenylhex-5-yn-1-<br>1 kg	Di-Tert-Butyl Dicarbonate (Boc Anhydride)	3.16 kg
2<br>ol Hydrochloride	CDX-034 Lyophilized Enzyme Powder	0.012 kg

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- Nitrophenyl)-1-Phenylhex-5-yn-1- 1 kg|Di-Tert-Butyl Dicarbonate (Boc Anhydride)|3.16 kg|| |2 ol Hydrochloride|CDX-034 Lyophilized Enzyme Powder|0.012 kg|| |||||

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3	Beta-Nicotinamide Adenine dinucleotide<br>phosphate Sodium salt (beta-NADP-Na)	0.008 kg
4	N-Heptane	3.00 kg
5	Tetra Hydro Furan	5.00 kg
6	Iso Propyl Alcohol (IPA)	10.00 kg
7	Methyl Tertiary-Butyl Ether (MTBE)	3.50 kg

Case No.	Case No.	Case No.	159 / NC/3/MEET/Feb/202223/20	159 / NC/3/MEET/Feb/202223/20	159 / NC/3/MEET/Feb/202223/20	159 / NC/3/MEET/Feb/202223/20	159 / NC/3/MEET/Feb/202223/20
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number			HQRNORM APPLY 00003580AM23
RA File Number			09AX04000557 AM23
Licence No and<br>Date			0911003763/07/10/2022

Date|||NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023||||| |HQ File Number|||HQRNORM APPLY 00003580AM23||||| |RA File Number|||09AX04000557 AM23||||| |Licence No and Date|||0911003763/07/10/2022||||| |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/Dec/202223/17 dated 13/01/2023against advance authorization No. 0911002024dt.08/12/2021, it was decided to ratify 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 Esmolol Hydrochloride 2100 mg 2 Flexible bags 1.02 Numbers Esmolol Hydrochloride in Sodium Chloride Injection 2000 mg per 100ml (20mg per ml) 100ml Bag(Condition: The firm should account for 95.240 Kgs of input at Sl No.1 and 47,620 Nos of 1 1 Number|||||||| |||Export Product||Qty|Sl. No.|Import Items|Qty| |||Esmolol Hydrochloride in Sodium Chloride Injection 2000 mg per 100ml (20mg per ml) 100ml Bag(Condition: The firm should account for 95.240 Kgs of input at Sl No.1 and 47,620 Nos of||1 Number|1|Esmolol Hydrochloride|2100 mg| ||||||2|Flexible bags|1.02 Numbers| |||||||||

UDIN00366605AM23

br>The firm should account for 95.240 Kgs of input at Sl No.1 and 47,620 Nos of||1 Number|1|Esmolol Hydrochloride|2100 mg| ||||||2|Flexible bags|1.02 Numbers| |||||||||

UDIN00366605AM23

	input at Sl No.2,3 each of the import list		3	Twist off port stoppers	1.01 Numbers
	in the resultant product which should be
	reflected in SBs.)
2	Esmolol<br>Hydrochloride<br>in<br>Sodium	1 Number	1	Esmolol Hydrochloride	2625 mg
	Chloride Injection 2500 mg per 250ml
	(10mg per ml), 250ml Bag(Condition:
	The firm should account for 160.000 Kgs		2	Flexible bags	1.02 Numbers
	of input at Sl No.4 and 64,000 Nos of
	input at Sl No.5,6 each of the import list<br>in the resultant product which should be		3	Twist off port stoppers	1.01 Numbers
	reflected in SBs.)

Case No.<br>160 / NC/3/MEET/Feb/202223/20
Case Status<br>Case Approved
Party Name<br>OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number<br>HQRNORM APPLY 00003585AM23
RA File Number<br>09AX04000598 AM23
Licence No and<br>Date<br>0911003765/08/10/2022
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/Dec/202223/17		dated13/01/2023against advance authorization No.

e as per agenda|and taking cue from earlier decision for||||same export product /||| |import item in Meeting No.NC/3/MEET/Dec/202223/17|||dated13/01/2023against advance authorization No.||||| |0911002118dt.21/12/2021, it was decided to ratify 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.|| |sodium (S)-4-oxo-4,6,7,8- tetrahydropyrrolo [1,2-a]pyrimidine-6- 1 kg||1||Methyl L-pyroglutamate||2.70 kg|| |carboxylate((Pyrimidinone acid, sodium salt))||2||Triethyl amine||2.27 kg|| |||3||2,5-Norbornadiene||1.73 kg||

UDIN00366605AM23

4	Chloro sulfonyl isocyanate	2.778 kg
5	Isopropyl alcohol	4.02 kg
6	Methyl tert butyl ether	5.91 kg
7	Toluene	5.72 Litre
8	Ethyl acetate	2.95 Litre
9	N-Heptane	1.82 kg
10	Ethyl benzene	1.00 kg
11	Methanol	1.50 kg
12	Methylene chloride	3.25 Litre

utyl ether|5.91 kg| ||||7|Toluene|5.72 Litre| ||||8|Ethyl acetate|2.95 Litre| ||||9|N-Heptane|1.82 kg| ||||10|Ethyl benzene|1.00 kg| ||||11|Methanol|1.50 kg| ||||12|Methylene chloride|3.25 Litre|

Case No.	161 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003592AM23
RA File Number	03AX04003536 AM23
Licence No and<br>Date	0311018438/09/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.<br>0310835448 dt. 17.03.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:

UDIN00366605AM23

Export Product<br>Qty<br>Sl. No. Import Items<br>Qty<br>1<br>CLARITHROMYCIN<br>0.2727 kg<br>CLARITHROMYCIN GRANULES 27.5%<br>1 kg<br>2<br>ACETONE<br>1.00 kg<br>RA concerned may take further necessary action as per above decision of NC.	Export Product<br>CLARITHROMYCIN GRANULES 27.5%	Qty	Sl. No.	Import Items	Qty
		1 kg	1	CLARITHROMYCIN	0.2727 kg
			2	ACETONE	1.00 kg

ion as per above decision of NC.	Export Product<br>CLARITHROMYCIN GRANULES 27.5%	Qty	Sl. No.	Import Items	Qty
		1 kg	1	CLARITHROMYCIN	0.2727 kg
			2	ACETONE	1.00 kg

Case No.	162 / NC/3/MEET/Feb/202223/20
Case Status	Case Approved
Party Name	AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003596AM23
RA File Number	03AX04003333 AM23
Licence No and<br>Date	0311018442/09/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Oct/202223/11 dated 31/10/2022 against advance authorization No.<br>0310838163 dt. 08/09/2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>ETHYLENE OXIDE<br>0.313 kg<br>N-BENZYLETHANOLAMINE<br>1 kg<br>2<br>BENZYL AMINE<br>0.7611 kg<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00366605AM23

Case No.	163 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003598AM23
RA File Number	03AX04003430 AM23
Licence No and<br>Date	0311018444/09/10/2022
Norms Committee Decision:
Deferred for comments of TE.

4/02/2023| |HQ File Number|HQRNORM APPLY 00003598AM23| |RA File Number|03AX04003430 AM23| |Licence No and Date|0311018444/09/10/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.<br>164 / NC/3/MEET/Feb/202223/20	Case No.<br>164 / NC/3/MEET/Feb/202223/20	Case No.<br>164 / NC/3/MEET/Feb/202223/20
Case Status<br>Case Approved
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/	202223/ 20 and 24/02/2023
HQ File Number<br>HQRNORM APPLY 00003604AM23
RA File Number<br>08AX04001050 AM23
Licence No and<br>Date<br>0811006214/10/10/2022
Norms Committee Decision:
The Committee considered the case as		per agenda and it was		decided to ratify norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:
Export product		Qty.	Sl. No.	Import items	Qty.
DOXYCYCLINE DISPERSIBLE		1 Number	1	DOXYCYCLINE MONOHYDRATE	<br>102.908 mg
TABLETS<br>100<br>MG(EACH				EP / BP / IP / USP / PH. EUR.
UNCOATED<br>DISPERSIBLE
TABLET<br>CONTAINS:
DOXYCYCLINE
MONOHYDRATE PH.EUR. EQ.
TO DOXYCYCLINE 100 MG [IN
WHICH ACTIVE INGREDIENT
DOXYCYCLINE
MONOHYDRATE<br>USED<br>IS

BLET CONTAINS:||||||| |DOXYCYCLINE||||||| |MONOHYDRATE PH.EUR. EQ.||||||| |TO DOXYCYCLINE 100 MG [IN||||||| |WHICH ACTIVE INGREDIENT||||||| |DOXYCYCLINE||||||| |MONOHYDRATE USED IS|||||||

Case No.<br>164 / NC/3/MEET/Feb/202223/20	Case No.<br>164 / NC/3/MEET/Feb/202223/20	Case No.<br>164 / NC/3/MEET/Feb/202223/20
Case Status<br>Case Approved
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/	202223/ 20 and 24/02/2023
HQ File Number<br>HQRNORM APPLY 00003604AM23
RA File Number<br>08AX04001050 AM23
Licence No and<br>Date<br>0811006214/10/10/2022
Norms Committee Decision:
The Committee considered the case as		per agenda and it was		decided to ratify norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:
Export product		Qty.	Sl. No.	Import items	Qty.
DOXYCYCLINE DISPERSIBLE		1 Number	1	DOXYCYCLINE MONOHYDRATE	<br>102.908 mg
TABLETS<br>100<br>MG(EACH				EP / BP / IP / USP / PH. EUR.
UNCOATED<br>DISPERSIBLE
TABLET<br>CONTAINS:
DOXYCYCLINE
MONOHYDRATE PH.EUR. EQ.
TO DOXYCYCLINE 100 MG [IN
WHICH ACTIVE INGREDIENT
DOXYCYCLINE
MONOHYDRATE<br>USED<br>IS

UDIN00366605AM23

53.000 KGS.])

RA may take appropriate action as per the decision of Norms Committee.

ICH ACTIVE INGREDIENT||||||| |DOXYCYCLINE||||||| |MONOHYDRATE USED IS|||||||

UDIN00366605AM23

53.000 KGS.])

RA may take appropriate action as per the decision of Norms Committee.

Case No.	165 / NC/3/MEET/Feb/202223/20
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number	HQRNORM APPLY 00003610AM23
RA File Number	34AX04000652 AM23
Licence No and<br>Date	3411002874/10/10/2022
Norms Committee Decision:<br>Deferred for comments of TE

Case No.	Case No.	166 / NC/3/MEET/Feb/202223/20	166 / NC/3/MEET/Feb/202223/20	166 / NC/3/MEET/Feb/202223/20	166 / NC/3/MEET/Feb/202223/20	166 / NC/3/MEET/Feb/202223/20
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202223/ 20 and 24/02/2023
HQ File Number		HQRNORM APPLY 00003614AM23
RA File Number		05AX04001900 AM23
Licence No and<br>Date		0511015213/10/10/2022
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.7/82-ALC4/2020 dated 04.12.2020 against advance authorization No.0510414856 dt.<br>10.08.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl.

856 dt.** 10.08.2020, it was decided to ratify 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.|

UDIN00366605AM23

Tobramycin<br>300mg<br>/<br>5<br>ml	Nebuliser	<br>834400
Solution(Tobramycin 300mg / 5 ml	Nebuliser
Solution (Each ml contains Tobramycin	Ph. Eur. 60	<br>Numbers
mg) (Equivalent to 250.320 Kg of Bulk Drug))

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