IN FORCE Advance Authorisation

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

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Nov/202223/14 DATED: 07/12/2022

Please Note

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

Meeting No. NC/3/MEET/Nov/202223/14 dated 07/12/2022 of Norms Committee - III for the year 2022-23 was held on 07/12/2022 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

cations for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	AJAY KUMAR,Deputy Director	Directorate General of Foreign Trade, Delhi
2	NAND Lal,Technical Authority	Technical Consultant,DGFT
3	SHAISH KUMAR,Technical Authority	Technical Consultant,DGFT
4	DINESHNARAIN MATHUR,Technical<br>Authority	Technical Consultant,DGFT

This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

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Case Details and Decision(s):

Case No.	Case No.	1 / NC/3/MEET/Nov/202223/14	1 / NC/3/MEET/Nov/202223/14	1 / NC/3/MEET/Nov/202223/14	1 / NC/3/MEET/Nov/202223/14	1 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		RISHABH METALS & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM REVIW00003297AM23
RA File Number		039504000554 AM21
Licence No and<br>Date		0311000111/null
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it wasdecided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. 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>1<br>DICYANDIAMIDE 99.5% MIN<br>0.16 kg<br>2<br>DETA (DIETHYLENE TRIAMINE)<br>0.051 kg<br>3<br>EPICHLOROHYDRIN<br>0.03 kg<br>POLYAMINE<br>DERIVATIVES<br>(64% solid content)<br>1 kg<br>4<br>POLYACRYLAMIDE<br>0.32 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	POLYAMINE<br>DERIVATIVES<br>(64% solid content)		<br>1 kg	1	DICYANDIAMIDE 99.5% MIN	0.16 kg
				2	DETA (DIETHYLENE TRIAMINE)	0.051 kg
				3	EPICHLOROHYDRIN	0.03 kg
				4	POLYACRYLAMIDE	0.32 kg
				as per above decision of NC.

ontent)|| 1 kg|1|DICYANDIAMIDE 99.5% MIN|0.16 kg| |||||2|DETA (DIETHYLENE TRIAMINE)|0.051 kg| |||||3|EPICHLOROHYDRIN|0.03 kg| |||||4|POLYACRYLAMIDE|0.32 kg| |||||as per above decision of NC.|||

Case No.	2 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	SCOTT EDIL PHARMACIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00004204AM23
RA File Number	222404000012 AM14
Licence No and<br>Date	2210013838/10/05/2013
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and it was decided to revise adhoc norms as

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under:

Export Product	Qty.	Sl. No.	Import Items	Qty.
Amoxycillin 500 mg Capsules	1 number	1	Amoxycillin Trihydrate BP/EP/USP	585.36 mg

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

Case No.	3 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	DAFFODIL PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00001402AM23
RA File Number	082404000449 AM15
Licence No and<br>Date	0810134978/31/03/2015
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was observed that the import item do not<br>match with the COA now furnished by the firm.<br> Hence, it was decided to call the firm for attendingPersonal Hearing<br> before Norms Committee to<br>explain its case.

mport item do not match with the COA now furnished by the firm. Hence, it was decided to call the firm for attendingPersonal Hearing before Norms Committee to explain its case.||

Case No.	4 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003288AM23
RA File Number	318304000178 AM16
Licence No and<br>Date	3110066046/14/03/2016
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and it was decided to call for following<br>information / documents from the firm:

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i. Actual Production / Consumption for the last three years duly certified by CA.
ii. Complete technical details as per Annexure to Appendix 4E.

iii Reason for very high consumption of Methanol in GST certificate.

n for the last three years duly certified by CA.**

ii. Complete technical details as per Annexure to Appendix 4E.

iii Reason for very high consumption of Methanol in GST certificate.

Case No.	5 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	ELPPE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003433AM23
RA File Number	039404000036 AM18
Licence No and<br>Date	0310812684/24/04/2017
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.10/82-ALC4/2017 dated 10.01.2018 against advance authorization<br>No.0310807534 dated 01.09.2016and it was decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>ISOPHTHALIC ACID<br>2.24 kg<br>2<br>CAUSTIC SODA FLAKES<br>2.00 kg<br>5-HYDROXY ISOPHTHALIC ACID<br>1 kg<br>3<br>CAUSTIC POTASH FLAKES<br>1.80 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	6 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003284AM23
RA File Number	052404000446 AM18
Licence No and<br>Date	0510405089/26/12/2017
Norms Committee Decision:

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14 and 07/12/2022| |HQ File Number|HQRNORM REVIW00003284AM23| |RA File Number|052404000446 AM18| |Licence No and Date|0510405089/26/12/2017| |Norms Committee Decision:||

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The Committee considered the request of firm for revision of adhoc norms and taking cue from SION A-3151 , it was decided to revise adhoc norms as under:

Export Product	Qty	Sl. No.	Import Items	Qty
PLASTICIZER (PVC) (DINP)	1 kg	1	PHTHALIC ANHYDRIDE	0.372 kg
		2	ISO NONANOL	0.726 kg

Case No.	7 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003287AM23
RA File Number	318304000129 AM18
Licence No and<br>Date	3110066979/13/02/2018
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and it was decided to call for following<br>information / documents from the firm:<br>Chemical name of DNOVO.<br>i.<br>Reason for giving chemical reaction starting from Phenol, when import item is 2,6 Xylenol.<br>ii.<br>Complete justification for yield of reaction when theoretically it comes to 0.85 kg/kg of Production.<br>iii.<br>Production consumption data for last three years duly certified by GST.<br>iv.

plete justification for yield of reaction when theoretically it comes to 0.85 kg/kg of Production.** iii. Production consumption data for last three years duly certified by GST. iv.||

Case No.	8 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003343AM23
RA File Number	039404000911 AM18
Licence No and<br>Date	0310819230/19/02/2018
Norms Committee Decision:

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The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing before Norms Committee alongwith sample of each import item and export item.

Case No.	Case No.	Case No.	9 / NC/3/MEET/Nov/202223/14	9 / NC/3/MEET/Nov/202223/14	9 / NC/3/MEET/Nov/202223/14	9 / NC/3/MEET/Nov/202223/14	9 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM REVIW00004051AM23
RA File Number			092404000229 AM19
Licence No and<br>Date			0910066775/26/10/2018

Date|||NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022||||| |HQ File Number|||HQRNORM REVIW00004051AM23||||| |RA File Number|||092404000229 AM19||||| |Licence No and Date|||0910066775/26/10/2018||||| |Norms Committee Decision: The Committee considered the request of firm for revision of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting NoNC/3/MEET/Sep/202223/7 dated 16/09/2022 against advance authorization No.0910067519 dated 14/05/2019and it was decided to revise adhoc norms as under: Sl. No. Export Product Qty Sl. No. Import Items Qty 1 Heparin Sodium 39.733 mg 2 Barrel Syringes Net + 5% wastage 3 Needle Shield Net to Net 4 Plunger Stoppers Net + 12% wastage 5 Plunger Rods Net + 2.5% wastage 1 Enoxaparin Sodium Injection 20mg Pre- filled Syringes 1 Number 6 Preventis Needle Shielding System Net + 3% wastage 1 Heparin Sodium 79.466 mg 2 Barrel Syringes Net + 5% wastage 3 Needle Shield Net to Net 4 Plunger Stoppers Net + 11.55% wastage 2 Enoxaparin Sodium Injection 40mg Pre- filled Syringes 1 Number|||||||| ||Sl. No.|Export Product||Qty|Sl.

edle Shield Net to Net 4 Plunger Stoppers Net + 11.55% wastage 2 Enoxaparin Sodium Injection 40mg Pre- filled Syringes 1 Number|||||||| ||Sl. No.|Export Product||Qty|Sl. No.|Import Items|Qty| ||1|Enoxaparin Sodium Injection 20mg Pre- filled Syringes|| 1 Number|1|Heparin Sodium|39.733 mg| ||||||2|Barrel Syringes|Net + 5% wastage| ||||||3|Needle Shield|Net to Net| ||||||4|Plunger Stoppers|Net + 12% wastage| ||||||5|Plunger Rods|Net + 2.5% wastage| ||||||6|Preventis Needle Shielding System|Net + 3% wastage| ||2|Enoxaparin Sodium Injection 40mg Pre- filled Syringes|| 1 Number|1|Heparin Sodium|79.466 mg| ||||||2|Barrel Syringes|Net + 5% wastage| ||||||3|Needle Shield|Net to Net| ||||||4|Plunger Stoppers|Net + 11.55% wastage|

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			5	Plunger Rods	Net + 2.5% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage
3	Enoxaparin<br>Sodium<br>Injection 60mg Pre-<br>filled Syringes	<br>1 Number	1	Heparin Sodium	119.187 mg
			2	Barrel Syringes	Net + 5% wastage
			3	Needle Shield	Net to Net
			4	Plunger Stoppers	Net + 10.85% wastage
			5	Plunger Rods	Net + 1.65% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage
4	Enoxaparin<br>Sodium<br>Injection 80mg Pre-<br>filled Syringes	<br>1 Number	1	Heparin Sodium	158.93 mg
			2	Barrel Syringes	Net + 4.65% wastage
			3	Needle Shield	Net to Net
			4	Plunger Stoppers	Net + 12% wastage
			5	Plunger Rods	Net + 2.5% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage

ges|Net + 4.65% wastage| |||||3|Needle Shield|Net to Net| |||||4|Plunger Stoppers|Net + 12% wastage| |||||5|Plunger Rods|Net + 2.5% wastage| |||||6|Preventis Needle Shielding System|Net + 3% wastage| ||5|Enoxaparin Sodium Injection 120mg Pre- filled Syringes| 1 Number|1|Heparin Sodium|238.40 mg| |||||2|Barrel Syringes|Net + 5% wastage| |||||3|Needle Shield|Net to Net| |||||4|Plunger Stoppers|Net + 12% wastage|

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			5	Plunger Rods	Net + 2.5% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage
6	Enoxaparin<br>Sodium<br>Injection 150mg Pre-<br>filled Syringes	<br>1 Number	1	Heparin Sodium	298.00 mg
			2	Barrel Syringes	Net + 5% wastage
			3	Needle Shield	Net to Net
			4	Plunger Stoppers	Net + 12% wastage
			5	Plunger Rods	Net + 2.5% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage

es|Net + 5% wastage| |||||3|Needle Shield|Net to Net| |||||4|Plunger Stoppers|Net + 12% wastage| |||||5|Plunger Rods|Net + 2.5% wastage| |||||6|Preventis Needle Shielding System|Net + 3% wastage|

Case No.	Case No.	10 / NC/3/MEET/Nov/202223/14	10 / NC/3/MEET/Nov/202223/14	10 / NC/3/MEET/Nov/202223/14	10 / NC/3/MEET/Nov/202223/14	10 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM REVIW00004310AM23
RA File Number		039504000692 AM19
Licence No and<br>Date		0310824780/29/10/2018
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting NoNC/3/MEET/Sep/202223/9 dated 07/10/2022 against advance<br>authorization No.0310829915 dated 25/06/2019and it was decided to revise adhoc norms as under:<br>Export Product<br>Qty<br>Sl. No. Import Items<br>Qty
	Export Product		Qty	Sl. No.	Import Items	Qty

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

y||||||| ||Export Product||Qty|Sl. No.|Import Items|Qty|

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

Case No.	Case No.	Case No.	11 / NC/3/MEET/Nov/202223/14	11 / NC/3/MEET/Nov/202223/14	11 / NC/3/MEET/Nov/202223/14	11 / NC/3/MEET/Nov/202223/14	11 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM REVIW00004045AM23
RA File Number			092404000420 AM19
Licence No and<br>Date			0910066931/03/12/2018
Norms Committee Decision:<br>T<br>The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for same export<br>product / import item in Meeting NoNC/3/MEET/Sep/202223/7 dated 16/09/2022against advance authorization No.<br>0910067519 dated 14/05/2019and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:<br>Sl. No. Export Product<br>Qty<br>Sl. No.

019**and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export Product Qty Sl. No. Import Items Qty 1 Heparin Sodium 39.733 mg 2 0.5ml Barrel Syringes Net + 5% wastage 3 0.5ml Needle Shield Net to Net 4 0.5ml Plunger Stoppers Net + 12% wastage 5 0.5ml Plunger Rods Net + 2.5% wastage 1 Enoxaparin Sodium Injection 20mg Pre-filled Syringes 1 Number 6 0.5ml Preventis Needle Shielding System Net + 3% wastage|||||||| ||Sl. No.|Export Product||Qty|Sl. No.|Import Items|Qty| ||1|Enoxaparin Sodium Injection 20mg Pre-filled Syringes|| 1 Number|1|Heparin Sodium|39.733 mg| ||||||2|0.5ml Barrel Syringes|Net + 5% wastage| ||||||3|0.5ml Needle Shield|Net to Net| ||||||4|0.5ml Plunger Stoppers|Net + 12% wastage| ||||||5|0.5ml Plunger Rods|Net + 2.5% wastage| ||||||6|0.5ml Preventis Needle Shielding System|Net + 3% wastage|

3|0.5ml Needle Shield|Net to Net| ||||||4|0.5ml Plunger Stoppers|Net + 12% wastage| ||||||5|0.5ml Plunger Rods|Net + 2.5% wastage| ||||||6|0.5ml Preventis Needle Shielding System|Net + 3% wastage|

Case No.	Case No.	Case No.	11 / NC/3/MEET/Nov/202223/14	11 / NC/3/MEET/Nov/202223/14	11 / NC/3/MEET/Nov/202223/14	11 / NC/3/MEET/Nov/202223/14	11 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM REVIW00004045AM23
RA File Number			092404000420 AM19
Licence No and<br>Date			0910066931/03/12/2018
Norms Committee Decision:<br>T<br>The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for same export<br>product / import item in Meeting NoNC/3/MEET/Sep/202223/7 dated 16/09/2022against advance authorization No.<br>0910067519 dated 14/05/2019and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:<br>Sl. No. Export Product<br>Qty<br>Sl. No.

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t to Net| ||||||4|0.5ml Plunger Stoppers|Net + 12% wastage| ||||||5|0.5ml Plunger Rods|Net + 2.5% wastage| ||||||6|0.5ml Preventis Needle Shielding System|Net + 3% wastage|

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1<br>Heparin Sodium<br>79.466 mg<br>2<br>0.5ml Barrel Syringes<br>Net + 5% wastage<br>3<br>0.5ml Needle Shield<br>Net to Net<br>4<br>0.5ml Plunger Stoppers<br>Net + 11.55% wastage<br>5<br>0.5ml Plunger Rods<br>Net + 2.5% wastage<br>2<br>Enoxaparin<br>Sodium<br>Injection 40mg Pre-filled<br>Syringes<br>1 Number<br>6<br>0.5ml Preventis Needle Shielding System<br>Net + 3% wastage<br>1<br>Heparin Sodium<br>119.187 mg<br>2<br>1 ml Barrel Syringes<br>Net + 5% wastage<br>3<br>1 ml Needle Shield<br>Net to Net<br>4<br>1 ml Plunger Stoppers<br>Net + 10.85% wastage<br>5<br>1 ml Plunger Rods<br>Net + 1.65% wastage<br>3<br>Enoxaparin<br>Sodium<br>Injection 60mg Pre-filled<br>Syringes<br>1 Number<br>6<br>1 ml Preventis Needle Shielding System<br>Net + 3% wastage<br>1<br>Heparin Sodium<br>158.93 mg<br>2<br>1 ml Barrel Syringes<br>Net + 4.65% wastage<br>3<br>1 ml Needle Shield<br>Net to Net<br>4<br>1 ml Plunger Stoppers<br>Net + 12% wastage<br>5<br>1 ml Plunger Rods<br>Net + 2.5% wastage<br>4<br>Enoxaparin<br>Sodium<br>Injection 80mg Pre-filled<br>Syringes<br>1 Number<br>6<br>1 ml Preventis Needle Shielding System<br>Net + 3% wastage<br> <br>RA concerned may take further necessary action as per above decision of NC.	2	Enoxaparin<br>Sodium<br>Injection 40mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	79.466 mg

2	Enoxaparin<br>Sodium<br>Injection 40mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	79.466 mg
			2	0.5ml Barrel Syringes	Net + 5% wastage
			3	0.5ml Needle Shield	Net to Net
			4	0.5ml Plunger Stoppers	Net + 11.55% wastage
			5	0.5ml Plunger Rods	Net + 2.5% wastage
			6	0.5ml Preventis Needle Shielding System	Net + 3% wastage
3	Enoxaparin<br>Sodium<br>Injection 60mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	119.187 mg
			2	1 ml Barrel Syringes	Net + 5% wastage
			3	1 ml Needle Shield	Net to Net
			4	1 ml Plunger Stoppers	Net + 10.85% wastage
			5	1 ml Plunger Rods	Net + 1.65% wastage
			6	1 ml Preventis Needle Shielding System	Net + 3% wastage
4	Enoxaparin<br>Sodium<br>Injection 80mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	158.93 mg
			2	1 ml Barrel Syringes	Net + 4.65% wastage
			3	1 ml Needle Shield	Net to Net
			4	1 ml Plunger Stoppers	Net + 12% wastage
			5	1 ml Plunger Rods	Net + 2.5% wastage
			6	1 ml Preventis Needle Shielding System	Net + 3% wastage

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d|Net to Net| |||||4|1 ml Plunger Stoppers|Net + 12% wastage| |||||5|1 ml Plunger Rods|Net + 2.5% wastage| |||||6|1 ml Preventis Needle Shielding System|Net + 3% wastage|

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Case No.	Case No.	Case No.	12 / NC/3/MEET/Nov/202223/14	12 / NC/3/MEET/Nov/202223/14	12 / NC/3/MEET/Nov/202223/14	12 / NC/3/MEET/Nov/202223/14	12 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM REVIW00004052AM23
RA File Number			092404000419 AM19
Licence No and<br>Date			0910066930/03/12/2018
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting NoNC/3/MEET/Sep/202223/7 dated 16/09/2022 against advance<br>authorization No.0910067519 dated 14/05/2019and it was decided to revise adhoc norms as under:<br>Sl. No.<br>Export Product<br>Qty<br>Sl.

/MEET/Sep/202223/7 dated 16/09/2022** against advance authorization No.0910067519 dated 14/05/2019and it was decided to revise adhoc norms as under: Sl. No. Export Product Qty Sl. No. Import Items Qty 1 Heparin Sodium 39.733 mg 2 0.5ml Barrel Syringes Net + 5% wastage 3 0.5ml Needle Shield Net to Net 4 0.5ml Plunger Stoppers Net + 12% wastage 5 0.5ml Plunger Rods Net + 2.5% wastage 1 Enoxaparin Sodium Injection 20mg Pre-filled Syringes 1 Number 6 0.5ml Preventis Needle Shielding System Net + 3% wastage 1 Heparin Sodium 79.466 mg 2 0.5ml Barrel Syringes Net + 5% wastage 3 0.5ml Needle Shield Net to Net 4 0.5ml Plunger Stoppers Net + 11.55% wastage 5 0.5ml Plunger Rods Net + 2.5% wastage 2 Enoxaparin Sodium Injection 40mg Pre-filled Syringes 1 Number 6 0.5ml Preventis Needle Shielding System Net + 3% wastage|||||||| ||Sl. No.|Export Product||Qty|Sl.

wastage 2 Enoxaparin Sodium Injection 40mg Pre-filled Syringes 1 Number 6 0.5ml Preventis Needle Shielding System Net + 3% wastage|||||||| ||Sl. No.|Export Product||Qty|Sl. No.|Import Items|Qty| ||1|Enoxaparin Sodium Injection 20mg Pre-filled Syringes|| 1 Number|1|Heparin Sodium|39.733 mg| ||||||2|0.5ml Barrel Syringes|Net + 5% wastage| ||||||3|0.5ml Needle Shield|Net to Net| ||||||4|0.5ml Plunger Stoppers|Net + 12% wastage| ||||||5|0.5ml Plunger Rods|Net + 2.5% wastage| ||||||6|0.5ml Preventis Needle Shielding System|Net + 3% wastage| ||2|Enoxaparin Sodium Injection 40mg Pre-filled Syringes|| 1 Number|1|Heparin Sodium|79.466 mg| ||||||2|0.5ml Barrel Syringes|Net + 5% wastage| ||||||3|0.5ml Needle Shield|Net to Net| ||||||4|0.5ml Plunger Stoppers|Net + 11.55% wastage| ||||||5|0.5ml Plunger Rods|Net + 2.5% wastage| ||||||6|0.5ml Preventis Needle Shielding System|Net + 3% wastage|

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Net| ||||||4|0.5ml Plunger Stoppers|Net + 11.55% wastage| ||||||5|0.5ml Plunger Rods|Net + 2.5% wastage| ||||||6|0.5ml Preventis Needle Shielding System|Net + 3% wastage|

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3	Enoxaparin<br>Sodium<br>Injection 60mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	119.187 mg
			2	1ml Barrel Syringes	Net + 5% wastage
			3	1ml Needle Shield	Net to Net
			4	1ml Plunger Stoppers	Net + 10.85% wastage
			5	1ml Plunger Rods	Net + 1.65% wastage
			6	1ml Preventis Needle Shielding System	Net + 3% wastage
4	Enoxaparin<br>Sodium<br>Injection 80mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	158.93 mg
			2	1ml Barrel Syringes	Net + 4.65% wastage

edle Shielding System|Net + 3% wastage| ||4|Enoxaparin Sodium Injection 80mg Pre-filled Syringes| 1 Number|1|Heparin Sodium|158.93 mg| |||||2|1ml Barrel Syringes|Net + 4.65% wastage| |||||3|1ml Needle Shield|Net to Net| |||||4|1ml Plunger Stoppers|Net + 12% wastage| |||||5|1ml Plunger Rods|Net + 2.5% wastage| |||||6|1ml Preventis Needle Shielding System|Net + 3% wastage|

Case No.	13 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003496AM23
RA File Number	522404000068 AM19
Licence No and<br>Date	5210042870/18/12/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:

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

Case No.	14 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	HEMA DYECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00001544AM23
RA File Number	039404001141 AM19
Licence No and<br>Date	0310828400/16/04/2019
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and it was decided to call for following<br>information / documents from the firm:<br>As per details furnished Residue generation is 6.2% and Distilled Loss is 5.1%. Please clarify it<br>i.<br>Production / Consumption data for last two years duly certified by GST.<br>ii.

Case No.	15 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003269AM23
RA File Number	039504000851 AM20
Licence No and<br>Date	0310833095/29/11/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms andit was observed that earlier the norms were<br>ratified as per SION A - 412. Hence, it was decided torejectthe case maintaining the status quo.<br> RA concerned may take further necessary action as per above decision of NC.

orms were ratified as per SION A - 412. Hence, it was decided torejectthe case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.||

Case No.	16 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
PartyName	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED

13 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

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Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003267AM23
RA File Number	039504000902 AM20
Licence No and<br>Date	0310833406/13/12/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms andit was observed that earlier the norms were<br>ratified as per SION A - 412. Hence, it was decided torejectthe case maintaining the status quo.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	17 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
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.

14 and 07/12/2022| |HQ File Number|018205001343AM21| |RA File Number|039404000110 AM21| |Licence No and Date|0310836469/01/06/2020| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.	Case No.	18 / NC/3/MEET/Nov/202223/14	18 / NC/3/MEET/Nov/202223/14	18 / NC/3/MEET/Nov/202223/14	18 / NC/3/MEET/Nov/202223/14	18 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM REVIW00004050AM23
RA File Number			092404000069 AM21
Licence No and<br>Date			0910068850/05/06/2020
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting NoNC/3/MEET/Sep/202223/7 dated 16/09/2022 against advance<br>authorization No.0910067519 dated 14/05/2019and it was decided to revise adhoc norms as under:<br>Sl. No. Export Product<br>Qty<br>Sl.<br>No.<br>Import Items<br>Qty
	Sl. No.	Export Product		Qty	Sl.<br>No.	Import Items	Qty

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ed to revise adhoc norms as under: Sl. No. Export Product Qty Sl. No. Import Items Qty|||||||| ||Sl. No.|Export Product||Qty|Sl. No.|Import Items|Qty|

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1<br>Heparin Sodium<br>39.733 mg<br>2<br>Barrel Syringes<br>Net + 5% wastage<br>3<br>Plunger Stoppers<br>Net + 12% wastage<br>4<br>Plunger Rods<br>Net + 2.5% wastage<br>1<br>Low<br>Molecular<br>Weight<br>Heparin Enoxaparin Sodium<br>Injection<br>20mg<br>Pre-filled<br>Syringes<br>1 Number<br>5<br>Preventis Needle Shielding<br>System<br>Net + 3% wastage<br>1<br>Heparin Sodium<br>59.6 mg<br>2<br>Barrel Syringes<br>Net + 5% wastage<br>3<br>Plunger Stoppers<br>Net + 12% wastage<br>4<br>Plunger Rods<br>Net + 2.5% wastage<br>2<br>Enoxaparin Sodium Injection<br>30mg/0.3ML<br>Pre-filled<br>Syringes<br>1 Number<br>5<br>Preventis Needle Shielding<br>System<br>Net + 3% wastage<br>1<br>Heparin Sodium<br>158.93 mg<br>2<br>Barrel Syringes<br>Net + 5% wastage<br>3<br>Plunger Stoppers<br>Net + 12% wastage<br>4<br>Plunger Rods<br>Net + 2.5% wastage<br>3<br>Low<br>Molecular<br>Weight<br>Heparin Enoxaparin Sodium<br>Injection<br>80mg<br>Pre-filled<br>Syringes<br>1 Number<br>5<br>Preventis Needle Shielding<br>System<br>Net + 3% wastage<br> <br>RA concerned may take further necessary action as per above decision of NC	1	Low<br>Molecular<br>Weight<br>Heparin Enoxaparin Sodium<br>Injection<br>20mg<br>Pre-filled<br>Syringes	<br> <br> <br>1 Number	1	Heparin Sodium	39.733 mg
				2	Barrel Syringes	Net + 5% wastage
				3	Plunger Stoppers	Net + 12% wastage

20mg Pre-filled Syringes| 1 Number|1|Heparin Sodium|39.733 mg| |---|---|---|---|---|---|---| |||||2|Barrel Syringes|Net + 5% wastage| |||||3|Plunger Stoppers|Net + 12% wastage| |||||4|Plunger Rods|Net + 2.5% wastage| |||||5|Preventis Needle Shielding System|Net + 3% wastage| ||2|Enoxaparin Sodium Injection 30mg/0.3ML Pre-filled Syringes| 1 Number|1|Heparin Sodium|59.6 mg| |||||2|Barrel Syringes|Net + 5% wastage| |||||3|Plunger Stoppers|Net + 12% wastage| |||||4|Plunger Rods|Net + 2.5% wastage| |||||5|Preventis Needle Shielding System|Net + 3% wastage| ||3|Low Molecular Weight Heparin Enoxaparin Sodium Injection 80mg Pre-filled Syringes| 1 Number|1|Heparin Sodium|158.93 mg| |||||2|Barrel Syringes|Net + 5% wastage| |||||3|Plunger Stoppers|Net + 12% wastage| |||||4|Plunger Rods|Net + 2.5% wastage| |||||5|Preventis Needle Shielding System|Net + 3% wastage|

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

Case No.	19 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	GLAND PHARMA LIMITED

UDIN00286113AM23

take further necessary action as per above decision of NC

Case No.	19 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	GLAND PHARMA LIMITED

UDIN00286113AM23

Meeting Number<br>and Date	Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM REVIW00004055AM23
RA File Number			092404000070 AM21
Licence No and<br>Date			0910068942/07/07/2020
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting NoNC/3/MEET/Sep/202223/7 dated 16/09/2022 against advance<br>authorization No.0910067519 dated 14/05/2019and it was decided to revise adhoc norms as under:<br>Sl. No.<br>Export Product<br>Qty<br>Sl. No.

T/Sep/202223/7 dated 16/09/2022** against advance authorization No.0910067519 dated 14/05/2019and it was decided to revise adhoc norms as under: Sl. No. Export Product Qty Sl. No. Import Items Qty 1 Heparin Sodium 198.664 mg 2 Barrel Syringes Net + 5% wastage 3 Needle Shield Net to Net 4 Plunger Stoppers Net + 12% wastage 5 Plunger Rods Net + 2.5% wastage 1 Enoxaparin Sodium Injection 100mg Pre-filled Syringes 1 Number 6 Preventis Needle Shielding System Net + 3% wastage 1 Heparin Sodium 238.40 mg 2 Barrel Syringes Net + 5% wastage 3 Needle Shield Net to Net 4 Plunger Stoppers Net + 12% wastage 5 Plunger Rods Net + 2.5% wastage 2 Enoxaparin Sodium Injection 120mg Pre-filled Syringes 1 Number 6 Preventis Needle Shielding System Net + 3% wastage 1 Heparin Sodium 298.00 mg Enoxaparin Sodium 1 Number 3|||||||| ||Sl. No.|Export Product||Qty|Sl.

Syringes 1 Number 6 Preventis Needle Shielding System Net + 3% wastage 1 Heparin Sodium 298.00 mg Enoxaparin Sodium 1 Number 3|||||||| ||Sl. No.|Export Product||Qty|Sl. No.|Import Items|Qty| ||1|Enoxaparin Sodium Injection 100mg Pre-filled Syringes|| 1 Number|1|Heparin Sodium|198.664 mg| ||||||2|Barrel Syringes|Net + 5% wastage| ||||||3|Needle Shield|Net to Net| ||||||4|Plunger Stoppers|Net + 12% wastage| ||||||5|Plunger Rods|Net + 2.5% wastage| ||||||6|Preventis Needle Shielding System|Net + 3% wastage| ||2|Enoxaparin Sodium Injection 120mg Pre-filled Syringes|| 1 Number|1|Heparin Sodium|238.40 mg| ||||||2|Barrel Syringes|Net + 5% wastage| ||||||3|Needle Shield|Net to Net| ||||||4|Plunger Stoppers|Net + 12% wastage| ||||||5|Plunger Rods|Net + 2.5% wastage| ||||||6|Preventis Needle Shielding System|Net + 3% wastage| ||3|Enoxaparin Sodium||1 Number|1|Heparin Sodium|298.00 mg|

UDIN00286113AM23

astage| ||||||5|Plunger Rods|Net + 2.5% wastage| ||||||6|Preventis Needle Shielding System|Net + 3% wastage| ||3|Enoxaparin Sodium||1 Number|1|Heparin Sodium|298.00 mg|

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2	Barrel Syringes	Net + 5% wastage
3	Needle Shield	Net to Net
4	Plunger Stoppers	Net + 12% wastage
5	Plunger Rods	Net + 2.5% wastage
6	Preventis Needle Shielding System	Net + 3% wastage

Case No.	Case No.	20 / NC/3/MEET/Nov/202223/14	20 / NC/3/MEET/Nov/202223/14	20 / NC/3/MEET/Nov/202223/14	20 / NC/3/MEET/Nov/202223/14	20 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00234858AM22
RA File Number		092404000482 AM21
Licence No and<br>Date		0910069522/27/11/2020

and Date||NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022||||| |HQ File Number||HQRNORM APPLY 00234858AM22||||| |RA File Number||092404000482 AM21||||| |Licence No and Date||0910069522/27/11/2020||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No NC/3/MEET/Sep/202223/9dated07/10/2022 against advance authorization No. 0910069418dated29/10/2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 4-Pentyn-1-ol 1.22 kg 2 Iodobenzene diacerate 4.78 kg 3 Di-tert-butyl dicarbonate (Boc anhydride) 3.16 kg 4 CDX-034 Lyophilized Enzyme Powder 0.030 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|4-Pentyn-1-ol|1.22 kg| |||||2|Iodobenzene diacerate|4.78 kg| |||||3|Di-tert-butyl dicarbonate (Boc anhydride)|3.16 kg| |||||4|CDX-034 Lyophilized Enzyme Powder|0.030 kg|

UDIN00286113AM23

	5	Beta-Nicotinamide adenine dinucleotide	<br>0.008 kg
		phosphate Sodium salt (beta-NADP-Na)
	6	P-Iodonitro benzene	0.904 kg

Powder|0.030 kg|

UDIN00286113AM23

	5	Beta-Nicotinamide adenine dinucleotide	<br>0.008 kg
		phosphate Sodium salt (beta-NADP-Na)
	6	P-Iodonitro benzene	0.904 kg

Case No.	21 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00049028AM21
RA File Number	07AA04006399 AM21
Licence No and<br>Date	0711000171/28/12/2020
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 technical details as per Annexure to Appendix 4E.

Case No.	22 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	YASH RASAYAN & CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00056208AM21
RA File Number	34AA04001756 AM21
Licence No and<br>Date	3411000089/06/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08/07/2022against advance authorization No.<br>3410044109 dated 27/04/2018, 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:

UDIN00286113AM23

dated 27/04/2018**, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:||

UDIN00286113AM23

Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>METHYL SALICYLATE<br>1.052 kg<br>2-METHOXY BENZOIC ACID<br>1 kg<br>2<br>DIMETHYL SULPHATE<br>0.8717 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl.<br>No.	Import items	Qty.
	2-METHOXY BENZOIC ACID	1 kg	1	METHYL SALICYLATE	1.052 kg
			2	DIMETHYL SULPHATE	0.8717 kg

Case No.	23 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00057063AM21
RA File Number	03AA04015653 AM21
Licence No and<br>Date	0311000731/07/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>NITROXOLINE (BP/USP)<br>1 kg<br>1<br>8 HYDROXY QUINOLINE<br>1.235 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

y. Sl. No. Import items Qty. NITROXOLINE (BP/USP) 1 kg 1 8 HYDROXY QUINOLINE 1.235 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	24 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003396AM23
RA File Number	08AA04006131 AM21
Licence No and	0811000317/08/01/2021

UDIN00286113AM23

Date

Norms Committee Decision:

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

Export product	Qty.	Sl. No.	Import items	Qty.
Meropenem<br>for<br>Injection<br>1gm((Net Content of Export Items<br>is<br>112.50<br>K.G.))<br>(Each<br>vial<br>contains Meropenem Trihydrate<br>USP equivalent to Anhydrous<br>Meropenem 1 gm)	<br> <br> <br> <br> <br>1 Number	1	STERILE MIXTURE OF MEROPENEM<br>AND SODIUM CARBONATE	<br>1.29 gram

Case No.	25 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00058376AM21
RA File Number	09AA04003607 AM21
Licence No and<br>Date	0911000131/08/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	26 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00066631AM21
RA File Number	03AA04019289 AM21

UDIN00286113AM23

Licence No and Date 0311001091/20/01/2021

Norms Committee Decision:

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

Licence No and Date	0311001091/20/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>(R)-3-Amino butan-1-ol<br>19.635 mg<br>2<br>1-(2,2-dimethoxyethyl)-5-methoxy-<br>6(methoxycarbonyl)<br>4-oxo-1,4-<br>dihydropyridine-3-carboxylic acid<br>Indigenously<br>procured<br>3<br>Lithium bromide anhydrous<br>Indigenously<br>procured<br>4<br>9-(R)-phosphonomethoxy<br>propyl<br>adenine<br>205.02 mg<br>Lamivudine 300mg + Tenofovir<br>disoproxil Fumarate 300mg +<br>Dolutegravir<br>Sodium<br>50mg<br>tablets(Lamivudine<br>300mg<br>+<br>Tenofovir<br>disoproxil<br>Fumarate<br>300mg + Dolutegravir Sodium<br>50mg<br>tablets<br>(Net<br>content:<br>3225.00 kgs Dolutegravir Sodium<br>+<br>19350.00<br>kgs<br>Tenofovir<br>Disoproxil Fumarate + 19350.00<br>kgs Lamivudine))<br>1 Number<br>5<br>LAMIVUDINE<br>Indigenously<br>procured<br> <br>RA concerned may take further necessary action as per above decision of NC.

Licence No and Date

0311001091/20/01/2021

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 (R)-3-Amino butan-1-ol 19.635 mg 2 1-(2,2-dimethoxyethyl)-5-methoxy- 6(methoxycarbonyl) 4-oxo-1,4- dihydropyridine-3-carboxylic acid Indigenously procured 3 Lithium bromide anhydrous Indigenously procured 4 9-(R)-phosphonomethoxy propyl adenine 205.02 mg Lamivudine 300mg + Tenofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets(Lamivudine 300mg + Tenofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets (Net content: 3225.00 kgs Dolutegravir Sodium + 19350.00 kgs Tenofovir Disoproxil Fumarate + 19350.00 kgs Lamivudine)) 1 Number 5 LAMIVUDINE Indigenously procured RA concerned may take further necessary action as per above decision of NC.

isoproxil Fumarate + 19350.00 kgs Lamivudine)) 1 Number 5 LAMIVUDINE Indigenously procured RA concerned may take further necessary action as per above decision of NC.||

Case No.	27 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00067524AM21
RA File Number	07AA04007364 AM21
Licence No and<br>Date	0711000345/21/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:

UDIN00286113AM23

Export product	Qty.	Sl. No.	Import items	Qty.
CLOMIPRAMINE HCL<br>(BP/EP/USP/JP)	1 kg	1	1 BROMO 3 CHLORO PROPANE	0.85 kg
		2	IMINODIBENZYL	1.00 kg
		3	METHANOL	1.20 kg
		4	IPA	0.50 kg
		5	TOLUENE	0.50 kg
		6	ACETONE	1.00 kg

||CLOMIPRAMINE HCL (BP/EP/USP/JP)|1 kg|1|1 BROMO 3 CHLORO PROPANE|0.85 kg| ||||2|IMINODIBENZYL|1.00 kg| ||||3|METHANOL|1.20 kg| ||||4|IPA|0.50 kg| ||||5|TOLUENE|0.50 kg| ||||6|ACETONE|1.00 kg|

Case No.	Case No.	28 / NC/3/MEET/Nov/202223/14	28 / NC/3/MEET/Nov/202223/14	28 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		MACLEODS PHARMACEUTICALS LTD
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00070745AM21
RA File Number		03AA04020126 AM21
Licence No and Date		0311001263/27/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>(R)-3-AMINO-1-BUTANOL<br>19.635 mg<br>2<br>1-(2,2-dimethoxyethyl)-5-methoxy-<br>6(methoxycarbonyl)<br>4-oxo-1,4-<br>dihydropyridine-3-carboxylic acid<br>Indigenously<br>procured<br>Lamivudine 300mg + Tenofovir<br>disoproxil Fumarate 300mg +<br>Dolutegravir<br>Sodium<br>50mg<br>tablets(Lamivudine 300mg +<br>1 Number
	Export product		Qty.	Sl.

r>Indigenously procured Lamivudine 300mg + Tenofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets(Lamivudine 300mg + 1 Number||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Lamivudine 300mg + Tenofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets(Lamivudine 300mg +|| 1 Number|1|(R)-3-AMINO-1-BUTANOL|19.635 mg| |||||2|1-(2,2-dimethoxyethyl)-5-methoxy- 6(methoxycarbonyl) 4-oxo-1,4- dihydropyridine-3-carboxylic acid|Indigenously procured|

UDIN00286113AM23

Tenofovir	disoproxil<br>Fumarate		3	Lithium bromide anhydrous	Indigenously
300mg +	Dolutegravir Sodium				procured
50mg<br>tablets<br>(Net<br>content:
17160.00<br>17160.00<br>Disoproxil	kgs<br>Lamivudine<br>+<br>kgs<br>Tenofovir<br>Fumarate + 2860.00	<br> <br>	4	(R)-9-(2-phosphonomethoxy propyl)-<br>adenine	205.02 mg
kgs Dolutegravir Sodium))
			5	LAMIVUDINE	Indigenously
					procured

br>+ kgs Tenofovir Fumarate + 2860.00| |4|(R)-9-(2-phosphonomethoxy propyl)- adenine|205.02 mg| |kgs Dolutegravir Sodium))|||||| ||||5|LAMIVUDINE|Indigenously| ||||||procured|

Case No.	29 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00071643AM21
RA File Number	07AA04007643 AM21
Licence No and<br>Date	0711000370/28/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	30 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00082860AM21
RA File Number	092404000486 AM21
Licence No and<br>Date	0911000238/12/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it wasdecided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:

UDIN00286113AM23

he case as per agenda and it wasdecided to ratify adhoc norms under Para 4.07 of HBP|| |Vol. I as per details given below or as applied by the firm, whichever is less:||

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Sl. No.	Export Product	Qty	Sl. No.	Import Items	Qty
1	Amoxycilin Capsules 250 mg<br>(Each<br>capsule<br>containing<br>Amoxycllin<br>Trihydrate<br>equivalent<br>to<br>250<br>mg<br>of<br>Amoxycillin))	<br> <br> <br> <br>1 Number	1	6-APA (6-Amino Penicillanic Acid)	162.50 mg
			2	Methyl d-(-)-4-hydroxy-phenylglycinate OR D-(-<br>)-4-hydroxyphenylglycine methyl ester [PHPG<br>Ester].	<br>140.93 mg
			3	Penicillin G Amidase (Particle size 250 - 500<br>micron, Creamish to Brown regularly shaped<br>beads)	<br> <br>0.50 mg
2	Amoxycilin Capsules 500 mg<br>(Each<br>capsule<br>containing<br>Amoxycllin<br>Trihydrate<br>equivalent<br>to<br>500<br>mg<br>of<br>Amoxycillin))	<br> <br> <br> <br>1 Number	1	6-APA (6-Amino Penicillanic Acid)	325.00 mg
			2	Methyl d-(-)-4-hydroxy-phenylglycinate OR D-(-<br>)-4-hydroxyphenylglycine methyl ester [PHPG<br>Ester].	<br>281.86 mg
			3	Penicillin G Amidase (Particle size 250 - 500<br>micron, Creamish to Brown regularly shaped<br>beads)	<br> <br>1.00 mg

)-4-hydroxyphenylglycine methyl ester [PHPG Ester].| 281.86 mg| ||||3|Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads)| 1.00 mg|

Case No.	31 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003397AM23
RA File Number	08AA04008543 AM21
Licence No and<br>Date	0811000672/15/02/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

UDIN00286113AM23

|Export product Qty. Sl. No. Import items Qty. MEROPENEM FOR INJECTION 1GM USP/ BP/ IP/ CEP/ EP/ ChP ((NET CONTENT OF EXPORT ITEM IS 110 K.G.)) (Each vial contains Meropenem Trihydrate USP equivalent to Anhydrous Meropenem 1 gm) 1 Number 1 STERILE MIXTURE OF MEROPENEM AND SODIUM CARBONATE 1.29 gram RA concerned may take further necessary action as per above decision of NC.|Export product|Qty.|Sl.

gm)<br>1 Number<br>1<br>STERILE MIXTURE OF MEROPENEM<br>AND SODIUM CARBONATE<br>1.29 gram<br> <br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl. No.	Import items	Qty.
	MEROPENEM FOR INJECTION<br>1GM USP/ BP/ IP/ CEP/ EP/ ChP<br>((NET CONTENT OF EXPORT<br>ITEM IS 110 K.G.)) (Each vial<br>contains Meropenem Trihydrate<br>USP equivalent to Anhydrous<br>Meropenem 1 gm)	<br> <br> <br> <br> <br> <br>1 Number	1	STERILE MIXTURE OF MEROPENEM<br>AND SODIUM CARBONATE	<br>1.29 gram

Case No.	32 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00085836AM21
RA File Number	34AA04001557 AM21
Licence No and<br>Date	3411000043/17/02/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	33 / NC/3/MEET/Nov/202223/14	33 / NC/3/MEET/Nov/202223/14	33 / NC/3/MEET/Nov/202223/14	33 / NC/3/MEET/Nov/202223/14	33 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		ATUL LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00087487AM21
RA File Number		08AA04009727 AM21
Licence No and Date		0811000726/19/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol.

|Licence No and Date||0811000726/19/02/2021||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Trimethylolpropane 0.42 kg Lapox ARD 55 (Triglycidyl ether of 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Lapox ARD 55 (Triglycidyl ether of||1 kg|1|Trimethylolpropane|0.42 kg|

Case No.	Case No.	33 / NC/3/MEET/Nov/202223/14	33 / NC/3/MEET/Nov/202223/14	33 / NC/3/MEET/Nov/202223/14	33 / NC/3/MEET/Nov/202223/14	33 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		ATUL LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00087487AM21
RA File Number		08AA04009727 AM21
Licence No and Date		0811000726/19/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Trimethylolpropane<br>0.42 kg<br>Lapox ARD 55 (Triglycidyl ether of 1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Lapox ARD 55 (Triglycidyl ether of		1 kg	1	Trimethylolpropane	0.42 kg

UDIN00286113AM23

r>Lapox ARD 55 (Triglycidyl ether of 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Lapox ARD 55 (Triglycidyl ether of||1 kg|1|Trimethylolpropane|0.42 kg|

UDIN00286113AM23

2<br>Epichlorohydrin<br>0.995 kg<br>3<br>Caustic Soda Lye 48 percentage<br>0.41 kg<br>trimethylolpropane)(Chemicals)<br>4<br>Toluene<br>Not allowed as no<br>details shown in<br>the process.<br> <br>RA concerned may take further necessary action as per above decision of NC	trimethylolpropane)(Chemicals)		2	Epichlorohydrin	0.995 kg
			3	Caustic Soda Lye 48 percentage	0.41 kg
			4	Toluene	Not allowed as no<br>details shown in<br>the process.

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

Case No.	34 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	SPEED INTERNATIONAL (INDIA) PRIAVTE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00089812AM21
RA File Number	03AA04022711 AM21
Licence No and<br>Date	0311001589/23/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	35 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	SHREE MAHADEV INTERMEDIATE
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00090280AM21
RA File Number	34AA04002739 AM21
Licence No and<br>Date	3411000251/23/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.

UDIN00286113AM23

Case No.	36 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00092003AM21
RA File Number	038504000144 AM21
Licence No and<br>Date	0311000450/25/02/2021
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>Taking into consideration molecular weight of Acetic Acid as 60 and 2 Moles are used to produce 1 Mole<br>of Export have molecular weight 158.20. Therefore yield should be 0.76 kg /kg and taking 96% yield,<br>the consumption should be 0.79 kg/kg, as compared to 1.210 kg. Please clarify it.<br>i.

ort have molecular weight 158.20. Therefore yield should be 0.76 kg /kg and taking 96% yield,** the consumption should be 0.79 kg/kg, as compared to 1.210 kg. Please clarify it. i.||

i. Taking into consideration molecular weight of Acetic Acid as 60 and 2 Moles are used to produce 1 Mole of Export have molecular weight 158.20. Therefore yield should be 0.76 kg /kg and taking 96% yield, the consumption should be 0.79 kg/kg, as compared to 1.210 kg. Please clarify it.

Case No.	Case No.	37 / NC/3/MEET/Nov/202223/14	37 / NC/3/MEET/Nov/202223/14	37 / NC/3/MEET/Nov/202223/14	37 / NC/3/MEET/Nov/202223/14	37 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00098861AM21
RA File Number		31AA04006764 AM21
Licence No and<br>Date		3111000201/08/03/2021
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 NoNC/3/MEET/Mar/202122/15 dated 17/03/2022against advance authorization No.<br>3111000148 dated 09-02-2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

021**, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 MONO ETHANOL AMINE 1.0374 kg Not allowed, as it is ETHYLENE DI AMINE (ORGANIC CHEMICAL) 1 kg 2 AMMONIA ANHYDROUS||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||ETHYLENE DI AMINE (ORGANIC CHEMICAL)||1 kg|1|MONO ETHANOL AMINE|1.0374 kg| |||||2|AMMONIA ANHYDROUS|Not allowed, as it is|

UDIN00286113AM23

shown indigenous

Case No.	38 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00098900AM21
RA File Number	31AA04006116 AM21
Licence No and<br>Date	3111000158/08/03/2021
Norms Committee Decision:<br>.<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No NC/3/MEET/Sep/202223/8dated 23/09/2022 against advance authorization No.<br>3111000445 dated 08/07/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

ng No NC/3/MEET/Sep/202223/8dated 23/09/2022 against advance authorization No. 3111000445 dated 08/07/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 DIETHYLENE GLYCOL 1.279 kg 2 AMMONIA ANHYDROUS 0.217 kg 3 HYDROGEN Not allowed, as it is procured indigenously. MORPHOLINE 1 kg 4 MORPHOLINE CATALYST Not allowed as no catalogue is available. RA concerned may take further necessary action as per above decision of NC.||

UDIN00286113AM23

Case No.	39 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00098795AM21
RA File Number	03AA04028082 AM21
Licence No and<br>Date	0311002315/08/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	40 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00098842AM21
RA File Number	03AA04028081 AM21
Licence No and<br>Date	0311002319/08/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	41 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	DISCOVERY LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00100529AM21
RA File Number	092404000465 AM21
Licence No and<br>Date	0911000490/10/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on

29 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

DGFT Portal. Hence, the Committee decided to reject the case.

y on||

29 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

DGFT Portal. Hence, the Committee decided to reject the case.

Case No.	42 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	LUPIN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00103407AM21
RA File Number	03AA04019762 AM21
Licence No and<br>Date	0311002479/15/03/2021
Norms Committee Decision:
The firm has furnished its reply on DGFT Portal stating that the subject Advance Authorization falls under para 4.18
of HBP Vol. I (Non-Infringing Process) and hence they should be exempted from approval of NC.
In view of above, the Committee decided to verify the same from RLA, Mumbai.

Case No.	43 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00104575AM21
RA File Number	52AA04007931 AM21
Licence No and<br>Date	5211000485/16/03/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	44 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	THERAPIVA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00104605AM21
RA File Number	09AA04005655 AM21
Licence No and<br>Date	0911000535/16/03/2021
Norms Committee Decision:

3/ MEET/ Nov/ 202223/ 14 and 07/12/2022| |HQ File Number|HQRNORM APPLY 00104605AM21| |RA File Number|09AA04005655 AM21| |Licence No and Date|0911000535/16/03/2021| |Norms Committee Decision:||

30 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

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

Case No.	45 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00106311AM21
RA File Number	09AA04004395 AM21
Licence No and<br>Date	0911000512/18/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	46 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00107278AM21
RA File Number	03AA04022151 AM21
Licence No and<br>Date	0311002655/19/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>DML for Export Product No. 1 and 2.

Case No.	47 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022

31 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

HQ File Number	HQRNORM APPLY 00107455AM21
RA File Number	02AA04010857 AM21
Licence No and<br>Date	0211000433/19/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	48 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00107042AM21
RA File Number	03AA04029353 AM21
Licence No and<br>Date	0311002597/19/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	49 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00109027AM21
RA File Number	03AA04031482 AM21
Licence No and<br>Date	0311002729/22/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Percentage yield at every stage of reaction.<br>i.<br>Stoichiometric balance on molar basis and percentage yield to arrive at the quantity of raw material asked<br>ii.

32 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

on molar basis and percentage yield to arrive at the quantity of raw material asked** ii.||

32 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

for.

iii. Function of Acetaldoxime in the reaction.

iv. Justification for low yield in overall reaction, that is, 36% v. Production / Consumption data for last one year duly certified by GST.

Case No.	Case No.	50 / NC/3/MEET/Nov/202223/14	50 / NC/3/MEET/Nov/202223/14	50 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00114107AM21
RA File Number		09AA04005572 AM21
Licence No and<br>Date		0911000481/26/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Azathioprine<br>150 kg<br>2<br>Cellulose Microcristalline<br>150 kg<br>3<br>Mannitol<br>150 kg<br>4<br>Corn Starch<br>42 kg<br>5<br>Croscarmellose Sodium<br>16.5 kg<br>6<br>Povidone K<br>24 kg<br>7<br>Sodium Stearyl Fumarate<br>7.5 kg<br>8<br>Hypromellose<br>6.9 kg<br>Azathioprine 50mg<br>3000000 Numbers<br>9<br>Macrogol<br>1.2 kg<br>
	Export product		Qty.	Sl.

r>Povidone K 24 kg 7 Sodium Stearyl Fumarate 7.5 kg 8 Hypromellose 6.9 kg Azathioprine 50mg 3000000 Numbers 9 Macrogol 1.2 kg ||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Azathioprine 50mg||3000000 Numbers|1|Azathioprine|150 kg| |||||2|Cellulose Microcristalline|150 kg| |||||3|Mannitol|150 kg| |||||4|Corn Starch|42 kg| |||||5|Croscarmellose Sodium|16.5 kg| |||||6|Povidone K|24 kg| |||||7|Sodium Stearyl Fumarate|7.5 kg| |||||8|Hypromellose|6.9 kg| |||||9|Macrogol|1.2 kg| ||||||||

UDIN00286113AM23

Case No.	51 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00114387AM21
RA File Number	03AA04029354 AM21
Licence No and<br>Date	0311002596/26/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	52 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00114423AM21
RA File Number	09AA04006434 AM21
Licence No and<br>Date	0911000598/26/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	53 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00115936AM21
RA File Number	09AA04006613 AM21
Licence No and<br>Date	0911000627/29/03/2021

34 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

Norms Committee Decision:

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

Export product	Qty.	Sl. No.	Import items	Qty.
Dronedarone HCL	1 kg	1	Salicylaldehyde	1.00 kg
(pharmaceutical product)
		2	Dimethyl formamide	1.00 kg
		3	Methylenedichloride	15.00 kg
		4	Iso propyl Alcohol	4.60 kg
		5	Di-n-butylamine	0.667 kg
		6	Methyl-2-bromo hexanoate	1.32 kg

Case No.<br>54 / NC/3/MEET/Nov/202223/14	Case No.<br>54 / NC/3/MEET/Nov/202223/14
Case Status<br>Case Approved
Party Name<br>BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number<br>HQRNORM APPLY 00116713AM21
RA File Number<br>31AA04007907 AM21
Licence No and<br>Date<br>3111000255/30/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm,		whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.

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

Case No.<br>54 / NC/3/MEET/Nov/202223/14	Case No.<br>54 / NC/3/MEET/Nov/202223/14
Case Status<br>Case Approved
Party Name<br>BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number<br>HQRNORM APPLY 00116713AM21
RA File Number<br>31AA04007907 AM21
Licence No and<br>Date<br>3111000255/30/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm,		whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.

UDIN00286113AM23

AMINO ETHYL PIPERAZINE	1 kg	1	MONO ETHANOL AMINE	1.07 kg
(ORGANIC CHEMICAL)

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

UDIN00286113AM23

AMINO ETHYL PIPERAZINE	1 kg	1	MONO ETHANOL AMINE	1.07 kg
(ORGANIC CHEMICAL)

Case No.	55 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	VERTELLUS SPECIALTY MATERIALS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00117102AM21
RA File Number	03AA04032376 AM21
Licence No and<br>Date	0311002851/31/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	56 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00020260AM22
RA File Number	34AA04000021 AM22
Licence No and<br>Date	3411000455/16/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Justification for 10% wastage.

Case No.	57 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD

UDIN00286113AM23

r>firm: Justification for 10% wastage.||

Case No.	57 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD

UDIN00286113AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003258AM23
RA File Number	03AA04000436 AM22
Licence No and<br>Date	0311003517/03/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>PARA CHLORO PHENYL ACETIC<br>ACID<br>1 kg<br>1<br>PARA CHLORO BENZYL CYANIDE<br>1.021 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	58 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003257AM23
RA File Number	03AA04000162 AM22
Licence No and<br>Date	0311003516/03/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

adhoc norms and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. PARA CHLORO PHENYL ACETIC ACID 1 kg 1 PARA CHLORO BENZYL CYANIDE 1.021 kg RA concerned may take further necessary action as per above decision of NC.||

UDIN00286113AM23

Case No.	59 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003400AM23
RA File Number	08AA04010958 AM21
Licence No and<br>Date	0811001148/20/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>MEROPENEM FOR INJECTION<br>1GM USP/ BP/ CEP/IP/ EP/ ChP<br>(Net Content of Export Item is 110<br>Kg))<br>(Each<br>vial<br>contains<br>Meropenem<br>Trihydrate<br>USP<br>equivalent<br>to<br>Anhydrous<br>Meropenem 1 gm)<br>1 Number<br>1<br>STERILE<br>MIXTURE<br>OF<br>MEROPENEM<br>AND<br>SODIUM<br>CARBONATE<br>1.29 gram<br> <br>RA concerned may take further necessary action as per above decision of NC.

em 1 gm) 1 Number 1 STERILE MIXTURE OF MEROPENEM AND SODIUM CARBONATE 1.29 gram RA concerned may take further necessary action as per above decision of NC.||

Case No.	60 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	SWISS PARENTERALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003401AM23
RA File Number	08AA04002347 AM22
Licence No and Date	0811001626/01/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it wasdecided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

UDIN00286113AM23

Sl.	Export Product		Qty.	Sl. No.	Import Items		Qty.
No.
1	CEFTAZIDIME<br>FOR	INJECTION	<br>1 Number	1	CEFTAZIDIME	FOR	<br>0.550 grams
	USP/BP/EP/CEP/IP/ChP	500MG			INJECTION IP
	(CEFTAZIDIME<br>FOR	<br>INJECTION
	USP/BP/EP/CEP/IP/ChP	500MG.<br>(NET
	CONTENT OF EXPORT ITEM IS 105KG))
2	CEFTAZIDIME<br>FOR	INJECTION	<br>1 Number	2	CEFTAZIDIME	FOR	<br>1.10 grams
	USP/BP/EP/CEP/IP/ChP	1GM			INJECTION IP
	(CEFTAZIDIME<br>FOR	<br>INJECTION
	USP/BP/EP/CEP/IP/ChP	1GM<br>(NET
	CONTENT OF EXPORT ITEM IS 150KG))
3	CEFTAZIDIME<br>FOR	INJECTION	<br>1 Number	3	CEFTAZIDIME	FOR	<br>2.20 grams
	USP/BP/EP/CEP/IP/ChP	2GM			INJECTION IP
	(CEFTAZIDIME<br>FOR	<br>INJECTION

OF EXPORT ITEM IS 150KG))||||||| |3|CEFTAZIDIME FOR|INJECTION| 1 Number|3|CEFTAZIDIME|FOR| 2.20 grams| ||USP/BP/EP/CEP/IP/ChP|2GM|||INJECTION IP||| ||(CEFTAZIDIME FOR| INJECTION|||||| ||USP/BP/EP/CEP/IP/ChP|2GM (NET|||||| ||CONTENT OF EXPORT ITEM IS 300KG))|||||||

Case No.	61 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003402AM23
RA File Number	08AA04005392 AM22
Licence No and<br>Date	0811001628/01/06/2021
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following
information / documents from the firm:
Master Batch Formula for export products.

Case No.	62 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred

UDIN00286113AM23

Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003403AM23
RA File Number	08AA04007143 AM22
Licence No and<br>Date	0811001742/15/06/2021
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following
information / documents from the firm:
Master Batch Formula for export products.

tee considered the request of firm for fixation of adhoc norms and it was decided to call for following|| |information / documents from the firm:|| |Master Batch Formula for export products.||

Case No.	63 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	INDORAMA VENTURES OXIDES ANKLESHWAR PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00116364AM22
RA File Number	03AA04018728 AM22
Licence No and<br>Date	0311004668/16/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	64 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00122106AM22
RA File Number	03AA04032146 AM22
Licence No and<br>Date	0311004837/23/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:

40 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

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

40 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

Export product	Qty.	Sl. No.	Import items	Qty.
NITROXOLINE	1 kg	1	8 HYDROXYQUINOLINE	1.235 kg

Case No.	65 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	GOPINATH CHEM-TECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00123213AM22
RA File Number	08AA04009668 AM22
Licence No and<br>Date	0811001833/24/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it wasdecided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>K ACID<br>1.50 kg<br>3-AMINO-4-((4-AMINO-2-SULPHOPHENYL)<br>DIAZENYL)5-HYDROXY<br>NAPHTHALENE-2,7<br>DISULFONIC ACID<br>1 kg<br>2<br>SODIUM NITRITE<br>0.225 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	66 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00123227AM22
RA File Number	09AA04005065 AM22
Licence No and<br>Date	0911001102/24/06/2021
Norms Committee Decision:

UDIN00286113AM23

and 07/12/2022| |HQ File Number|HQRNORM APPLY 00123227AM22| |RA File Number|09AA04005065 AM22| |Licence No and Date|0911001102/24/06/2021| |Norms Committee Decision:||

UDIN00286113AM23

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

Export product	Qty.	Sl. No.	Import items	Qty.
DRONEDARONE HCL<br>(Pharmaceutical product)	1 kg	1	Salicylaldehyde	1.00 kg
		2	Dimethyl Formamide	1.00 kg
		3	Methylenedichloride	15.00 kg
		4	ISO Propyl Alcohol	4.60 kg
		5	Di N Butylamine	0.667 kg

Case No.	67 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	ZEE LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00124557AM22
RA File Number	05AA04028399 AM22
Licence No and<br>Date	0511003336/25/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	68 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022

UDIN00286113AM23

/Nov/202223/14| |---|---| |Case Status|Case Rejected| |Party Name|ASCENT FINECHEM PRIVATE LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022|

UDIN00286113AM23

HQ File Number	HQRNORM APPLY 00124729AM22
RA File Number	08AA04009431 AM22
Licence No and<br>Date	0811001850/25/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	69 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00126124AM22
RA File Number	34AA04004372 AM22
Licence No and<br>Date	3411000778/28/06/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00126124AM22| |RA File Number|34AA04004372 AM22| |Licence No and Date|3411000778/28/06/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	70 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00125843AM22
RA File Number	34AA04002140 AM22
Licence No and<br>Date	3411000771/28/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	71 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022

UDIN00286113AM23

1 / NC/3/MEET/Nov/202223/14| |---|---| |Case Status|Case Approved| |Party Name|ETERNIS FINE CHEMICALS LIMITED| |Meeting Number|NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022|

UDIN00286113AM23

and Date	and Date
HQ File Number		HQRNORM APPLY 00126786AM22
RA File Number		03AA04025749 AM22
Licence No and<br>Date		0311005018/29/06/2021
Norms Committee Decision:<br>T<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No 6/82-ALC4/2020 dated 13.11.2020 against advance authorization No.0310837390 dated<br>23.07.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PENTYL ENDO (2 Pentyl-2-<br>Cyclopentene -1-one)<br>0.760 kg<br>2<br>DIMETHYL MALONATE<br>0.660 kg<br>3<br>Sodium Methoxide<br>0.120 kg<br>METHYL - 3 - OXO - 2 - PENTYL -<br>1 - CYCLOPENTANE ACETATE<br>1 kg<br>4<br>MS Barrel (Lacquered)<br>Relevant as per packing<br>policy<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl.

ETATE 1 kg 4 MS Barrel (Lacquered) Relevant as per packing policy RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import items|Qty.| ||METHYL - 3 - OXO - 2 - PENTYL - 1 - CYCLOPENTANE ACETATE|| 1 kg|1|PENTYL ENDO (2 Pentyl-2- Cyclopentene -1-one)|0.760 kg| |||||2|DIMETHYL MALONATE|0.660 kg| |||||3|Sodium Methoxide|0.120 kg| |||||4|MS Barrel (Lacquered)|Relevant as per packing policy| |||||as per above decision of NC.|||

Case No.	72 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	SCOTT EDIL PHARMACIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00127163AM22
RA File Number	30AA04008308 AM22
Licence No and<br>Date	3011000821/30/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology

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(DBT) for obtaining their comments.

ee Decision: The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology||

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(DBT) for obtaining their comments.

Case No.	Case No.	Case No.	73 / NC/3/MEET/Nov/202223/14	73 / NC/3/MEET/Nov/202223/14	73 / NC/3/MEET/Nov/202223/14	73 / NC/3/MEET/Nov/202223/14	73 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM APPLY 00129541AM22
RA File Number			03AA04033537 AM22
Licence No and<br>Date			0311005080/02/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting NoNC/3/MEET/Oct/202122/9 dated 15/10/2021 against advance authorization No.<br>0310838214 dated 11-09-2020and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Clindamycin Phosphate USP<br>262.50 mg /<br>pack<br>1<br>Clindamycin & Benzoyl Peroxide Gel<br>1percent/5percent (Pack Size 25gm )((Net<br>Wt. of Import Item Sr. No. 1 is 25.00 Kgs. &<br>Sr. No.

1 Clindamycin Phosphate USP 262.50 mg / pack 1 Clindamycin & Benzoyl Peroxide Gel 1percent/5percent (Pack Size 25gm )((Net Wt. of Import Item Sr. No. 1 is 25.00 Kgs. & Sr. No. 2 is 125.00 Kgs.)) 1 Number Pack 2 HYDROUS BENZOYL PEROXIDE USP 1312.50 mg / pack 3 Clindamycin Phosphate USP 367.50 mg / pack 2 Clindamycin & Benzoyl Peroxide Gel 1percent/5percent (Pack Size 35gm )((Net Wt. of Import Item Sr. No. 1 is 35.00 Kgs. & Sr. No. 2 is 175.00 Kgs.)) 1 Number Pack 4 HYDROUS BENZOYL PEROXIDE USP 1837.50 mg / pack 5 Clindamycin Phosphate USP 525.00 mg / pack 3 Clindamycin & Benzoyl Peroxide Gel 1percent/5percent (Pack Size 50gm )((Net Wt. of Import Item Sr. No. 1 is 200.00 Kgs. & Sr. No. 2 is 1000.00 Kgs.)) 1 Number Pack 6 HYDROUS BENZOYL PEROXIDE USP 2625.00 mg / pack 4 Adapalene & Benzoyl Peroxide Gel 0.1percent/2.5percent (Pack Size 45gm )((Net Wt. of Import Item Sr. No. 2 is 11.25 Kgs.)) 1 Number Pack 7 HYDROUS BENZOYL PEROXIDE USP 1181.25 mg / pack|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Clindamycin & Benzoyl Peroxide Gel 1percent/5percent (Pack Size 25gm )((Net Wt. of Import Item Sr. No. 1 is 25.00 Kgs. & Sr. No.

||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Clindamycin & Benzoyl Peroxide Gel 1percent/5percent (Pack Size 25gm )((Net Wt. of Import Item Sr. No. 1 is 25.00 Kgs. & Sr. No. 2 is 125.00 Kgs.))|| 1 Number Pack|1|Clindamycin Phosphate USP|262.50 mg / pack| ||||||2|HYDROUS BENZOYL PEROXIDE USP|1312.50 mg / pack| ||2|Clindamycin & Benzoyl Peroxide Gel 1percent/5percent (Pack Size 35gm )((Net Wt. of Import Item Sr. No. 1 is 35.00 Kgs. & Sr. No. 2 is 175.00 Kgs.))|| 1 Number Pack|3|Clindamycin Phosphate USP|367.50 mg / pack| ||||||4|HYDROUS BENZOYL PEROXIDE USP|1837.50 mg / pack| ||3|Clindamycin & Benzoyl Peroxide Gel 1percent/5percent (Pack Size 50gm )((Net Wt. of Import Item Sr. No. 1 is 200.00 Kgs. & Sr. No. 2 is 1000.00 Kgs.))|| 1 Number Pack|5|Clindamycin Phosphate USP|525.00 mg / pack| ||||||6|HYDROUS BENZOYL PEROXIDE USP|2625.00 mg / pack| ||4|Adapalene & Benzoyl Peroxide Gel 0.1percent/2.5percent (Pack Size 45gm )((Net Wt. of Import Item Sr. No. 2 is 11.25 Kgs.))|| 1 Number Pack|7|HYDROUS BENZOYL PEROXIDE USP|1181.25 mg / pack|

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

5 Kgs.))|| 1 Number Pack|7|HYDROUS BENZOYL PEROXIDE USP|1181.25 mg / pack|

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

Case No.	74 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	ORGANIC INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00129686AM22
RA File Number	06AA04003603 AM22
Licence No and<br>Date	0611000533/02/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>DML of each Export Product showing the Approved Composition.<br>i.<br>COA of import item from foreign supplier.<br>ii.

Case No.	Case No.	Case No.	75 / NC/3/MEET/Nov/202223/14	75 / NC/3/MEET/Nov/202223/14	75 / NC/3/MEET/Nov/202223/14	75 / NC/3/MEET/Nov/202223/14	75 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			INDOCO REMEDIES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM APPLY 00130667AM22
RA File Number			03AA04041463 AM22
Licence No and<br>Date			0311005091/04/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>(A)<br>Sl.

ee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: (A) Sl. No. Export Product Qty. Sl. No. Import Items Qty. ALLOPURINOL TABLETS 100MG (Each Allopurinol Tablet of 100mg 1 1 Number 1 Allopurinol 102.00 mg / 100 mg Tablet|||||||| ||Sl. No.|Export Product||Qty.|Sl. No.|Import Items|Qty.| ||1|ALLOPURINOL TABLETS 100MG (Each Allopurinol Tablet of 100mg||1 Number|1|Allopurinol|102.00 mg / 100 mg Tablet|

Case No.	Case No.	Case No.	75 / NC/3/MEET/Nov/202223/14	75 / NC/3/MEET/Nov/202223/14	75 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			INDOCO REMEDIES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM APPLY 00130667AM22
RA File Number			03AA04041463 AM22
Licence No and<br>Date			0311005091/04/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>(A)<br>Sl. No.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>ALLOPURINOL TABLETS 100MG<br>(Each Allopurinol Tablet of 100mg<br>1<br>1 Number<br>1<br>Allopurinol<br>102.00 mg / 100<br>mg Tablet
	Sl. No.	Export Product		Qty.	Sl.

Import Items Qty. ALLOPURINOL TABLETS 100MG (Each Allopurinol Tablet of 100mg 1 1 Number 1 Allopurinol 102.00 mg / 100 mg Tablet|||||||| ||Sl. No.|Export Product||Qty.|Sl. No.|Import Items|Qty.| ||1|ALLOPURINOL TABLETS 100MG (Each Allopurinol Tablet of 100mg||1 Number|1|Allopurinol|102.00 mg / 100 mg Tablet|

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contains Allopurinol 100mg) (Equivalent to:-Cyano Acetamide 0.0001mg ,Triethyl Ortho-formate 0.00021mg, Formamide 0.00015 mg, Morpholine 0.00013mg , Hydrazine Hydrate 0.00006 mg) (Cross SION Norms of Allopurinol SION No.A2321 & Tablets/Capsules SION NoA412.)) 2 ALLOPURINOL TABLETS 300MG 1 Number 2 Allopurinol 306.00 mg / 300 (Each Allopurinol Tablet of 300mg mg Tablet contains Allopurinol 300 mg)(Equivalent to:-Cyano Acetamide 0.0003mg ,Triethyl Ortho-formate 0.00063mg, Formamide 0.00045 mg, Morpholine 0.00039mg , Hydrazine Hydrate 0.00018 mg) (Cross SION Norms of Allopurinol SION No.A2321 & Tablets/Capsules SION NoA412.))

(B)

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

47 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

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3|Formamide|1.50 kg| |||4|Morpholine|1.30 kg| |||5|Cyano Acetamide|0.60 kg|

47 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

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Case No.		76 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		DORF-KETAL CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022

HQ File Number		HQRNORM APPLY 00130670AM22
RA File Number		03AA04035632 AM22

Licence No and<br>		0311005092/04/07/2021
Date

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



	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Chemical Name Tetra n- Butyl Titanate Tyzor		<br>1 kg	1	Titanium Tetrachloride Ticl4	057 kg
	<br>TNBT /D-140(Chemical Name Tetra n- Butyl		<br> <br>			.
	<br>Titanate Tyzor T	<br>NBT /D-140)				<br>
				2	N Butanol NBA Normal Butanol n<br>	<br>0.90 kg
					Butyl Alcohol

				3	Heptane Heptanes	0.20 kg



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


Case No.		77 / NC/3/MEET/Nov/202223/14
C Stt		C Ad
ase aus		ase pprove

Party Name		BALAJI SPECIALITY CHEMICALS LIMITED
Mi Nb

ion of NC.||||| |||||||| |||||||| |Case No.||77 / NC/3/MEET/Nov/202223/14||||| |C Stt||C Ad||||| |ase aus||ase pprove||||| |||||||| |Party Name||BALAJI SPECIALITY CHEMICALS LIMITED||||| |Mi Nb||||||| |eetng umer and Date||NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022||||| |||||||| |HQ File Number||HQRNORM REVIW00003426AM23||||| |||||||| |RA File Number||31AA04000987 AM22||||| |Li N d||||||| |cence o an Date||3111000484/28/07/2021||||| |||||||| |Norms Committee||Decision:||||| | The Committee co|| nsidered the request of firm for fixation of adhoc norms and taking cue from earlier decision for||||| |same export product / import item in Meeting No NC/3/MEET/Mar/202122/15 dated 17/03/2022 against advance authorization No.3111000148 dated 09-02-2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:||||||| ||||||||

Case No.	77 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003426AM23
RA File Number	31AA04000987 AM22
Licence No and<br>Date	3111000484/28/07/2021
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for
same export product / import item in Meeting No NC/3/MEET/Mar/202122/15 dated 17/03/2022 against advance

uest of firm for fixation of adhoc norms and taking cue from earlier decision for|| |same export product / import item in Meeting No NC/3/MEET/Mar/202122/15 dated 17/03/2022 against advance|| |authorization No.|3111000148 dated 09-02-2021, it was decided to ratify adhoc norms under Para 4.07 of HBP| |Vol. I as per details given below or as applied by the firm, whichever is less:||

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Export product	Qty.	Sl. No.	Import items	Qty.
DI ETHYLENE TRI AMINE	1 kg	1	MONO ETHANOL AMINE	1.0374 kg
ORGANIC CHEMICAL)
		2	AMMONIA ANHYDROUS	Not allowed, as it is
				shown indigenous

Case No.<br>78 / NC/3/MEET/Nov/202223/14	Case No.<br>78 / NC/3/MEET/Nov/202223/14	Case No.<br>78 / NC/3/MEET/Nov/202223/14
Case Status<br>Case Approved
Party Name<br>BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number<br>HQRNORM APPLY 00164145AM22
RA File Number<br>34AA04006527 AM22
Licence No and<br>Date<br>3411000984/17/08/2021
Norms Committee Decision:
The Committee considered the case as per agenda		and it wasdecided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export Product<br>Qty.	Sl.

as per agenda||and it wasdecided to ratify adhoc norms under Para 4.07 of HBP|||| |Vol. I as per details given below or as applied by the firm, whichever is less:|||||| ||Export Product Qty.|Sl. No.|Import Items|Qty.|| ||Limbunile(3,7-Dimethyl-2(3), 6- 1 kg|1|Ethyl Heptenone|0.922 kg|| ||nonadienonitrile))||||| |||2|Cyano Acetic acid|0.559 kg|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	79 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022

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and Date
HQ File Number	HQRNORM APPLY 00164102AM22
RA File Number	03AA04065031 AM22
Licence No and<br>Date	0311006216/17/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Complete chemistry, molecular weight and percentage yield on molar basis for each step of manufacturing<br>process.<br>i.<br>Material balance for each step of manufacturing process.<br>ii.

lete chemistry, molecular weight and percentage yield on molar basis for each step of manufacturing** process. i. Material balance for each step of manufacturing process. ii.||

Case No.	80 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00164975AM22
RA File Number	34AA04006491 AM22
Licence No and<br>Date	3411000985/18/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it wasdecided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Cyclo Hexyl Salicylate<br>(Cyclohexyl-2-Hydroxy Benzoate)<br>1 kg<br>1<br>Methyl Salicylate<br>0.725 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	81 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	ANTILA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00165364AM22

UDIN00286113AM23

RA File Number	08AA04018980 AM22
Licence No and<br>Date	0811002348/18/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>DML of Export Product showing the Approved Composition.<br>i.

ommittee considered the case as per agenda and it was decided to call for following information / documents from the firm: DML of Export Product showing the Approved Composition. i.||

Case No.	82 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00165403AM22
RA File Number	05AA04062260 AM22
Licence No and<br>Date	0511004178/18/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	83 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00165816AM22
RA File Number	05AA04070414 AM22
Licence No and<br>Date	0511004197/18/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the quantity mentioned in the Advance<br>Authorization against Export Product and import item is confusing. Hence,it was decided to call the firm for attending<br>Personal Hearing<br> before Norms Committee to explain its case.

Case No.	84 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00168909AM22
RA File Number	31AA04024928 AM22

51 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

Licence No and 3111000540/23/08/2021 Date Norms Committee Decision: Deferred for comments of TE.

Case No.	85 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00169050AM22
RA File Number	03AA04027384 AM22
Licence No and<br>Date	0311006375/23/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Specification of Export Product alongwith COA.

Case No.	86 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	LITMUS ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00169051AM22
RA File Number	03AA04044240 AM22
Licence No and<br>Date	0311006376/23/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	87 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00169946AM22

52 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

RA File Number

03AA04066953 AM22

Licence No and Date

0311006419/25/08/2021

HLORO BENZYL CHLORIDE 1.154 kg 2,4-DICHLOROBENZYL CYANIDE(N.A.) 1 kg 2 SODIUM CYANIDE 0.286 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	88 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	SI GROUP - INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00170117AM22
RA File Number	03AA04063156 AM22
Licence No and<br>Date	0311006435/25/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	89 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00170350AM22
RA File Number	03AA04069090 AM22
Licence No and<br>Date	0311006443/25/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

UDIN00286113AM23

Case No.	90 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00170357AM22
RA File Number	03AA04069088 AM22
Licence No and<br>Date	0311006444/25/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00170357AM22| |RA File Number|03AA04069088 AM22| |Licence No and Date|0311006444/25/08/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	91 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00171241AM22
RA File Number	31AA04025740 AM22
Licence No and<br>Date	3111000548/26/08/2021
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/Mar/202122/15 dated 17/03/2022 against advance authorization No.<br>3111000148 dated 09-02-2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>MONO ETHANOL AMINE<br>1.0374 kg<br>DI<br>ETHYLENE<br>TRI<br>AMINE<br>(ORGANIC CHEMICALS)<br>1 kg<br>2<br>AMMONIA ANHYDROUS<br>Not allowed, as it is<br>shown indigenous<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	92 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD

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necessary action as per above decision of NC.||

Case No.	92 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD

UDIN00286113AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00171413AM22
RA File Number	50AA04002705 AM22
Licence No and<br>Date	0311006477/26/08/2021
Norms Committee Decision:<br>T<br>The Committee considered the case as per agenda and it wasdecided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>2 4 DICHLORO BENZYL CHLORIDE<br>1.154 kg<br>2,4-DICHLOROBENZYL<br>CYANIDE(N.A.)<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.	93 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	HARMONY ORGANICS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00171602AM22
RA File Number	31AA04024595 AM22
Licence No and<br>Date	3111000549/26/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Yield of reactions giving justification / reason for low yield.<br>i.<br>Stoichiometric balance between import and export on molar basis.<br>ii.

ormation / documents from the firm: Yield of reactions giving justification / reason for low yield. i. Stoichiometric balance between import and export on molar basis. ii.||

Case No.	94 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	IPCA LABORATORIES LIMITED

UDIN00286113AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00172940AM22
RA File Number	03AA04051423 AM22
Licence No and<br>Date	0311006518/28/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Lasamide<br>0.910 kg<br>2<br>Furfurylamine<br>1.207 kg<br>FRUSEMIDE / FUROSEMIDE<br>1 kg<br>3<br>Iso Propyl Alcohol<br>1.00 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

kg 2 Furfurylamine 1.207 kg FRUSEMIDE / FUROSEMIDE 1 kg 3 Iso Propyl Alcohol 1.00 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	95 / NC/3/MEET/Nov/202223/14	95 / NC/3/MEET/Nov/202223/14	95 / NC/3/MEET/Nov/202223/14	95 / NC/3/MEET/Nov/202223/14	95 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00173574AM22
RA File Number		09AA04010955 AM22
Licence No and<br>Date		0911001455/30/08/2021
Norms Committee Decision:<br>.<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/9 dated 07/10/2022against advance authorization No.<br>0911002609 dated 03/03/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Sl.<br>Export product<br>Qty.<br>Import items<br>Qty.
	Export product		Qty.	Sl.	Import items	Qty.

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					No.
(R)-2-(Diphenylmethyl)	pyrrolidine	hydrochloride	<br>1	kg	1	D-Proline/R-Proline	1.167	kg
(RDPH-II)

ty.|

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					No.
(R)-2-(Diphenylmethyl)	pyrrolidine	hydrochloride	<br>1	kg	1	D-Proline/R-Proline	1.167	kg
(RDPH-II)

Case No.	96 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	BHARAT PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00175489AM22
RA File Number	34AA04006862 AM22
Licence No and<br>Date	3411001052/02/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it wasdecided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>CEFACLOR<br>CAPSULES<br>USP<br>500MG((EACH<br>HARD<br>GELATIN<br>CAPSULE CONTAIN CEFACLOR USP<br>EQ<br>TO<br>ANHYDROUS<br>CEFACLOR<br>500MG)(TOTAL<br>CONTENT:<br>CEFACLOR<br>IP/BP/USP<br>100.005<br>KGS)200010 Capsules)<br>200010 Number of<br>Capsules<br>1<br>CEFACLOR<br>102 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	97 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00175852AM22

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RA File Number	34AA04006370 AM22
Licence No and<br>Date	3411000952/02/09/2021
Norms Committee Decision:
Deferred for comments of TE.

Y 00175852AM22|

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RA File Number	34AA04006370 AM22
Licence No and<br>Date	3411000952/02/09/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	Case No.		98 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ	File Number		HQRNORM APPLY 00176177AM22
RA File Number			03AA04077623 AM22
Licence No and<br>Date			0311006660/03/09/2021
Norms Committee Decision:
The Committee		considered the case as per agenda and it was decided to ratify adhoc norms as under:
	Sl. No.	Export Product		SION No.
	1	Erythromycin Base/Erythromycin		A-215
	2	Erythromycin Oxime Base (Erythromycin A-9 Oxime)		A-2244
RA concerned may take further necessary action as per above decision of NC.

Case No.	99 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	BAZAYAN ENTERPRISES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM REVIW00003373AM23
RA File Number	03AA04078009 AM22
Licence No and<br>Date	0311008047/29/10/2021
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following
information / documents from the firm:

UDIN00286113AM23

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

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Particle size of import and export item may be indicated, supported by COA of export item and COA of import item from foreign supplier.

Case No.	100 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00300023AM22
RA File Number	08AX04000140 AM22
Licence No and<br>Date	0811003577/28/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	Case No.	Case No.	101 / NC/3/MEET/Nov/202223/14	101 / NC/3/MEET/Nov/202223/14	101 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM APPLY 00301053AM22
RA File Number			34AX04000076 AM22
Licence No and<br>Date			3411001604/29/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Duloxetine Hydrochloride Ph,Eur.<br>22.88 mg<br>2<br>Sugar<br>Spheres<br>(30-35<br>PHARM-A-<br>SPHERES)<br>20.33 mg<br>1<br>Duloxetine<br>Caps.20<br>mg<br>(Duloxetine Caps.20 mg (Net<br>content of active ingredients<br>110.000 kgs ))<br>1 Number<br>Capsule
	Sl. No.	Export product		Qty.	Sl.

ES) 20.33 mg 1 Duloxetine Caps.20 mg (Duloxetine Caps.20 mg (Net content of active ingredients 110.000 kgs )) 1 Number Capsule|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Duloxetine Caps.20 mg (Duloxetine Caps.20 mg (Net content of active ingredients 110.000 kgs ))|| 1 Number Capsule|1|Duloxetine Hydrochloride Ph,Eur.|22.88 mg| ||||||2|Sugar Spheres (30-35 PHARM-A- SPHERES)|20.33 mg|

Case No.	Case No.	101 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00301053AM22
RA File Number		34AX04000076 AM22
Licence No and<br>Date		3411001604/29/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Duloxetine Hydrochloride Ph,Eur.<br>22.88 mg<br>2<br>Sugar<br>Spheres<br>(30-35<br>PHARM-A-<br>SPHERES)<br>20.33 mg<br>1<br>Duloxetine<br>Caps.20<br>mg<br>(Duloxetine Caps.20 mg (Net<br>content of active ingredients<br>110.000 kgs ))<br>1 Number<br>Capsule
	Sl.

r>(30-35 PHARM-A- SPHERES) 20.33 mg 1 Duloxetine Caps.20 mg (Duloxetine Caps.20 mg (Net content of active ingredients 110.000 kgs )) 1 Number Capsule|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Duloxetine Caps.20 mg (Duloxetine Caps.20 mg (Net content of active ingredients 110.000 kgs ))|| 1 Number Capsule|1|Duloxetine Hydrochloride Ph,Eur.|22.88 mg| ||||||2|Sugar Spheres (30-35 PHARM-A- SPHERES)|20.33 mg|

UDIN00286113AM23


			3	Hypromellose (Pharmacoat 606)			20.00 mg

			4	Talc (Luzenac Pharma Ultra Micronised			12.63 mg
				grade)
			5	Sucrose (Compressuc PS)			15.67 mg
			6	Hypromellose Phthalate (HP 55)			12.07 mg
			7	Triethyl Citrate			1.21 mg

2	Duloxetine<br>Caps.<br>30	<br>1 Number	1	Dulox	etine Hy	drochloride Ph,Eur.	34.36 mg
	mg(Duloxetine Caps.

er packing policy| ||4|Atorvastatin Calcium Tablets USP 40mg (Pack Size 90 tabs)((Net wt. of Import Sr. No. 1 is 2023.456kgs, Sr. No. 2 is 11207.403kg, Sr. No. 3 is 3182.522kg, Sr. No. 5 is 515100 Nos.))| 1 Number Tablet|1|Atorvastatin Calcium Propylene Glycol Solvate USP| 45.595 mg| |||||2|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)| 258.08 mg| |||||3|Calcium Acetate|71.963 mg| |||||4|Strippax Sorbent 50 C & 50 SG 2gm (Silica Gel Dessicants)| Relevant as per packing policy| ||5|Atorvastatin Calcium Tablets USP 40mg (Pack Size 1000 tabs)((Net wt. of Import Sr. No. 1 is 2055.196kgs, Sr. No. 2 is 11383.205kg, Sr. No. 3 is 3232.444kg, Sr. No. 5 is 47086 Nos.))| 1 Number Tablet|1|Atorvastatin Calcium Propylene Glycol Solvate USP| 45.595 mg| |||||2|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)| 258.08 mg| |||||3|Calcium Acetate|71.963 mg| |||||4|Strippax Sorbent 50 C & 50 SG 2gm (Silica Gel Dessicants)| Relevant as per packing policy| ||6|Atorvastatin Calcium Tablets USP 80mg (Pack Size 90 tabs)((Net wt. of Import Sr. No. 1 is 1658.44kgs, Sr. No. 2 is 9229.86kg, Sr. No. 3 is 2619.048kg, Sr. No.

s per packing policy| ||6|Atorvastatin Calcium Tablets USP 80mg (Pack Size 90 tabs)((Net wt. of Import Sr. No. 1 is 1658.44kgs, Sr. No. 2 is 9229.86kg, Sr. No. 3 is 2619.048kg, Sr. No. 4 is 211090 Nos.))| 1 Number Tablet|1|Atorvastatin Calcium Propylene Glycol Solvate USP| 91.20 mg| |||||2|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)| 518.206 mg| |||||3|Calcium Acetate|144.929 mg| |||||4|Strippax Sorbent 50 C & 50 SG 2gm (Silica Gel Dessicants)| Relevant as per packing policy|

UDIN00286113AM23

7	Atorvastatin Calcium Tablets USP	Atorvastatin Calcium Tablets USP	<br>1 Number	1<br>Atorvastatin<br>Calcium	<br>91.20 mg
	80mg (Pack Size 1000 tabs)((Net		<br>Tablet	Glycol Solvate USP
	wt. of Import Sr. No.	1 is
	1908.837kgs,<br>Sr.<br>No.	2<br>is
	10623.417kg,<br>Sr.<br>No.	3<br>is		2<br>Microcrystalline Cellulose (MCC)	<br>518.206 mg
	3014.481kg, Sr. No. 4 is	21867		NF (Avicel PH 102)
	Nos.))
				3<br>Calcium Acetate	144.929 mg
				4<br>Strippax Sorbent 50 C & 50 SG 2gm	<br>Relevant as per
				(Silica Gel Dessicants)	packing policy
Note:	The above norms are valid	only for subject to fulfillment of following conditions:
1.	Export Product being Patented Medicine, be filed<br>			with USFDA filing ANDA (A New Drug Application) of Apotex
	**Corp, US.

or subject to fulfillment of following conditions:**||||| |1.|Export Product being Patented Medicine, be filed |||with USFDA filing ANDA (A New Drug Application) of Apotex||| ||Corp, US. Agent for Apotex Inc., Candada.|||||| |2.|Export to USA only. |||||| |3.|Firm holding Certificate of Manufacturing Exclusivity. ||||||

Case No.<br>120 / NC/3/MEET/Nov/202223/14
Case Status<br>Case Approved
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number<br>HQRNORM APPLY 00313838AM22
RA File Number<br>08AX04000177 AM22
Licence No and<br>Date<br>0811003727/10/01/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08/04/2022against advance authorization No.
0811002920 dated 20/10/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP			Vol. I as per
details given below or as applied by the firm, whichever is less:
Sl. No.<br>Export product<br>Qty.	Sl. No.	Import items	Qty.
			(for 1 Number
			Vial)

UDIN00286113AM23

er|| |details given below or as applied by the firm, whichever is less:||||| |Sl. No. Export product Qty.|Sl. No.|Import items|Qty.|| ||||(for 1 Number|| ||||Vial)||

UDIN00286113AM23

|1 METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. 55.00 mg 2 METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. 550.00 mg 3 METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. 1100.00 mg 4 METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. 275.00 mg 5 METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number 5 METHOTREXATE EP / BP / IP / USP / PH. EUR. 525.00 mg 6 METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number 6 METHOTREXATE EP / BP / IP / USP / PH.

1	METHOTREXATE INJECTION BP 25MG/ML<br>[2ML<br>VIAL](EACH<br>ML<br>CONTAINS:<br>METHOTREXATE PH. EUR. 25MG)	<br> <br>1 Number	1	METHOTREXATE EP / BP /<br>IP / USP / PH. EUR.	<br>55.00 mg
2	METHOTREXATE INJECTION BP 100MG/ML<br>[5<br>ML<br>VIAL](EACH<br>ML<br>CONTAINS:<br>METHOTREXATE PH. EUR. 100 MG)	<br> <br>1 Number	2	METHOTREXATE EP / BP /<br>IP / USP / PH. EUR.	<br>550.00 mg
3	METHOTREXATE INJECTION BP 100MG/ML<br>[10ML<br>VIAL](EACH<br>ML<br>CONTAINS:<br>METHOREXATE PH. EUR. 100MG)	<br> <br>1 Number	3	METHOTREXATE EP / BP /<br>IP / USP / PH. EUR.	<br>1100.00 mg
4	METHOTREXATE INJECTION USP 25MG/ML<br>[10ML<br>VIAL](EACH<br>ML<br>CONTAINS:<br>METHOTREXATE USP 25MG)	<br> <br>1 Number	4	METHOTREXATE EP / BP /<br>IP / USP / PH. EUR.	<br>275.00 mg
5	METHOTREXATE INJECTION BP 25MG/ML<br>[20ML<br>VIAL](EACH<br>ML<br>CONTAINS:<br>METHOTREXATE PH. EUR. 25MG)	<br> <br>1 Number	5	METHOTREXATE EP / BP /<br>IP / USP / PH.

P / PH. EUR.| 275.00 mg| ||5|METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)| 1 Number|5|METHOTREXATE EP / BP / IP / USP / PH. EUR.| 525.00 mg| ||6|METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)| 1 Number|6|METHOTREXATE EP / BP / IP / USP / PH. EUR.| 1050.00 mg| ||7|METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100MG [IN WHICH ACTIVE INGREDIENT METHOTREXATE USED IS 13.375 KGS.])| 1 Number|7|METHOTREXATE EP / BP / IP / USP / PH. EUR.| 5250.00 mg|

Case No.	121 / NC/3/MEET/Nov/202223/14
Case Status	Case Rejected
Party Name	ASOJ SOFT CAPS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00313907AM22
RA File Number	34AX04000142 AM22
Licence No and<br>Date	3411001665/10/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the import item No. 6 – Fish Oil (55<br>Percentage) (33:22) (Fish Lipid Oil) having ITC HS – 15042020 comes under Chapter 15 and as per para 4.11 (A) (i)

UDIN00286113AM23

of the FTP 2015-20 , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self- declaration basis under para 4.07 of the FTP.

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

ible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self- declaration basis under para 4.07 of the FTP.

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

Case No.	122 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00314623AM22
RA File Number	05AX04000321 AM22
Licence No and<br>Date	0511007823/11/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology<br>(DBT) for obtaining their comments.

Case No.	Case No.	123 / NC/3/MEET/Nov/202223/14	123 / NC/3/MEET/Nov/202223/14	123 / NC/3/MEET/Nov/202223/14	123 / NC/3/MEET/Nov/202223/14	123 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		UTTAM CAMPHOR WORKS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00315086AM22
RA File Number		06AA04008356 AM22
Licence No and<br>Date		0611001053/11/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. CAMPHOR TABLETS (NET CONTENTS OF CAMPHOR POWER (SYNTHETIC) 9524 KGS. 10000 kg 1 CAMPHOR POWDER (SYNTHETIC) 9619.24 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||CAMPHOR TABLETS (NET CONTENTS OF CAMPHOR POWER (SYNTHETIC) 9524 KGS.|| 10000 kg|1|CAMPHOR POWDER (SYNTHETIC)| 9619.24 kg|

UDIN00286113AM23

FOR<br>EXPORT<br>OF	10000	KGS
CAMPHOR TABLETS)

Case No.	124 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00315693AM22
RA File Number	09AX04000098 AM22
Licence No and<br>Date	0911002275/12/01/2022

|Meeting Number and Date|NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022| |HQ File Number|HQRNORM APPLY 00315693AM22| |RA File Number|09AX04000098 AM22| |Licence No and Date|0911002275/12/01/2022| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: (i)End use of Export Product. (ii) Step wise manufacturing process. (iii) Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis. (iv) Complete technical details as per Annexure to Appendix 4E for chemical products. (v) Stoichiometric balance between import and export on molar basis. (vi) Details of indigenous input with quantity.||

Case No.	125 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00315825AM22
RA File Number	09AX04000108 AM22
Licence No and<br>Date	0911002281/12/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

UDIN00286113AM23

|HQRNORM APPLY 00315825AM22| |RA File Number|09AX04000108 AM22| |Licence No and Date|0911002281/12/01/2022| |Norms Committee Decision: Deferred for comments of TE.||

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Case No.	126 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00317040AM22
RA File Number	08AX04000199 AM22
Licence No and<br>Date	0811003776/13/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	127 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	VISWAAT CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00318314AM22
RA File Number	03AX04000704 AM22
Licence No and<br>Date	0311010518/14/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Information given for NVM in import and export is not matching since item of import at Sl. No. 1 – MIXED<br>TERPENES AND TERPENOIDS IN AROMATIC SOLVENT [AS/01/031] is having 30% NVM and export is having<br>99.5% NVM.

ort and export is not matching since item of import at Sl. No. 1 – MIXED** TERPENES AND TERPENOIDS IN AROMATIC SOLVENT [AS/01/031] is having 30% NVM and export is having 99.5% NVM.||

Case No.	128 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00318349AM22
RA File Number	31AX04000040 AM22
Licence No and<br>Date	3111000876/14/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:

79 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

i. To give balanced chemical reaction of manufacturing of each export product giving Molecular weight with theoretical quantity and practical quantity obtained in the reaction. ii. Justification for low yield, if any.

Case No.	129 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00320005AM22
RA File Number	07AX04000209 AM22
Licence No and<br>Date	0711002880/16/01/2022
Norms Committee Decision:
Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00320005AM22| |RA File Number|07AX04000209 AM22| |Licence No and Date|0711002880/16/01/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	130 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00321421AM22
RA File Number	34AX04000074 AM22
Licence No and<br>Date	3411001688/17/01/2022
Norms Committee	Decision:
.
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in	Meeting No NC/3/MEET/Sep/202223/9 dated 07/10/2022 against advance authorization No.
3411000643 dated 27/05/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP		Vol. I as per
details given below or as applied by the firm, whichever is less:
Export Product	Qty<br>Sl. No.<br>Import Item Name.	Qty.
PIPERAZINE ANHYDROUS<br>1 kg<br>1<br>PIPERAZINE CRUDE OR PIPERAZINE		2.047 kg
	MIXTURE (Percentage purity NMT 48.1%)

UDIN00286113AM23

y Sl. No. Import Item Name.|Qty.|| |PIPERAZINE ANHYDROUS 1 kg 1 PIPERAZINE CRUDE OR PIPERAZINE||2.047 kg|| ||MIXTURE (Percentage purity NMT 48.1%)||| |||||

UDIN00286113AM23

Case No.	131 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00320688AM22
RA File Number	31AX04000045 AM22
Licence No and<br>Date	3111000884/17/01/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Chemistry with yield.<br>i.
Production<br>ii.	/ Consumption data duly certified by CA.

Case No.	132 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00321040AM22
RA File Number	03AX04000043 AM22
Licence No and<br>Date	0311010585/17/01/2022
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.

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

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

Case No.	133 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED

81 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00321046AM22
RA File Number	038504000145 AM21
Licence No and<br>Date	0311010587/17/01/2022
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/Sep/202223/9 dated07/10/2022 against advance authorization No.<br>0311011997 dated 28/02/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

28/02/2022**, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Acetic Acid 1.209 kg (with 25% wastage METHYL ACETOACETATE (ACETO ACETIC METHYL ESTER) 1 kg 2 Methanol 0.284 kg (with 3% wastage) RA concerned may take further necessary action as per above decision of NC.||

Case No.	134 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00321275AM22
RA File Number	05AX04000573 AM22
Licence No and<br>Date	0511007997/17/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>As per process diagram, there is blending involved.<br>i.<br>Item of Blending and its quantity.<br>ii.

Case No.	135 / NC/3/MEET/Nov/202223/14

UDIN00286113AM23

e firm: As per process diagram, there is blending involved. i. Item of Blending and its quantity. ii.|| ||| |Case No.|135 / NC/3/MEET/Nov/202223/14|

UDIN00286113AM23

Case Status	Case Status	Case Approved
Party Name		SWATI MENTHOL AND ALLIED CHEMICALS		LIMITED
Meeting Number<br>and Date		<br>NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00321279AM22
RA File Number		05AX04000574 AM22
Licence No and<br>Date		0511007998/17/01/2022
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/202122/2 dated 02/07/2021 against advance authorization No.
0511002498dated 08/05/2021, it was decided to ratify adhoc norms under Para					4.07 of HBP	Vol. I as per
details given below or as applied by the firm, whichever is less:
	Export Product<br>Qty.		Sl. No.	Import items		Qty.
	TRANS	ANETHOLE<br>DOUBLE<br>155200 kg	1	ANETHOLE	<br>CONTAINING	<br>156782 kg
	DISTILLED	99.6 PERCENT TO 99.8		TRANS ANETHOLE 99
	PERCENT
				PERCENT
<br>RA concerned may take further necessary action as per above decision of NC.

G| 156782 kg|| ||DISTILLED|99.6 PERCENT TO 99.8||TRANS ANETHOLE 99|||| ||PERCENT||||||| |||||PERCENT|||| | RA concerned may take further necessary action as per above decision of NC.||||||||

Case No.<br>136 / NC/3/MEET/Nov/202223/14	Case No.<br>136 / NC/3/MEET/Nov/202223/14	Case No.<br>136 / NC/3/MEET/Nov/202223/14
Case Status<br>Case Approved
Party Name<br>OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number<br>HQRNORM APPLY 00322542AM22
RA File Number<br>09AX04000129 AM22
Licence No and<br>Date<br>0911002311/18/01/2022
Norms Committee Decision:
The Committee considered the case	as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No NC/3/MEET/Nov/202223/12 dated18/11/2022 against advance authorization No.
0911002994dated13/05/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP			Vol. I as per
details given below or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.

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

Case No.<br>136 / NC/3/MEET/Nov/202223/14	Case No.<br>136 / NC/3/MEET/Nov/202223/14	Case No.<br>136 / NC/3/MEET/Nov/202223/14
Case Status<br>Case Approved
Party Name<br>OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number<br>HQRNORM APPLY 00322542AM22
RA File Number<br>09AX04000129 AM22
Licence No and<br>Date<br>0911002311/18/01/2022
Norms Committee Decision:
The Committee considered the case	as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No NC/3/MEET/Nov/202223/12 dated18/11/2022 against advance authorization No.
0911002994dated13/05/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP			Vol. I as per
details given below or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.

UDIN00286113AM23

orms 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.||

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1	3,4-Difluoro Nitrobenzene	0.80 kg
2	(S)-(+)-Epichlorohydrin<br>(OR)<br>(s)-(+)-2-<br>(Chloromethyl) Oxirane	0.80 kg
3	Triethyl Amine	0.20 kg
4	Ethyl Acetate	2.50 kg
5	Isopropyl Alcohol (IPA)	2.00 kg
6	Hydrazine Hydrate	1.00 kg
7	Methylene Di Chloride (MDC)	0.80 kg
8	Methanol	1.50 kg

Case No.	137 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00323538AM22
RA File Number	09AX04000097 AM22
Licence No and<br>Date	0911002338/19/01/2022
Norms Committee Decision:<br>Deferred for comments of TE

7/12/2022| |HQ File Number|HQRNORM APPLY 00323538AM22| |RA File Number|09AX04000097 AM22| |Licence No and Date|0911002338/19/01/2022| |Norms Committee Decision: Deferred for comments of TE||

Case No.	138 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00324009AM22
RA File Number	03AX04000495 AM22
Licence No and	0311010688/19/01/2022

UDIN00286113AM23

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. Molecular weight of Export Product.

ii. Stoichiometric balance on molecular weight basis for second stage to arrive at the quantity of raw material asked for.

Case No.	Case No.	Case No.	139 / NC/3/MEET/Nov/202223/14	139 / NC/3/MEET/Nov/202223/14	139 / NC/3/MEET/Nov/202223/14	139 / NC/3/MEET/Nov/202223/14	139 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			INDOCO REMEDIES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM APPLY 00326435AM22
RA File Number			03AX04000846 AM22
Licence No and<br>Date			0311010768/21/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>(A)<br>Sl. No.<br>Export Product<br>Qty.<br>Sl.

and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: (A) Sl. No. Export Product Qty. Sl. No. Import Items Qty. 1 ALLOPURINOL TABLETS 100MG (Each Allopurinol Tablet of 100mg contains Allopurinol 100mg) (Equivalent to:-Cyano Acetamide 0.0001mg ,Triethyl Ortho formate 0.00021mg, Formamide 0.00015 mg, Morpholine 0.00013mg , Hydrazine Hydrate 0.00006 mg) (Cross SION Norms of Allopurinol SION No.A2321 & Tablets/Capsules SION NoA412)) 1 Number 1 Allopurinol 102.00 mg / 100 mg Tablet ALLOPURINOL TABLETS 300MG (Each Allopurinol Tablet of 300mg contains Allopurinol 300 mg)(Equivalent to:-Cyano Acetamide 2 1 Number 2 Allopurinol 306.00 mg / 300 mg Tablet|||||||| ||Sl. No.|Export Product||Qty.|Sl. No.|Import Items|Qty.| ||1|ALLOPURINOL TABLETS 100MG (Each Allopurinol Tablet of 100mg contains Allopurinol 100mg) (Equivalent to:-Cyano Acetamide 0.0001mg ,Triethyl Ortho formate 0.00021mg, Formamide 0.00015 mg, Morpholine 0.00013mg , Hydrazine Hydrate 0.00006 mg) (Cross SION Norms of Allopurinol SION No.A2321 & Tablets/Capsules SION NoA412))||1 Number|1|Allopurinol|102.00 mg / 100 mg Tablet| ||2|ALLOPURINOL TABLETS 300MG (Each Allopurinol Tablet of 300mg contains Allopurinol 300 mg)(Equivalent to:-Cyano Acetamide|| 1 Number|2|Allopurinol|306.00 mg / 300 mg Tablet|

TS 300MG (Each Allopurinol Tablet of 300mg contains Allopurinol 300 mg)(Equivalent to:-Cyano Acetamide|| 1 Number|2|Allopurinol|306.00 mg / 300 mg Tablet|

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0.0003mg ,Triethyl Ortho-formate 0.00063mg, Formamide 0.00045 mg, Morpholine 0.00039mg , Hydrazine Hydrate 0.00018 mg) (Cross SION Norms of Allopurinol SION No.A2321 & Tablets/Capsules SION NoA412.))

(B)

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

Case No.	140 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00326509AM22
RA File Number	03AX04000816 AM22
Licence No and<br>Date	0311010772/21/01/2022
Norms Committee Decision:

86 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

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

Sl. No.	Export	Product			Qty	Sl. No.	Import Items	Qty
1	Sodium	<br>Chloride	0.9%	100ml	<br>1 Number	1	Sodium Chloride (SANAL)(EP)	0.945 gram
	Infusion
2	Sodium	<br>Chloride	0.9%	500ml	<br>1 Number	2	Sodium Chloride (SANAL)(EP)	4.725 gram
	Infusion
3	Sodium	<br>Chloride	0.9%	1000ml	<br>1 Number	3	Sodium Chloride (SANAL)(EP)	9.450 gram
	Infusion

Case No.	141 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00326841AM22
RA File Number	09AA04016329 AM22
Licence No and<br>Date	0911002348/21/01/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	142 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00329136AM22
RA File Number	03AX04000717 AM22
Licence No and<br>Date	0311010813/24/01/2022
Norms Committee Decision:

UDIN00286113AM23

Deferred for comments of TE.

r|HQRNORM APPLY 00329136AM22| |RA File Number|03AX04000717 AM22| |Licence No and Date|0311010813/24/01/2022| |Norms Committee Decision:||

UDIN00286113AM23

Deferred for comments of TE.

Case No.	143 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00329031AM22
RA File Number	09AX04000163 AM22
Licence No and<br>Date	0911002351/24/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Meropenem for Injection<br>(Sterile Bulk) (containing NLT 84% Sterile<br>Meropenem)<br>1 kg<br>1<br>Meropenem Trihydrate Non Sterile<br>0.8968 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Bulk) (containing NLT 84% Sterile Meropenem) 1 kg 1 Meropenem Trihydrate Non Sterile 0.8968 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	144 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00331260AM22
RA File Number	03AX04000915 AM22
Licence No and<br>Date	0311010867/25/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to callthe firm for attendingPersonal Hearing<br>before Norms Committee to explain its case alongwithfollowing information / documents from the firm:<br>Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>i.

UDIN00286113AM23

name.

ii. Details of Packaging Material may be furnished.

iii. Copy of Master Batch Formula for export item indicating net content of inputs in each export.

Case No.	145 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00331317AM22
RA File Number	03AX04000937 AM22
Licence No and<br>Date	0311010878/25/01/2022
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 2/82-ALC4/2020 dated 10.07.2020 against advance authorization No.0310835058dated<br>25.02.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>FLUTICASONE LOTION 0.05 Percent<br>(Pack 60 ML) (Net wt. of Fluticasone<br>Propionate USP is 1.50 Kgs.)<br>50000<br>Numbers<br>1<br>Fluticasone Propionate USP<br>1.53 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Fluticasone Propionate USP is 1.50 Kgs.) 50000 Numbers 1 Fluticasone Propionate USP 1.53 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	146 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	VISION DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00332326AM22
RA File Number	09AX04000156 AM22
Licence No and<br>Date	0911002377/27/01/2022
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 5/82-ALC4/2019 dated 02.08.2019against advance authorization No.0910067431 dated

UDIN00286113AM23

01.05.2019 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

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

Piroctone Olamine<br>(Pharmaceutical product)	1 kg	1	3,3-dimet	hylacrylic acid	0.84 kg

		2	Isononan	oyl Chloride	1.30 kg

		3	Hydroxylamine Hcl		0.73 kg

|||||| |Piroctone Olamine (Pharmaceutical product)|1 kg||1||3,3-dimet|hylacrylic acid||0.84 kg| |||||||||| ||||2||Isononan|oyl Chloride||1.30 kg| |||||||||| ||||3||Hydroxylamine Hcl|||0.73 kg|

Case No.	147 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00332964AM22
RA File Number	09AX04000151 AM22
Licence No and<br>Date	0911002396/27/01/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Name of the API produced from the export item stated to be a Drug – Intermediate.<br>i.
Technical justification for the difference in the applied norms for FMP in the two licences taken in<br>ii.
January 2022 and February 2022.
Foreign collaborators’ Guaranteed Norms, if any, for the above export.<br>iii.
Copy of Technical Literature in support of yields claimed.<br>iv.

Case No.	148 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00332998AM22

UDIN00286113AM23

UDIN00286113AM23

RA File Number

03AX04000818 AM22

Licence No and Date

0311010921/27/01/2022

Norms Committee Decision: The Committee considered the case as per agenda and on the basis o0f 90% yield it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. Dimethyl-2-methyl glutarate 1 kg 1 2-methyl glutaronitrile (Purity 86-87%) 0.80 kg RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	Case No.	149 / NC/3/MEET/Nov/202223/14	149 / NC/3/MEET/Nov/202223/14	149 / NC/3/MEET/Nov/202223/14	149 / NC/3/MEET/Nov/202223/14	149 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM APPLY 00334092AM22
RA File Number			08AX04000340 AM22
Licence No and<br>Date			0811003916/28/01/2022

Date|||NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022||||| |HQ File Number|||HQRNORM APPLY 00334092AM22||||| |RA File Number|||08AX04000340 AM22||||| |Licence No and Date|||0811003916/28/01/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08/04/2022against advance authorization No. 0811002920 dated 20/10/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. (for 1 Number Vial) 1 METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. 55.00 mg METHOTREXATE INJECTION BP 100MG/ML [5 ML METHOTREXATE EP / BP / IP / 2 1 Number 2 550.00 mg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty. (for 1 Number Vial)| ||1|METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|| 1 Number|1|METHOTREXATE EP / BP / IP / USP / PH. EUR.|55.00 mg| ||2|METHOTREXATE INJECTION BP 100MG/ML [5 ML|| 1 Number|2|METHOTREXATE EP / BP / IP /|550.00 mg|

E PH. EUR. 25MG)|| 1 Number|1|METHOTREXATE EP / BP / IP / USP / PH. EUR.|55.00 mg| ||2|METHOTREXATE INJECTION BP 100MG/ML [5 ML|| 1 Number|2|METHOTREXATE EP / BP / IP /|550.00 mg|

Case No.	Case No.	Case No.	149 / NC/3/MEET/Nov/202223/14	149 / NC/3/MEET/Nov/202223/14	149 / NC/3/MEET/Nov/202223/14
Case Status			Case Approved
Party Name			INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number			HQRNORM APPLY 00334092AM22
RA File Number			08AX04000340 AM22
Licence No and<br>Date			0811003916/28/01/2022
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/Mar/202122/16 dated 08/04/2022against advance authorization No.<br>0811002920 dated 20/10/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>(for 1 Number<br>Vial)<br>1<br>METHOTREXATE INJECTION BP 25MG/ML [2ML<br>VIAL](EACH ML CONTAINS: METHOTREXATE PH.<br>EUR. 25MG)<br>1 Number<br>1<br>METHOTREXATE EP / BP / IP /<br>USP / PH. EUR.<br>55.00 mg<br>METHOTREXATE INJECTION BP 100MG/ML [5 ML<br>METHOTREXATE EP / BP / IP /<br>2<br>1 Number<br>2<br>550.00 mg
	Sl. No.	Export product		Qty.	Sl.

E EP / BP / IP / USP / PH. EUR. 55.00 mg METHOTREXATE INJECTION BP 100MG/ML [5 ML METHOTREXATE EP / BP / IP / 2 1 Number 2 550.00 mg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty. (for 1 Number Vial)| ||1|METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|| 1 Number|1|METHOTREXATE EP / BP / IP / USP / PH. EUR.|55.00 mg| ||2|METHOTREXATE INJECTION BP 100MG/ML [5 ML|| 1 Number|2|METHOTREXATE EP / BP / IP /|550.00 mg|

UDIN00286113AM23

|VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR 100 MG) USP / PH. EUR. 3 METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. 1100.00 mg 4 METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number 4 METHOTREXATE EP / BP / IP / USP / PH. EUR. 275.00 mg 5 METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number 5 METHOTREXATE EP / BP / IP / USP / PH. EUR. 525.00 mg 6 METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number 6 METHOTREXATE EP / BP / IP / USP / PH. EUR. 1050.00 mg 7 METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.

	VIAL](EACH ML CONTAINS: METHOTREXATE PH.<br>EUR 100 MG)			USP / PH. EUR.
3	METHOTREXATE INJECTION BP 100MG/ML [10ML<br>VIAL](EACH ML CONTAINS: METHOREXATE PH.<br>EUR. 100MG)	<br> <br>1 Number	3	METHOTREXATE EP / BP / IP /<br>USP / PH. EUR.	1100.00 mg
4	METHOTREXATE INJECTION USP 25MG/ML [10ML<br>VIAL](EACH ML CONTAINS: METHOTREXATE USP<br>25MG)	<br> <br>1 Number	4	METHOTREXATE EP / BP / IP /<br>USP / PH. EUR.	275.00 mg
5	METHOTREXATE INJECTION BP 25MG/ML [20ML<br>VIAL](EACH ML CONTAINS: METHOTREXATE PH.<br>EUR. 25MG)	<br> <br>1 Number	5	METHOTREXATE EP / BP / IP /<br>USP / PH. EUR.	525.00 mg
6	METHOTREXATE INJECTION BP 25MG/ML [40ML<br>VIAL](EACH ML CONTAINS: METHOTREXATE PH.<br>EUR. 25MG)	<br> <br>1 Number	6	METHOTREXATE EP / BP / IP /<br>USP / PH. EUR.	1050.00 mg
7	METHOTREXATE INJECTION BP 100MG/ML [50ML<br>VIAL](EACH ML CONTAINS: METHOTREXATE PH.<br>EUR. 100MG [IN WHICH ACTIVE INGREDIENT<br>METHOTREXATE USED IS 41.525 KGS.])	<br> <br> <br>1 Number	7	METHOTREXATE EP / BP / IP /<br>USP / PH. EUR.	5250.00 mg

Case No.	Case No.	150 / NC/3/MEET/Nov/202223/14	150 / NC/3/MEET/Nov/202223/14	150 / NC/3/MEET/Nov/202223/14	150 / NC/3/MEET/Nov/202223/14	150 / NC/3/MEET/Nov/202223/14
Case Status		Case Approved
Party Name		GLAND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00333745AM22
RA File Number		09AX04000069 AM22
Licence No and<br>Date		0911002409/28/01/2022
Norms Committee Decision:<br>.<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

UDIN00286113AM23

iven 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.|

UDIN00286113AM23

1	Nadroparin Calcium	52.25 mg
2	Barrel Syringes	1.05 Numbers
3	Plunger Stoppers	1.1085 Numbers
4	Plunger Rods	1.0165 Numbers
5	Preventis Needle Shielding System	1.05 Numbers

5 mg| |---|---|---|---|---|---| ||||2|Barrel Syringes|1.05 Numbers| ||||3|Plunger Stoppers|1.1085 Numbers| ||||4|Plunger Rods|1.0165 Numbers| ||||5|Preventis Needle Shielding System|1.05 Numbers|

Case No.	151 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	SYMED LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00333903AM22
RA File Number	09AX04000106 AM22
Licence No and<br>Date	0911002414/28/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Iso Valeraldehyde<br>0.515 kg<br>2<br>Di n Propyl Amine<br>0.070 kg<br>3 - Cyno-2-ethoxy carbonyl -5- Methyl-hexanoic<br>acid ethyl ester<br>1 kg<br>3<br>Diethyl Malonate<br>0.870 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

UDIN00286113AM23

-5- Methyl-hexanoic acid ethyl ester 1 kg 3 Diethyl Malonate 0.870 kg RA concerned may take further necessary action as per above decision of NC.||

UDIN00286113AM23

Case No.	152 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
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 it was decided to call for following information / documents from the<br>firm:<br>Chemistry with yield.<br>i.<br>Production / Consumption data duly certified by CA.<br>ii.

Case No.<br>	Case No.<br>	153 / NC/3/MEET/Nov/202223/14	153 / NC/3/MEET/Nov/202223/14	153 / NC/3/MEET/Nov/202223/14	153 / NC/3/MEET/Nov/202223/14	153 / NC/3/MEET/Nov/202223/14
Case Status<br>		Case Approved
Party Name<br>		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number<br>		HQRNORM APPLY 00342862AM22
RA File Number<br>		09AX04000195 AM22
Licence No and<br>Date<br>		0911002452/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

s per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 6-bromo-3-hydroxypyrazine-2- carboxamide 2.32 kg 2 Triethylamine 2.15 kg 3 NN Dimethylformamide 5.00 kg 4 Tri-n-butylamine 3.40 kg 6-Fluoro-3-hydroxypyrazine-2-carboxamide 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||6-Fluoro-3-hydroxypyrazine-2-carboxamide||1 kg|1|6-bromo-3-hydroxypyrazine-2- carboxamide|2.32 kg| |||||2|Triethylamine|2.15 kg| |||||3|NN Dimethylformamide|5.00 kg| |||||4|Tri-n-butylamine|3.40 kg|

UDIN00286113AM23

5 Dimethyl Sulfoxide 2.59 kg

Case No.	154 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	NORM APPLY 00343126AM22
RA File Number	31AX04000059 AM22
Licence No and<br>Date	3111000968/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Complete chemistry starting from import items with calculations based on molecular weight.<br>i.<br>Yield of the reaction with justification for low yield, if any.<br>ii.<br>Production / Consumption data duly certified by GST.<br>iii.

calculations based on molecular weight.** i. Yield of the reaction with justification for low yield, if any. ii. Production / Consumption data duly certified by GST. iii.||

Case No.	155 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
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 it was decided to call for following information / documents from the<br>firm:<br>Complete chemistry giving molecular weight and percentage yield on molar basis for each step of<br>manufacturing process.<br>i.<br>(ii)Application / function of Magnesium Turning.

Case No. 156 / NC/3/MEET/Nov/202223/14

UDIN00286113AM23

Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00343395AM22
RA File Number	03AX04001061 AM22
Licence No and<br>Date	0311011086/04/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00343395AM22| |RA File Number|03AX04001061 AM22| |Licence No and Date|0311011086/04/02/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	157 / NC/3/MEET/Nov/202223/14
Case Status	Case Approved
Party Name	DANOPHARM CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00343441AM22
RA File Number	039404000360 AM21
Licence No and<br>Date	0311011114/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2<br>AMINO<br>5<br>CHLORO<br>BENZOPHENONE<br>1.257 kg<br>2<br>POTASSIUM CARBONATE<br>0.750 kg<br>5-CHLORO-2-METHYL<br>AMINO<br>BENZOPHENONE (ANTI DEPRESSION)<br>1 kg<br>3<br>TETRABUTYL<br>AMMONIUM<br>HYDREGEN SULPHATE<br>0.100 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	158 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED

UDIN00286113AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00343443AM22
RA File Number	03AX04000895 AM22
Licence No and<br>Date	0311011115/04/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

|---|---| |HQ File Number|HQRNORM APPLY 00343443AM22| |RA File Number|03AX04000895 AM22| |Licence No and Date|0311011115/04/02/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	159 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00343444AM22
RA File Number	03AX04000893 AM22
Licence No and<br>Date	0311011116/04/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	160 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00343445AM22
RA File Number	03AX04000892 AM22
Licence No and<br>Date	0311011117/04/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	161 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00345204AM22
RA File Number	03AX04001106 AM22
Licence No and<br>Date	0311011140/06/02/2022
Norms Committee Decision:

97 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

|Licence No and Date|0311011140/06/02/2022| |Norms Committee Decision:||

97 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

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

i. As per manufacturing process, molecular weight of finished product is 384.69, while as per catalogue attached, molecular weight is 150. Please explain it.
ii. How in step 2, yield is more than 100%, that is, 121%.
iii. Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.

Case No.	162 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00345730AM22
RA File Number	03AX04000898 AM22
Licence No and<br>Date	0311011149/07/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	163 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00345828AM22
RA File Number	09AX04000205 AM22
Licence No and<br>Date	0911002465/07/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00345828AM22| |RA File Number|09AX04000205 AM22| |Licence No and Date|0911002465/07/02/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	164 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00345974AM22
RA File Number	03AX04001021 AM22
Licence No and<br>Date	0311010996/07/02/2022
Norms Committee Decision:

UDIN00286113AM23

Deferred for comments of TE


Deferred for comme		nts of TE


Case No.		165 / NC/3/MEET/Nov/202223/14
Case Status		Case Deferred

Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number		HQRNORM APPLY 00346268AM22
RA File Number		34AX04000204 AM22
Li<br>D	cence No and<br>ate	3411001767/07/02/2022
N<br>D
	orms Committee Decision:<br>eferred for comments of TE.


C	ase No.	166 / NC/3/MEET/Nov/20222	3/14
C	ase Status	Case Deferred
P	arty Name	PUNISKA HEALTHCARE PR	IVATE	LIMITED
M<br>an	eeting Number<br>d Date	NC/ 3/ MEET/ Nov/ 202223/ 1	4 and 07/
				12/2022
H	Q File Number	HQRNORM APPLY 0034730	6AM22

R	A File Number	08AX04000205 AM22
Licence No and<br>Date		0811003993/08/02/2022
Norms Committee Decision:

|||||12/2022||| |H|Q File Number|HQRNORM APPLY 0034730|6AM22|||| |||||||| |R|A File Number|08AX04000205 AM22||||| |Licence No and Date||0811003993/08/02/2022||||| |Norms Committee Decision:||||||| |||||||| |Deferred for comme||nts of TE.||||| |||||||| |||||||| |||||||| |Case No||167 / NC/3/MEET/Nov/202223/14||||| |.||||||| |Case Status||Case Deferred||||| |||||||| |Party Name||ARKRAY HEALTHCARE PRIVATE LIMITED||||| |||||||| |Meeting Number and Date||NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022||||| |||||||| |HQ File Number||HQRNORM APPLY 00347493AM22||||| |||||||| |RA File Number||52AX04000059 AM22||||| |Licence No and Date||5211001995/08/02/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology (DBT) for obtaining their comments.||||||| |||||||| |C N||168 / NC/3/MEET/N/202223/14||||| |ase o.||ov||||| |C S||C Dfd||||| |ase tatus||ase eerre||||| |P N||ENCUBE ETHICALS PRIVATE LIMITED||||| |arty ame|||||||

Case No.	168 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED

99 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

99 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00348248AM22
RA File Number	03AX04001105 AM22
Licence No and<br>Date	0311011230/09/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to callthe firm for attendingPersonal Hearing
before Norms Committee to explain its case alongwithfollowing information / documents from the firm:
Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>i.
name.
Details of Packaging Material may be furnished.<br>ii.
Copy of Master Batch Formula for export item indicating net content of inputs in each export.<br>iii.

Meeting Number	Meeting Number	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
and Date
HQ File Number		HQRNORM APPLY 00348248AM22
RA File Number		03AX04001105 AM22
Licence No and
		0311011230/09/02/2022
Date
Norms Committee		Decision:

mber||HQRNORM APPLY 00348248AM22||||||| |RA File Number||03AX04001105 AM22||||||| |Licence No and||||||||| |||0311011230/09/02/2022||||||| |Date||||||||| |Norms Committee||Decision:||||||| |||||||||| |The Committee con bf N C||sidered the case as per agenda and it was decided to callthe firm for attendingPersonal Hearing i li i lihflli ifi / d f h fi||||||| |eore orms om||mttee to expan ts case aongwtoowng normaton ocuments rom te rm:||||||| |||||||||| | ||||||||| |Descriptio i.||n of all Excipients shown in items to be imported may be furnished as per their chemical||||||| | ||||||||| |name.||||||||| |Details of P ii.||ackaging Material may be furnished.||||||| |Co of M iii||ster Batch Formla for exort item indicatin net content of ints in each exort||||||| |py .||u p g pu p.||||||| |||||||||| |||||||||| |||||||||| |Case No.||169 / NC/3/MEET/Nov/202223/14||||||| |||||||||| |Case Status||Case Approved||||||| |||||||||| |Party Name||DANOPHARM CHEMICALS PRIVATE LIMITED||||||| |Meeting Number ||NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022||||||| |and Date||||||||| |HQ File Number||HQRNORM APPLY 00348260AM22||||||| |RA File Number||039404000358 AM21||||||| |||||||||| |Licence No and ||0311000653/09/02/2022||||||| |Date||||||||| |Norms Committee||Decision:||||||| |||||||||| |||||||||| |The Committee co||nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP||||||| |||||||||| ||Vol.

| |Norms Committee||Decision:||||||| |||||||||| |||||||||| |The Committee co||nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP||||||| |||||||||| ||Vol. I as per deta|ils given below or as applied by the firm, whichever is less:||||||| |||||||||| |||||||||| |||||||||| |||||||||| |||||||||| |||||||||| ||Export product||Qty.|Sl. No.|Import items|||Qty.| |||||||||| |||||||||| |||||||||| ||Alpha-(2,4-Dichlorophenyl)-1H-Imidazole- 1-Ehtanol(Anti Inflammatory)||1 kg|1|2 4 Dichloro Acetophenone|||1.45 kg| |||||2|Imidazole|||0.53 kg| |||||3|Sodium Borohydride|||0.10 kg| |||||||||| |||||4|Dimethyl Sulphoxide|||1.00 kg| |||||||||| |||||||||| |||||||||| |||||||||| ||||||||||

100

UDIN00286113AM23

Case No.	170 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	VENKATA NARAYANA ACTIVE INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00348986AM22
RA File Number	04AX04000023 AM22
Licence No and<br>Date	0411002608/09/02/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	171 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00350237AM22
RA File Number	05AX04000943 AM22
Licence No and<br>Date	0511008753/10/02/2022
Norms Committee Decision:
Deferred for comments of TE.

/12/2022| |HQ File Number|HQRNORM APPLY 00350237AM22| |RA File Number|05AX04000943 AM22| |Licence No and Date|0511008753/10/02/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	172 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 00351303AM22
RA File Number	09AX04000191 AM22
Licence No and<br>Date	0911002504/11/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Name of the API produced from the export item stated to be a Drug – Intermediate.<br>i.
Technical justification for the difference in the applied norms for FMP in the two licences taken in<br>ii.

101 This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-12-2022 16:47:16.

UDIN00286113AM23

January 2022 and February 2022.

iii. Foreign collaborators’ Guaranteed Norms, if any, for the above export. iv. Copy of Technical Literature in support of yields claimed.

Case No.<br>173 / NC/3/MEET/Nov/202223/14
Case Status<br>Case Deferred
Party Name<br>LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number<br>HQRNORM APPLY 00351870AM22
RA File Number<br>03AX04000936 AM22
Licence No and<br>Date<br>0311011342/11/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to callthe firm for attendingPersonal Hearing
before Norms Committee to explain its case alongwithfollowing information / documents from the firm:
As per manufacturing process, Acetic Acid is cracked to get Ketone as such other than obtained in cracking<br>i.
with their value.
Stoichiometric balance with molecular weight to arrive at the quantity of raw material asked for.<br>ii.
Production / Consumption data for last two years duly certified by GST.<br>iii.

Case No.	174 / NC/3/MEET/Nov/202223/14
Case Status	Case Deferred
Party Name	PIL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 14 and 07/12/2022
HQ File Number	HQRNORM APPLY 003

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