IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-11-18

DGFT Committee Minutes

Document text

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Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / व्यापार महकमा 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

(DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Nov/202223/12 DATED: 18/11/2022

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/202223/12 dated 18/11/2022 of Norms Committee - III for the year 2022-23 was held on 18/11/2022 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	AJAY KUMAR,Deputy Director	Directorate General of Foreign Trade, Delhi
2	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 28-11-2022 19:16:54.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00002967AM23
RA File Number	092404000044 AM15
Licence No and<br>Date	0910059969/01/05/2014
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms andit was observed that the firm has not
provided any technical data in support of its request. 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.	2 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	RIDDHI PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003951AM23
RA File Number	342404000266 AM15
Licence No and<br>Date	3410040864/12/01/2015
Norms Committee Decision:
The firm vide e-mail dated01.11.2022has informed that they are satisfied with the adhoc norms ratified by Norms
Committee-3 in its Meeting No.3/AM21 dated 02.09.2020and hence they would like to withdraw their request.
In view of above e-mail, the Committee decided towithdrawthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	3 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	ALKALOIDS CORPORATION
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00000462AM23
RA File Number	022404000145 AM17

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Licence No and<br>Date	0210207123/07/11/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23/09/2022against advance<br>authorization No.0210207904 dated 24/10/2017, it was decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Papaverine Hydrochloride BP<br>1 kg<br>1<br>Papaverine Crude Content 95%<br>1.158 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Licence No and Date

0210207123/07/11/2016

Norms Committee Decision: The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23/09/2022against advance authorization No.0210207904 dated 24/10/2017, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. Papaverine Hydrochloride BP 1 kg 1 Papaverine Crude Content 95% 1.158 kg RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	4 / NC/3/MEET/Nov/202223/12	4 / NC/3/MEET/Nov/202223/12	4 / NC/3/MEET/Nov/202223/12	4 / NC/3/MEET/Nov/202223/12	4 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM REVIW00003159AM23
RA File Number		052404000478 AM17
Licence No and<br>Date		0510401740/21/02/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue fromSION A - 3151, it<br>was decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PHTHALIC ANHYDRIDE<br>0.372 kg<br>PLASTICIZER (PVC) (DINP)<br>1 kg<br>2<br>ISO Nonanol<br>0.726 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.				adhoc norms and taking cue fromSION A - 3151, it
	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. 5 / NC/3/MEET/Nov/202223/12

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Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00002756AM23
RA File Number	522404000085 AM18
Licence No and<br>Date	5210042570/20/03/2018
Norms Committee Decision:
Deferred for comments of TE.

Case No.	6 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003008AM23
RA File Number	318304000171 AM18
Licence No and<br>Date	3110067030/12/04/2018
Norms Committee Decision:
Deferred for comments of TE.

Case No.	7 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003044AM23
RA File Number	092404000001 AM19
Licence No and<br>Date	0910066235/15/05/2018
Norms Committee Decision:
The Committee considered the request of firm for enhancement of in the quantity of import item No. 6 – Activated Carbon
andit was observed that the firm has not provided any technical data in support of its request. 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.	8 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003137AM23
RA File Number	318304000005 AM19
Licence No and<br>Date	3110067060/23/05/2018
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	9 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003005AM23
RA File Number	318304000081 AM19
Licence No and<br>Date	3110067162/24/08/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information/documents from the firm:<br>Quantity of Higher Methylated Phenol as a By-Product produced during reaction against 1 kg of Export and its<br>Commercial Value alongwith sale invoice copy.

Case No.	Case No.	10 / NC/3/MEET/Nov/202223/12	10 / NC/3/MEET/Nov/202223/12	10 / NC/3/MEET/Nov/202223/12	10 / NC/3/MEET/Nov/202223/12	10 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		DCM SHRIRAM INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM REVIW00003431AM23
RA File Number		052304000242 AM19
Licence No and<br>Date		0510407689/05/09/2018
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.
	Export product		Qty.	Sl. No.	Import items	Qty.

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1<br>D (-) Alpha Phenyl Glycine Base<br>0.512 kg<br>2<br>Ethyl Aceto Acetate<br>0.409 kg<br>D<br>(-)<br>Alpha<br>Phenyl<br>Glycine<br>Ethyl<br>Potassium Dane Salt.<br>1 kg<br>3<br>Potassium Hydroxide<br>0.215 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.	D<br>(-)<br>Alpha<br>Phenyl<br>Glycine<br>Ethyl<br>Potassium Dane Salt.	<br>1 kg	1	D (-) Alpha Phenyl Glycine Base	0.512 kg
			2	Ethyl Aceto Acetate	0.409 kg
			3	Potassium Hydroxide	0.215 kg

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

Case No.	11 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003183AM23
RA File Number	052404000392 AM19
Licence No and<br>Date	0510408318/02/11/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms andit was observed that the firm has not<br>provided any technical data in support of its request. Hence, it was decided torejectthe case maintaining the status<br>quo.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	12 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003070AM23
RA File Number	052404000473 AM19
Licence No and<br>Date	0510408806/06/12/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.13/82-ALC4/2018 dated 14.01.2019against advance authorization<br>No.0510407655 dated 31.08.2018, it was decided to revise adhoc norms as under:

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Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PURE TERE PHTHALIC ACID<br>0.447 kg<br>PLASTICIZER (PVC)<br>(DI-OCTYL TERAPHTHALATE (DOTP)<br>1 kg<br>2<br>2 ETHYL HEXANOL<br>0.680 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl. No.	Import items	Qty.
	PLASTICIZER (PVC)<br>(DI-OCTYL TERAPHTHALATE (DOTP)	1 kg	1	PURE TERE PHTHALIC ACID	0.447 kg
			2	2 ETHYL HEXANOL	0.680 kg

Case No.	13 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MALLADI DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00002622AM23
RA File Number	042404000143 AM19
Licence No and<br>Date	0410164962/10/12/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc normsand it was observed that the norms applied by<br>the firm are higher than supported by the chemistry and material balance. Also, the Export Product is a new<br>molecule.<br>Hence, it was decided to call the firm for attendingPersonal Hearing<br> before Norms Committee to<br>explain its case.

Case No.	14 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003104AM23
RA File Number	052404000511 AM19
Licence No and<br>Date	0510408987/19/12/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.13/82-ALC4/2018 dated 14.01.2019against advance authorization<br>No.0510407655 dated 31.08.2018, it was decided to revise adhoc norms as under:

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Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PURE TERA PHTHALIC ACID<br>0.447 kg<br>PLASTICIZER (PVC) (DOTP)<br>1 kg<br>2<br>2 ETHYL HEXANOL<br>0.680 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl. No.	Import items	Qty.
	PLASTICIZER (PVC) (DOTP)	1 kg	1	PURE TERA PHTHALIC ACID	0.447 kg
			2	2 ETHYL HEXANOL	0.680 kg

Case No.	15 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00002987AM23
RA File Number	318304000157 AM19
Licence No and<br>Date	3110067278/09/01/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information/documents from the firm:<br>Quantity of Higher Methylated Phenol as a By-Product produced during reaction against 1 kg of Export and its<br>Commercial Value alongwith sale invoice copy.

Case No.	16 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00002822AM23
RA File Number	052404000650 AM19
Licence No and<br>Date	0510409704/20/02/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.13/82-ALC4/2018 dated 14.01.2019against advance authorization<br>No.0510407655 dated 31.08.2018, it was decided to revise adhoc norms as under:

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Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PURE TERA PHTHALIC ACID<br>0.447 kg<br>PVC PLASTICIZER (DOTP)<br>1 kg<br>2<br>2 ETHYL HEXANOL<br>0.680 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.	Export product<br>	Qty.	Sl. No.	Import items	Qty.
	PVC PLASTICIZER (DOTP)	1 kg	1	PURE TERA PHTHALIC ACID	0.447 kg
			2	2 ETHYL HEXANOL	0.680 kg

Case No.	17 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003142AM23
RA File Number	052404000647 AM19
Licence No and<br>Date	0510409744/22/02/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.13/82-ALC4/2018 dated 14.01.2019against advance authorization<br>No.0510407655 dated 31.08.2018, it was decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Pure Tera Phthalic Acid<br>0.447 kg<br>PVC PLASTICIZER (DOTP)<br>1 kg<br>2<br>2 Ethyl Hexanol<br>0.680 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	18 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003268AM23

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RA File Number	039504001191 AM20
Licence No and<br>Date	0310835417/17/03/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms andit was observed that earlier the norms 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.	19 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SRI CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00002991AM23
RA File Number	042404000109 AM21
Licence No and<br>Date	0410167147/07/10/2020
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following
information/documents from the firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.
Export Product description mentioned in the Advance Authorization is in Brand Name. Please furnish<br>vi.
exact chemical name of Export Product with its technical catalogue.

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

Case No.	20 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SCOTT EDIL PHARMACIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00002997AM23
RA File Number	30AA04004572 AM21
Licence No and<br>Date	3011000300/24/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case toDepartment of

10 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

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Biotechnology (DBT) for obtaining its comments.

Case No.	21 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003215AM23
RA File Number	03AA04025038 AM21
Licence No and<br>Date	0311002397/10/03/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms andit was observed that earlier the norms 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.	22 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00002912AM23
RA File Number	05AA04041798 AM21
Licence No and<br>Date	0511001982/01/04/2021
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was observed that the norms applied are
very high and no chemistry was given. Hence, it was decided to call for following information/documents from the firm:
Complete chemistry, molecular weight, percentage yield on molar basis.<br>i.
ii Material balance for entire process.

Case No.	23 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003219AM23
RA File Number	03AA04033912 AM21

11 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

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Licence No and 0311003102/09/04/2021 Date Norms Committee Decision: The Committee considered the request of firm for review of adhoc norms and it was observed that earlier the norms were ratified as per SION A - 412. Hence, it was decided to reject the case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.

Case No.	24 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003216AM23
RA File Number	03AA04033058 AM21
Licence No and<br>Date	0311003205/21/04/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms andit was observed that earlier the norms 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.	25 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00002621AM23
RA File Number	30AA04004647 AM22
Licence No and<br>Date	3011000736/12/06/2021
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:
Percentage yield on molar basis for each step with supporting literature.

Case No.	26 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected

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Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003217AM23
RA File Number	03AA04028999 AM22
Licence No and<br>Date	0311004821/22/06/2021
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.	27 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003220AM23
RA File Number	03AA04044353 AM22
Licence No and<br>Date	0311005322/12/07/2021
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.	28 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003218AM23
RA File Number	03AA04066488 AM22
Licence No and<br>Date	0311006599/01/09/2021
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.

13 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

Case No.	29 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM REVIW00003221AM23
RA File Number	03AA04066551 AM22
Licence No and<br>Date	0311006600/01/09/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms andit was observed that earlier the norms 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.<br>30 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM REVIW00003191AM23
RA File Number<br>03AX04001249 AM22
Licence No and<br>Date<br>0311011408/15/02/2022
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for
same export product / import item in Meeting No.3/82-ALC4/2018 dated 05.06.2018
against advance authorization No.0310815607 dated 07.09.2017, it was decided to revise adhoc norms as under:
Export product<br>Qty.	Sl. No.	Import items	Qty.
ORLISTAT PELLETS 50 %<br>1 kg	1	ORLISTAT	0.505 kg
<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00265785AM23

Case No.	31 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00381096AM22
RA File Number	34AX04000347 AM22
Licence No and<br>Date	3411001937/09/03/2022
Norms Committee Decision:<br>Deferred for comments of TE

Case No.	32 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	GUPTA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00381776AM22
RA File Number	05AX04001230 AM22
Licence No and<br>Date	0511010862/10/03/2022
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>Indicate the chemical name of export and import item.<br>i.<br>Chemistry of the reaction indicating calculation of requirement of raw materials, molecular weight, etc. with<br>yield<br>ii.<br>Production / Consumption data duly certified by CA.<br>iii.

Case No.	33 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00381846AM22
RA File Number	03AX04001634 AM22
Licence No and<br>Date	0311012524/10/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export<br>product / import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29/04/2022against advance authorization

15 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

No. 0311009325 dated 09.12.2021 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

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

CHLORAMPHENICOL EYE DROPS 10<br> <br> <br>	<br> <br>1	Vial	1	Chloramphenicol Micronized	5<br>	1.00 mg / 10<br>
ML((EACH<br>VIAL<br>CONTAINS<br>CHLORAMPHENICOL<br>MICRONIZED<br>0.050GM NET WT OF BULK DRUG IS<br>20.85 KGS))	<br> <br>				m	l Vial

Case No.	34 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00382075AM22
RA File Number	50AX04000031 AM22
Licence No and<br>Date	5011000413/10/03/2022
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 COA of Export Product.
ii COA of Import item from foreign supplier.
iii Content of By-Products, its recovery and solvents.
iv Complete technical details, wastage claimed etc. as per Annexure to Appendix 4E.

Case No.	35 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00382170AM22
RA File Number	34AX04000358 AM22

UDIN00265785AM23

Licence No and 3411001942/10/03/2022 Date Norms Committee Decision:

Deferred for comments of TE.

Licence No and	Licence No and	Licence No and	3411001942/10/03/2022	3411001942/10/03/2022	3411001942/10/03/2022	3411001942/10/03/2022	3411001942/10/03/2022
Date
Norms Committee			Decision:
Deferred for comme			nts of TE.

Case No.			36 / NC/3/MEET/Nov/202223/12
Case Status			Case Approved
Party Name			AUROBINDO PHARMA LTD

Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00383395AM22
RA File Number			09AX04000280 AM22
Licence No and			0911002654/11/03/2022
Date
Norms Committee			Decision:
The Committee co<br>Vol I as per detai			nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>ls given below or as applied by the firm whichever is less:
	.		,


	Sl No	Export pr	oduct	Qt	Sl No	Import items	Qt
	. .			y.	. .		y.
	1	Cefalexin<br>Tablets<br>250mg(Cefalexin<br>Tablets 250mg (Each film coated tablet		<br> <br>1 Number	1	Cefalexin Monohydrate Ph Eur<br>(Powder)	268.2 mg / 250<br>mg Tablet
		<br>contains<br>Cefalexin<br>Monohydrate		<br>
		Ph.Eur<br>	equivalent<br>to<br>anhydrous<br>	<br>
		Cefalexin<br>dr in th	250mg) [The relevant bulk<br>e exort rodct is 75 Ks])
		ug	p pu g
	2	Cefalexin<br>	<br>Tablets<br>500mg(Cefalexin<br>	<br> <br>1 Number	1	Cefalexin Monohydrate Ph Eur<br>	536.4 mg / 500<br>
		Tablets 5<br>contains	00mg (Each film coated tablet<br>Cefalexin<br>Monohdrate	<br>		(Powder)	mg Tablet
		<br>Ph.Eur	<br>y<br>equivalent<br>to<br>anhydrous	<br>
		Cefalexin<br>drug in<br>	<br> <br>500mg) [The relevant bulk<br>the export product is 2925	<br> <br>
Kgs])<br> <br>RA concerned may take further necessary action as per above decision of NC.		Kgs])

C	ase No.		37 / NC/3/MEET/Nov/202223/12
C	ase Status
			Case Deferred
P	arty Name		AASHA BIOCHEM
M	eeting Number
and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

Case No.	37 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AASHA BIOCHEM
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

UDIN00265785AM23

HQ File Number	HQRNORM APPLY 00383526AM22
RA File Number	10AX04000077 AM22
Licence No and<br>Date	1011000943/11/03/2022
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>(i) COA indicating moisture content of both export and impor<br>(ii) Calculation with requirement of raw material for the manufacturing of export item giving<br>justification for wastage.

Case No.	38 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00383845AM22
RA File Number	05AX04001021 AM22
Licence No and<br>Date	0511010960/11/03/2022
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-ALC4/2020 dated 09.10.2020against advance authorization No.0510413470<br>dated 29.01.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Ceftriaxone Sodium Sterile<br>1 kg<br>1<br>Ceftriaxone Sodium Non Sterile<br>1.04 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	39 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00386066AM22

UDIN00265785AM23

RA File Number	RA File Number	03AX04001619 AM22	03AX04001619 AM22	03AX04001619 AM22	03AX04001619 AM22	03AX04001619 AM22	03AX04001619 AM22	03AX04001619 AM22	03AX04001619 AM22	03AX04001619 AM22
Licence No and<br>Date		0311012706/14/03/2022
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>2N-PROPYL-4-METHYL-6-(1-METHYL-<br>BENZIMIDAZOL-2-YL)BENZIMIDAZOLE<br>0.763 kg<br>2<br>4-METHYL-2-BIPHENYL CARBOXYLIC ACID<br>METHYL ESTER<br>0.60 kg<br>3<br>METHANOL<br>3.69 kg<br>4<br>METHYLENE CHLORIDE<br>2.20 kg<br>TELMISARTAN<br>1 kg<br>5<br>ACETIC ACID GLACIAL<br>0.90 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.				per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>applied by the firm, whichever is less:
	Export product		Qty.	Sl. No.		Imp	ort items		Qty.

	TELMISARTAN		1 kg	1		2N-<br>	PROPYL<br>	-4-METHYL-6-(1-METHYL-<br>	0	.763 kg
						BEN	ZIMID	AZOL-2-YL)BENZIMIDAZOLE
				2		4-M<br>ME
							ETHYL<br>THYL E	-2-BIPHENYL CARBOXYLIC ACID<br>STER	0	.60 kg
				3		ME	THANO	L	3	.69 kg
				4		ME	THYLE	NE CHLORIDE	2	.20 kg
				5		ACE	TIC AC	ID GLACIAL	0	.90 kg
	<br>A concerned may take further necessary a				ction as
							per abov	e decision of NC.

C	ase No.	40 / NC/3/MEET/Nov/2			02223/12
C	ase Status	Case Deferred
P	arty Name	AETHER INDUSTRIES			LIMITE
							D
M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Nov/ 202			223/ 12 a		nd 18/11	/2022

H	Q File Number	HQRNORM APPLY 00			386506A		M22
R	A File Number	52AX04000090 AM22
L<br>D	icence No and<br>ate	5211002165/14/03/2022
N<br>D	orms Committee Decision:<br>eferred for comments of TE.



C	ase No.	41 / NC/3/MEET/Nov/202223/12
C	ase Status	Case Approved
P	arty Name	GLENMARK PHARMACEUTIC					ALS LIMITED

Case No.	40 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00386506AM22
RA File Number	52AX04000090 AM22
Licence No and<br>Date	5211002165/14/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	41 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED

UDIN00265785AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00386082AM22
RA File Number	03AX04001667 AM22
Licence No and<br>Date	0311012710/14/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202122/2 dated 02.07.2021 against advance authorization No.<br>0311003273 dated 22.04.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>AZELAIC ACID GEL 15 percent (Pack<br>Size 50 Grams) (Net Wt. of Azelaic Acid<br>is 2250.00 Kgs.)<br>300000<br>Numbers<br>1<br>Azelaic Acid<br>2295.00 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	42 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	GUPTA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00386306AM22
RA File Number	05AX04001267 AM22
Licence No and<br>Date	0511010970/14/03/2022
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>Indicate the chemical name of export and import item.<br>i.<br>Chemistry of the reaction indicating calculation of requirement of raw materials, molecular weight, etc. with<br>yield<br>ii.<br>Production / Consumption data duly certified by CA..<br>iii.

Case No.	43 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred

UDIN00265785AM23

Party Name<br>PROEC ENERGY LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00386396AM22
RA File Number<br>05AX04001262 AM22
Licence No and<br>Date<br>0511010975/14/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.
COA and percentage composition of export indicating net content of each input in export.<br>vi.

Case No.<br>44 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00386424AM22
RA File Number<br>03AX04001657 AM22
Licence No and<br>Date<br>0311012790/14/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking and	taking cue from earlier decision for same export
product / import item in Meeting No.NC/3/MEET/May/202223/3	dated	27/05/2022against advance authorization
No.0310814635 dated 14.07.2017, it was decided to ratify adhoc norms			under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:
Sl. No. Export product<br>Qty.	Sl. No		Import items	Qty.
Benzydamine<br>Hydrochloride<br>And<br>1000<br>1	1.		Benzydamine	3.06 gram
Cetylpyridinium<br>Chloride<br>Anti-			Hydrochloride

Case No.<br>44 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00386424AM22
RA File Number<br>03AX04001657 AM22
Licence No and<br>Date<br>0311012790/14/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking and	taking cue from earlier decision for same export
product / import item in Meeting No.NC/3/MEET/May/202223/3	dated	27/05/2022against advance authorization
No.0310814635 dated 14.07.2017, it was decided to ratify adhoc norms			under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:
Sl. No. Export product<br>Qty.	Sl. No		Import items	Qty.
Benzydamine<br>Hydrochloride<br>And<br>1000<br>1	1.		Benzydamine	3.06 gram
Cetylpyridinium<br>Chloride<br>Anti-			Hydrochloride

UDIN00265785AM23

	Inflammatory And Antiseptic Lozenges<br>Sugar Free and(all other flavours. Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium Chloride- 1.33mg (iii)<br>Isomalt ST-M - 2586mg.<br>Net content (i) 33.333 Kgs (ii) 14.778<br>Kgs (iii) 28733.356 Kgs.)	<br>Number	2	Cetylpyridinium<br>Chloride	1.356 gram
			3	Isomalt ST-M	2586 gram
2	Benzydamine<br>Hydrochloride,<br>2,4-<br>Dichlorobenzyl Alcohol And Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial Lozenges<br>Sugar Free. Each lozenge contains (i)<br>Benzydamine Hydrochloride - 3mg (ii)<br>Isomalt ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)	1000<br>Number	4	Benzydamine<br>Hydrochloride	3.06 gram
			5	Isomalt ST-M	2586 grram
3	Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each lozenge contains (i) Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-M -<br>2586mg. Net content (i) 12 Kgs. (ii)<br>10344 Kgs.)	<br> <br> <br> <br>1000<br>Number	6	Benzydamine<br>Hydrochloride	3.06 gram
			7	Isomalt ST-M	2586 gram
4	Cetylpyridinium<br>Chloride<br>And<br>Bromhexine Hydrochloride Antiseptic<br>Lozenges Sugar Free and all other<br>flavours.(Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium Chloride - 1.33mg (ii)<br>Isomalt ST-M - 2586 mg. Net content (i)<br>13.333 Kg (ii) 25924.878 Kg)	<br> <br> <br> <br> <br> <br>1000<br>Number	8	Cetylpyridinium<br>Chloride	1.356 gram
			9	Isomalt ST-M	2586 gram
5	Cetylpyridinium<br>Chloride<br>And<br>Benzydamine Hydrochloride Antiseptic<br>Lozenges Suger Free. Each lozenge<br>contains((i) Cetylpyridinium Chloride-<br>1mg (ii) Isomalt ST-M - 2586mg. Net<br>content (i) 5.22 Kg (ii) 13498.92 Kg)	<br> <br> <br> <br> <br>1000<br>Number	9	Cetylpyridinium<br>Chloride	1.02 gram
			10	Isomalt ST-M	2586 gram

UDIN00265785AM23

Case No.	45 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AARTI INDUSTRIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00386427AM22
RA File Number	03AX04001504 AM22
Licence No and<br>Date	0311012791/14/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	46 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00386436AM22
RA File Number	03AX04001649 AM22
Licence No and<br>Date	0311012801/14/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	47 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00386056AM22
RA File Number	08AX04000650 AM22
Licence No and<br>Date	0811004377/14/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Copy of COA of import item from foreign supplier showing Potency of Actual Import

Case No.	48 / NC/3/MEET/Nov/202223/12

Case Status	Case Deferred

Party Name	HALDIA PETROCHEMICALS LIMITED

23 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00386453AM22
RA File Number	02AX04000187 AM22
Licence No and<br>Date	0211002100/14/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case toDepartment of Chemical &
Petrochemicals (D/o C&PC).

Case No.	49 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00387157AM22
RA File Number	07AX04000477 AM22
Licence No and<br>Date	0711003428/15/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	50 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	DPB ANTIBIOTICS
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00387310AM22
RA File Number	03AX04001617 AM22
Licence No and<br>Date	0311012908/15/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
DML for export item.<br>i.
Master Batch Formula.<br>ii.
iii COA of import item from foreign supplier.

Case No.	51 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	HALDIA PETROCHEMICALS LIMITED

24 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00389089AM22
RA File Number	02AX04000201 AM22
Licence No and<br>Date	0211002113/16/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case toDepartment of Chemical &
Petrochemicals (D/o C&PC).

Case No.	52 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00389497AM22
RA File Number	05AX04001229 AM22
Licence No and<br>Date	0511011065/16/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>53 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00389551AM22
RA File Number<br>05AX04001320 AM22
Licence No and<br>Date<br>0511011068/16/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided		to ratify adhoc norms under	Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever		is less:
Export product<br>Qty.	Sl. No.	Import items		Qty.
Dorzolamide and Timolol Ophthalmic<br>26000	1	Dorzolamide Hydrochloride		3.044 kg
Solution,<br>2.0%w/v<br>+<br>0.5%w/v,<br>5ml
(TIMODOL<br>Sterile<br>Eye<br>Drops)<br>(LOFTEMIDE)((Each<br>ml<br>contains<br>Numbers	2	Timolol Maleate		0.928 kg

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Dorzolamide Hydrochloride equivalent to Dorzolamide 20 mg (Equivalent 2.600Kg of Bulk Drug), and Timolol Maleate equivalent to Timolol 5.0 mg (Equivalent to 0.650 Kg. of Bulk Drug))

Case No.	Case No.	54 / NC/3/MEET/Nov/202223/12	54 / NC/3/MEET/Nov/202223/12	54 / NC/3/MEET/Nov/202223/12	54 / NC/3/MEET/Nov/202223/12	54 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00390668AM22
RA File Number		03AX04001604 AM22
Licence No and<br>Date		0311013055/17/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>0311004037 dated 25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	55 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00390677AM22

UDIN00265785AM23

RA File Number	RA File Number	03AX04001595 AM22	03AX04001595 AM22	03AX04001595 AM22	03AX04001595 AM22	03AX04001595 AM22
Licence No and<br>Date		0311013059/17/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>0311004037 dated 25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	Case No.	56 / NC/3/MEET/Nov/202223/12	56 / NC/3/MEET/Nov/202223/12	56 / NC/3/MEET/Nov/202223/12	56 / NC/3/MEET/Nov/202223/12	56 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00390678AM22
RA File Number		03AX04001592 AM22
Licence No and<br>Date		0311013060/17/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>0311004037 dated 25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg

Case No.	Case No.	56 / NC/3/MEET/Nov/202223/12	56 / NC/3/MEET/Nov/202223/12	56 / NC/3/MEET/Nov/202223/12	56 / NC/3/MEET/Nov/202223/12	56 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00390678AM22
RA File Number		03AX04001592 AM22
Licence No and<br>Date		0311013060/17/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>0311004037 dated 25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg

UDIN00265785AM23

Piperazine Anhydrous 0.390 kg

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

Case No.	57 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00390743AM22
RA File Number	05AX04001256 AM22
Licence No and<br>Date	0511011170/17/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.7/82-ALC4/2020 dated 04.12.2020against advance authorization No.0510415732<br>dated 03.11.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>CEFEPIME FOR INJECTION<br>1 kg<br>1<br>CEFEPIME HCL NON STERILE<br>0.655 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	58 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00390945AM22
RA File Number	02AX04000207 AM22
Licence No and<br>Date	0211002128/17/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDepartment of Chemical &<br>Petrochemicals (D/o C&PC).

UDIN00265785AM23

Case No.	Case No.	Case No.	59 / NC/3/MEET/Nov/202223/12	59 / NC/3/MEET/Nov/202223/12	59 / NC/3/MEET/Nov/202223/12	59 / NC/3/MEET/Nov/202223/12	59 / NC/3/MEET/Nov/202223/12
Case Status			Case Approved
Party Name			J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00391117AM22
RA File Number			03AX04001728 AM22
Licence No and<br>Date			0311013108/17/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export<br>product / import item in Meeting No.NC/3/MEET/May/202223/3 dated 27/05/2022against advance authorization<br>No.0310814635 dated 14.07.2017, 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>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>1<br>Benzydamine<br>Hydrochloride<br>And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory And Antiseptic Lozenges<br>Sugar Free and(all other flavours. Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium Chloride- 1.33mg (iii)<br>Isomalt ST-M - 2586mg. Net content (i)<br>33.333 Kgs (ii) 14.778 Kgs (iii)<br>28733.356 Kgs.)<br>1000<br>Number<br>3<br>Isomalt ST-M<br>2586 gram<br>4<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Benzydamine<br>Hydrochloride,<br>2,4-<br>Dichlorobenzyl Alcohol And Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial Lozenges<br>Sugar Free. Each lozenge contains (i)<br>Benzydamine Hydrochloride - 3mg (ii)<br>Isomalt ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)<br>1000<br>Number<br>5<br>Isomalt ST-M<br>2586 grram<br>6<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each lozenge contains (i) Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-M -<br>2586mg. Net content (i) 12 Kgs. (ii)<br>3<br>1000<br>Number<br>7<br>Isomalt ST-M<br>2586 gram
	Sl. No.	Export product		Qty.	Sl. No	Import items	Qty.
	1	Benzydamine<br>Hydrochloride<br>And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory And Antiseptic Lozenges<br>Sugar Free and(all other flavours. Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium Chloride- 1.33mg (iii)<br>Isomalt ST-M - 2586mg. Net content (i)<br>33.333 Kgs (ii) 14.778 Kgs (iii)<br>28733.356 Kgs.)		1000<br>Number	1.	Benzydamine<br>Hydrochloride	3.06 gram
					2	Cetylpyridinium<br>Chloride	1.356 gram
					3	Isomalt ST-M	2586 gram
	2	Benzydamine<br>Hydrochloride,<br>2,4-<br>Dichlorobenzyl Alcohol And Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial Lozenges<br>Sugar Free. Each lozenge contains (i)<br>Benzydamine Hydrochloride - 3mg (ii)<br>Isomalt ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)		<br> <br> <br> <br> <br> <br>1000<br>Number	4	Benzydamine<br>Hydrochloride	3.06 gram
					5	Isomalt ST-M	2586 grram
	3	Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each lozenge contains (i) Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-M -<br>2586mg. Net content (i) 12 Kgs. (ii)		<br> <br> <br> <br>1000<br>Number	6	Benzydamine<br>Hydrochloride	3.06 gram
					7	Isomalt ST-M	2586 gram

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

Case No.	60 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00390551AM22
RA File Number	03AX04001792 AM22
Licence No and<br>Date	0311013033/17/03/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	61 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00390573AM22
RA File Number	03AX04001802 AM22
Licence No and<br>Date	0311013041/17/03/2022
Norms Committee Decision:

UDIN00265785AM23

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Jan/202122/13 dated 21.01.2022 against advance authorization No. 0910068574 dated 13.03.2020 , 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.
PROPYL PARABEN	1 kg	1	PARA HYDROXY BENZOIC ACID	0.80 kg
		2	N PROPANOL	0.347 kg

Case No.	Case No.	62 / NC/3/MEET/Nov/202223/12	62 / NC/3/MEET/Nov/202223/12	62 / NC/3/MEET/Nov/202223/12	62 / NC/3/MEET/Nov/202223/12	62 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		MERIDIAN ENTERPRISES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00394323AM22
RA File Number		03AX04001862 AM22
Licence No and<br>Date		0311013150/21/03/2022
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>Dequalinium Chloride Oral Spray (Dequadin<br>Oral<br>Spray)<br>25<br>ML<br>Bottle(Dequalinium<br>Chloride Oral Spray (Dequadin Oral Spray) 25<br>ML Bottle. (Each ml contains: Dequalinium<br>Chloride 0.5 percent (net content of Input per<br>ml=5mg,Net content per 25ml bottle =125mg<br>Total net content = 2.597 kgs))<br>1 Number<br>1<br>Dequalinium Chloride<br>127.50 mg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Dequalinium Chloride Oral Spray (Dequadin<br>Oral<br>Spray)<br>25<br>ML<br>Bottle(Dequalinium<br>Chloride Oral Spray (Dequadin Oral Spray) 25<br>ML Bottle. (Each ml contains: Dequalinium<br>Chloride 0.5 percent (net content of Input per<br>ml=5mg,Net content per 25ml bottle =125mg<br>Total net content = 2.597 kgs))		1 Number	1	Dequalinium Chloride	127.50 mg

Case No.	Case No.	62 / NC/3/MEET/Nov/202223/12	62 / NC/3/MEET/Nov/202223/12	62 / NC/3/MEET/Nov/202223/12	62 / NC/3/MEET/Nov/202223/12	62 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		MERIDIAN ENTERPRISES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00394323AM22
RA File Number		03AX04001862 AM22
Licence No and<br>Date		0311013150/21/03/2022
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>Dequalinium Chloride Oral Spray (Dequadin<br>Oral<br>Spray)<br>25<br>ML<br>Bottle(Dequalinium<br>Chloride Oral Spray (Dequadin Oral Spray) 25<br>ML Bottle. (Each ml contains: Dequalinium<br>Chloride 0.5 percent (net content of Input per<br>ml=5mg,Net content per 25ml bottle =125mg<br>Total net content = 2.597 kgs))<br>1 Number<br>1<br>Dequalinium Chloride<br>127.50 mg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Dequalinium Chloride Oral Spray (Dequadin<br>Oral<br>Spray)<br>25<br>ML<br>Bottle(Dequalinium<br>Chloride Oral Spray (Dequadin Oral Spray) 25<br>ML Bottle. (Each ml contains: Dequalinium<br>Chloride 0.5 percent (net content of Input per<br>ml=5mg,Net content per 25ml bottle =125mg<br>Total net content = 2.597 kgs))		1 Number	1	Dequalinium Chloride	127.50 mg

UDIN00265785AM23

Case No.	63 / NC/3/MEET/Nov/202223/12
Case Status	Case Rejected
Party Name	ASOJ SOFT CAPS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00394911AM22
RA File Number	34AX04000397 AM22
Licence No and<br>Date	3411001990/21/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the import item – Fish Lipid Oil (33:22)<br>(For Product WELLOMEGA MAX) having ITC HS – 15042020 comes under Chapter 15 and as per para 4.11 (A) (i)<br>of theFTP 2015-20<br> , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on<br>self- declaration basis under para 4.07 of the FTP.<br>In view of above, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	64 / NC/3/MEET/Nov/202223/12	64 / NC/3/MEET/Nov/202223/12	64 / NC/3/MEET/Nov/202223/12	64 / NC/3/MEET/Nov/202223/12	64 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		KRISHNA ANTIOXIDANTS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00396339AM22
RA File Number		03AX04001822 AM22
Licence No and<br>Date		0311013212/22/03/2022
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.3/82-ALC4/2019 dated 05.07.2019against advance authorization No.0310821359 dated<br>31.05.2018, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Sl.<br>Export product<br>Qty.<br>Import items<br>Qty.
	Export product		Qty.	Sl.	Import items	Qty.

UDIN00265785AM23

		No.
TRI ISODECYL PHOSPHITE	1 kg	1	YELLOW PHOSPHORUS	0.065 kg
		2	PHENOL	0.090 kg
		3	ISODECYL ALCOHOL	0.973 kg

Case No.	Case No.	Case No.	65 / NC/3/MEET/Nov/202223/12	65 / NC/3/MEET/Nov/202223/12	65 / NC/3/MEET/Nov/202223/12	65 / NC/3/MEET/Nov/202223/12	65 / NC/3/MEET/Nov/202223/12
Case Status			Case Approved
Party Name			CIPLA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00396819AM22
RA File Number			03AX04001590 AM22
Licence No and<br>Date			0311013222/22/03/2022
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>Sl. No.<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Telmisartan and Amlodipine Tablets 40/10mg. Each<br>uncoated tablets contains :(Telmisartan 40 mg equivalent<br>to Telmisartan granules 67.36mg Amlodipine Besilate<br>equivalent to Amlodipine USP 10mg Net wt of<br>Telmisartan Granules is 2020.800 Kgs Net wt of<br>Amlodipine Besilate is 300.000 Kgs.)<br>1 Number<br>1<br>Amlodipine Besilate 10.20 mg<br>2<br>Telmisartan and Amlodipine Tablets 80/10mg. Each<br>uncoated tablets contains :(Telmisartan 80 mg equivalent<br>to Telmisartan granules 134.72mg Amlodipine Besilate<br>equivalent to Amlodipine USP 10mg . Net wt of<br>Telmisartan Granules is 10777.600 Kgs. Net wt of<br>Amlodipine Besilate is 800.000 Kgs.)<br>1 Number<br>2<br>Amlodipine Besilate 10.20 mg
	Sl. No.	Export Product		Qty.	Sl. No.	Import items	Qty.
	1	Telmisartan and Amlodipine Tablets 40/10mg. Each<br>uncoated tablets contains :(Telmisartan 40 mg equivalent<br>to Telmisartan granules 67.36mg Amlodipine Besilate<br>equivalent to Amlodipine USP 10mg Net wt of<br>Telmisartan Granules is 2020.800 Kgs Net wt of<br>Amlodipine Besilate is 300.000 Kgs.)		<br> <br> <br> <br> <br>1 Number	1	Amlodipine Besilate	10.20 mg
	2	Telmisartan and Amlodipine Tablets 80/10mg. Each<br>uncoated tablets contains :(Telmisartan 80 mg equivalent<br>to Telmisartan granules 134.72mg Amlodipine Besilate<br>equivalent to Amlodipine USP 10mg . Net wt of<br>Telmisartan Granules is 10777.600 Kgs. Net wt of<br>Amlodipine Besilate is 800.000 Kgs.)		<br> <br> <br> <br> <br>1 Number	2	Amlodipine Besilate	10.20 mg

Case No.	Case No.	Case No.	65 / NC/3/MEET/Nov/202223/12	65 / NC/3/MEET/Nov/202223/12	65 / NC/3/MEET/Nov/202223/12	65 / NC/3/MEET/Nov/202223/12	65 / NC/3/MEET/Nov/202223/12
Case Status			Case Approved
Party Name			CIPLA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00396819AM22
RA File Number			03AX04001590 AM22
Licence No and<br>Date			0311013222/22/03/2022
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>Sl. No.<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Telmisartan and Amlodipine Tablets 40/10mg. Each<br>uncoated tablets contains :(Telmisartan 40 mg equivalent<br>to Telmisartan granules 67.36mg Amlodipine Besilate<br>equivalent to Amlodipine USP 10mg Net wt of<br>Telmisartan Granules is 2020.800 Kgs Net wt of<br>Amlodipine Besilate is 300.000 Kgs.)<br>1 Number<br>1<br>Amlodipine Besilate 10.20 mg<br>2<br>Telmisartan and Amlodipine Tablets 80/10mg. Each<br>uncoated tablets contains :(Telmisartan 80 mg equivalent<br>to Telmisartan granules 134.72mg Amlodipine Besilate<br>equivalent to Amlodipine USP 10mg . Net wt of<br>Telmisartan Granules is 10777.600 Kgs. Net wt of<br>Amlodipine Besilate is 800.000 Kgs.)<br>1 Number<br>2<br>Amlodipine Besilate 10.20 mg
	Sl. No.	Export Product		Qty.	Sl. No.	Import items	Qty.
	1	Telmisartan and Amlodipine Tablets 40/10mg. Each<br>uncoated tablets contains :(Telmisartan 40 mg equivalent<br>to Telmisartan granules 67.36mg Amlodipine Besilate<br>equivalent to Amlodipine USP 10mg Net wt of<br>Telmisartan Granules is 2020.800 Kgs Net wt of<br>Amlodipine Besilate is 300.000 Kgs.)		<br> <br> <br> <br> <br>1 Number	1	Amlodipine Besilate	10.20 mg
	2	Telmisartan and Amlodipine Tablets 80/10mg. Each<br>uncoated tablets contains :(Telmisartan 80 mg equivalent<br>to Telmisartan granules 134.72mg Amlodipine Besilate<br>equivalent to Amlodipine USP 10mg . Net wt of<br>Telmisartan Granules is 10777.600 Kgs. Net wt of<br>Amlodipine Besilate is 800.000 Kgs.)		<br> <br> <br> <br> <br>1 Number	2	Amlodipine Besilate	10.20 mg

UDIN00265785AM23

3	Telmisartan and Amlodipine Tablets 40/5mg. Each	<br>1 Number	3	Amlodipine Besilate	5.10 mg
	uncoated tablets contains :(Telmisartan 40 mg equivalent
	to Telmisartan granules 67.36mg Amlodipine Besilate
	equivalent to Amlodipine USP 5mg Net wt of Telmisartan
	Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate
	is 466.667 Kgs.)
4	Telmisartan and Amlodipine Tablets 80/5mg. Each	<br>1 Number	4	Amlodipine Besilate	5.10 mg
	uncoated tablets contains :(Telmisartan 80 mg equivalent
	to Telmisartan granules 134.72mg Amlodipine Besilate
	equivalent to Amlodipine USP 5mg Net wt of Telmisartan
	Granules is 10777.600 Kgs. Net wt of Amlodipine
	Besilate is 400.000 Kgs.)

	3	Telmisartan and Amlodipine Tablets 40/5mg. Each<br>uncoated tablets contains :(Telmisartan 40 mg equivalent<br>to Telmisartan granules 67.36mg Amlodipine Besilate<br>equivalent to Amlodipine USP 5mg Net wt of Telmisartan<br>Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate<br>is 466.667 Kgs.)	Telmisartan and Amlodipine Tablets 40/5mg. Each<br>uncoated tablets contains :(Telmisartan 40 mg equivalent<br>to Telmisartan granules 67.36mg Amlodipine Besilate<br>equivalent to Amlodipine USP 5mg Net wt of Telmisartan<br>Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate<br>is 466.667 Kgs.)	Telmisartan and Amlodipine Tablets 40/5mg. Each<br>uncoated tablets contains :(Telmisartan 40 mg equivalent<br>to Telmisartan granules 67.36mg Amlodipine Besilate<br>equivalent to Amlodipine USP 5mg Net wt of Telmisartan<br>Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate<br>is 466.667 Kgs.)	Telmisartan and Amlodipine Tablets 40/5mg. Each<br>uncoated tablets contains :(Telmisartan 40 mg equivalent<br>to Telmisartan granules 67.36mg Amlodipine Besilate<br>equivalent to Amlodipine USP 5mg Net wt of Telmisartan<br>Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate<br>is 466.667 Kgs.)	Telmisartan and Amlodipine Tablets 40/5mg. Each<br>uncoated tablets contains :(Telmisartan 40 mg equivalent<br>to Telmisartan granules 67.36mg Amlodipine Besilate<br>equivalent to Amlodipine USP 5mg Net wt of Telmisartan<br>Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate<br>is 466.667 Kgs.)	Telmisartan and Amlodipine Tablets 40/5mg. Each<br>uncoated tablets contains :(Telmisartan 40 mg equivalent<br>to Telmisartan granules 67.36mg Amlodipine Besilate<br>equivalent to Amlodipine USP 5mg Net wt of Telmisartan<br>Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate<br>is 466.667 Kgs.)	<br> <br> <br> <br> <br>1 Number	3	Amlodipine Besilate	5.10 mg
	4	Telmisartan and Amlodipine Tablets 80/5mg. Each						<br>1 Number	4	Amlodipine Besilate	5.10 mg
		uncoated tablets contains :(Telmisartan 80 mg equivalent
		to Telmi<br>	sartan granules 134.72mg Amlodipine Besilate<br>					<br>
		equivalen<br>Granules	t to Amlodipine USP 5mg Net wt of Telmisartan<br>is 10777.600 Kgs. Net wt of Amlodipine					<br>
		<br>Besilate i	<br>s 400.000 Kgs.)



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


Case No.				66 / NC/3/MEET/Nov/202223/12
Case Status				Case Approved
Party Name				SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number and<br>Date				NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number				HQRNORM APPLY 00398099AM22
RA File Number				09AX04000273 AM22
Licence No and Date				0911002734/23/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.13/82-ALC4/2018 dated 14/01/2019 against advance authorization No.0910066244<br>dated 18.05.2018, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product				Qty.	Sl. No.	Import items				Qty.


	VALACYCLOV		IR		1 kg	1	Carbobenzyloxy L valine CBZ L Valine				1.1824 kg
	HYDROCHLOR		IDE

	MONOHYDRA		TE(SOLID)			2	N N DICYCLOHEXYL CARBODIIMIDE DCC				1061 k
											. g

						3	4 DIMETHYLAMINO PYRIDINE DMAP				0.028 kg


						4	ACYCLOVIR				0.758 kg

UDIN00265785AM23

Case No.	67 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	ZENTIVA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00398312AM22
RA File Number	03AX04001894 AM22
Licence No and Date	0311013248/23/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022 against advance authorization No.<br>0311009262 dated 07.12.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Hydrochlorothiazide<br>12.75<br>mg<br>/<br>Tablet<br>1<br>Ramilich / Ramilich Comp / Ramipril<br>HCT ZT/ZTV 5-12.5mg, (Net Wt.<br>Hydrochlorothiazide 125.00 KGS)((Net<br>Wt. Ramipril 50.00 KGS))<br>1 Number<br>2<br>Ramipril<br>5.10 mg<br>1<br>Hydrochlorothiazide<br>12.75<br>mg<br>/<br>Tablet<br>2<br>Ramilich / Ramilich Comp / Ramipril<br>HCT ZT/ZTV 2.5-12.5mg (Net Wt.<br>Hydrochlorothiazide 125.00 KGS)((Net<br>Wt. Ramipril 25.00 KGS))<br>1 Number<br>2<br>Ramipril<br>2.55 mg<br>1<br>Hydrochlorothiazide<br>25.50<br>mg<br>/<br>Tablet<br>3<br>Ramilich / Ramilich Comp / Ramipril<br>HCT<br>ZT/ZTV<br>5-25mg<br>(Net<br>Wt.<br>Hydrochlorothiazide 750.00 KGS)((Net<br>Wt. Ramipril 150.00 KGS))<br>1 Number<br>2<br>Ramipril<br>5.10 mg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No. 68 / NC/3/MEET/Nov/202223/12

UDIN00265785AM23

Case Status	Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name			PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00398377AM22

RA File Number			03AX04001895 AM22

Licence No and
Date			0311013250/23/03/2022
Norms Committee			Decision:
The Committee co<br>			nsidered the case as per agenda and taking cue from earlier decision for same export product /<br>
import item in M<br>0311005566 d			eeting No.NC/3/MEET/Dec/202122/12 dated 17.12.2021against advance authorization No.<br>23072021i didd if dh d P 407 f HBP Vl I
ate<br>details given below			.., t was ece to raty aoc nor<br>or as applied b the firm whichever is less:				s uner ara . o o. as per
			y ,

	Export Product<br>Bempedoic Acid and Ezetimibe Fixed Dose<br>Combination<br>Tablets<br>Each<br>Tablet<br>content<br>Bempedoic<br>Acid<br>180mg<br>and<br>Ezetimibe<br>10mg)((Net content of Bempedoic Acid 2700kg				Qty.		Sl. No.	Import items	Qty.
					<br> <br> <br> <br>1 Number		1	Bempedoic Acid	189.90 mg
							2	Ezetimibe	10.55 mg
	<br>and Ezetimibe 150kgs in Total Export Qty) (AA				<br>
	<br>for Free of cost		<br>material as per Para 4.11 of HBP		<br>
	<br>& Para 4.19 of		<br>FTP & RBI Master Circular C-26 -		<br>
	Disallowing r		emittances for material being
	supplied free of		cost)

	Note: The ab		ove norms are valid only for subject to fulfillment of following conditions:

	Exort<br>1		roduct bein Patented Medicine be filed with USFDA as an NDA (New Dru Alication
<br>R	p g , g pp.<br>.<br>Export to USA and Europe only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.

	<br>A conce	<br>rned may take further necessar		y action as p	er above	decision of NC.


C	ase No.		69 / NC/3/MEET/No	v/202223/12
C	ase Statu	s	Case Approved
P	arty Nam	e	SENTISS PHARMA	PRIVATE L	IMITED
M<br>	eeting N<br>	umber	NC/ 3/ MEET/ Nov/	202223/ 12 an	d 18/11	/2022
and Date

Case No.	69 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

UDIN00265785AM23

HQ File Number	HQRNORM APPLY 00398576AM22
RA File Number	05AX04001357 AM22
Licence No and<br>Date	0511011310/23/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Oct/202122/10 dated 12.11.2021against advance authorization No.<br>0511000306 dated 21.12.2020, 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>Mydrimax Eye Drops 5ml Vial<br>(Each ml Containing 8 mg Tropicamide)<br>1 Vial<br>1<br>Tropicamide<br>40.8 mg / 5 ml vial<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	70 / NC/3/MEET/Nov/202223/12	70 / NC/3/MEET/Nov/202223/12	70 / NC/3/MEET/Nov/202223/12	70 / NC/3/MEET/Nov/202223/12	70 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00398579AM22
RA File Number		05AX04001403 AM22
Licence No and<br>Date		0511011311/23/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>0511003876 dated 28.07.2021, 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.<br>Import items<br>Qty.<br>Inokain Eye Drops 0.4% 5ml<br>1 Vial<br>1<br>Benoxinate HCL<br>20.4 mg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Inokain Eye Drops 0.4% 5ml		1 Vial	1	Benoxinate HCL	20.4 mg

Case No.	Case No.	70 / NC/3/MEET/Nov/202223/12	70 / NC/3/MEET/Nov/202223/12	70 / NC/3/MEET/Nov/202223/12	70 / NC/3/MEET/Nov/202223/12	70 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00398579AM22
RA File Number		05AX04001403 AM22
Licence No and<br>Date		0511011311/23/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>0511003876 dated 28.07.2021, 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.<br>Import items<br>Qty.<br>Inokain Eye Drops 0.4% 5ml<br>1 Vial<br>1<br>Benoxinate HCL<br>20.4 mg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Inokain Eye Drops 0.4% 5ml		1 Vial	1	Benoxinate HCL	20.4 mg

UDIN00265785AM23

Case No.	71 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00400127AM22
RA File Number	05AX04001269 AM22
Licence No and<br>Date	0511011349/24/03/2022
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/AM20 dated 02.08.2019against advance authorization No.0510398377 dated<br>04.05.2016, 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>2-Deoxy-2,-difluoro-D-<br>ribofuranose-3,5-dibenzoate-1-<br>methanesulphonate (T-8).<br>5.40 gram<br>Gemcitabine Hydrochloride(USP)<br>1 gram<br>2<br>N-Acetyl Cytosine<br>2.92 gram<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	72 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00401252AM22
RA File Number	03AX04001906 AM22
Licence No and<br>Date	0311013320/25/03/2022
Norms Committee Decision:

UDIN00265785AM23

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

Case No.		73 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number		NC/ 3/ MEET/ N/ 202223/ 12 nd 18/11/2022
and Date		ov a
HQ File Number		HQRNORM APPLY 00401410AM22
RA File Number		03AX04001856 AM22
Licence No and<br>Date		0311013341/25/03/2022
Norms Committee		Decision:
The Committee c		nsidered the case as per agenda and taking cue from earlier decision for same export product /
<br>import item in M<br>0311004037 dated		<br>eeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items			Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3<br>5Fluoro	Cyclopropylamino-2(2,4 Dichloro<br>benzoyl) Acrylate	-	1.240 kg
				2
					Piperaz	ine Anhydrous		0.390 kg

	<br>A concerned may take further necessary action a			s per ab
					ove deci	sion of NC.

C	ase No.	74 / NC/3/MEET/Nov/202223/		12
C
	ase Status	Case Approved
P	arty Name	CIPLA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

HQ File Number		HQRNORM APPLY 00401442AM22
RA File Number		03AX04001811 AM22
Licence No and<br>		0311013347/25/03/2022
Date

Norms Committee<br>The Committee co		Decision:<br>nsidered the case as per agenda and taking cue from earlier decision for same export product /
<br>import item in Mee		<br>ting No.5/82-ALC4/2020 dated 09.10.2020against advance authorization No.0310836020 dated
<br>27.04.2020, it was		<br>decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as

Case No.	74 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00401442AM22
RA File Number	03AX04001811 AM22
Licence No and<br>Date	0311013347/25/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.5/82-ALC4/2020 dated 09.10.2020against advance authorization No.0310836020 dated
27.04.2020, it was	decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as

UDIN00265785AM23

applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Testosterone Topical Solution 30 /<br>1.5mg / ml Pack Size 110ml(Each<br>Actuation delivers : Testosterone<br>USP- 30mg Also contains Alcohol<br>USP ?. Approx. 49.55% w/v (QS to<br>100% w/v))	<br> <br> <br> <br> <br>50000<br>Numbers	1	Testosterone USP	96.39 kg
		2	Alcohol (Ethanol 95% v/v)	2725.00 kg

Case No.	Case No.	75 / NC/3/MEET/Nov/202223/12	75 / NC/3/MEET/Nov/202223/12	75 / NC/3/MEET/Nov/202223/12	75 / NC/3/MEET/Nov/202223/12	75 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00401443AM22
RA File Number		03AX04001843 AM22
Licence No and<br>Date		0311013348/25/03/2022
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/202223/8 dated 23.09.2022against advance authorization No.<br>0311004037 dated 25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg

UDIN00265785AM23

Case No.	76 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00401447AM22
RA File Number	03AX04001591 AM22
Licence No and<br>Date	0311013350/25/03/2022
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.<br>Import items<br>Qty.<br>1<br>Ortho Tertiary Butyl Phenol<br>0.79 kg<br>AMBERCORE<br>1 kg<br>2<br>1,2 Epoxy butane<br>0.379 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	77 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	BIOXERA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00404711AM22
RA File Number	03AX04002017 AM22
Licence No and<br>Date	0311013410/28/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>0311009297 dated 08.12.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:

UDIN00265785AM23

Export product	Qty.	Sl. No. Import items	Qty.
BENFOTIAMINE	1 kg	1<br>VITAMIN B1	0.922 kg

<br>R	Export product<br>BENFOTIAMINE<br> <br>A concerned may take further necessary	Export product	Export product	Export product			Qty.			Sl.	No.	No.	No.	Import items	Q	ty.	ty.
		BENFOTIAMINE					1 kg			1				VITAMIN B1	0.	922 kg
					action as
								per abov			e decision of NC.

Case No.				78 / NC/3/MEET/Nov/202223/12
Case Status				Case Approved
Party Name				HETERO LABS LIMITED
Meeting Number
<br>and Date				NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number				HQRNORM APPLY 00404330AM22
RA File Number				09AX04000308 AM22
Licence No and
Date				0911002668/28/03/2022
Norms Committee				Decision:

The Committee co<br>				nsidered the case as per agenda and taking cue from earlier decision for same export product /<br>
import item in M<br>0911001814 dated<br>ien belo or as				eeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022against advance authorization No.<br>03.11.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>lied b the firm hicheer is less:
gv w pp y , wv<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>(S,E)-5-AMINO-2-<br>(DIBENZYLAMINO)-1,6-<br>DIPHENYLHEX-4-EN-3-ONE<br>1.77 kg<br>2<br>SODIUM BORO HYDRIDE<br>0.45 kg<br>3<br>TETRA HYDRO FURAN<br>0.48 kg<br>4<br>2,2,2 TRI FLUORO ACETIC ACID<br>2.16 kg<br>(2S,3S,5S)-2-amino-3-hydroxy-5-tert<br>butyl<br>carbonyl<br>amino-1,6-diphenyl-<br>hexane((2S,3S,5S)-2-amino-3-hydroxy-<br>5-tert<br>butyl<br>carbonyl<br>amino-1,6-<br>diphenyl-hexane)<br>1 kg<br>5<br>DI TERT.BUTYL DI CARBONATE<br>0.92 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product<br>						Qty.		Sl. No.			Import items				Qty.

	(2S,3S,5S)-<br>butyl<br>car<br>		2-amino-3-hydroxy-5-tert<br>bonyl<br>amino-1,6-diphenyl<br>			-<br>	1 kg		1			(S<br>(<br>	,E)-5-AMINO-2-<br>DIBENZYLAMINO)-1,6-<br>				1.77 kg
	hexane((2S,<br>5-tert<br>bu<br>diphenyl-he		3S,5S)-2-amino-3-hydroxy-<br>tyl<br>carbonyl<br>amino-1,6<br>xane)			-						D	IPHENYLHEX-4-EN-3-ONE
									2
												S	ODIUM BORO HYDRIDE				.45 kg
									3
												T	ETRA HYDRO FURAN				0.48 kg
									4
												2,	2,2 TRI FLUORO ACETIC ACID				2.16 kg
									5
												D	I TERT.BUTYL DI CARBONATE				0.92 kg
	<br>A concerned		<br>may take further necessary a			ction as per
										above d			ecision of NC.

UDIN00265785AM23

Case No.	Case No.	79 / NC/3/MEET/Nov/202223/12	79 / NC/3/MEET/Nov/202223/12	79 / NC/3/MEET/Nov/202223/12	79 / NC/3/MEET/Nov/202223/12	79 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00404660AM22
RA File Number		03AX04001844 AM22
Licence No and<br>Date		0311013405/28/03/2022
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/202223/8 dated 23.09.2022against advance authorization No.<br>0311004037 dated 25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.	80 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00404671AM22
RA File Number	34AX04000254 AM22
Licence No and<br>Date	3411002035/28/03/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	81 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MAHIMA LIFESCIENCES PRIVATE LIMITED

UDIN00265785AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00405626AM22
RA File Number	05AX04001435 AM22
Licence No and<br>Date	0511011420/29/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents from the
firm:
Complete chemistry, molecular weight and percentage yield on molar basis as per Annexure to Appendix 4E.

M<br>a	eeting Number<br>nd Date	eeting Number<br>nd Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and	NC/ 3/ MEET/ Nov/ 202223/ 12 and	18/11/2022	18/11/2022	18/11/2022	18/11/2022
H	Q File Number		HQRNORM APPLY 00405626AM2		2
R	A File Number		05AX04001435 AM22
L<br>D	icence No and<br>ate		0511011420/29/03/2022
N<br>T<br>fi<br>C	orms Committee Decision:<br>he Committee considered the case as per agenda and it<br>rm:<br>omplete chemistry, molecular weight and percentage				was decided to call for following information/documents from the<br>yield on molar basis as per Annexure to Appendix 4E.

C	ase No.		82 / NC/3/MEET/Nov/202223/12
C	ase Status		Case Approved
P	arty Name		MAIVA PHARMA PRIVATE LIMI		TED
M<br>a	eeting Number<br>nd Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and		18/11/2022
H	Q File Number		HQRNORM APPLY 00405985AM2		2
R	A File Number		07AX04000527 AM22
L<br>D	icence No and<br>ate		0711003531/29/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jul/202122/4 dated 15.07.2021against advance authorization No.<br>0711000657 dated 15.03.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:	orms Committee Decision:<br>he Committee considered the case as per agenda an<br>mport item in Meeting No.NC/3/MEET/Jul/2021<br>711000657 dated 15.03.2021, it was decided to ratify				d taking cue from earlier decision for same export product /<br>22/4 dated 15.07.2021against advance authorization No.<br>adhoc norms under Para 4.07 of HBP Vol. I as per details

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

	1		id i 1 2	<br>2		1	1	<br>l
		Furosem<br>Vial(2m	e Injecton 0mg/mL - mL<br>L Vial - filled with 20m of	<br> <br>70000			Grey Westar RS SIL<br>(13mm<br>Chlorobutle	<br> <br>Reevant as per<br>ackin olic
		<br>furosem<br>water fo	g<br>ide as bulk drug mixed in<br>r injection and filled in 2mL	<br> <br> <br>Numbers			<br>y<br>Rubber Stopper Grey RFS)	<br>pg py
		<br>Vial<br>a	<br>nd<br>capped<br>with<br>13mm	<br>
		chlorobu	<br>tyle Rubber Stopper)

	2	F	id Ii 10/L 4L	<br>450000		1	G W RS SIL 1	<br>Rl
		uroseme njecton mgm - m<br>Vial(4mL Vial - filled with 40mg of<br>furosemide as bulk drug mixed in<br>water for injection and filled in 4mL<br>Vial<br>and<br>capped<br>with<br>13mm<br>chlorobutyle Rubber Stopper)		<br> <br> <br> <br> <br><br>Numbers			rey estar<br>(13mm<br>Chlorobutyle<br>Rubber Stopper Grey RFS)	<br> <br>eevant as per<br>packing policy

UDIN00265785AM23

Case No.	83 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	PANACEA BIOTEC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00406012AM22
RA File Number	05AX04001414 AM22
Licence No and<br>Date	0511011438/29/03/2022
Norms Committee Decision:<br>The firm vide e-mail dated02.11.2022has enclosed a copy of Surrender Letter dated25.05.2022issued by CLA,<br>New Delhi. In view of above e-mail of firm, the Committee decided towithdrawthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	84 / NC/3/MEET/Nov/202223/12	84 / NC/3/MEET/Nov/202223/12	84 / NC/3/MEET/Nov/202223/12	84 / NC/3/MEET/Nov/202223/12	84 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		COVALENT LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00408811AM22
RA File Number		09AX04000089 AM22
Licence No and<br>Date		0911002806/30/03/2022
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 10.07.2020against advance authorization No.0910068464 dated<br>07.02.2020, 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>1<br>Ceftriaxone Sodium Non Sterile 1.04 kg<br>2<br>Acetone<br>1.72 kg<br>Ceftriaxone Sodium Sterile (PKD 10<br>KG IN 20LTRS )(API)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ceftriaxone Sodium Sterile (PKD 10<br>KG IN 20LTRS )(API)		<br>1 kg	1	Ceftriaxone Sodium Non Sterile	1.04 kg
				2	Acetone	1.72 kg

UDIN00265785AM23

<br>R			3	Activated<br>Carbon<br>[Carbon<br>Enoanticromos]	<br>51.66 gram
			4	Aluminium Canisters 20L with<br>inner & Outer Lids	<br>Relevant as per packing<br>policy<br>with<br>accountability
	<br>A concerned may take further necessary action as		per above decision of NC.

Case No.	85 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00408905AM22
RA File Number	34AX04000448 AM22
Licence No and<br>Date	3411002052/30/03/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	86 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00408949AM22
RA File Number	52AX04000101 AM22
Licence No and<br>Date	5211002273/30/03/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	87 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00407947AM22
RA File Number	09AX04000343 AM22
Licence No and	0911002789/30/03/2022

UDIN00265785AM23

Date

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Apr/202223/1 dated 29.04.2022 against advance authorization No. 0911002135 dated 22.12.2021 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Molnupiravir	1 kg	1	Cytidine	1.35 kg
		2	2,2-Dimethoxy Propane	3.00 kg
		3	DBU (1, 8-diazabicyclo [5.4.0] undec-7-ene	1.50 kg
		4	Isobutyric Anhydride	0.90 kg
		5	Isopropyl Alcohol (IPA)	2.00 kg

Case No.<br>88 / NC/3/MEET/Nov/202223/12	Case No.<br>88 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00408086AM22
RA File Number<br>03AX04002023 AM22
Licence No and<br>Date<br>0311013460/30/03/2022
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/Jan/202122/13 dated 21.01.2022against advance				authorization No.
0311007209 dated 25.09.2021, 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.

UDIN00265785AM23

Colesevelam HCL for oral suspension<br>3.75 GM ( Per Pack 30 Pouchs) (Total<br>5000<br>Packs)((Net.<br>Content<br>of<br>Colesevelam Hydrochloride is 562.50<br>kgs))<br>5000<br>Packs<br>1<br>Colesevelam Hydrochloride<br>590.625 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.	Colesevelam HCL for oral suspension<br>3.75 GM ( Per Pack 30 Pouchs) (Total<br>5000<br>Packs)((Net.<br>Content<br>of<br>Colesevelam Hydrochloride is 562.50<br>kgs))	<br> <br> <br> <br>5000<br>Packs	1	Colesevelam Hydrochloride	590.625 kg

Case No.	89 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00408410AM22
RA File Number	56AX04000134 AM22
Licence No and<br>Date	5611000874/30/03/2022
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 specification of import item with COA from foreign supplier.<br>i.<br>Difference in specification of export and import item.<br>ii.<br>iii Justification of wastage claimed.

Case No.	90 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	PANACEA BIOTEC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00408439AM22
RA File Number	05AX04001517 AM22
Licence No and<br>Date	0511011486/30/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDepartment of<br>Biotechnology (DBT)for obtaining its comments.

Case No.	91 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved

UDIN00265785AM23

Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00409415AM22
RA File Number	31AX04000109 AM22
Licence No and<br>Date	3111001213/31/03/2022
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.<br>Import items<br>Qty.<br>1<br>Hydroquinone<br>1.07 kg<br>2<br>Sodium Chlorate<br>0.345 kg<br>Para Benzoquinone (PBQ)<br>1 kg<br>3<br>MDC<br>0.25 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	92 / NC/3/MEET/Nov/202223/12	92 / NC/3/MEET/Nov/202223/12	92 / NC/3/MEET/Nov/202223/12	92 / NC/3/MEET/Nov/202223/12	92 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00410198AM22
RA File Number		34AX04000463 AM22
Licence No and<br>Date		3411002081/31/03/2022
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.<br>Import items<br>Qty.<br>Phenol<br>6250 MT<br>1<br>Cumene<br>5279.126 MT
	Export product		Qty.	Sl. No.	Import items	Qty.
	Phenol		6250 MT	1	Cumene	5279.126 MT

UDIN00265785AM23

Case No.	93 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00409452AM22
RA File Number	34AX04000441 AM22
Licence No and<br>Date	3411002060/31/03/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	94 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ORGANIC INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00410276AM22
RA File Number	06AX04000155 AM22
Licence No and<br>Date	0611001257/31/03/2022
Norms Committee Decision:<br>The Committee considered the case as per Agenda and it was observed that the Export Product appears to be food<br>items, which is dealt in Norms Committee-6. Hence, it was decided totransfer the case to Norms Committee-6.

Case No.	95 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00409480AM22
RA File Number	34AX04000458 AM22
Licence No and<br>Date	3411002061/31/03/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No. 96 / NC/3/MEET/Nov/202223/12

50 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

C	ase Statu	ase Statu	s	Case Approved
P	arty Nam		e	J B CHEMICALS AND	PHARMACE		UTICAL	S LIMITED
M<br>an	eeting N<br>d Date		umber	NC/ 3/ MEET/ Nov/ 202	223/ 12 and 18
							/11/2022
H	Q File N		umber	HQRNORM APPLY 00	409172AM22
R	A File N		umber	03AX04002005 AM22

L<br>D	icence N<br>ate		o and	0311013493/31/03/2022
N<br>T<br>im<br>0<br>d<br> <br>R	orms Co<br>he Com<br>ort ite		mmittee Decision:<br>mittee considered the case as pe<br>m in Meetin NoNC/3/ME		r agenda and<br>ET/Jul/20212		taking c<br>/4 date	ue<br>d	from earlier decision for same<br>15072021aainst advance a		export product /<br>uthorization No
	p<br>3110020<br>etails giv		g . <br>50 dated 03.03.2021, it was dec<br>en below or as applied by the fir		<br>ided to ratify<br>m, whichever i		<br>adhoc n<br>s less:	<br>or<br>	..g<br>ms under Para 4.07 of HBP<br>		.<br>Vol. I as per

	Sl.<br>No.		Export product			Qt	y.		Sl. No.	Import items		Qty.

	1	<br> <br>f<br>	Rinza sip with Vitamin C<br>Orange/ Lemon/ Black Curra<br>lavours) &(Rinza Sip (Flavour<br>		(Flavours<br>nt/ Other<br>s Orange/<br>	1 N<br>Sa
							umber<br>chet		1	Caffeine<br>Anhydro<br>Powder	us	<br>30.30 mg /<br>5 gm sachet
		<br> <br> <br> <br>	emon/ Black currant/ Cranber<br>Lemon/ Other flavours). Each<br>5gm contains Caffeine Anhydro<br>30mg. Net content of Caffeine<br>Powder 23.64 Kgs.)		ry/ Honey<br>sachet of<br>us Powder<br>Anhydrous

	2	<br> <br> <br> <br>	Rinza<br>Tablets.<br>Each<br>tablet<br>Caffeine Anhydrous Powder 3<br>Paracetamol BP 500 mg.(Net Co<br>Caffeine Anhydrous Powder - 1<br>and Paracetamol BP- 2829.27 Kg		Contains<br>0 mg and<br>ntent of<br>69.76 Kgs<br>s.)	<br> <br> <br>1 N<br>Ta	umber		2	Caffeine<br>Anhydro	us	<br>30.60 mg
							<br>blet			<br> <br>Powder		<br> <br>/ 30 mg<br>tablet

									3	Paracetamol BP		510 mg /<br>
												500 mg tablet
	3	<br> <br> <br>	Rinza<br>Sip<br>for<br>Children<br>Raspberry/ other flavours). Each<br>3gm<br>contains<br>Paracetamol<br>280mg.(Net content- 96.15 Kgs.)		(Flavours<br>sachet of<br> <br>BP<br>-	<br> <br> <br>1 N<br>Sa	umber		4	Paracetamol BP		282.80 mg /
							chet					3 gm sachet
	<br>A concer		<br>ned may take further necessary a		ction as per ab
							ove deci	sion of NC.


Case No.				97 / NC/3/MEET/Nov/202223/12

Case No. 97 / NC/3/MEET/Nov/202223/12

UDIN00265785AM23

Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00409618AM22
RA File Number		31AX04000100 AM22
Licence No and<br>Date		3111001215/31/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export<br>product / import item in Meeting No.NC/3/MEET/Mar/2022122/15 dated 17/03/2022against advance<br>authorization No.3111000148 dated 09.02.2021, it was decided to ratify adhoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>MONO ETHANOL AMINE<br>1.0374 kg<br>ETHYLENE DI AMINE (ORGANIC<br>CHEMICAL)<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
	Export product		Qty.	Sl. No.	Import items	Qty.
	ETHYLENE DI AMINE (ORGANIC<br>CHEMICAL)		<br>1 kg	1	MONO ETHANOL AMINE	1.0374 kg
				2	AMMONIA ANHYDROUS	Not allowed, as it is<br>shown indigenous
				s per above decision of NC

Case No.	98 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00409264AM22
RA File Number	03AX04002067 AM22
Licence No and<br>Date	0311013503/31/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents<br>from the firm:<br> Stoichiometric balance between import and export on molar basis and yield to arrive at the quantity of<br>raw material asked for.<br>i.<br>If DMSO is used as a solvent, then recovery of same.<br>ii.

i. Stoichiometric balance between import and export on molar basis and yield to arrive at the quantity of raw material asked for.

UDIN00265785AM23

iii. End use of export product.

Case No.	99 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00409628AM22
RA File Number	31AX04000110 AM22
Licence No and<br>Date	3111001216/31/03/2022
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>Phenol<br>0.749 kg<br>2<br>Methanol<br>0.255 kg<br>3<br>Hydrogen Peroxide (60%)<br>0.452 kg<br>4<br>Acetone (Solvent)<br>0.078 kg<br>5<br>Dimethyl Sulphate<br>0.502 kg<br>Veratrole (1,2, Dimethoxy Benzene)<br>1 kg<br>6<br>Caustic Soda Lye<br>0.36 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	100 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00409265AM22
RA File Number	03AX04002070 AM22

UDIN00265785AM23

Licence No and 0311013504/31/03/2022 Date Norms Committee Decision:

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

i. End use of Export Product.
ii. Stoichiometric balance between import and export on molar basis and yield to arrive at the quantity of raw material asked for.
iii. Recovery of solvent of DMSO & N-Heptane.

Case No.<br>101 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00409822AM22
RA File Number<br>05AX04001370 AM22
Licence No and<br>Date<br>0511011543/31/03/2022
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/Jan/202021/4 dated	12.02.2021against advance authorization No.
0510414007 dated 16.04.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP		Vol. I as per
details given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
VANCOMYCIN HYDROCHLORIDE<br>1 kg<br>1	Vancomycin HCL (Non Sterile)	1.01 kg
( STERILE)
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	102 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00409266AM22

UDIN00265785AM23

RA File Number	03AX04002071 AM22
Licence No and<br>Date	0311013505/31/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:
End use of<br>i.	Export Product.
Stoichiometric Balance between import and export on molar basis, percentage yield at each stage to<br>ii.
arrive at the quantity of raw material asked for.
Recovery of solvent Acetaldoxime.<br>iii.

ii. Stoichiometric Balance between import and export on molar basis, percentage yield at each stage to arrive at the quantity of raw material asked for.

Case No.	103 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00410005AM22
RA File Number	09AX04000194 AM22
Licence No and<br>Date	0911002814/31/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>104 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00409269AM22
RA File Number<br>03AX04002072 AM22
Licence No and<br>Date<br>0311013506/31/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Apr/202223/1dated29.04.2022 against advance authorization No.
0311005238 dated09.07.2021, 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<br>Qty.<br>Sl. No.	Import items	Qty.

UDIN00265785AM23


	8-Chloro-6-(Trifluoromethyl		1 kg	1	2-Amino-3-chloro-5-(TFM) Pyridine	1.035 kg
	imidazo	1,2-a]pyridine-2-
	carboxylic acid (QEK31)			2	Ethyl Pyruvate	0.676 kg
				3	Bromine	1.143 kg
				4	Dichloromethane	Not allowed, as it is
						being reused
				5	Acetic acid	Not allowed, as it is
						being reused
<br>	<br>A concerned may take further necessary action as per above decision of NC.

Case No.	105 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00410013AM22
RA File Number	09AX04000193 AM22
Licence No and<br>Date	0911002816/31/03/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	106 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000024AM23
RA File Number	09AX04000398 AM22
Licence No and<br>Date	0911002823/01/04/2022
Norms Committee Decision:
T
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Mar/202122/16dated 08/04/2022 against advance authorization No.

UDIN00265785AM23

0911001871 dated 17/11/2021 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export Product	Qty.	Sl. No.	Import items	Qty.
IBREXAFUNGERP CITRATE	1 kg	1	ENFUMAFUNGIN	4.55 kg

Case No.	107 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000032AM23
RA File Number	13AX04000126 AM22
Licence No and Date	1311001135/01/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance authorization No.<br>1311000341 dated 19-05-2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<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>AZODICARBONAMIDE<br>(BLOWING<br>AGENT), PURITY MINIMUM 99.50<br>PERCENT, PARTICLE SIZE 4.5 TO 5.5<br>PERCENT MICRON<br>200000 kg<br>1<br>AZODICARBONAMIDE<br>CRUDE PURITY MINIMUM<br>97 PERCENT PARTICLE SIZE<br>13 TO 15 PERCENT<br>MICRON<br>201000 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	108 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED

UDIN00265785AM23

Meeting Number<br>and Date	Meeting Number<br>and Date	Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022


H	Q	File Number		HQRNORM APPLY 0000		041AM23

R		File Number		07AX04000598 AM22

L<br>D	c	ence No and
	a	e		0711003587/03/04/2022

N	o	rms Committee		Decision:
<br>T	<br>h	<br>Committee co		<br>nsidered the case as er a		enda and it was decided to ratif adhoc norms under Para 407 of HBP
				p g		y .
	V	ol. I as per deta		ils given below or as applie		d by the firm, whichever is less:




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

	1		Sodium Chloride Injection USP 90<br>10mL Vial.(10mL Vial - filled with<br>of Sodium Chloride as bulk drug<br>			mg per<br>90mg<br>	<br> <br> <br>642375<br>Numbers	1	13mm<br>GreySerum<br>ChlorobutyI<br>R/S-RFS-<br>C14226422GS6TP3	<br>Relevant as per<br>Packing Policy
			filled in 10mL Vial and capped with<br>13mm Grey Serum ChlorobutyI Rubber<br>S				<br>
			topper)


	2		Sterile	Water<br>for<br>Injection<br>10mL			<br>900000	2	13mm<br>GreySerum	<br>Relevant as per
			Vial(Ste<br>	rile Water for injection, filled in<br>			<br> <br>Numbers		ChlorobutyI<br>R/S-RFS-<br>	Packing Policy
			10mL V	ial and capped with 13mm Grey			<br>		C14226422GS6TP3
			<br>Serum C	<br>hlorobutyI Rubber S	<br>topper)



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


C	a	se No.		109 / NC/3/MEET/Nov/202223/12
C	a	se Status		Case Approved
Party Name				MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date				NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number				HQRNORM APPLY 00000042AM23
RA File Number				07AX04000596 AM22
Licence No and<br>Date				0711003588/03/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
<br>Vol. I as per deta				<br>ils given below or as applied by the firm, whichever is less:

Case No.	109 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000042AM23
RA File Number	07AX04000596 AM22
Licence No and<br>Date	0711003588/03/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:

UDIN00265785AM23

	Sl. No.	Export p	roduct	roduct	roduct	Qty.	Qty.	Qty.	Qty.	Sl. No.	Sl. No.	Import items	Import items	Qty.


	1	Sodium	Chloride Injection USP 90mg			<br>360000				1		13mm<br>GreySerum		<br>Relevant as per
		<br>per 10m<br>90mg of	<br>L Vial.(10mL Vial - filled with<br>Sodium Chloride as bulk drug			<br> <br>Numbers						<br>ChlorobutyI<br>R/S-RFS-<br>C14226422GS6TP3		<br> <br>Packing Policy
<br>R		filled in 10mL Vial and capped with<br>13mm GreySerum ChlorobutyI Rubber<br>Stopper)				<br>
	2	Sterile<br>Water<br>for<br>Injection<br>10mL<br>Vial(Sterile Water for injection, filled in<br>10mL Vial and capped with 13mm				<br> <br> <br>668250<br>Numbers				2		13mm<br>GreySerum<br>ChlorobutyI<br>R/S-RFS-<br>C14226422GS6TP3		<br>Relevant as per<br>Packing Policy
		GreySerum<br>ChlorobutyI<br> <br>Stopper)		Rubber
	<br>A concerned may take further necessary ac			tion as pe			r above		decision of NC.

C	ase No.		110 / NC/3/MEET/Nov/2	02223/12
C
	ase Status		Case Approved
P	arty Name		MAIVA PHARMA PRIVATE LIM				ITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

HQ File Number			HQRNORM APPLY 00000054AM23

RA File Number			07AX04000570 AM22

Licence No and<br>			0711003549/04/04/2022
Date
i			ii
Norms Commttee<br>The Committee co			ecson:<br>nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
<br>	<br>Vol. I as per deta		<br>ils given below or as applied by the firm, whichever is less:



	Export product				Qty.			Sl. No.			Import items		Qty.
	Valproate Sodium Injection 100mg/mL,<br>5ml(5mL Vial - filled with 20mg of<br>Valporate Sodium as bulk drug is filled in<br>5mL Vial and capped with 20mm<br>chlorobutyle Rubber Stopper)				<br> <br> <br> <br>270000<br>Numbers			1			WPS S10-F451 4432/50G<br>B2-40<br>WESTARRS1m/PK<br>(20mm<br>Chlorobutyle<br>Rubber Stopper)		<br> <br>Relevant<br>as<br>per<br>Packing Policy

UDIN00265785AM23

Case No.	111 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000057AM23
RA File Number	03AX04001875 AM22
Licence No and<br>Date	0311013605/04/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jul/202122/4 dated 15.07.2021against advance authorization No.<br>0311001996 dated 08.03.2021, 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.<br>Import items<br>Qty.<br>Betamethasone Dipropionate<br>IP/BP/EP/USP<br>115 kg<br>1<br>Betamethasone IP/BP/EP/USP<br>99.82 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	112 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000058AM23
RA File Number	03AX04002119 AM22
Licence No and<br>Date	0311013606/04/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09/09/2022 against advance authorization No.<br>0311010684 dated 19/01/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:

UDIN00265785AM23

Export product	Qty.	Sl. No.	Import items	Qty.
DI<br>ISODECYL<br>PHENYL<br>PHOSPHITE((DDPP))	<br>1 kg	1	PHENOL	0.238 kg
		2	ISODECYL ALCOHOL OR 2 PROPYL<br>HEPTANOL	<br>0.734 kg
		3	YELLOW PHOSPHORUS	0.075 kg

Case No.	Case No.	113 / NC/3/MEET/Nov/202223/12	113 / NC/3/MEET/Nov/202223/12	113 / NC/3/MEET/Nov/202223/12	113 / NC/3/MEET/Nov/202223/12	113 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000061AM23
RA File Number		03AX04002100 AM22
Licence No and<br>Date		0311013612/05/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23/09/2022against advance authorization No.<br>0311002962 dated 31/03/2021, 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. Import items<br>Qty.<br>1<br>Atorvastatin Calcium Propylene<br>Glycol Solvate USP<br>11.415 mg<br>2<br>Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102)<br>64.578 mg<br>3<br>Calcium Acetate<br>18.049 mg<br>1<br>Atorvastatin Calcium Tablets<br>USP 10mg((Pack Size 90 tabs)<br>(Net wt. of Import Sr. No. 1 is<br>793.512kgs,<br>Sr.<br>No.<br>2<br>is<br>4394.736kg,<br>Sr.<br>No.<br>3<br>is<br>1247.976kg,<br>Sr.<br>No.<br>5<br>is<br>808000 Nos.))<br>1 Number<br>Tablet
	Export Product		Qty.	Sl. No.	Import items	Qty.
	Atorvastatin Calcium Tablets<br>USP 10mg((Pack Size 90 tabs)<br>(Net wt. of Import Sr. No. 1 is<br>793.512kgs,<br>Sr.<br>No.<br>2<br>is<br>4394.736kg,<br>Sr.<br>No.<br>3<br>is<br>1247.976kg,<br>Sr.<br>No.<br>5<br>is<br>808000 Nos.))		<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin Calcium Propylene<br>Glycol Solvate USP	<br>11.415 mg
				2	Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102)	<br>64.578 mg
				3	Calcium Acetate	18.049 mg

UDIN00265785AM23

			4	Strippax Sorbent 50 C & 50 SG<br>2gm (Silica Gel Dessicants)	<br>Relevant as per<br>packing policy
2	Atorvastatin Calcium Tablets<br>USP 10mg((Pack Size 1000<br>tabs) (Net wt. of Import Sr. No.<br>1 is 826.575kgs, Sr. No. 2 is<br>4577.85kg,<br>Sr.<br>No.<br>3<br>is<br>1299.975kg, Sr. No. 5 is 75750<br>Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin Calcium Propylene<br>Glycol Solvate USP	<br>11.415 mg
			2	Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102)	<br>64.578 mg
			3	Calcium Acetate	18.049 mg
			4	250cc Rnd White 53/400 Hdpe<br>Sclair 58a (Plastic Bottles 250CC<br>white HDPE Round 38mm)	<br> <br>Relevant as per<br>packing policy
3	Atorvastatin Calcium Tablets<br>USP 20mg((Pack Size 90 tabs)<br>(Net wt. of Import Sr. No. 1 is<br>148.784kgs,<br>Sr.<br>No.<br>2<br>is<br>826.929kg,<br>Sr.<br>No.<br>3<br>is<br>234.698kg, Sr. No. 5 is 75750<br>Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin Calcium Propylene<br>Glycol Solvate USP	<br>22.830 mg
			2	Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102)	<br>129.427 mg
			3	Calcium Acetate	36.090 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
4	Atorvastatin Calcium Tablets<br>USP 40mg((Pack Size 90 tabs)<br>(Net wt. of Import Sr. No. 1 is<br>2023.456kgs, Sr. No. 2 is<br>11207.403kg, Sr. No. 3 is<br>3182.522kg,<br>Sr.<br>No.<br>5<br>is<br>515100 Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin Calcium Propylene<br>Glycol Solvate USP	<br>45.595 mg
			2	Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102)	<br>258.08 mg
			3	Calcium Acetate	71.963 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
5	Atorvastatin Calcium Tablets<br>USP 40mg((Pack Size 1000<br>tabs) (Net wt. of Import Sr. No.<br>1 is 2055.196kgs, Sr. No. 2 is	<br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin Calcium Propylene<br>Glycol Solvate USP	<br>45.595 mg
			2	Microcrystalline Cellulose (MCC)	<br>258.08 mg

UDIN00265785AM23

	11383.205kg, Sr. No. 3 is<br>3232.444kg, Sr. No. 5 is 47086<br>Nos.))	<br>		NF (Avicel PH 102)
			3	Calcium Acetate	71.963 mg
			4	Plastic<br>Bottles<br>120CC<br>white<br>HDPE Round 38mm	<br>Relevant as per<br>packing policy
6	Atorvastatin Calcium Tablets<br>USP 80mg((Pack Size 90 tabs)<br>(Net wt. of Import Sr. No. 1 is<br>1658.44kgs,<br>Sr.<br>No.<br>2<br>is<br>9229.86kg,<br>Sr.<br>No.<br>3<br>is<br>2619.048kg,<br>Sr.<br>No.<br>4<br>is<br>211090 Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin Calcium Propylene<br>Glycol Solvate USP	<br>91.20 mg
			2	Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102)	<br>518.206 mg
			3	Calcium Acetate	144.929 mg
			4	1500cc Round Extrusion 89/400<br>Neck<br>White<br>(Plastic<br>Bottles<br>1500CC white HDPE Round<br>38mm)	<br> <br> <br>Relevant as per<br>packing policy
7	Atorvastatin Calcium Tablets<br>USP 80mg((Pack Size 1000<br>tabs) (Net wt. of Import Sr. No.<br>1 is 1908.837kgs, Sr. No. 2 is<br>10623.417kg, Sr. No. 3 is<br>3014.481kg, Sr. No. 4 is 21867<br>Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin Calcium Propylene<br>Glycol Solvate USP	<br>91.20 mg
			2	Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102)	<br>518.206 mg
			3	Calcium Acetate	144.929 mg
			4	1500cc Round Extrusion 89/400<br>Neck<br>White<br>(Plastic<br>Bottles<br>1500CC white HDPE Round<br>38mm)	<br> <br> <br>Relevant as per<br>packing policy
Note: The above norms are valid only for subject to fulfillment of following conditions:<br>Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug<br>Application) of Apotex Corp, US. Agent for Apotex Inc., Candada.<br>1.<br>Export to USA only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.

Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex Corp, US. Agent for Apotex Inc., Candada.
Export to USA only.

UDIN00265785AM23

Case No.	114 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000064AM23
RA File Number	09AX04000330 AM22
Licence No and<br>Date	0911002827/05/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	115 / NC/3/MEET/Nov/202223/12	115 / NC/3/MEET/Nov/202223/12	115 / NC/3/MEET/Nov/202223/12	115 / NC/3/MEET/Nov/202223/12	115 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000066AM23
RA File Number		03AX04001985 AM22
Licence No and<br>Date		0311013625/05/04/2022
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>5-(4-CHLOROBUTYL)-1-CYCLOHEXYL 1H TETRAZOLE<br>0.85 kg<br>2<br>6-HYDROXY-2 OXO-1,2,3,4-TETRAHYDROQUINOLINE<br>0.59 kg<br>3<br>METHANOL<br>4.00 kg<br>4<br>TOLUENE<br>0.30 kg<br>CILOSTAZOL<br>1 kg<br>5<br>TRICAPRLY METHYL AMMONIUM CHLORIDE<br>0.100 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.				se as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>or as applied by the firm, whichever is less:
	Export product		Qty.	Sl. No.	Import items	Qty.
	CILOSTAZOL		1 kg	1	5-(4-CHLOROBUTYL)-1-CYCLOHEXYL 1H TETRAZOLE	0.85 kg
				2	6-HYDROXY-2 OXO-1,2,3,4-TETRAHYDROQUINOLINE	0.59 kg
				3	METHANOL	4.00 kg
				4	TOLUENE	0.30 kg
				5	TRICAPRLY METHYL AMMONIUM CHLORIDE	0.100 kg

UDIN00265785AM23

Case No.	116 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000086AM23
RA File Number	07AX04000582 AM22
Licence No and<br>Date	0711003633/06/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	117 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000087AM23
RA File Number	07AX04000581 AM22
Licence No and<br>Date	0711003634/06/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>118 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000101AM23
RA File Number<br>03AX04002054 AM22
Licence No and<br>Date<br>0311013691/07/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same			export product /
import item in Meeting No.NC/3/MEET/Sep/202223/9dated 07.10.2022 against advance authorization No.
03110011707 dated23.02.2022, 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<br>Qty.	Sl. No.	Import items	Qty.

UDIN00265785AM23

ACETONITRILE	<br>(Purity	Min.	99.9%,	<br>350 MT	1	ACETONITRILE – LOW	416.51 MT
Moisture less than	500 PPM)					PURITY (Purity 98%)

Case No.<br>119 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000106AM23
RA File Number<br>03AX04000074 AM23
Licence No and<br>Date<br>0311013696/07/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same				export product /
import item in Meeting No.NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance			authorization No.
0311003205 dated 21.04.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP					Vol. I as per
details given below or as applied by the firm, whichever is less:
Export Product<br>Qty.	Sl. No.	Import items			Qty.
AMANTADINE HYDROCHLORIDE 100<br>1350000	1	AMANTADINE			137.70 kg
MG CAPSULES		HYDROCHLORIDE<br>CEP	Ph
Numbers		EUR RA001136
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	120 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000109AM23
RA File Number	09AX04000400 AM22
Licence No and<br>Date	0911002840/07/04/2022
Norms Committee Decision:

UDIN00265785AM23

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Mar/202122/16 dated 08/04/2022 against advance authorization No. 0911001871 dated 17/11/2021 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export Product<br>IBREXAFUNGERP CITRATE	Qty.	Sl. No.	Import items	Qty.
	1 kg	1	ENFUMAFUNGIN	4.55 kg

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

Case No.	Case No.	Case No.	121 / NC/3/MEET/Nov/202223/12	121 / NC/3/MEET/Nov/202223/12	121 / NC/3/MEET/Nov/202223/12	121 / NC/3/MEET/Nov/202223/12	121 / NC/3/MEET/Nov/202223/12
Case Status			Case Approved
Party Name			ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00000139AM23
RA File Number			08AX04000776 AM22
Licence No and<br>Date			0811004611/08/04/2022
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>Sl. No.<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>DEXAMETHASONE USP<br>0.510 mg<br>2<br>CORN STARCH NF<br>6.75 mg<br>3<br>LACTOSE<br>MONOHYDRATE<br>NF/PH.EUR<br>39.485 mg<br>4<br>SUCROSE NF<br>2.50 mg<br>1<br>DEXAMETHASONE TABLETS USP<br>0.5<br>MG((ACTIVE<br>INGREDIENT:<br>DEXAMETHASONE USP - NET WT.<br>4.693 KGS.))<br>1 Number<br>Tablet<br>5<br>MAGNESIUM<br>STEARATE<br>PH.EUR/NF<br>0.77 mg
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	DEXAMETHASONE TABLETS USP<br>0.5<br>MG((ACTIVE<br>INGREDIENT:<br>DEXAMETHASONE USP - NET WT.<br>4.693 KGS.))		<br> <br> <br>1 Number<br>Tablet	1	DEXAMETHASONE USP	0.510 mg
					2	CORN STARCH NF	6.75 mg
					3	LACTOSE<br>MONOHYDRATE<br>NF/PH.EUR	39.485 mg
					4	SUCROSE NF	2.50 mg
					5	MAGNESIUM<br>STEARATE<br>PH.EUR/NF	0.77 mg

Case No.	Case No.	Case No.	121 / NC/3/MEET/Nov/202223/12	121 / NC/3/MEET/Nov/202223/12	121 / NC/3/MEET/Nov/202223/12	121 / NC/3/MEET/Nov/202223/12	121 / NC/3/MEET/Nov/202223/12
Case Status			Case Approved
Party Name			ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00000139AM23
RA File Number			08AX04000776 AM22
Licence No and<br>Date			0811004611/08/04/2022
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>Sl. No.<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>DEXAMETHASONE USP<br>0.510 mg<br>2<br>CORN STARCH NF<br>6.75 mg<br>3<br>LACTOSE<br>MONOHYDRATE<br>NF/PH.EUR<br>39.485 mg<br>4<br>SUCROSE NF<br>2.50 mg<br>1<br>DEXAMETHASONE TABLETS USP<br>0.5<br>MG((ACTIVE<br>INGREDIENT:<br>DEXAMETHASONE USP - NET WT.<br>4.693 KGS.))<br>1 Number<br>Tablet<br>5<br>MAGNESIUM<br>STEARATE<br>PH.EUR/NF<br>0.77 mg
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	DEXAMETHASONE TABLETS USP<br>0.5<br>MG((ACTIVE<br>INGREDIENT:<br>DEXAMETHASONE USP - NET WT.<br>4.693 KGS.))		<br> <br> <br>1 Number<br>Tablet	1	DEXAMETHASONE USP	0.510 mg
					2	CORN STARCH NF	6.75 mg
					3	LACTOSE<br>MONOHYDRATE<br>NF/PH.EUR	39.485 mg
					4	SUCROSE NF	2.50 mg
					5	MAGNESIUM<br>STEARATE<br>PH.EUR/NF	0.77 mg

UDIN00265785AM23


2	DEXAM<br>0.75<br>M<br>DEXAM	ETHASONE TABLETS USP<br>G((ACTIVE<br>INGREDIENT:<br>ETHASONE USP - NET WT		<br> <br>1 Number<br>Tablet			1	DEXAMETHASONE USP		0.765 mg

	.<br>4.318 KGS.))						2	CORN STARCH NF		10.125 mg
							3	LACTOSE<br>MONOHYDRATE<br>NF/PH.EUR		58.303 mg

							4	SUCROSE NF		3	.70 mg

							5	MAGNESIUM<br>STEARATE<br>PH.EUR/NF		1	.12 mg
3	DEXAMETHASONE TABLETS USP		1	<br>1 Numb		er	1	DEXAMETHASONE USP		1	.02 mg
	MG((ACTIVE<br>INGREDIENT:<br>DEXAMETHASONE USP - NET WT.<br>14.010 KGS.))			<br>Tablet
							2	CORN STARCH NF		13.50 mg

							3	LACTOSE<br>MONOHYDRATE<br>		78.970 mg
								NF/PH.EUR


							4	SUCROSE NF		5.00 mg

							5	MAGNESIUM<br>STEARATE		1.50 mg
								PH.EUR/NF


4	DEXAM<br>1.5<br>M	ETHASONE TABLETS USP<br>G((ACTIVE<br>INGREDIENT:		<br> <br>1 Number<br>Tablet			1	DEXAMETHASONE USP		1.53 mg
	DEXAMETHASONE USP - NET WT.<br>3.630 KGS.))						2	CORN STARCH NF		13.50 mg
							3	LACTOSE<br>MONOHYDRATE<br>NF/PH.EUR		78.476 mg
							4	SUCROSE NF		5.00 mg

							5	MA<br>PH.E	GNESIUM<br>STEARATE<br>UR/NF	1.50 mg
5	DEXAMETHASONE TABLETS USP 2			<br>1 N	b		1	DE	AMETHASONE USP	204
	<br>MG((ACTIVE<br>INGREDIENT:<br>DEXAMETHASONE USP - NET WT.<br>79.013 KGS.))			<br> <br>um<br>Tablet	er					. mg
							2	COR	N STARCH NF	13.50 mg
							3	LAC	TOSE<br>MONOHYDRATE	78.00 mg

UDIN00265785AM23

										NF/P	H.EUR

									4	SUC	ROSE NF	5.00 mg
									5	MA<br>	GNESIUM<br>STEARATE<br>	1.50 mg
										PH.E	UR/NF
	6	DEXAMETHASONE TABLETS USP 4<br>MG((ACTIVE<br>INGREDIENT:			<br> <br>1 Num<br>Tablet		ber		1	DEX	AMETHASONE USP	4.08 mg
		<br>DEXAMETHASONE USP - NET WT.<br>301.008 KGS.))							2	COR	N STARCH NF	13.50 mg
											<br>
									3	LAC<br>NF/P	TOSE<br>MONOHYDRATE<br>H.EUR	75.985 mg
									4	SUC	ROSE NF	5.00 mg

									5	MA<br>PH.E	GNESIUM<br>STEARATE<br>UR/NF	1.50 mg

	7	DEXAMETHASONE TABLETS USP 6<br>MG((ACTIVE<br>INGREDIENT:<br>DEXAMETHASONE USP - NET WT.<br>			<br> <br>1 Number<br>Tablet				1	DEXAMETHASONE USP		6.12 mg
									2	CORN STARCH NF		13.50 mg
		101.983 KGS.))

									3	LACTOSE<br>MONOHYDRATE		73.99 mg
										NF/PH.EUR


									4	SUCROSE NF		5.00 mg
										<br>
									5	MAGNESIUM<br>STEARATE<br>PH.EUR/NF		1.50 mg


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

Case No.			122 / NC/3/MEET/Nov/202223/12
C	ase Status		Case Deferred
P	arty Name		KusuMa PharMa
M<br>a
	eeting Number<br>nd Date		NC/ 3/ MEET/	Nov/ 202223/ 1		2 and 1		8/11/2022
H	Q File Number		HQRNORM A	PPLY 0000015		0AM23
RA File Number			03AX04000018 AM23

Case No.	122 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000150AM23
RA File Number	03AX04000018 AM23

UDIN00265785AM23

Licence No and 0311013747/08/04/2022 Date Norms Committee Decision:

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

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

Case No.	123 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000151AM23
RA File Number	09AX04000402 AM22
Licence No and<br>Date	0911002848/08/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	124 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000158AM23
RA File Number	03AX04000111 AM23
Licence No and<br>Date	0311013749/10/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/May/202223/4dated17/06/2022 against advance authorization No.
0311004509dated	10/06/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:

70 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

Export Product	Qty.	Sl. No.	Import items	Qty.
DINONYLATED DIPHENYLAMINE	1 kg	1	DIPHENYLAMINE	0.4134 kg
(YALUB DND)
		2	NONENE	0.4 kg
		3	ACTIVATED CLAY	0.05 kg


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


	DINONYLATE	D DIPHENYLAMINE<br>	1 kg	1		DIPHENYLAMINE	0.4134 kg
	(YALUB DND)
				2		NONENE	0.4 kg

				3		ACTIVATED CLAY	0.05 kg
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.		125 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved

Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
and Date

HQ File Number		HQRNORM APPLY 00000159AM23

RA File Number		03AX04000094 AM23
Licence No and<br>		0311013750/10/04/2022
Date

Norms Committee		Decision:
The Committee co<br>import item in M		nsidered the case as per agenda and taking cue from earlier decision for same export product /<br>eeting No.NC/3/MEET/May/202223/4 dated17/06/2022 against advance authorization No.
<br>0311004509dated 10/06/2021, 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.<br>Import items<br>Qty.<br>1<br>DIPHENYLAMINE<br>0.4134 kg<br>2<br>NONENE<br>0.4 kg<br>DINONYLATED DIPHENYLAMINE<br>(YALUB DND)<br>1 kg<br>3<br>ACTIVATED CLAY<br>0.05 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.		Import items	Qty.

	DINONYLATED DIPHENYLAMINE		1 kg	1		DIPHENYLAMINE	0	.4134 kg
	(YALUB DND)
				2		NONENE	0	.4 kg
				3		ACTIVATED CLAY	0	.05 kg
	<br>A concerned may take further necessary action		as per abo
				ve decis	ion of NC.

Case No.		126 / NC/3/MEET/Nov/202223/12

Case No. 126 / NC/3/MEET/Nov/202223/12

UDIN00265785AM23

C	ase Status	Case Approved	Case Approved
P	arty Name	SANDHYA ORGANIC CHE		MICALS P		VT LT	D
Meeting Number<br>and Date
		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000161AM23
RA File Number		03AX04000062 AM23

Licence No and<br>Dt		0311013759/11/04/2022
ae
Norms Committee		Decision:

The Committee co		nsidered the case as per agenda and taking cue from earlier decision for same export product /
import item in M<br>0311010684 dated		eeting No.NC/3/MEET/Aug/202223/6 dated 09/09/2022 against advance authorization No.<br>19/01/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as a		pplied by the firm, whichever is less:



	Export product		Qty.		Sl. No.	Import items		Qty.
	DIPHENYL<br>ISODECYL<br>PHOSPHITE((DPDP))		<br>1 kg		1	PHENOL		0.238 kg
					2	ISODECYL ALCOHOL OR 2 PROPYL<br>HEPTANOL		<br>0.734 kg
					3	YELLOW PHOSPHORUS		0.075 kg




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



Case No.		127 / NC/3/MEET/Nov/202223/12

Case Status		Case Deferred

Party Name		GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
and Date
HQ File Number		HQRNORM APPLY 00000168AM23
RA File Number		03AX04000080 AM23
Licence No and<br>Date		0311013777/11/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.		128 / NC/3/MEET/Nov/202223/12

Case Status		Case Approved

Case No.	127 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000168AM23
RA File Number	03AX04000080 AM23
Licence No and<br>Date	0311013777/11/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	128 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved

UDIN00265785AM23

Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000169AM23
RA File Number<br>03AX04000017 AM23
Licence No and<br>Date<br>0311013787/11/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.
0311004037 dated 25.05.2021, 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.<br>Sl. No. Import items	Qty.
1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>Ciprofloxacin<br>Hydrochloride<br>1 kg	1.240 kg
5Fluorobenzoyl) Acrylate<br>BP/EP/USP (Ciprofloxacin)
2<br>Piperazine Anhydrous	0.390 kg
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.<br>129 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Deferred
Party Name<br>SUNSHIELD CHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000186AM23
RA File Number<br>03AX04000112 AM23
Licence No and<br>Date<br>0311013797/11/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:
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.

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

UDIN00265785AM23

iv. Stoichiometric balance between import and export on molar basis. v. Details of indigenous input with quantity.

Case No.	130 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ENVEE DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000202AM23
RA File Number	34AX04000001 AM23
Licence No and<br>Date	3411002110/12/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Stoichiom<br>iv.<br>	Stoichiom<br>iv.<br>	etric balance between import and export on molar basis.<br>	etric balance between import and export on molar basis.<br>	etric balance between import and export on molar basis.<br>	etric balance between import and export on molar basis.<br>	etric balance between import and export on molar basis.<br>
Details of<br>v.		indigenous input with quantity.



Case No.		130 / NC/3/MEET/Nov/202223/12
C Stt		C Dfd
ase aus		ase eerre
Party Name		ENVEE DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000202AM23

RA File Number		34AX04000001 AM23

Licence No and
Date		3411002110/12/04/2022
Norms Committee<br>		Decision:<br>
Deferred for comme		nts of TE.



Case No.		131 / NC/3/MEET/Nov/202223/12
C Stt		C Ad
ase aus		ase pprove
Party Name		AHLCON PARENTERALS (INDIA) LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000211AM23

RA File Number		05AX04001545 AM22

Licence No and
Date		0511011860/12/04/2022
Norms Committee<br>		Decision:<br>
The Committee co<br>		nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>
Vol. I as per detai		ls given below or as applied by the firm, whichever is less:

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

	SODIUM<br>CHLORIDE		<br>1 kg	1	PURELL PE 3220D	1.05 kg /kg content
	INTRAVENOU<br> <br>	S<br>INFUSION<br>0.9%<br> <br>	<br>		(LDPE Granule)	in<br>the<br>export<br>
	1000ML<br>(S<br>INTRAVENO	ODIUM<br>CHLORIDE<br>S<br>INFUSION<br>09%	<br>			product
	<br>1000ML (Emp	<br> <br>.<br>ty bottle weight - 39	<br>
	<br>Grms, Filled b<br>Chloride - 1082	<br>ottle weight of Sodium<br>grams))	<br>
						<br>
				2	4903 TPE 8558/45A TRIM<br>TEC CAP PLASTIC CAP	<br>Relevant<br>as<br>per<br>ki li
						pacng pocy

UDIN00265785AM23

Case No.	132 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000197AM23
RA File Number	09AX04000016 AM23
Licence No and<br>Date	0911002850/12/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	133 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000199AM23
RA File Number	09AX04000304 AM22
Licence No and<br>Date	0911002851/12/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	134 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000220AM23
RA File Number	08AX04000742 AM22
Licence No and<br>Date	0811004640/13/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	135 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
MeetingNumber	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

UDIN00265785AM23

and Date
HQ File Number	HQRNORM APPLY 00000248AM23
RA File Number	03AX04000163 AM23
Licence No and<br>Date	0311013879/17/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/4dated17/06/2022 against advance authorization No.<br>0311004509dated10/06/2021, 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.<br>Import items<br>Qty.<br>1<br>DIPHENYLAMINE<br>0.4134 kg<br>2<br>NONENE<br>0.4 kg<br>DINONYLATED DIPHENYLAMINE<br>(YALUB DND)<br>1 kg<br>3<br>ACTIVATED CLAY<br>0.05 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	136 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000274AM23
RA File Number	30AX04000006 AM23
Licence No and<br>Date	3011002023/18/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information /documents from the<br>firm:<br> Complete chemistry, molecular weight and percentage yield on molar basis may be furnished in line<br>with Annexure to Appendix 4E.<br>i.

i. Complete chemistry, molecular weight and percentage yield on molar basis may be furnished in line with Annexure to Appendix 4E.

Case No. 137 / NC/3/MEET/Nov/202223/12

UDIN00265785AM23

Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000256AM23
RA File Number	09AX04000404 AM22
Licence No and<br>Date	0911002859/18/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	138 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ANUH PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000257AM23
RA File Number	03AX04001828 AM22
Licence No and<br>Date	0311013920/18/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>139 / NC/3/MEET/Nov/202223/12	Case No.<br>139 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000260AM23
RA File Number<br>03AX04000065 AM23
Licence No and<br>Date<br>0311013922/18/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29/04/2022against advance authorization No.
0310796757 dated 23/06/2015, it was decided to ratify adhoc norms under Para 4.07 of HBP			Vol. I as per
details given below or as applied by the firm, whichever is less:
	Export Product<br>Qty.<br>Sl. No.	Import items	Qty.
	AZITHROMYCIN DIHYDRATE<br>1 kg<br>1	AZITHROMYCIN AMINE	1.04 kg

UDIN00265785AM23

Case No.	140 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	NEXUS PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000267AM23
RA File Number	08AX04000024 AM23
Licence No and<br>Date	0811004699/18/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Oct/202223/11 dated 31/10/2022against advance authorization No.<br>0811003272 dated 01.12.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Clobetasol Propionate USP<br>1 kg<br>1<br>Betamethasone base<br>1.00 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	141 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MITHILA RASAYAN PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000290AM23
RA File Number	03AX04000086 AM23
Licence No and<br>Date	0311013960/19/04/2022
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:

UDIN00265785AM23

i. Percentage of Zinc Diacrylate in Export Product.

ii. How the export is modified.

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

Case No.	142 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AMANTA HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000291AM23
RA File Number	08AX04000760 AM22
Licence No and<br>Date	0811004729/19/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	143 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SUVEN PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000293AM23
RA File Number	09AX04000008 AM23
Licence No and<br>Date	0911002860/19/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	144 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000298AM23
RA File Number	03AX04002053 AM22
Licence No and<br>Date	0311013980/19/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	145 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved

UDIN00265785AM23

Party Name<br>HETERO DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000299AM23
RA File Number<br>09AX04000007 AM23
Licence No and<br>Date<br>0911002862/19/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same	export product /
import item in Meeting No.6/82-ALC4/2018 dated 26.07.2018against advance authorization No.0910065042 dated
15.05.2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as
applied by the firm, whichever is less:
Export Product<br>Qty.<br>Sl. No. Import items		Qty.
APREPITANT<br>1 kg<br>1<br>(1R)-1[3,5<br>BIS<br>(TRIFLUOROMETHYL)		<br>2.10 kg
PHENYL(2r,3s)-3-(4-fluoro phenyl) morpholinyl
ether,p-toluene sulphonic acid salt
<br>RA concerned may take further necessary action as per above decision of NC

Case No.	146 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	RAVOO'S LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000343AM23
RA File Number	09AX04000225 AM22
Licence No and<br>Date	0911002468/20/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	147 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AVID ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000351AM23
RA File Number	34AX04000065 AM23

UDIN00265785AM23

Licence No and 3411002146/20/04/2022 Date Norms Committee Decision:

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

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

Case No.	Case No.	148 / NC/3/MEET/Nov/202223/12	148 / NC/3/MEET/Nov/202223/12	148 / NC/3/MEET/Nov/202223/12	148 / NC/3/MEET/Nov/202223/12	148 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		INDIA GLYCOLS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000352AM23
RA File Number		05AX04000147 AM23
Licence No and<br>Date		0511011991/20/04/2022
Norms Committee Decision:<br>T<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep202223/8 dated 23.09.2022<br> against advance authorization No.0511005996 dated 08.11.2021, it was decided to ratify adhoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Denatured Ethyl Alcohol<br>1.123 kg<br>2<br>Silver Catalyst (Activity 17% to 18%)<br>0.000228 kg<br>Mono Ethylene Glycol (MEG)<br>1 kg<br>3<br>Alumina Catalyst<br>0.000362 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Mono Ethylene Glycol (MEG)		1 kg	1	Denatured Ethyl Alcohol	1.123 kg
				2	Silver Catalyst (Activity 17% to 18%)	0.000228 kg
				3	Alumina Catalyst	0.000362 kg
				as per above decision of NC.

Case No. 149 / NC/3/MEET/Nov/202223/12

UDIN00265785AM23

Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000333AM23
RA File Number	07AX04000044 AM23
Licence No and<br>Date	0711003752/20/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	150 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000337AM23
RA File Number	03AX04000169 AM23
Licence No and<br>Date	0311014011/20/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	151 / NC/3/MEET/Nov/202223/12	151 / NC/3/MEET/Nov/202223/12	151 / NC/3/MEET/Nov/202223/12	151 / NC/3/MEET/Nov/202223/12	151 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		HONOUR LAB LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000361AM23
RA File Number		09AX04000399 AM22
Licence No and<br>Date		0911002884/21/04/2022
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>Amino Acetyldehyde Di Methyl Acetal<br>0.575 kg<br>1-(2,2-DIMETHOXYETHYL)-5-<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	1-(2,2-DIMETHOXYETHYL)-5-		1 kg	1	Amino Acetyldehyde Di Methyl Acetal	0.575 kg

UDIN00265785AM23

METHOXY-6-	2	Methyl-4-Methoxy Acetoacetate	0.725 kg
(METHOXYCARBONYL)-4-OXO
	3	Di Methyl Oxalate	1.17 kg
	4	Lithium Hydroxide	0.300 kg

Case No.	Case No.	152 / NC/3/MEET/Nov/202223/12	152 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		BIOXERA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ	File Number	HQRNORM APPLY 00000365AM23
RA	File Number	03AX04000297 AM23
Licence No and<br>Date		0311014046/21/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and				taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.
0311009297 dated 08.12.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.						I as per details
given below or as applied by the firm, whichever is less:
	Export product		Qty.	Sl. No.	Import items	Qty.
	BENFOTIAMINE		1 kg	1	VITAMIN B1	0.922 kg
<br>RA	<br>concerned may take further necessary action as per above decision of NC.

Case No.	153 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ZYTEX BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000381AM23
RA File Number	03AX04000342 AM23
Licence No and	0311014101/22/04/2022

UDIN00265785AM23

Date

The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology (DBT) for obtaining its comments.

Date	Date
Norms Committee		Decision:

The Committee co<br>Bihl D		nsidered the case as per agenda and it was decided to refer the case toDepartment of<br>Tf bii i
otecnoogy (		)or otanng ts comments.


Case No.				154 / NC/3/MEET/Nov/202223/12
Case Status				Case Approved
Party Name				GLENMARK LIFE SCIENCES LIMITED
Meeting Number and Date				NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number				HQRNORM APPLY 00000369AM23
RA File Number				03AX04000145 AM23
Licence No and Date				0311014065/22/04/2022

Norms Committee Decision:

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


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

	AMIODARON	E HCL	1 kg		1	2-Butyl-3-(3,5-Diiodo-4-Hydroxy Benzoyl)	0.9135 kg
<br> <br> <br>2<br>Toluene<br>2.70 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
					2	Toluene	2.70 kg

Case No.	155 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000370AM23
RA File Number	03AX04000191 AM23
Licence No and<br>Date	0311014067/22/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>0311004037 dated 25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:

UDIN00265785AM23

Export product	Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
		2	Piperazine Anhydrous	0.390 kg

Case No.	156 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000374AM23
RA File Number	03AX04000319 AM23
Licence No and<br>Date	0311014080/22/04/2022
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> Difference between YAPOX CL 30/10 (for which norms have already been fixed) and current Export<br>Product YAPOX LM 30/10, since chemical name remains same.<br>i.

Case No.	157 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000389AM23
RA File Number	08AX04000767 AM22
Licence No and<br>Date	0811004766/23/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

UDIN00265785AM23

Case No.	Case No.	158 / NC/3/MEET/Nov/202223/12	158 / NC/3/MEET/Nov/202223/12	158 / NC/3/MEET/Nov/202223/12	158 / NC/3/MEET/Nov/202223/12	158 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000391AM23
RA File Number		03AX04000196 AM23
Licence No and<br>Date		0311014132/25/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>0311004037 dated 25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
				2	Piperazine Anhydrous	0.390 kg
				s per above decision of NC.

Case No.<br>	159 / NC/3/MEET/Nov/202223/12
Case Status<br>	Case Approved
Party Name<br>	BIOXERA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>	HQRNORM APPLY 00000400AM23
RA File Number<br>	03AX04000344 AM23
Licence No and<br>Date<br>	0311014146/25/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>0311009297 dated 08.12.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:

UDIN00265785AM23

Export product	Qty.	Sl. No. Import items	Qty.
BENFOTIAMINE	1 kg	1<br>VITAMIN B1	0.922 kg

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

Case No.	160 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000403AM23
RA File Number	31AX04000003 AM23
Licence No and<br>Date	3111001301/25/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>161 / NC/3/MEET/Nov/202223/12	Case No.<br>161 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>BIOLOGICAL E. LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000425AM23
RA File Number<br>09AX04000026 AM23
Licence No and<br>Date<br>0911002902/26/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and		taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance				authorization No.
0210207903 dated 24.10.2017, it was decided to ratify		adhoc norms under Para 4.07 of HBP Vol.			I as per details
given below or as applied by the firm, whichever is less:
	Export Product<br>Qty.<br>Sl. No.		Import items		Qty.
	NOSCAPINE USP/BP/Ph.Eur/JP<br>1 kg<br>1		NOSCAPINE CRUDE 95 PERCENT		1.15 kg

UDIN00265785AM23

Case No.	162 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000432AM23
RA File Number	09AX04000029 AM23
Licence No and<br>Date	0911002905/26/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>163 / NC/3/MEET/Nov/202223/12	Case No.<br>163 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000436AM23
RA File Number<br>03AX04000252 AM23
Licence No and<br>Date<br>0311014187/26/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and		taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.
0310796757 dated 23.06.2015, 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.
AZITHROMYCIN DIHYDRATE<br>1 kg	1		AZITHROMYCIN AMINE	1.04 kg
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	164 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

UDIN00265785AM23

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

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

Case No.		165 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number
and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000410AM23
RA File Number		07AX04000034 AM23
Licence No and
Date		0711003861/26/04/2022
Norms Committee		Decision:
T<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/9 dated 07.10.2022against advance authorization No.<br>0711003323 dated 02.03.2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>TRANEXAMIC<br>ACID<br>INJECTION<br>SOLUTION<br>1000MG/10ML<br> <br> <br> <br>1 Number<br>1<br>TRANEXAMIC ACID<br>1100 mg / 10 ml Vial
	Export Product		Qty.	Sl. No.	Import items	Qty.
	TRANEXAMIC<br>ACID<br>INJECTION<br>SOLUTION<br>1000MG/10ML<br> <br> <br>		<br> <br> <br>1 Number	1	TRANEXAMIC ACID	1100 mg / 10 ml Vial
	TRANEXAMIC<br>ACID<br>INJECTION<br>SOLUTION 1000MG/10ML BP/EP/USP/IP		<br>
	<br>323.80 KG)


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


Case No.		166 / NC/3/MEET/Nov/202223/12
Case Status		Case Deferred
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000411AM23

Case No.	166 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000411AM23

UDIN00265785AM23

RA File Number	07AX04000019 AM23
Licence No and<br>Date	0711003862/26/04/2022
Norms Committee Decision:
Deferred for comments of TE.

R	A File N	umber	07AX04000019 AM23
L<br>D	icence N<br>ate	o and	0711003862/26/04/2022
N<br>D	orms Co<br>eferred f	mmittee Decision:<br>or comments of TE.

C	ase No.		167 / NC/3/MEET/Nov/202223/	12
C	ase Statu	s	Case Approved
P	arty Nam	e	MAIVA PHARMA PRIVATE L	IMITED
M<br>a	eeting N<br>nd Date	umber	NC/ 3/ MEET/ Nov/ 202223/ 12	and 18/11/20		22
H	Q File N	umber	HQRNORM APPLY 00000412A	M23
R	A File N	umber	07AX04000610 AM22
L<br>D	icence N<br>ate	o and	0711003606/26/04/2022
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:


	l						l	i
	S. No.	Export pr	oduct		Qty.		S. No.	Import tems	Qty.
	1	Bumetani<br>	de Inj USP 1mg / 4mL(Bumetanide<br>		<br> <br>91800		1	13FO LQ 3768 GREEN<br> <br> <br>	<br> <br>Relevant<br>as<br>per<br>
		Injection<br>d fill	0.25mg/mL, 4mL vial - 1mg of bulk<br>d i 4L il d d ith 13		<br> <br>Numbers			MATTE<br>TOP<br>(13mm<br>G Cl Mtt Fiih	<br> <br>Packing Policy
		rug e<br>Rubber S	n m va an cappe w mm<br>topper & 13mm Green colour Matte		<br> <br>			reen oor ae ns<br>Flip Off Seals)
		<br>finish Sea	<br>ls)
	2	Bumetanide Inj USP 1mg /10mL (Bumetanide<br>Injection 0.25mg/mL, 10mL vial - 2.5mg of<br>bulk drug filled in 10mL vial and capped with<br>13mm Rubber Stopper & 13mm Green colour<br>Matte finish Seals)			<br> <br> <br> <br>91800<br>Numbers		2	13FO LQ 3768 GREEN<br>MATTE<br>TOP<br>(13mm<br>Green Color Matte Finish<br>Flip Off Seals)	<br> <br> <br>Relevant<br>as<br>per<br>Packing Policy
					<br>				<br>
	3	Phenytoin Sodium Inj USP100mg /2mL<br>("Phntin Sdim Injtin USP 50m/mL			<br>91800		3	13FO LQ 3768 GREEN<br>MATTE<br>TOP<br>(13mm	<br> <br>Relevant<br>as<br>per<br>Pkin Pli
		ey<br>100mg o	ou eco g -<br>f Phenytoin Sodium as bulk drug		<br>Numbers			<br> <br> <br>Green Color Matte Finish	<br> <br>acg ocy
		<br>filled in	<br>2mL Vial and capped with 13mm		<br>			Flip Off Seals)
		Rubber S<br>	topper & 13mm Green colour Matte<br>"
		finish Se	ls)

	4	Phenytoi	n Sodium Inj USP250mg /5mL		<br>91800		4	13FO LQ 3768 GREEN	<br>Relevant<br>as<br>per
		(Phenytoi<br>	n Sodium Injection USP 50mg/mL -<br>		<br> <br>Numbers			MATTE<br>TOP<br>(13mm<br>	<br> <br>Packing Policy
		250mg o<br>capped w	f bulk drug filled in 5mL Vial and<br>ith 13mm Rubber Stopper & 13mm		<br> <br>			Green Color Matte Finish<br>Flip Off Seals)

UDIN00265785AM23

Green colour Matte finish Seals)

Case No.	Case No.	Case No.	168 / NC/3/MEET/Nov/202223/12	168 / NC/3/MEET/Nov/202223/12	168 / NC/3/MEET/Nov/202223/12	168 / NC/3/MEET/Nov/202223/12	168 / NC/3/MEET/Nov/202223/12
Case Status			Case Approved
Party Name			VENOR PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00000455AM23
RA File Number			05AX04000735 AM22
Licence No and<br>Date			0511012122/27/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>0511004978 dated 27.09.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Tablet Morphine Sulphate 10 mg<br>(NR/PR/CR)(Finished formulation of Morphine<br>Sulphate)<br>1 Number<br>1<br>Morphine Sulphate<br>10.2 mg<br>2<br>Tab. Morphine Sulphate 20 mg<br>(NR/PR/CR)(Finished formulation of Morphine<br>Sulphate)<br>1 Number<br>2<br>Morphine Sulphate<br>20.4 mg<br>3<br>Tab. Morphine Sulphate 30 mg<br>(NR/PR/CR)(Finished Formulation of Morphine<br>Sulphate)<br>1 Number<br>3<br>Morphine Sulphate<br>30.6 mg<br>4<br>Tab. Morphine Sulphate 15 mg<br>(NR/CR/PR)(Finished formulation of Morphine<br>Sulphate)<br>1 Number<br>4<br>Morphine Sulphate<br>15.3 mg<br>Inj.<br>Morphine<br>Sulphate<br>10<br>mg/ml,<br>1ml<br>5<br>1 Number<br>5<br>Morphine Sulphate<br>11.00 mg
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	Tablet Morphine Sulphate 10 mg<br>(NR/PR/CR)(Finished formulation of Morphine<br>Sulphate)		<br>1 Number	1	Morphine Sulphate	10.2 mg
	2	Tab. Morphine Sulphate 20 mg<br>(NR/PR/CR)(Finished formulation of Morphine<br>Sulphate)		1 Number	2	Morphine Sulphate	20.4 mg
	3	Tab. Morphine Sulphate 30 mg<br>(NR/PR/CR)(Finished Formulation of Morphine<br>Sulphate)		1 Number	3	Morphine Sulphate	30.6 mg
	4	Tab. Morphine Sulphate 15 mg<br>(NR/CR/PR)(Finished formulation of Morphine<br>Sulphate)		1 Number	4	Morphine Sulphate	15.3 mg
	5	Inj.<br>Morphine<br>Sulphate<br>10<br>mg/ml,<br>1ml		1 Number	5	Morphine Sulphate	11.00 mg

UDIN00265785AM23

	Ampoule(Finished	Formulation	of	Morphine
	Sulphate)
6	Inj.<br>Morphine	Sulphate<br>15mg/ml,		<br>1<br>ml	1 Number	6	Morphine Sulphate	16.5 mg
	Ampoule(Finished	Formulation	of	Morphine
	Sulphate)
7	Tab.<br>Morphine<br>Sulphate		60<br>mg		1 Number	7	Morphine Sulphate	61.20 mg
	(NR/CR/PR)(Finished Formulation		of	Morphine
	Sulphate)

Case No.	169 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000445AM23
RA File Number	03AX04000383 AM23
Licence No and<br>Date	0311014211/27/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	170 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000450AM23
RA File Number	05AX04000232 AM23
Licence No and<br>Date	0511012110/27/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	171 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

UDIN00265785AM23

and Date
HQ File Number<br>HQRNORM APPLY 00000451AM23
RA File Number<br>05AX04000231 AM23
Licence No and<br>Date<br>0511012109/27/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.3/82-ALC4/2015 dated 20.05.2015against advance authorization No.			0510390257 dated
11.08.2014, 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.		Import items	Qty.
Xonef Eye Drops / Betaxolol 0.5% Eye Drops 5ml<br>1 Vial		Betaxolol Hydrochloride	28.52 mg / 5 ml
Vials			Vial
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.<br>172 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>VENOR PHARMA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and	18/11/2022
HQ File Number<br>HQRNORM APPLY 00000454AM23
RA File Number<br>05AX04000738 AM22
Licence No and<br>Date<br>0511012121/27/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue		from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Sep/202223/8 dated		23.09.2022against advance authorization No.
0511004978 dated 27.09.2021, 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.
Tablet Morphine Sulphate 10 mg<br>1	1 Number		1	Morphine Sulphate	10.2 mg
(NR/PR/CR)(Finished<br>formulation<br>of

UDIN00265785AM23

	Morphine Sulphate)
2	Tab. Morphine Sulphate 20 mg<br>(NR/PR/CR)(Finished<br>formulation<br>of<br>Morphine Sulphate)	1 Number	1	Morphine Sulphate	20.4 mg
3	Tab. Morphine Sulphate 30 mg<br>(NR/PR/CR)(Finished<br>Formulation<br>of<br>Morphine Sulphate)	1 Number	1	Morphine Sulphate	30.6 mg
4	Tab. Morphine Sulphate 15 mg<br>(NR/CR/PR)(Finished<br>formulation<br>of<br>Morphine Sulphate)	1 Number	1	Morphine Sulphate	15.3 mg
5	Inj. Morphine Sulphate 10 mg/ml, 1ml<br>Ampoule<br>(Finished<br>Formulation<br>of<br>Morphine Sulphate)	1 Number	1	Morphine Sulphate	11.00 mg
6	Inj. Morphine Sulphate 15mg/ml, 1 ml<br>Ampoule<br>(Finished<br>Formulation<br>of<br>Morphine Sulphate)	1 Number	1	Morphine Sulphate	16.5 mg

Case No.	173 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	UNITED BIOCEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000479AM23
RA File Number	05AX04000238 AM23
Licence No and<br>Date	0511012150/28/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	174 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED

UDIN00265785AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000483AM23
RA File Number	03AX04000200 AM23
Licence No and<br>Date	0311014256/28/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda andit was decided to call the firm for attendingPersonal Hearing
before Norms Committee to explain its case.

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000483AM23
RA File Number		03AX04000200 AM23
L<br>D	icence No and<br>ate	0311014256/28/04/20				22
N<br>T<br>b	orms Committee Decision:
	<br>he Committee considered the case as per<br>efore Norms Committee to explain its c					agenda an<br>ase.	dit was	decided to call the firm for attending	Persona	l Hearing



C	ase No.	175 / NC/3/MEET/No				v/202223	/12
Case Status		Case Deferred
Party Name		SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000502AM23
RA File Number		09AX04000389 AM22
Licence No and		0911002926/29/04/2022
Date

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

Case No.		176 / NC/3/MEET/Nov/202223/12
Case Status		Case Deferred
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
H	Q File Number	HQRNO		RM APPLY 00000506AM23
R	A File Number	09AX04		000079 AM23
L<br>D	icence No and
	<br>ate	09	11002	928/29/0	4/2022
N<br>D	orms Committee De<br>eferred for comment		cision:
			s of TE	.


C	ase No.	17	7 / NC	/3/MEET	/Nov/202223/12
C	ase Status	C	ase Def	erred

P	arty Name	IN	TAS P	HARMA	CEUTICALS LIMITED
M<br>a	eeting Number<br>nd Date	N	C/ 3/ M	EET/ N	v/ 202223/ 12 and 18/11/2022

H	Q File Number	H	QRNO	RM APP	LY 00000512AM23
R	A File Number	08	AX04	00074	M23

L<br>D	icence No and<br>ate	08	11004	832/29/0	4/2022

95 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

Case No.	178 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000485AM23
RA File Number	03AX04000399 AM23
Licence No and<br>Date	0311014263/29/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	179 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000513AM23
RA File Number	08AX04000823 AM22
Licence No and<br>Date	0811004833/29/04/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	180 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	CHIROS PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000495AM23
RA File Number	30AX04000016 AM23
Licence No and<br>Date	3011002069/29/04/2022
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:

96 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

Export product	Export product		Qty.	Sl. No.	Import items	Qty.
Ampicillin	<br>Tablets<br>USP	<br>1000	<br>1 Number	1	Ampicillin Trihydrate	1154 mg / 1000 mg
mg((Each	film coated tablet	contains				Tablet
Ampicillin	Trihydrate eq. to ampicillin
1000 mg))

Case No.	181 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000499AM23
RA File Number	08AX04000097 AM23
Licence No and<br>Date	0811004820/29/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	182 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000500AM23
RA File Number	09AX04000372 AM22
Licence No and<br>Date	0911002924/29/04/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	183 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000501AM23
RA File Number	09AX04000388 AM22
Licence No and	0911002925/29/04/2022

UDIN00265785AM23

Date

D	ate
N<br>D	orms Committee Decision:<br>eferred for comments of TE.



C	ase No.	184 / NC/3/MEET/Nov/				202223/1		2
C	ase Status	Case Approved
P	arty Name	HETERO LABS LIMIT				ED
M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Nov/ 20				2223/ 12		and 18/1		1/2022
H	Q File Number	HQRNORM APPLY 00				000532A
								M23
R	A File Number	09AX04000395 AM22
L<br>D	icence No and<br>ate	0911002933/02/05/2022

Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022against advance authorization No.<br>0911001814 dated 03.11.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:	orms Committee Decision:<br>he Committee considered the case as					r aend		and ta		in cue from earlier decision for same ex			ort roduct /



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


	(2S,3S,5S)-2-am<br>btl<br>rbn	ino-3-hydroxy-5-tert<br>l<br>min16dihnl					1 kg		1		(S,E)-5-AMINO-2-<br>(DIBENZYLAMINO)16	1.77 kg
	uy<br>cao<br>hexane((2S3S5	<br>ao-,-pey-<br>S)-2-amino-3-hydroxy-									-,-<br>DIPHENYLHEX-4-EN-3-ONE
	,,<br>5-tert<br>butyl	carbonyl<br>amino-1,6-
	<br>diphenyl-hexane	<br>)							2		SODIUM BORO HYDRIDE	0.45 kg
<br>R
									3		TETRA HYDRO FURAN	0.48 kg
									4		2,2,2 TRI FLUORO ACETIC ACID	2.16 kg

									5		DI TERT.BUTYL DI CARBONATE	0.92 kg

	<br>A concerned may ta		ke furt	her nece	ssary action as per above decision of NC


C	ase No.	18	5 / NC
				/3/MEET	/Nov/202223/12
C	ase Status	C	ase Def	erred
P	arty Name	V	EKO C	ARE PR	IVATE LIMITED
MeetingNumber		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

Case No.	185 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	VEKO CARE PRIVATE LIMITED
MeetingNumber	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

UDIN00265785AM23

and Date
HQ File Number	HQRNORM APPLY 00000535AM23
RA File Number	31AX04000023 AM23
Licence No and<br>Date	3111001324/02/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:
Composition given in the Export Product No. 1, 2, 5 and 6 are not matching with the given DML. Please<br>i.
furnish relevant DML for all the export products.

i. Composition given in the Export Product No. 1, 2, 5 and 6 are not matching with the given DML. Please furnish relevant DML for all the export products.

Case No.<br>186 / NC/3/MEET/Nov/202223/12	Case No.<br>186 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>HETERO LABS LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000537AM23
RA File Number<br>09AX04000087 AM23
Licence No and Date<br>0911002931/02/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify		adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.<br>Sl. No. Import items			Qty.
	1<br>(4R,12AS)-7-METHXOY-4-METHYL-6,8-<br>DOLUTEGRAVIR SODIUM<br>1 kg			0.90 kg
	DIOXO-3,4,6,8,12,12A-HEXAHYDRO-2H-
	PYRIDO<br>1',2',4,5]	YRAZINO	[2,1-
	B][1,3]OXAZINE-9-CARBOXILIC ACID
	2<br>2,4-DIFLUOROBENZYLAMINE			0.426 kg
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	187 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved

UDIN00265785AM23

Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000538AM23
RA File Number	09AX04000065 AM23
Licence No and<br>Date	0911002947/02/05/2022
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>Cefalexin Tablets 500mg<br>(Cefalexin Tablets 500mg (Each<br>tablet<br>contains<br>Cefalexin<br>Monohydrate equivalent to<br>Cefalexin 500mg) ))<br>1 Number<br>1<br>Cefalexin Monohydrate Ph Eur<br>(Powder)<br>536.4 mg / 500<br>mg Tablet<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	188 / NC/3/MEET/Nov/202223/12	188 / NC/3/MEET/Nov/202223/12	188 / NC/3/MEET/Nov/202223/12	188 / NC/3/MEET/Nov/202223/12	188 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000519AM23
RA File Number		09AX04000060 AM23
Licence No and<br>Date		0911002929/02/05/2022
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>Di Tert Butyl Dicarbonate<br>3.16 kg<br>(1R,2R)-2-Amino-6-(4-<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	(1R,2R)-2-Amino-6-(4-		1 kg	1	Di Tert Butyl Dicarbonate	3.16 kg

100

UDIN00265785AM23

2	CDX-034 Lyophilized Enzyme Powder	0.012 kg
3	Beta Nicotinamide Adenine dinucleotide<br>phosphate Sodium salt (beta-NADP-Na)	<br>0.008 kg
4	N-Heptane	3.00 kg
5	Tetra Hydro Furan	5.00 kg
6	Iso Propyl Alcohol	10.00 kg
7	Methyl Tertiary-Butyl Ether	3.50 kg

Case No.	189 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000520AM23
RA File Number	03AX04000222 AM23
Licence No and<br>Date	0311014302/02/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.13/82-ALC4/2019 dated 31.01.2020against advance authorization No.0310833490<br>dated 18.12.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>DIPENTENE (MIXTURE OF MONOCYCLIC<br>TERPENES)<br>1 kg<br>1<br>GUM TURPENTINE OIL<br>1.03 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

101

UDIN00265785AM23


Case No.		190 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

H Fil Nb		HRNORM APPLY 00000522AM23
Q e umer		Q
RA Fil Nb		09AX04000392 AM22
e umer
Li N d
cence o an<br>Date		0911002892/02/05/2022

Norms Committee		Decision:
The Committee co		nsidered the case as per agenda and taking cue from earlier decision for same export product /
import item in M<br>		eeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance authorization No.<br>
0911002160 dt. 31<br>or as applied by the		.12.2021, it was decided to ratify<br>firm, whichever is less:			norms under Para 4.07 of HBP Vol. I as per details given below

	Export product			Qty.	Sl. No.	Import items	Qty.
	(2S,3S,5S)-2-amino-3-hydroxy-5-tert<br>butyl<br>carbonyl<br>amino-1,6-diphenyl-			1 kg	1	(S,E)-5-AMINO-2-<br>(DIBENZYLAMINO)-1,6-	1.77 kg
	<br> <br><br>hexane((2S,3S,5S)-2-amino-3-hydroxy<br>tert butyl carbonyl amino-1,6-diphen<br>		-5-<br>yl-			DIPHENYLHEX-4-EN-3-ONE

	hexane)				2	SODIUM BORO HYDRIDE	0.45 kg
					3	TETRA HYDRO FURAN	0.48 kg

					4	2,2,2 TRI FLUORO ACETIC ACID	2.16 kg

					5	DI TERT.BUTYL DI CARBONATE	0.92 kg


RA d		k fh i			b dii f NC
concerne may		tae urter necessary acton as per aove ecson o .

Case No.		191 / NC/3/MEET/Nov/202223/12
Case Status		Case Deferred

Party Name		GRANULES INDIA LIMITED

Meeting Number
<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000531AM23

RA File Number		26AX04000006 AM23

Licence No and		2611000569/02/05/2022

Case No.	191 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	GRANULES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000531AM23
RA File Number	26AX04000006 AM23
Licence No and	2611000569/02/05/2022

102

UDIN00265785AM23

Date

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

Master Batch Formula duly certified by Quality Control in Charge.

Case No.	192 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000548AM23
RA File Number	03AX04000420 AM23
Licence No and<br>Date	0311014381/04/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda andit was decided to call the firm for attendingPersonal Hearing
before Norms Committee to explain its case.

Case No.<br>193 / NC/3/MEET/Nov/202223/12	Case No.<br>193 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12	and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000552AM23
RA File Number<br>07AX04000126 AM23
Licence No and<br>Date<br>0711003904/04/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same				export product /
import item in Meeting No.6/82-ALC4/2019 dated 16.08.2019 against advance authorization				No.0710115110
dated 27.06.2019, it was decided to ratify adhoc	norms under Para		4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Sl. No. Export product	Qty.	Sl. No.	Import items		Qty.
1<br>MAGNESIUM PIDOLATE (Eur.Ph)	1 MT	1	L-PYROGLUTAMIC ACID		0.90 MT
(MAGNESIUM PIDOLATE (Eur.Ph))

103

UDIN00265785AM23

2	CALCIUM	PIDOLATE	(CALCIUM	1	MT	2	L-PYROGLUTAMIC ACID	0.82	MT
	PIDOLATE)

Case No.	194 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000559AM23
RA File Number	09AX04000086 AM23
Licence No and Date	0911002930/04/05/2022
Norms Committee Decision:<br>T<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>(4R,12AS)-7-METHXOY-4-METHYL-6,8-<br>DIOXO-3,4,6,8,12,12A-HEXAHYDRO-2H-<br>PYRIDO [1',2',4,5]PYRAZINO [2,1-B][1,3]<br>OXAZINE-9-CARBOXILIC ACID<br>0.90 kg<br>DOLUTEGRAVIR SODIUM<br>1 kg<br>2<br>2,4-DIFLUOROBENZYLAMINE<br>0.426 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	195 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000575AM23
RA File Number	09AX04000107 AM23
Licence No and	0911002951/04/05/2022

104

UDIN00265785AM23

Date

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

Export product	Qty.	Sl. No.	Import items	Qty.
Daptomycin for Injection 500mg/vial	1 Number	1	Daptomycin	550 mg / Vial

Case No.	196 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000579AM23
RA File Number	09AX04000072 AM23
Licence No and<br>Date	0911002953/05/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jul/202122/4 dated 15/07/2021 against advance authorization No.<br>0911000214 dated 20/01/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Amoxicillin Trihydrate<br>2876.055 kg<br>Clavamox Drops 62.50 mg/mL -<br>15mL((Each mL contains Amoxicillin<br>Trihydrate equivalent to Amoxicillin 50<br>mg and Clavulanate potassium syloid<br>1:1 equivalent to Clavulanic acid<br>12.5mg))<br>3276000<br>Numbers<br>2<br>Potassium<br>Clavulanate<br>diluted<br>with Silicon Dioxide (Syloid)(1:1)<br>1492.739 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

105

UDIN00265785AM23

Case No.	197 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	WANKSONS CHEMICALS INDUSTRIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000590AM23
RA File Number	03AX04000353 AM23
Licence No and<br>Date	0311014492/05/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Dec/202122/12 dated 17/12/2021 against advance authorization No.<br>0311005179 dated 07/07/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>CHLORAL<br>1 kg<br>1<br>ETHYL ALCOHOL<br>0.878 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	198 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SHREYANS CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000593AM23
RA File Number	03AX04000546 AM23
Licence No and<br>Date	0311014500/05/05/2022
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>End use of Export Product.<br>i.<br>Justification for low yield of 61.6%.<br>ii.<br>iii Production / Consumption data for last two years duly certified by GST.

106

UDIN00265785AM23

Case No.<br>199 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000599AM23
RA File Number<br>09AX04000351 AM22
Licence No and<br>Date<br>0911002964/05/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue			from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Jul/202122/4 dated		15/07/2021 against advance		authorization No.
0911000447 dated 26/02/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.		Import items	Qty.
Daptomycin for Injection 500mg/vial<br>1 Number	1		Daptomycin	550 mg / Vial
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.<br>200 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Deferred
Party Name<br>TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000601AM23
RA File Number<br>07AX04000602 AM22
Licence No and<br>Date<br>0711003913/05/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.

107

UDIN00265785AM23

v. Details of indigenous input with quantity.

Case No.	201 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000633AM23
RA File Number	07AX04000046 AM23
Licence No and<br>Date	0711003906/06/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents from the
firm:
COA report of both import and export item, clearly indicating purity and moisture content.<br>i.
Manufacturing process indicating stage wise wastage of raw materials.<br>ii.
iii Production / Consumption data duly certified by CA.

Case No.	202 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000634AM23
RA File Number	07AX04000114 AM23
Licence No and<br>Date	0711003926/06/05/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	203 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000635AM23
RA File Number	07AX04000115 AM23
Licence No and<br>Date	0711003928/06/05/2022
Norms Committee Decision:

108 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

D	eferred f	or comments of TE.	or comments of TE.

C	ase No.		204 / NC/3/MEET/Nov/	202223/12

C	ase Statu	s	Case Approved
P	arty Nam	e	RUBICON RESEARCH	PRIVATE LI		MITED
M<br>a	eeting N<br>nd Date	umber
			NC/ 3/ MEET/ Nov/ 202	223/ 12 and 18		/11/202	2
H	Q File N	umber	HQRNORM APPLY 00	000612AM23
R	A File N	umber	03AX04000440 AM23
L<br>D	icence N<br>ate	o and	0311014526/06/05/2022
N<br>T<br>i<br>0<br>g<br> <br>R	orms Co<br>he Com<br>mport ite<br>3110094<br>iven belo	mmittee Decision:<br>mittee considered the case as pe<br>m in Meeting No.NC/3/MEE<br>14 dated 13/12/2021, it was dec<br>w or as applied by the firm, whic		r agenda and<br>T/Oct/202223<br>ided to ratify<br>hever is less:
						taking c<br>/11 dat	ue from earlier decision for same<br>ed 31/10/2022 against advance a			export product /<br>uthorization No.
						adhoc n	orms under Para 4.07 of HBP Vo			l. I as per details

	Sl. No.	Export product			Q	ty.		Sl. No.	Import items	Qty.
	1	Maxigesic<br>cold<br>&<br>flu<br>H<br>500mg/150mg Sachets (Parac<br>Ibuprofen<br>Sachets<br>500<br>mg<br>mg)(Maxigesic cold & flu<br>500mg/150mg Sachets (Parac<br>Ibuprofen Sachets 500 mg & 15		ot<br>Drink<br>etamol &<br> <br>&<br>150<br>Hot Drink<br>etamol &<br>0 mg) No	1	Number		1	Ibuprofen Lysine Salt<br>IH	<br>258.88 mg /<br>Sachet

		<br>of Sachets 170,000 (Net content<br>Ibuprofen Lysine Salt IH API 43		.<br>of<br>.61 kg))

	2	Maxigesic<br>cold<br>&<br>flu<br>H<br>1000mg/300mg Sachets (Parac<br>Ibuprofen Sachets 1000 mg<br>mg)(Maxigesic cold & flu<br>1000mg/300mg Sachets (Parac<br>Ibuprofen Sachets 1000 mg & 30<br>of Sachets 280,000 (Net content<br>Ibuprofen Lysine Salt IH API 14		ot<br>Drink<br>etamol &<br>& 300<br>Hot Drink<br>etamol &<br>0 mg) No.<br>of<br>3.64 kg))	1	Number		2	Ibuprofen Lysine Salt<br>IH	<br>517.77 mg /<br>Sachet



	<br>A conce	<br>rned may take further necessary a		ction as per ab		d	i f NC
						ove ec	son o .

C	ase No.		205 / NC/3/MEET/Nov/	202223/12

Case No. 205 / NC/3/MEET/Nov/202223/12

109

UDIN00265785AM23

Case Status	Case Deferred
Party Name	APTRA SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000622AM23
RA File Number	26AX04000005 AM23
Licence No and<br>Date	2611000572/06/05/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>206 / NC/3/MEET/Nov/202223/12	Case No.<br>206 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>HETERO LABS LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000628AM23
RA File Number<br>09AX04000048 AM23
Licence No and Date<br>0911002943/06/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.<br>Sl. No. Import items	Qty.
	1<br>(4R,12AS)-7-METHXOY-4-METHYL-6,8-<br>DOLUTEGRAVIR SODIUM<br>1 kg	0.90 kg
	DIOXO-3,4,6,8,12,12A-HEXAHYDRO-2H-
	PYRIDO [1',2',4,5]PYRAZINO [2,1-B][1,3]
	OXAZINE-9-CARBOXILIC ACID
	2<br>2,4-DIFLUOROBENZYLAMINE	0.426 kg
<br>RA concerned may take further necessary action as per above decision of NC

Case No.	207 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000676AM23

110

UDIN00265785AM23

RA File Number

05AA04033196 AM21

Licence No and Date

0511012352/09/05/2022

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.2/82-ALC4/2018 dated 16.05.2018against advance authorization No.0510398839 dated 17.06.2016, 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 Denatured Ethyl Alcohol 3.90 kg 2 Ammonia 0.90 kg Alpha Picoline 1 kg 3 Catalyst (CP7191) 0.0025 kg RA concerned may take further necessary action as per above decision of NC.

Case No.	208 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000716AM23
RA File Number	52AX04000029 AM23
Licence No and<br>Date	5211002458/11/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents<br>from the firm:<br>Reason for indicating Ethyl-3-oxobutanoate in place of Ethyl Aceto Acetate in chemical reaction and<br>also difference in two chemicals.<br>i.<br>Reason with justification for low yield of export item.<br>ii.<br>Commercial value of By-Product obtained during the process and its enclosed invoice.<br>iii.

Case No.	209 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved

111

UDIN00265785AM23

Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000717AM23
RA File Number	05AX04000343 AM23
Licence No and<br>Date	0511012466/11/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Dec/202122/12 dated 17/12/2021 against advance authorization No.<br>0511003790 dated 23/07/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Ceftriaxone Sodium Sterile<br>1 kg<br>1<br>Ceftriaxone Sodium Non Sterile<br>1.04 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	210 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000720AM23
RA File Number	08AX04000212 AM23
Licence No and<br>Date	0811004914/11/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	211 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000703AM23
RA File Number	09AX04000059 AM23
Licence No and<br>Date	0911002979/11/05/2022

112

UDIN00265785AM23

Norms Committee Decision:

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

i. DML.

ii Potency of import item supported by COA from foreign supplier.

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

ii Potency of		it it td b COA f fi li
	oency o	mpor em suppor	e y	ro	oregn supper.



C
	ase No	212 / NC/3/MEET/No	v/202223	/12
	.
C	ase Status	Case Deferred
	N	INNOVARE LABS P	IVATE	IMITE
	arty ame
	i b
<br>a	eetng Numer<br>nd Date	NC/ 3/ MEET/ Nov/ 2	02223/ 12	and 18/	11/2022

H	Q File Number	HQRNORM APPLY	00000708	AM23
RA Fil Nb		26AX04000007 AM23
e umer
Licence No and<br>Date		2611000574/11/05/2022
Norms Committee Decision:
fd f f
Deerre or comm		nts o TE.

Case No.		213 / NC/3/MEET/Nov/202223/12

Case Status		Case Deferred

Party Name		CLEAN SCIENCE AND TECHNOLOGY LIMITED


Meeting Number
<br>d Dt		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
an ae
H Fil Nb		HRNORM APPLY 00000711AM23
Q e umer		Q
RA File Number		31AX04000042 AM23


Licence No and<br>Dt		3111001345/11/05/2022
ae
N Citt		ii
orms ommee<br>The Committee con		ecson:<br>sidered the case as per agenda and it was decided to call for following information /documents from the
f	irm:
	Complete chemical reactions w<br>t i t ild<br>i.		ith mole<br>l b	cular an<br>i	d structural formula and molecular weig	hts along with
	sage wse percenage yes on		moar a	ss.

C	ase No.	214 / NC/3/MEET/No	v/202223	/12
C	ase Status	Case Deferred
P
	arty Name	ASTEC LIFESCIENC	ES LIMI	TED
M<br>a
	eeting Number<br>nd Date	NC/ 3/ MEET/ Nov/ 2	02223/ 12	and 18/	11/2022

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

Case No.	214 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

113 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

HQ File Number	HQRNORM APPLY 00000715AM23
RA File Number	03AX04000356 AM23
Licence No and<br>Date	0311014646/11/05/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	215 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000727AM23
RA File Number	03AX04000667 AM23
Licence No and<br>Date	0311014663/12/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.

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

Case No.<br>216 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>BIOXERA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000729AM23
RA File Number<br>03AX04000618 AM23
Licence No and<br>Date<br>0311014664/12/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.
0311009297 dated 08.12.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:

114 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

Export product	Qty.	Sl. No. Import items	Qty.
BENFOTIAMINE	1 kg	1<br>VITAMIN B1	0.922 kg

Case No.	217 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000730AM23
RA File Number	03AX04000676 AM23
Licence No and<br>Date	0311014666/12/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents from the
firm:
End use<br>i.	of Export Product.
Whether DMSO is used as a solvent or reactant.<br>ii.
If DMSO used as a reactant, then please furnish the details of its molecular weight.<br>iii.
If DMSO is used as a solvent, then furnish the details of its recovery.<br>iv.
Quantity and value of Methanol as a By-Product.<br>v.
Stoichiometric balance on molar basis.<br>vi.
Yield at every stage of reaction.<br>vii.

Case No.	218 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	PANACEA BIOTEC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000732AM23
RA File Number	05AX04000321 AM23
Licence No and<br>Date	0511012512/12/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance authorization No.
0510413419 dated 22.01.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details

115

UDIN00265785AM23

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

Export product	Qty.	Sl. No.	Import items	Qty.
Easy Five TT Vaccine<br>DTwP-Hep<br>B-Hib-<br>Pentavalent Vaccine (Each<br>vial of 0.5 ml contains 1<br>dose)	<br> <br> <br>1<br>Million<br>Vials	1<br>	Purified Diptheria Toxoid Concentrate<br>Antigen Bulk @2050 Lf/ml	13.33 Litre
		2	Purified Tetanus Toxoid Concentrate<br>Antigen @1900 Lf/ml	5.23 Litre
		3	Inactivated Whole Cell Pertussis Bulk<br>@192 OU/ml	<br>86.46 Litre
		4	Rubber Stopper	1010000 Numbers
		5	AGS HB Purification MABS Column	5.4 Litre
		6	Tetanus Toxoid for conjugation	6.15 Litre

Case No.	219 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000750AM23
RA File Number	34AX04000127 AM23
Licence No and<br>Date	3411002246/13/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	220 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

116

UDIN00265785AM23

HQ File Number	HQRNORM APPLY 00000753AM23
RA File Number	52AX04000039 AM23
Licence No and<br>Date	5211002485/13/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information /documents<br>from the firm:<br>Function / Application of Dimethyl Formamide and to give complete process of using the solvent.<br>i.<br>Reason with justification for applying very high quantity of Dimethyl Formamid<br>ii.<br>Recovery process of Dimethyl Formamide.<br>iii.

Case No.	Case No.	221 / NC/3/MEET/Nov/202223/12	221 / NC/3/MEET/Nov/202223/12	221 / NC/3/MEET/Nov/202223/12	221 / NC/3/MEET/Nov/202223/12	221 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000756AM23
RA File Number		09AX04000102 AM23
Licence No and<br>Date		0911002994/13/05/2022
Norms Committee Decision:<br>The Committee considered the case<br>Vol. I as per details given below or<br>Export product<br>Qty.<br>LINEZOLID<br>1 kg				as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>as applied by the firm, whichever is less:
	Export product		Qty.	Sl. No.	Import items	Qty.
	LINEZOLID		1 kg	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

Case No.	Case No.	221 / NC/3/MEET/Nov/202223/12	221 / NC/3/MEET/Nov/202223/12	221 / NC/3/MEET/Nov/202223/12	221 / NC/3/MEET/Nov/202223/12	221 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000756AM23
RA File Number		09AX04000102 AM23
Licence No and<br>Date		0911002994/13/05/2022
Norms Committee Decision:<br>The Committee considered the case<br>Vol. I as per details given below or<br>Export product<br>Qty.<br>LINEZOLID<br>1 kg				as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>as applied by the firm, whichever is less:
	Export product		Qty.	Sl. No.	Import items	Qty.
	LINEZOLID		1 kg	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

117

UDIN00265785AM23

	7	Methylene Di Chloride (MDC)	0.80	kg
	8	Methanol	1.50	kg

Case No.	222 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	UNITED BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000757AM23
RA File Number	05AX04000267 AM23
Licence No and<br>Date	0511012548/13/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case toDepartment of
Biotechnology (DBT)for obtaining its comments.

Case No.	223 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000741AM23
RA File Number	07AX04000110 AM23
Licence No and<br>Date	0711003978/13/05/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	224 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000801AM23
RA File Number	03AX04000672 AM23
Licence No and<br>Date	0311014751/17/05/2022

118

UDIN00265785AM23

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. Justification for low yield in Hydrogenaration reaction.
iii. Quantity and Commercial Value of Isometric impurities (As By-Product).

iv Stoichiometric balance on molar basis and percentage yield to arrive at the quantity of raw material asked for.

Case No.	225 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	KOSHA CHEMTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000806AM23
RA File Number	03AX04000276 AM23
Licence No and<br>Date	0311014758/17/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.

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

Case No.	226 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000807AM23
RA File Number	31AX04000028 AM23
Licence No and<br>Date	3111001358/17/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /

119 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

import item in Meeting No. NC/3/MEET/Sep/202223/8 dated 23.09.2022 against advance authorization No. 3110067490 dated 02.08.2019 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

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

Case No.	227 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000815AM23
RA File Number	31AX04000039 AM23
Licence No and<br>Date	3111001366/17/05/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following<br>information/documents from the firm:<br>Give separate quantity of Phenol and O-Cresol in OCP-50 and then drive the quantity of 2, 6 Xylenol<br>from both.<br>i.<br>Complete calculation of formulation of 2, 6 Xylenol from both with yield.<br>ii.

Case No.	228 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

120

UDIN00265785AM23

HQ File Number	HQRNORM APPLY 00000792AM23
RA File Number	03AX04000631 AM23
Licence No and<br>Date	0311014729/17/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.1/82-ALC4/2018 dated 01.05.2018against advance authorization No.0310812799<br>dated 26.04.2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>STEARIC ACID<br>1.06 kg<br>Neutralized Amide Ester<br>1 kg<br>2<br>Mono Ethanol Amine<br>0.114 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	229 / NC/3/MEET/Nov/202223/12	229 / NC/3/MEET/Nov/202223/12	229 / NC/3/MEET/Nov/202223/12	229 / NC/3/MEET/Nov/202223/12	229 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000794AM23
RA File Number		03AX04000640 AM23
Licence No and<br>Date		0311014736/17/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>0311004037 dated 25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.240 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)		<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg

121

UDIN00265785AM23

2 Piperazine Anhydrous 0.390 kg

Case No.	230 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ANUH PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000796AM23
RA File Number	03AX04000377 AM23
Licence No and<br>Date	0311014743/17/05/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	231 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000797AM23
RA File Number	03AX04000463 AM23
Licence No and<br>Date	0311014744/17/05/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	232 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000856AM23
RA File Number	50AX04000018 AM23
Licence No and<br>Date	5011000486/18/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents from the
firm:

122

UDIN00265785AM23

i. COA of import and export item indicating percentage purity.
ii. If any, By-Product obtained, please furnish details of quantity and value of such ByProduct.

End use of Export Product.


E	COA of import and ex<br>i.<br>If any, By-Product ob<br>Product.<br>ii.<br>nd use of Export Product.					port item<br>tained,
								indicat<br>please f	ing percentage purity.<br>urnish details of quantity and value of such							By-


Case No.				233 / NC/3/MEET/Nov/202223/12

Case Status				Case Approved

Party Name				J B CHEMICALS AND PHARMACEUTICALS LIMITED

Meeting Number
and Date				NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number				HQRNORM APPLY 00000874AM23
RA File Number				03AX04000715 AM23

Licence No and
Date				0311014851/19/05/2022
Norms Committee				Decision:

The Committee c				nsidered the case as er aenda and takin cue from earlier decision for same exort roduct /
<br>import item in M<br>0310814635 dated				p g g p p<br>eeting No.NC/3/MEET/May/202223/3 dated 27/05/2022against advance authorization No.<br>14.07.2017it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
,<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>1<br>Benzydamine Hydrochloride And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory<br>And<br>Antiseptic<br>Lozenges Sugar Free and(all other<br>flavours. Each lozenge contains (i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg<br>(iii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 33.333 Kgs<br>1000<br>Number
		Sl. No.	Export pr		oduct					Qty.	Sl. No	Import items		Qty	.

		1	Benzydam<br>Ctli		ine Hy<br>ii		drochlo<br>Chli	ride And<br> <br>Ati		1000	1.	Benzyd<br>Hd	amine<br>hlid	3.06	gr		am
			eypyr<br>Inflamma<br>Lozenges<br>flavours		num<br>tory<br>A<br>Sugar F<br>Each loz		or<br>nd<br>ree an<br>ene c	e<br>n-<br>Antiseptic<br>d(all other<br>ntains (i)		Number		yroc	ore
											2	Cetylpy	ridinium	1.35	6 g		ram
			. g<br>Benzydamine<br>Hydrochloride-3mg									Chlorid	e
			<br> <br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg<br>(iii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 33.333 Kgs
											3	Isomalt	ST-M	2586 gr			am
			(ii) 14.778 Kgs (iii) 28733.356
			Kgs.	)


		2	Benz	ydamine Hydrochloride, 2,4-						1000	4	Benzyd	amine	3.06 gr			am
			Dih	lbl<br>Alhl<br>Ad								Hydroc	hloride
			c<br>Lido	oroenzy<br>coo<br>n<br>caine<br>Hydrochloride						<br> <br>Number

			Ana<br>	esthetic,<br>Anti-<br>							5	Isomalt	ST-M	2586			am
			Infla	mmatory,(Anti-Bacterial										g

			Loze<br>cont	nges Sugar Free. Each lozenge<br>ains<br>(i)<br>Benzydamine						<br>

123

UDIN00265785AM23

		Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)	Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)	Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)	Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)	Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)	<br>
	3	Benzydamine Hydrochloride Anti-					1000	6	Benzydamine	3.06 gram
		<br>Inflammato<br>Each<br>lo<br>Benzydami		<br>ry Lozen<br>zenge<br>ne	<br>ges Su<br>contai	<br>gar Free.<br>ns<br>(i)	<br> <br>Number		<br>Hydrochloride
								7	Isomalt ST-M	2586	gram
		Hydrochlor<br>M - 2586m<br>(ii) 10344 K		ide-(3mg<br>g. Net co<br>gs.)	(ii) Iso<br>ntent (i)	malt ST-<br>12 Kgs.

	4	Cetylpyridi<br>Bromhexin<br>Antiseptic<br>all other fla<br>lozenge con<br>Chloride - 1<br>- 2586 mg.		nium<br> <br>e<br>Lozenges<br>vours.(E<br>tains (i)<br>.33mg (i<br>Net co		<br>	<br>
					Chlorid<br>Hydro<br>Sugar<br>ach	e<br>And<br>chloride<br>Free and	<br> <br> <br>1000<br>Number	8	Cetylpyridinium<br>Chloride	1.356	gram

					Cetylpy<br>i) Isom<br>ntent (i	ridinium<br>alt ST-M<br>) 13.333	<br> <br>	9	Isomalt ST-M	2586	gram
		Kg (ii) 25924.878 Kg)
	5	Cetylpyridinium<br>Chloride<br>And<br>Benzydamine<br>Hydrochloride					<br> <br>1000	10	Cetylpyridinium<br>Chloride	1.02 gram
		<br> <br>Antiseptic Lozenges Suger Free.					<br> <br>Number
		Each	<br>lozenge<br>contains((i)
		Cety<br>	lpyridinium Chloride- 1mg (ii)<br>				<br>	11	Isomalt ST-M	2586 gram
		Isom<br>	alt ST-M - 2586mg. Net<br>				<br>
		cont<br>Kg)	ent (i) 5.22 Kg (ii) 13498.92




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

Case No.			234 / NC/3/MEET/Nov/202223/12
Case Status			Case Approved
Party Name			J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00000875AM23
RA File Number			03AX04000406 AM23
Licence No and			0311014852/19/05/2022
Date

Case No.	234 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000875AM23
RA File Number	03AX04000406 AM23
Licence No and<br>Date	0311014852/19/05/2022

124

UDIN00265785AM23

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/May/202223/3 dated 27/05/2022 against advance authorization No. 0310814635 dated 14.07.2017 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/3 dated 27/05/2022against advance authorization No.<br>0310814635 dated 14.07.2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No<br>Import items<br>Qty.<br>1.<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>1<br>Benzydamine Hydrochloride And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory<br>And<br>Antiseptic<br>Lozenges Sugar Free and(all other<br>flavours. Each lozenge contains (i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg<br>(iii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 33.333 Kgs<br>(ii) 14.778 Kgs (iii) 28733.356<br>Kgs.)<br>1000<br>Number<br>3<br>Isomalt ST-M<br>2586 gram<br>4<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Benzydamine Hydrochloride, 2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial<br>Lozenges Sugar Free. Each lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)<br>1000<br>Number<br>5<br>Isomalt ST-M<br>2586 gram<br>6<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>3<br>Benzydamine Hydrochloride Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-<br>M - 2586mg. Net content (i) 12 Kgs.<br>(ii) 10344 Kgs.)<br>1000<br>Number<br>7<br>Isomalt ST-M<br>2586 gram<br>8<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>Cetylpyridinium<br>Chloride<br>And<br>Bromhexine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free and<br>all other flavours.(Each<br>lozenge contains (i) Cetylpyridinium<br>4<br>1000<br>Number<br>9<br>Isomalt ST-M<br>2586 gram	Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/3 dated 27/05/2022against advance authorization No.<br>0310814635 dated 14.07.2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No<br>Import items<br>Qty.<br>1.<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>1<br>Benzydamine Hydrochloride And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory<br>And<br>Antiseptic<br>Lozenges Sugar Free and(all other<br>flavours. Each lozenge contains (i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg<br>(iii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 33.333 Kgs<br>(ii) 14.778 Kgs (iii) 28733.356<br>Kgs.)<br>1000<br>Number<br>3<br>Isomalt ST-M<br>2586 gram<br>4<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Benzydamine Hydrochloride, 2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial<br>Lozenges Sugar Free. Each lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)<br>1000<br>Number<br>5<br>Isomalt ST-M<br>2586 gram<br>6<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>3<br>Benzydamine Hydrochloride Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-<br>M - 2586mg. Net content (i) 12 Kgs.<br>(ii) 10344 Kgs.)<br>1000<br>Number<br>7<br>Isomalt ST-M<br>2586 gram<br>8<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>Cetylpyridinium<br>Chloride<br>And<br>Bromhexine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free and<br>all other flavours.(Each<br>lozenge contains (i) Cetylpyridinium<br>4<br>1000<br>Number<br>9<br>Isomalt ST-M<br>2586 gram	Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/3 dated 27/05/2022against advance authorization No.<br>0310814635 dated 14.07.2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No<br>Import items<br>Qty.<br>1.<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>1<br>Benzydamine Hydrochloride And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory<br>And<br>Antiseptic<br>Lozenges Sugar Free and(all other<br>flavours. Each lozenge contains (i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg<br>(iii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 33.333 Kgs<br>(ii) 14.778 Kgs (iii) 28733.356<br>Kgs.)<br>1000<br>Number<br>3<br>Isomalt ST-M<br>2586 gram<br>4<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Benzydamine Hydrochloride, 2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial<br>Lozenges Sugar Free. Each lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)<br>1000<br>Number<br>5<br>Isomalt ST-M<br>2586 gram<br>6<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>3<br>Benzydamine Hydrochloride Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-<br>M - 2586mg. Net content (i) 12 Kgs.<br>(ii) 10344 Kgs.)<br>1000<br>Number<br>7<br>Isomalt ST-M<br>2586 gram<br>8<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>Cetylpyridinium<br>Chloride<br>And<br>Bromhexine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free and<br>all other flavours.(Each<br>lozenge contains (i) Cetylpyridinium<br>4<br>1000<br>Number<br>9<br>Isomalt ST-M<br>2586 gram	Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/3 dated 27/05/2022against advance authorization No.<br>0310814635 dated 14.07.2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No<br>Import items<br>Qty.<br>1.<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>1<br>Benzydamine Hydrochloride And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory<br>And<br>Antiseptic<br>Lozenges Sugar Free and(all other<br>flavours. Each lozenge contains (i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg<br>(iii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 33.333 Kgs<br>(ii) 14.778 Kgs (iii) 28733.356<br>Kgs.)<br>1000<br>Number<br>3<br>Isomalt ST-M<br>2586 gram<br>4<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Benzydamine Hydrochloride, 2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial<br>Lozenges Sugar Free. Each lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)<br>1000<br>Number<br>5<br>Isomalt ST-M<br>2586 gram<br>6<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>3<br>Benzydamine Hydrochloride Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-<br>M - 2586mg. Net content (i) 12 Kgs.<br>(ii) 10344 Kgs.)<br>1000<br>Number<br>7<br>Isomalt ST-M<br>2586 gram<br>8<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>Cetylpyridinium<br>Chloride<br>And<br>Bromhexine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free and<br>all other flavours.(Each<br>lozenge contains (i) Cetylpyridinium<br>4<br>1000<br>Number<br>9<br>Isomalt ST-M<br>2586 gram	Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/3 dated 27/05/2022against advance authorization No.<br>0310814635 dated 14.07.2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No<br>Import items<br>Qty.<br>1.<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>1<br>Benzydamine Hydrochloride And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory<br>And<br>Antiseptic<br>Lozenges Sugar Free and(all other<br>flavours. Each lozenge contains (i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg<br>(iii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 33.333 Kgs<br>(ii) 14.778 Kgs (iii) 28733.356<br>Kgs.)<br>1000<br>Number<br>3<br>Isomalt ST-M<br>2586 gram<br>4<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Benzydamine Hydrochloride, 2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial<br>Lozenges Sugar Free. Each lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)<br>1000<br>Number<br>5<br>Isomalt ST-M<br>2586 gram<br>6<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>3<br>Benzydamine Hydrochloride Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-<br>M - 2586mg. Net content (i) 12 Kgs.<br>(ii) 10344 Kgs.)<br>1000<br>Number<br>7<br>Isomalt ST-M<br>2586 gram<br>8<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>Cetylpyridinium<br>Chloride<br>And<br>Bromhexine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free and<br>all other flavours.(Each<br>lozenge contains (i) Cetylpyridinium<br>4<br>1000<br>Number<br>9<br>Isomalt ST-M<br>2586 gram	Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/3 dated 27/05/2022against advance authorization No.<br>0310814635 dated 14.07.2017, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No<br>Import items<br>Qty.<br>1.<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>1<br>Benzydamine Hydrochloride And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory<br>And<br>Antiseptic<br>Lozenges Sugar Free and(all other<br>flavours. Each lozenge contains (i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg<br>(iii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 33.333 Kgs<br>(ii) 14.778 Kgs (iii) 28733.356<br>Kgs.)<br>1000<br>Number<br>3<br>Isomalt ST-M<br>2586 gram<br>4<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Benzydamine Hydrochloride, 2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial<br>Lozenges Sugar Free. Each lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)<br>1000<br>Number<br>5<br>Isomalt ST-M<br>2586 gram<br>6<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>3<br>Benzydamine Hydrochloride Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-<br>M - 2586mg. Net content (i) 12 Kgs.<br>(ii) 10344 Kgs.)<br>1000<br>Number<br>7<br>Isomalt ST-M<br>2586 gram<br>8<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>Cetylpyridinium<br>Chloride<br>And<br>Bromhexine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free and<br>all other flavours.(Each<br>lozenge contains (i) Cetylpyridinium<br>4<br>1000<br>Number<br>9<br>Isomalt ST-M<br>2586 gram
Sl. No.	Export product	Qty.	Sl. No	Import items	Qty.
1	Benzydamine Hydrochloride And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory<br>And<br>Antiseptic<br>Lozenges Sugar Free and(all other<br>flavours. Each lozenge contains (i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg<br>(iii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 33.333 Kgs<br>(ii) 14.778 Kgs (iii) 28733.356<br>Kgs.)	1000<br>Number	1.	Benzydamine<br>Hydrochloride	3.06 gram
			2	Cetylpyridinium<br>Chloride	1.356 gram
			3	Isomalt ST-M	2586 gram
2	Benzydamine Hydrochloride, 2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-<br>Inflammatory,(Anti-Bacterial<br>Lozenges Sugar Free. Each lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride - 3mg (ii) Isomalt<br>ST-M- 2586mg. Net content (i)<br>21.333 Kgs. (ii) 18389.439 Kgs.)	<br> <br> <br> <br> <br> <br> <br>1000<br>Number	4	Benzydamine<br>Hydrochloride	3.06 gram
			5	Isomalt ST-M	2586 gram
3	Benzydamine Hydrochloride Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-(3mg (ii) Isomalt ST-<br>M - 2586mg. Net content (i) 12 Kgs.<br>(ii) 10344 Kgs.)	<br> <br> <br>1000<br>Number	6	Benzydamine<br>Hydrochloride	3.06 gram
			7	Isomalt ST-M	2586 gram
4	Cetylpyridinium<br>Chloride<br>And<br>Bromhexine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free and<br>all other flavours.(Each<br>lozenge contains (i) Cetylpyridinium	<br> <br> <br> <br>1000<br>Number	8	Cetylpyridinium<br>Chloride	1.356 gram
			9	Isomalt ST-M	2586 gram

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Chloride - 1.33mg (ii) Isomalt ST-M<br>- 2586 mg. Net content (i) 13.333<br>Kg (ii) 25924.878 Kg)<br>10<br>Cetylpyridinium<br>Chloride<br>1.02 gram<br>5<br>Cetylpyridinium<br>Chloride<br>And<br>Benzydamine<br>Hydrochloride<br>Antiseptic Lozenges Suger Free.<br>Each<br>lozenge<br>contains((i)<br>Cetylpyridinium Chloride- 1mg (ii)<br>Isomalt ST-M - 2586mg. Net<br>content (i) 5.22 Kg (ii) 13498.92<br>Kg)<br>1000<br>Number<br>11<br>Isomalt ST-M<br>2586 gram<br> <br>RA concerned may take further necessary action as per above decision of NC.		Chloride - 1.33mg (ii) Isomalt ST-M<br>- 2586 mg. Net content (i) 13.333<br>Kg (ii) 25924.878 Kg)	<br>
	5	Cetylpyridinium<br>Chloride<br>And<br>Benzydamine<br>Hydrochloride<br>Antiseptic Lozenges Suger Free.<br>Each<br>lozenge<br>contains((i)<br>Cetylpyridinium Chloride- 1mg (ii)<br>Isomalt ST-M - 2586mg. Net<br>content (i) 5.22 Kg (ii) 13498.92<br>Kg)	<br> <br> <br> <br> <br> <br> <br>1000<br>Number	10	Cetylpyridinium<br>Chloride	1.02 gram
				11	Isomalt ST-M	2586 gram

Case No.	235 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ALG CHEMICALS.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000883AM23
RA File Number	03AX04000006 AM23
Licence No and<br>Date	0311014857/19/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>i.<br>Justification for wastage.<br>ii.<br>Production / Consumption data duly certified by CA.<br>iii.<br>Indicate the By-Product with their Commercial Value.<br>iv.

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

Case No.	236 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000884AM23

126

UDIN00265785AM23

R	A File Number	A File Number	A File Number	A File Number	03AX	04000407	AM23
L	icence No and Date				03110	14858/19/	05/2022
N<br> <br>i<br>0<br>g	orms Committee Decision:<br>The Committee considered th<br>mport item in Meeting No.<br>310814635 dated 14.07.2017<br>iven below or as applied by th					e case as<br>NC/3/M<br> , it was<br>e firm, w
							per age<br>	nda and taking cue from earlier decision for same<br>							export product /<br>
							EET/M<br>decided<br>hichever	ay/202223/3 dated 27/05/2022against advance a<br>to ratify adhoc norms under Para 4.07 of HBP Vo<br>is less:							uthorization No.<br>l. I as per details




		Sl. No.	Expo	rt product						Qty.		Sl. No	Import items	Qty.


		1	Ben	ydamine Hydrochloride And						1000		1.	Benzydamine	3.06 gram
			Cet	lridinium<br>Chloride<br>Anti-									Hdrochloride
			y	py<br> <br>									y
			Infla	mmatory<br>And<br>Antiseptic						Number
			<br>	<br> <br>
			Loze<br>fl	nges Sugar Free and(all other<br>Eh l i i								2	Cetylpyridinium	1.356 gram
			av	urs. ac ozenge contans ()
			<br>Ben	<br>damine<br>Hdrochloride-3m									Chloride
			<br>(ii)<br>1.33	y<br>yg<br>Cetylpyridinium<br>Chloride-<br>mg<br>(iii)<br>Isomalt<br>ST-M<br>-

			<br>2586	<br> <br>mg. Net content (i) 33.333 Kgs								3	Isomalt ST-M	2586 gram
			(ii)	14.778 Kgs (iii) 28733.356
			Kgs.	)

		2	Benzydamine Hydrochlor<br>Dichlorobenzyl<br>Alcoho<br> <br>				ide, 2,4-<br>l<br>And<br>			1000<br>Numb	er	4	Benzydamine<br>Hydrochloride	3.06		gram
			Lidocaine<br>Hydr<br>Anaesthetic,<br>Inflammatory,(Anti-Bacte<br>Lozenges<br>Sugar<br>Free<br>lozenge contains (i) Benz<br>Hydrochloride - 3mg (ii)<br>ST-M- 2586mg.				ochloride<br>Anti-<br>rial<br>.<br>Each<br>ydamine<br>Isomalt
												5	Isomalt ST-M	2586		gram


			Net content (i) 21333 Ks (ii						)
			<br>1838	. g.<br>9.439 Kgs.)



		3	Benz	ydamine Hydrochloride Anti-						1000		6	Benzydamine	3.06 gram
			<br>Infla	<br>mmatory Lozenges Sugar Free.						<br>			<br>Hydrochloride
			E	<br>l<br>ti<br>i						<br>Number
			ac	<br>ozenge<br>conans<br>()

			Ben	ydamine
												7	Isomalt ST-M	2586 ram
														g
			Hydr<br>M -	ochloride-(3mg (ii) Isomalt ST-<br>2586mg Net content (i) 12 Kgs
				. .
			(ii) 1	0344 Kgs.)

		4	Cety	lpyridinium<br>Chloride<br>And						1000		8	Cetylpyridinium	1.356 gram

127

UDIN00265785AM23

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

Case No.	Case No.	237 / NC/3/MEET/Nov/202223/12	237 / NC/3/MEET/Nov/202223/12	237 / NC/3/MEET/Nov/202223/12	237 / NC/3/MEET/Nov/202223/12	237 / NC/3/MEET/Nov/202223/12
Case Status		Case Approved
Party Name		AMI ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000885AM23
RA File Number		52AX04000042 AM23
Licence No and<br>Date		5211002509/19/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in M<br>eeting No.NC/3/MEET/May/202223/4 dated 17/06/2022against advance authorization No.0311003601 dated 06.05.2021, it<br>was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>ParaHydroxy Benzoic Acid<br>0.97 kg<br>Methyl Paraben<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Methyl Paraben		1 kg	1	ParaHydroxy Benzoic Acid	0.97 kg

128

UDIN00265785AM23

2 Methanol 0.50 kg

Case No.<br>238 / NC/3/MEET/Nov/202223/12	Case No.<br>238 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>MAIVA PHARMA PRIVATE LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000864AM23
RA File Number<br>07AX04000096 AM23
Licence No and Date<br>0711003985/19/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc				norms under Para			4.07 of	HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items				Qty.
Prochlorperazine<br>Edisylate<br>Injection<br>307800	1	110010718			V9239	<br>Relevant	as	per
10mg/2mL(Prochlorperazine<br>Edisylate<br>Numbers		FM259/0	FLCO		<br>015	<br>Packing Policy
Injection 10mg, 2mL vial - 10 mg of bulk		(13mm	Omniflexplus
drug filled in 2 mL vial and capped with		Coated	BB	R/S-RFS
13mm<br>Rubber<br>Stopper<br>&<br>13mm		V9239 FM259/0)
Omniflexplus Coated(Dark Grey) Seals)
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	239 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000886AM23
RA File Number	07AX04000116 AM23
Licence No and<br>Date	0711003901/19/05/2022
Norms Committee Decision:

129

UDIN00265785AM23

T<br> <br> <br>R	he Com<br>Vol. I as	mittee considered the case as per<br>per details given below or as app	mittee considered the case as per<br>per details given below or as app	agenda and it<br>lied by the fir	agenda and it<br>lied by the fir	was deci<br>m, which	ded to ratify adhoc norms under<br>ever is less:	ded to ratify adhoc norms under<br>ever is less:	Para 4.07 of HBP

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

	1	Ephedrine Sulfate Injection USP 5<br>2mL Vial(2mL Vial - filled with<br>Ephedrine Sulfate as bulk drug mix<br>for injection and filled in 2mL Vial<br>with 13mm chlorobutyl Rubber Stop		0mg/mL -<br>50 mg of<br>ed in water<br>and capped<br>per)	<br> <br> <br> <br>513<br>Num	000	1	Grey Westar RS SIL 1	<br>Relevant<br>as<br>per
						bers		<br>(13mm<br>Chlorobutyle<br>Rubber Stopper Grey RFS)	<br> <br> <br>Packing Policy
	2	Cyanocobalamin Injection USP 100<br>2mL Vial(2mL Vial - filled wit<br>Cyanocobalamin as bulk drug mixe<br>for injection and filled in 2mL Vial<br>with 13mm chlorobutyl Rubber Stop		0mcg/mL -<br>h 1mg of<br>d in water<br>and capped<br>per)	<br> <br> <br> <br>360<br>Num	000<br>bers	2	Grey Westar RS SIL 1<br>(13mm<br>Chlorobutyle<br>Rubber Stopper Grey RFS)	<br> <br>Relevant<br>as<br>per<br>Packing Policy

	3	Furosemide<br>Injection<br>10mg/mL<br>Vial(2mL Vial - filled with<br>furosemide as bulk drug mixed in<br>injection and filled in 2mL Vial a<br>with 13mm chlorobutyle Rubber Sto		<br>-<br>2mL<br>20mg of<br>water for<br>nd capped<br>pper)	<br> <br> <br> <br>414<br>Num	000<br>bers	3	Grey Westar RS SIL 1<br>(13mm<br>Chlorobutyle<br>Rubber Stopper Grey RFS)	<br> <br>Relevant<br>as<br>per<br>Packing Policy

	4	Furosemide<br>Injection<br>10mg/mL<br>Vial(4mL Vial - filled with<br>furosemide as bulk drug mixed in<br>injection and filled in 4mL Vial a<br>with 13mm chlorobutyle Rubber Sto		<br>-<br>4mL<br>40mg of<br>water for<br>nd capped<br>pper)	<br> <br> <br> <br>225<br>Num
						000<br>bers	4	Grey Westar RS SIL 1<br>(13mm<br>Chlorobutyle<br>Rbb S G RFS	<br> <br>Relevant<br>as<br>per<br>Packing Policy
								uer topper rey )
	<br>A conce	<br>rned may take further necessary a		ction as per ab
						ove deci	sion of NC.


C	ase No.		240 / NC/3/MEET/Nov/	202223/12
C	ase Statu	s	Case Deferred
P	arty Nam	e	KUMAR ORGANIC PR	ODUCTS LIM
						ITED
M<br>a	eeting N<br>nd Date	umber	NC/ 3/ MEET/ Nov/ 202	223/ 12 and 18		/11/2022
H	Q File N	umber	HQRNORM APPLY 00	000865AM23

R	A File N	umber	07AX04000056 AM23
L<br>D	icence N<br>ate	o and	0711004017/19/05/2022

N<br>T	orms Co<br>he Com	mmittee Decision:<br>mittee considered the case as e		r aenda and		it was d	cided to call for followin infor		ation/documents
p g g

130

UDIN00265785AM23

from the firm:

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

Case No.	241 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000867AM23
RA File Number	07AX04000185 AM23
Licence No and<br>Date	0711004021/19/05/2022
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>Sterile Water for Injection 10mL Vial<br>470095<br>Numbers<br>1<br>10ML,23.0X55.5MM,13 A/S 3X<br>(EMPTY VIALS) T2710W02BP<br>Relevant as per Packing<br>Policy<br>with<br>Accountability Clause<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	242 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000906AM23
RA File Number	05AX04000406 AM23
Licence No and Date	0511012696/20/05/2022
Norms Committee Decision:

131

UDIN00265785AM23

The Committee considered the case as per agenda and taking and taking cue from earlier decision for same export product / import item in Meeting No. 4/82-ALC4/2018 dated 19.06.2018 against advance authorization No. 0510405547 dated 06.02.2018 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Tan<br>Endo/<br>Powder(4-Nitrobenzyl<br>-2-<br>((1R,5R)-3-benzyl-7-oxo-4-thia-2,6-<br>diazabicyclo[3.2.0]hept-2-en-6-yl)-3-<br>methylbut-2-enoate)	1 kg	1	POTASSIUM PEN G<br>(FIRST CRYSTAL)	1.089 kg
		2	DIMETHYLFORMAMIDE	4.685 kg
		3	TRIETHYLAMINE	0.279 kg
		4	METHYLENE CHLORIDE	2.783 kg
		5	ACETONE	2.525 kg
		6	Toluene	0.852 kg

Case No.	243 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	BRAWN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000909AM23
RA File Number	05AX04000521 AM23
Licence No and<br>Date	0511012700/20/05/2022
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:

132

UDIN00265785AM23

Sl.<br>No.<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>CIPROFLOXACIN<br>TABLET<br>250MG((LIGHT<br>YELLOW<br>COLORED, ROUND, BICONVEX,<br>FILM COATED TABLETS))<br>1 Number<br>1<br>CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>277.50 mg /<br>250 mg Tablet<br>2<br>CIPROFLOXACIN<br>TABLET<br>500MG((WHITE,<br>ELONGATED,<br>BICONVEX,<br>FLIM<br>COATED<br>TABLETS WITH BREAKLINE ON<br>ONE SIDE))<br>1 Number<br>1<br>CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>555 mg /500 mg<br>Tablet<br> <br>RA concerned may take further necessary action as per above decision of NC.	Sl.<br>No.	Export Product	Qty.	Sl.<br>No.	Import items	Qty.
	1	CIPROFLOXACIN<br>TABLET<br>250MG((LIGHT<br>YELLOW<br>COLORED, ROUND, BICONVEX,<br>FILM COATED TABLETS))	<br> <br> <br>1 Number	1	CIPROFLOXACIN<br>HYDROCHLORIDE USP	277.50 mg /<br>250 mg Tablet
	2	CIPROFLOXACIN<br>TABLET<br>500MG((WHITE,<br>ELONGATED,<br>BICONVEX,<br>FLIM<br>COATED<br>TABLETS WITH BREAKLINE ON<br>ONE SIDE))	<br> <br> <br> <br>1 Number	1	CIPROFLOXACIN<br>HYDROCHLORIDE USP	555 mg /500 mg<br>Tablet

Case No.	244 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000912AM23
RA File Number	09AX04000058 AM23
Licence No and<br>Date	0911003033/20/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents<br>from the firm:<br>DML.<br>i.<br>COA of import item from foreign supplier.<br>ii.<br>Wastage applied with calculation.

Case No.	245 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	VISION DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000893AM23
RA File Number	09AX04000124 AM23

133

UDIN00265785AM23

Licence No and 0911003032/20/05/2022 Date Norms Committee Decision: Deferred for comments of TE.

Case No.	246 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000901AM23
RA File Number	30AX04000049 AM23
Licence No and<br>Date	3011002146/20/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDepartment of<br>Biotechnology (DBT)for obtaining its comments.

Case No.	247 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000918AM23
RA File Number	07AX04000117 AM23
Licence No and<br>Date	0711004046/21/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	248 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	METROPOLITAN EXIMCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000920AM23
RA File Number	03AX04000550 AM23
Licence No and<br>Date	0311014915/22/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

134 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

Case No.	249 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000939AM23
RA File Number	07AX04000122 AM23
Licence No and<br>Date	0711004059/23/05/2022
Norms Committee Decision:
Deferred for comments of TE.

C	ase No.		249 / NC/3/MEET/Nov/	249 / NC/3/MEET/Nov/	202223/12	202223/12
C	ase Statu	s	Case Deferred
P	arty Nam	e	MICRO LABS LIMITE		D

M<br>an	eeting N<br>d Date	umber	NC/ 3/ MEET/ Nov/ 20		2223/ 12 and 18		/11/202	2
H	Q File N	umber	HQRNORM APPLY 00		000939AM23
R
	A File Number		07AX04000122 AM23
L<br>D	icence No and<br>ate		0711004059/23/05/2022
N<br>D	orms Committee Decision:<br>eferred for comments of TE.

Case No.				250 / NC/3/MEET/Nov/202223/12
Case Status				Case Approved
Party Name				RECKITT BENCKISER (INDIA) PRIVATE LIMITED

Meeting Number and<br>Date				NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number				HQRNORM APPLY 00000941AM23
RA File Number				05AX04000520 AM23

Licence No and Da			e	0511012742/23/05/2022

Norms Committee			ecision:
The Committee co			nsidered the case as per agenda and taking cue from earlier decision for same export product /
import item in M<br>0511005203 dated			eeting No.NC/3/MEET/Sep/202233/8 dated 23.09.2022against advance authorization No.<br>05.10.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as a			pplied by the firm, whichever is less:



	Sl. No.	Export product				Qty.	Sl. No.		Import items		Qty.
	1<br> <br> <br> <br>	DISPRIN<br>REGUALAR<br>(ASPIRIN<br>PH.EUR<br>300MG)(ACETYL<br>SALICYLIC ACID 300 mg Tablet<br>(ASPIRIN))				<br> <br> <br>1 Number<br>Tablet	1		CITIRIC ACID ANHYDROUS F4020		30.00 mg
							2		SACCHARIN BASE 55Ox		4.50 mg

							3		CALCIUM CARBONATE	EP	90.00 mg

	2	DISPRIN,ZA,EXTRA<br>(ASPIRIN<br>PH.EUR<br>500MG)(ACETYL<br>SALICYLIC ACID 500 mg Tablet<br>(ASPIRIN))				<br> <br> <br>1 Number<br>Tablet	4		CITIRIC ACID ANHYDRO	US F4020	50.00 mg

							5		SACCHARIN BASE 55Ox		7.50 mg

							6		CALCIUM CARBONATE EP		150.00 mg

135

UDIN00265785AM23

3	DSPRN,ZA,MELTS,(ASPIRIN<br>PH.EUR<br>300MG)(ACETYL<br>SALICYLIC ACID 300 mg Tablet<br>(ASPIRIN))	<br> <br>1 Number<br>Tablet	7	SACCHARIN BASE 55Ox	1.00 mg
			8	GLYCINE EP	133.30 mg
4	DSPRN,ZA,DIRECTS,(ASPIRIN<br>PH.EUR<br>300MG)(ACETYL<br>SALICYLIC ACID 300 mg Tablet<br>(ASPIRIN))	<br> <br>1 Number<br>Tablet	9	SACCHARIN BASE 55Ox	1.00 mg
			10	GLYCINE EP	133.30 mg
5	DISPRIN CARDIOCARE (ASPIRIN<br>BP 100MG)(ACETYL SALICYLIC<br>ACID 100 mg Tablet (ASPIRIN))	<br> <br>1 Number<br>Tablet	11	SACCHARIN BASE 55Ox	0.334 mg
			12	GLYCINE EP	44.40 mg

Case No.	251 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000944AM23
RA File Number	09AX04000145 AM23
Licence No and<br>Date	0911003039/23/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	252 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000922AM23
RA File Number	07AX04000113 AM23
Licence No and<br>Date	0711004050/23/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in M<br>eeting No.1/82-ALC4/2018 dated 01/05/2018against advance authorization No.0510401908 dt. 09.03.2017, it was decided to<br>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:

136

UDIN00265785AM23

Sl.	Export Product	Qty.	Sl.	Import items	Qty.
No.			No.
1	CAFFEINE CITRATE INJECTION 60MG	<br>1 Number	1	CAFFEINE	33 mg/3 ml vial
	/ 3ML(CAFFEINE CITRATE INJECTION			ANHYDROUS
	60 MG/3 ML (EQUIVALENT TO 30 MG
	OF CAFFEINE BASE) EP/BP/USP/IP
	24.375 KG)
2	CAFFEINE CITRATE ORAL SOLUTION	<br>1 Number	1	CAFFEINE	33 mg/3 ml vial
	60 MG / 3 ML (CAFFEINE CITRATE			ANHYDROUS
	ORAL SOLUTION 60 MG / 3 ML
	(EQUIVALENT<br>TO<br>30<br>MG<br>OF
	CAFFEINE BASE) BP/EP/USP/IP 15.000
	KG)

Case No.	253 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000924AM23
RA File Number	03AX04000850 AM23
Licence No and<br>Date	0311014924/23/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms as perSION A-2244.
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	254 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
and Date
HQ File Number	HQRNORM APPLY 00000937AM23

137

UDIN00265785AM23

RA File Number	30AX04000065 AM23
Licence No and<br>Date	3011002150/23/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case toDepartment of
Biotechnology (DBT)for obtaining its comments.

Case No.<br>255 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>ENVEE DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00000950AM23
RA File Number<br>34AX04000170 AM23
Licence No and<br>Date<br>3411002299/24/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in M
eeting No.NC/3/MEET/Mar/202122/16 dated 08/04/2022against advance authorization No.0311000563,		it was decided to
ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items		Qty.
BETAMETHASONE SODIUM<br>1 kg<br>1	BETAMETHASONE IP BP EP USP		0.78 kg
PHOSPHATE BP/USP/EP(BP/UPS/EP)
<br>RA concerned may take further necessary action as per above decision	of NC.

Case No.	256 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000981AM23
RA File Number	03AX04000820 AM23
Licence No and<br>Date	0311014993/25/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in M

138

UDIN00265785AM23

eeting No. NC/3/MEET/Jan/202021/4 dated 12/02/2021 against advance authorization No. 0310836157 dated 11.05.2020 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Sl. No.	Export Product	Qty	Sl. No.	Import Items	Qty
1	Cetylpyridinium Chloride, Benzydamine<br>Hydrochloride and Pholcodine Lozenges<br>Sugar Free Blackcurrant/ Pineapple &<br>Lime/(Honey, Lemon & Ginger/Other<br>Flavours. Each Lozenge contains (i)<br>Pholcodine 5.50mg (ii) Benzydamine<br>Hydrochloride<br>1.50<br>mg<br>(iii)<br>Cetylpyridinium<br>Chloride<br>1.33<br>mg<br>(iv)Isomalt ST-M 2583 mg. Net Content<br>(i) 43.80 kg (ii) 11.94 kg (iii) 10.59 kg<br>(iv) 20568 Kg)	1 Number	1	Pholcodine	5.61 mg
			2	Benzydamine Hydrochloride	1.53mg
			3	Cetylpyridinium Chloride	1.357 mg
			4	Isomalt ST-M	2583.0 mg
2	Pholcodine and Cetylpyridinium Chloride<br>Lozenges Sugar Free Orange / Lemon and<br>Other Flavours. Each Lozenge contains ((i)<br>Pholcodine<br>5.50<br>mg<br>(ii)<br>Cetylpyridinium Chloride 1.33 mg (iii)<br>Isomalt ST-M 2579 mg. Net Content (i)<br>Pholcodine-30.77 kg (ii) Cetylpyridinium<br>Chloride-7.44 kg (iii) Isomalt ST-M-<br>14427.96 kg.)	<br> <br> <br> <br> <br> <br> <br>1 Number	5	Pholcodine	5.61 mg
			6	Cetylpyridinium Chloride	1.357 mg
			7	Isomalt ST-M	2579.0 mg

Case No.	257 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000982AM23
RA File Number	03AX04000697 AM23
Licence No and<br>Date	0311014994/25/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.<br>0311004037 dated 25.05.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:

139

UDIN00265785AM23

Export product	Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.240 kg
		2	Piperazine Anhydrous	0.390 kg

Case No.	258 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000987AM23
RA File Number	05AX04000414 AM23
Licence No and<br>Date	0511012794/25/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information /documents<br>from the firm:<br>Percentage purity of export item.<br>i.<br>COA of export item.

Case No.	259 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ASSOCIATED DYESTUFF PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000991AM23
RA File Number	08AX04000268 AM23
Licence No and<br>Date	0811005014/25/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the

140

UDIN00265785AM23

firm:

i. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
ii. By-Product and its value.

Justification for wastage.

fi<br>J	rm:	rm:
	Complete chemical reactions with<br>stage wise percentage yields on mol<br>i.<br>By-Product and its value.<br>ii.<br>ustification for wastage.		molecular a<br>ar basis.		nd struc	tural formula and mole	cular weights along with




C	ase No.	260 / NC/3/MEET/Nov/2	02223/12
C	ase Status	Case Deferred

P	arty Name	HETERO DRUGS LIMIT	ED
M<br>an	eeting Number<br>d Date	NC/ 3/ MEET/ Nov/ 2022	23/ 12 and 18		/11/2022
HQ File Number		HQRNORM APPLY 00000975AM23
RA File Number		09AX04000080 AM23
Licence No and<br>Date		0911003042/25/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.		261 / NC/3/MEET/Nov/202223/12
Case Status		Case Deferred
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000976AM23
RA File Number		09AX04000136 AM23
Licence No and<br>Date		0911003043/25/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.		262 / NC/3/MEET/Nov/202		223/12
Case Status		Case Deferred
Party Name		SRINI PHARMACEUTICA		LS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202223		/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000978AM23
RA File Number		09AX04000133 AM23
Licence No and<br>Date		0911003044/25/05/2022
Norms Committee		Decision:

141 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

Case No.	263 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00000980AM23
RA File Number	03AX04000822 AM23
Licence No and<br>Date	0311014992/25/05/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	264 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001004AM23
RA File Number	05AX04000553 AM23
Licence No and<br>Date	0511012820/26/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.

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

Case No.	265 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001010AM23
RA File Number	04AX04000178 AM23
Licence No and	0411003383/26/05/2022

142 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

UDIN00265785AM23

Date

Date
Norms Committee	Decision:

Deferred for comme	nts of TE.


Case No	266 / NC/3/MEET/Nov/202223/12
.
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 0000099	2AM23
RA File Number	09AX04000139 AM23
Licence No and<br>Date	0911003051/26/05/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	Case No.	267 / NC/3/MEET/Nov/202223/12	267 / NC/3/MEET/Nov/202223/12	267 / NC/3/MEET/Nov/202223/12	267 / NC/3/MEET/Nov/202223/12	267 / NC/3/MEET/Nov/202223/12	267 / NC/3/MEET/Nov/202223/12

Case Status		Case Approved

Party Name		OPTIMUS DRUGS PRIVATE LIMITED

Meeting Number
<br>and Date		NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number		HQRNORM APPLY 00000995AM23

RA File Number		09AX04000148 AM23

Licence No and
Date		0911003052/26/05/2022
Norms Committee		Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<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>Di Tert Butyl Dicarbonate<br>3.16 kg<br>(1R,2R)-2-Amino-6-(4-<br>1 kg
	Export product		Qty.	S	l. No.	Import items	Qty.
	(1R,2R)-2-Amino-6-(4-		1 kg	1		Di Tert Butyl Dicarbonate	3.16 kg

	Nitrophenyl)-1-Phenylhex-5-yn-<br>1-ol Hydrochloride
				2		CDX-034 Lyophilized Enzyme Powder	0.012 kg
							<br>
				3		Beta Nicotinamide Adenine dinucleotide<br>	<br>0.008 kg
						phosphate Sodium salt (beta-NADP-Na)


				4		N-Heptane	3.00 kg

143

UDIN00265785AM23

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

Case No.	268 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001000AM23
RA File Number	07AX04000159 AM23
Licence No and<br>Date	0711004100/26/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202122/2 dated 02/07/2021 against advance authorization No.<br>0711000830 dated 05.04.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>DICLOXACILLIN<br>CAPSULES<br>DICLOXACILLIN<br>CAPSULES<br>500 MG BP/EP/IP/USP 1999.99<br>KG)<br>3999990<br>Numbers<br>1<br>DICLOXACILLIN SODIUM<br>2140 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	269 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

144

UDIN00265785AM23

HQ File Number	HQRNORM APPLY 00001002AM23
RA File Number	07AX04000209 AM23
Licence No and<br>Date	0711004103/26/05/2022
Norms Committee Decision:
Deferred for comments of TE.

HQ File Number	HQ File Number	HQRNORM APPLY 00001002AM23	HQRNORM APPLY 00001002AM23	HQRNORM APPLY 00001002AM23	HQRNORM APPLY 00001002AM23	HQRNORM APPLY 00001002AM23	HQRNORM APPLY 00001002AM23	HQRNORM APPLY 00001002AM23
RA File Number		07AX04000209 AM23
Licence No and<br>Date		0711004103/26/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.			270 / NC/3/MEET/Nov	/202223/12
Case Status			Case Approved
Party Name			YASHO INDUSTRIE	S LIMITED
Meeting Number and<br>Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00001012AM23
RA File Number			03AX04000926 AM23
Licence No and Da		te	0311015038/27/05/2022
Norms Committee		Decision:

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


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

	DI-OCTYLATED<br>DIPHENYLAMINE(YALUB DODPA)				1 kg	1	DIPHENYLAMINE	0.459 kg
						2	DI-ISOBUTYLENE	0.60 kg
						3	ACTIVATED CLAY	0.10 kg

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

Case No.	271 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number
<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001015AM23
RA File Number	03AX04000924 AM23
Licence No and
Date	0311015041/27/05/2022
Norms Committee	Decision:

145

UDIN00265785AM23

Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.	Deferred for comments of TE.

Case No.			272 / NC/3/MEET/Nov/202223/12
Case Status			Case Approved
Party Name			VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number			HQRNORM APPLY 00001016AM23
RA File Number			03AX04000627 AM23
Licence No and<br>Date			0311015042/27/05/2022
Norms Committee Decision:

The Committee co<br>dt / it it			nsidered the case as per agenda and taking and taking cue from earlier decision for same export<br>i Mti NNC/3/MEET/202122/13 dtd 21012022it d thiti N
prouc mpor<br>0311006599 dated			em n eeng o.ae .. agans avance auorzaon o.<br>01092021it was decided to ratify adhoc norms under Para 407 of HBP Vol I as per details
<br>given below or as a			.., . .<br>pplied by the firm, whichever is less:



	Sl. No.	Export	product	Qty.	Sl. No.	Import items	Qty.
	1	Alverine<br>Citrate<br>120mg<br>Hard<br>Capsules		<br>1 Number	1	Alverine Citrate	122.40 mg /<br>Capsule
	2	Alverine Citrate 60mg Hard Capsules		1 Number	2	Alverine Citrate	61.20 mg /<br>Capsule

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

Case No.	273 / NC/3/MEET/Nov/202223/12
Case Status	Case Aroved
	pp
Part Name	AUROBINDO PHARMA LTD
y
Meetin Number
g<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022

HQ File Number	HQRNORM APPLY 00001038AM23
RA File Number	09AX04000156 AM23

Licence No and
<br>Date	0911003067/27/05/2022

Norms Committee	Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.12/82-ALC4/2013 dated 19.09.2013against advance authorization No.0810123477

146

UDIN00265785AM23

dated 05.08.2013 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Sl.	Export product	Qty.	Sl.	Import items	Qty.
No.			No.
1	ACEBUTOLOL Tablets 200 mg([Each	<br>1 Number.	1	Acebutolol	221.698 mg
	film coated tablet contains Acebutolol			Hydrochloride Ph.Eur
	Hydrochloride Ph.Eur equivalent to
	Acebutolol 200mg])
2	ACEBUTOLOL Tablets 400 mg([Each	<br>1 Number.	2	Acebutolol	443.396 mg
	film coated tablet contains Acebutolol			Hydrochloride Ph.Eur
	Hydrochloride Ph.Eur equivalent to
	Acebutolol 400mg])

Case No.<br>274 / NC/3/MEET/Nov/202223/12	Case No.<br>274 / NC/3/MEET/Nov/202223/12
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number<br>HQRNORM APPLY 00001064AM23
RA File Number<br>03AX04000874 AM23
Licence No and<br>Date<br>0311015096/30/05/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No.
0311004037 dated 25.05.2021, 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.<br>Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride<br>1 kg<br>1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.240 kg

147

UDIN00265785AM23

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

Case No.	275 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001065AM23
RA File Number	03AX04000506 AM23
Licence No and<br>Date	0311015097/30/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	276 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001068AM23
RA File Number	03AX04000845 AM23
Licence No and<br>Date	0311015100/30/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	277 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	CONNEX PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001077AM23
RA File Number	26AX04000015 AM23
Licence No and<br>Date	2611000601/30/05/2022
Norms Committee Decision:

148

UDIN00265785AM23

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Apr/20223/1 dated 29.04.2022 against advance authorization No. 2611000203 dated 26.07.2021 , 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.<br>No.	Import items	Qty.
CHLOROMETHYL<br>ISOPROPYL<br>CARBONATE (API)	<br>1 kg	1	METHYLCHLORO FORMATE	0.943 kg

Case No.	278 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001061AM23
RA File Number	03AX04000415 AM23
Licence No and<br>Date	0311015092/30/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda andit was decided to call the firm for attending<br>before Norms Committee to explain its case.		Personal Hearing

Case No.	279 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001063AM23
RA File Number	03AX04000468 AM23
Licence No and<br>Date	0311015094/30/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

149

UDIN00265785AM23

Case No.	280 / NC/3/MEET/Nov/202223/12
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001081AM23
RA File Number	52AX04000053 AM23
Licence No and<br>Date	5211002556/31/05/2022
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.<br>Import items<br>Qty.<br>PARA ANISIC ACID<br>100000 kg<br>1<br>ParaHydroxy Benzoic Acid<br>103000 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	281 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001082AM23
RA File Number	04AX04000075 AM23
Licence No and<br>Date	0411003399/31/05/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	282 / NC/3/MEET/Nov/202223/12
Case Status	Case Deferred
Party Name	ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATELIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202223/ 12 and 18/11/2022
HQ File Number	HQRNORM APPLY 00001090AM23
RA File Number	09AX04000132 AM23
Licence No and<br>Date	0911003083/31/05/2022

150

UDIN00265785AM23

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. Percentage yield at difference stage of reaction.

Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.

151 This document has been digitally signed by AJAY KUMAR, Deputy Director on 28-11-2022 19:16:54.

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