IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-04-29

DGFT Committee Minutes

Document text

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Government of India Ministry of Commerce and Industry Department of Commerce

DIRECTORATE GENERAL OF FOREIGN TRADE (DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Apr/202223/1 DATED: 29/04/2022

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/Apr/202223/1 dated 29/04/2022 of Norms Committee - III for the year 2022-23 was held on 29/04/2022 under the Chairmanship of Amiya Chandra,Additional 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	SHAISH KUMAR,Technical Authority	Technical Consultant,DGFT
3	DINESHNARAIN MATHUR,Technical<br>Authority	Technical Consultant,DGFT

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signe Name: Ajay Kumar( Deputy Director ) Name: Ajay Kumar( uty Director ) Date: 03-Jun-2022 13:51:24 Date: 03-Jun-2022 f6:51:24 Reason: AJAY.DHIMAN88@GOV.IN Reason: AJAY. IAN88@GOV.IN Location: DGFT(HQ) Location: DGFTIHG)

This document has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Jun-2022.

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Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00235235AM22
RA File Number<br>092404000488 AM21
Licence No and<br>Date<br>0911000087/null
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para	4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.<br>Import items		Qty.
1<br>S(+)-2-Amino Butyramide HCL<br>LEVETIRACETAM<br>1 kg		0.95 kg
2<br>Activated Carbon (Carbon Enoanticromos )		0.012 kg
3<br>Methylene chloride (MDC)		2.26 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>2 / NC/3/MEET/Apr/202223/1	Case No.<br>2 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM REVIW00229507AM22
RA File Number<br>092404000105 AM13
Licence No and<br>Date<br>0910052851/31/05/2012
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms andit was decided				to revise adhoc norms as
under:
	Export Product<br>Qty.<br>Sl. No.	Import Items			Qty.
	1<br>RACTOPAMINE HCL (for<br>1 kg	(RS)4-(2	AMINO-1-HYDROXY	ETHYL)	<br>1.063 kg
	Veternery use)	PHENOL HCL

Case No.<br>2 / NC/3/MEET/Apr/202223/1	Case No.<br>2 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM REVIW00229507AM22
RA File Number<br>092404000105 AM13
Licence No and<br>Date<br>0910052851/31/05/2012
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms andit was decided				to revise adhoc norms as
under:
	Export Product<br>Qty.<br>Sl. No.	Import Items			Qty.
	1<br>RACTOPAMINE HCL (for<br>1 kg	(RS)4-(2	AMINO-1-HYDROXY	ETHYL)	<br>1.063 kg
	Veternery use)	PHENOL HCL

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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2 4(4-HYDROXY PHENYL)-2-BUTANONE 0.978 kg

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

Case No.	3 / NC/3/MEET/Apr/202223/1
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00219542AM22
RA File Number	092404000239 AM13
Licence No and<br>Date	0910053490/14/08/2012
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of 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.

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

Case No.	4 / NC/3/MEET/Apr/202223/1
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00229497AM22
RA File Number	092404000374 AM15
Licence No and<br>Date	0910061119/17/10/2014
Norms Committee Decision:<br>The Committee considered the request of firm for allowing import item No. 2 – Nitro Methane andit was observed that<br>import item No 2 – Nitro Methane was earlier shown as reactant and now the firm is claiming that it is solvent.<br>In view of above discrepancy, the Committeerejectthe request of firm, decided not to allow import item<br>No. 2 - Nitro Methane.<br> RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.	Case No.	5 / NC/3/MEET/Apr/202223/1	5 / NC/3/MEET/Apr/202223/1	5 / NC/3/MEET/Apr/202223/1	5 / NC/3/MEET/Apr/202223/1	5 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM REVIW00285240AM22
RA File Number		039404000164 AM16
Licence No and<br>Date		0310796757/23/06/2015
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms andit was decided to revise adhoc norms as<br>under:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>AZITHROMYCIN AMINE<br>1.04 kg<br>AZITHROMYCIN<br>DIHYDRATE<br>1 kg<br>2<br>ACETONE<br>0.90 kg<br>RA concerned may take further necessary action as per above decision of NC.				of firm for enhancement of norms andit was decided to revise adhoc norms as
	Export product		Qty.	Sl. No.	Import items	Qty.
	AZITHROMYCIN<br>DIHYDRATE		1 kg	1	AZITHROMYCIN AMINE	1.04 kg
				2	ACETONE	0.90 kg

Case No.	6 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	U SQUARE LIFESCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00268752AM22
RA File Number	082404000306 AM16
Licence No and<br>Date	0810136712/11/12/2015
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to call for following information<br>/ documents from the firm:<br>COA of import item from foreign supplier for the relevant import for this Advance Authorization.

Case No.	7 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Party Name	Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ	File Number	HQRNORM REVIW00273961AM22
RA File Number		039404001110 AM16
Licence No and<br>Date		0310806126/12/07/2016
Norms Committee Decision:
The	Committee considered the request of firm for enhancement of norms andit was decided to revise		adhoc norms as
under:
	Export product<br>Qty.<br>Sl. No.<br>Import items		Qty.
	1<br>AZITHROMYCIN AMINE<br>AZITHROMYCIN<br>1 kg		1.04 kg
	DIHYDRATE
		2<br>ACETONE	0.90 kg
RA	concerned may take further necessary action as per above decision of NC.

Case No.	8 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00349952AM22
RA File Number	522404000042 AM17
Licence No and<br>Date	5210042032/30/09/2016
Norms Committee Decision:
The Committee considered the request of firm for enhancement of 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 alongwith stage<br>ii.
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.
End use of export product.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.	9 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00342368AM22
RA File Number	039404001099 AM17
Licence No and<br>Date	0310811662/07/03/2017
Norms Committee Decision:
The Committee considered the request of firm for enhancement of 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 alongwith<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.
Recovery of solvents.<br>v.
Production<br>vi.	/ Consumption data for the year 2017-18 duly certified by GST Authorities.

Case No.	10 / NC/3/MEET/Apr/202223/1
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00285059AM22
RA File Number	039404000575 AM18
Licence No and<br>Date	0310816510/25/10/2017
Norms Committee Decision:
The Committee considered the request of firm for enhancement of 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.	11 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00354679AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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RA File Number	022404000188 AM18
Licence No and<br>Date	0210208260/07/03/2018
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to call for following information<br>/ documents from the firm:<br>COA of import item from foreign supplier for the relevant import.<br>i.<br>Past Production / Consumption data for last three years duly certified by Central Taxes & GST Authorities.

Case No.	12 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	AVA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00266331AM22
RA File Number	039404000146 AM19
Licence No and<br>Date	0310821149/22/05/2018
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to call for following<br>information / documents from the firm:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Production / Consumption data for the year 2018-19 duly certified by GST Authorities.<br>v.

Case No.	13 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	KUSUMA PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00279795AM22
RA File Number	039404000236 AM19
Licence No and<br>Date	0310822077/02/07/2018
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to call for following

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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information / documents from the firm:

i. COA of import item (from foreign supplier) and export product indicating percentage purity and impurity profile.

Case No.	14 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	KUSUMA PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00280735AM22
RA File Number	039404000237 AM19
Licence No and<br>Date	0310822078/02/07/2018
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to revise adhoc norms as<br>under:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>SACCHARIN POWDER<br>(PURE/AR ) (DENTAL GRADE)(Not<br>less than 98% purity)<br>1 kg<br>1<br>SODIUM SACCHARIN<br>1.38 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	15 / NC/3/MEET/Apr/202223/1
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00285187AM22
RA File Number	039404000541 AM19
Licence No and<br>Date	0310824058/28/09/2018
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms andit was observed that the firm has not

The Committee considered the request of firm for enhancement of norms and it was observed that the firm has not

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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provided any technical data in support of its request. Hence, it was decided to reject the case maintaining the status quo.

Case No.	16 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00354757AM22
RA File Number	022404000113 AM19
Licence No and<br>Date	0210208784/01/11/2018
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to call for following information<br>/ documents from the firm:<br>COA of import item from foreign supplier for the relevant import.<br>i.<br>Past Production / Consumption data for last three years duly certified by Central Taxes & GST Authorities.

Case No.	17 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	U SQUARE LIFESCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00296493AM22
RA File Number	082404000329 AM19
Licence No and<br>Date	0810144243/07/01/2019
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to call for following information<br>/ documents from the firm:<br>COA of import item from foreign supplier for the relevant import for this Advance Authorization.

Case No.	18 / NC/3/MEET/Apr/202223/1
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00292348AM22
RA File Number	039404000922 AM19
Licence No and<br>Date	0310826698/30/01/2019
Norms Committee Decision:
The Committee considered the request of firm for enhancement of 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.	19 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00354703AM22
RA File Number	022404000173 AM19
Licence No and<br>Date	0210209010/26/02/2019
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
COA of import item from foreign supplier for the relevant import.<br>i.
Past Production / Consumption data for last three years duly certified by Central Taxes & GST Authorities.

Case No.	20 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	DIPS BIOSCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00340357AM22
RA File Number	039404000199 AM20
Licence No and<br>Date	0310829573/12/06/2019
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Sl. No.	Export Product	Qty.	Sl.<br>No.	Import items	Qty.
1	AGROZEN<br>FORTE<br>23.6gm<br>Sachet. Each sachet contains -<br>-(a) Diminazene Diaceturate BP<br>Vet 10.5gm, (b) Vitamin B12 BP<br>10.0mg,<br>(c)<br>Vitamin<br>B6<br>BP<br>50.0mg,<br>(d)<br>Excipients..<br>q.s.=<br>100000 Sachets (10 Sachets in each<br>Box)	<br> <br> <br> <br> <br> <br>10000 Boxes	1	CYANOCOBALAMIN BP<br>(VITAMIN B12)	4.39 kg
2	TRYPTAZENE<br>PLUS<br>23.6gm<br>Sachet contains - (a) Diminazene<br>Diaceturate BP Vet 10.5gm,<br>(b) Vitamin B12 BP 15.0mg, (c)<br>Vitamin<br>B6<br>BP<br>60.0mg,<br>(d)<br>Vitamin B1 BP 100mg (e) Vitamin<br>B2 BP 1.0mg, (f) Vitamin PP<br>(Niacin<br>BP)<br>100.0mg<br>(g)<br>Excipients.. QS...23.6gm = 100000<br>Sachets (10 Sachets in each Box)	<br> <br> <br> <br> <br> <br> <br> <br>10000 Boxes
3	VETOZEN PLUS 23.6gm Sachet.<br>Each sachet contains -<br>-(a) Diminazene Diaceturate BP<br>Vet 10.5gm, (b) Vitamin B12 BP<br>10.0mg,<br>(c)<br>Excipients..<br>q.s.=<br>100000 Sachets (10 Sachets in each<br>Box)	<br> <br> <br> <br> <br>10000 Boxes
4	APPYVET 23.6gm Sachet. Each<br>Sachet contains -<br>-(a) Diminazene Diaceturate BP<br>Vet 10.5gm, (b) Vitamin B12 BP<br>10.0mg, (c) Excipients.. q.s. =<br>84730 Sachets (10 Sachets in each<br>Box)	<br> <br> <br> <br> <br>8473 Boxes

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.<br>21 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Deferred
Party Name<br>TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>018205000340AM20
RA File Number<br>039504000318 AM20
Licence No and<br>Date<br>0310830043/03/07/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm to attendPersonal Hearing
before Norms Committee alongwith following documents / information:
Import item No.2 is not matching with Master Batch Formula.<br>i.
Quantity of import item No. 3 and 4 are not matching with Master Batch Formula and Batch Record.

Case No.	22 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00288853AM22
RA File Number	022404000076 AM20
Licence No and<br>Date	0210209378/16/08/2019
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
COA of import item from foreign supplier for the relevant import.<br>i.
Past Production / Consumption data for last three years duly certified by Central Taxes & GST Authorities.

Case No.	23 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	PANACEA BIOTEC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM REVIW00348357AM22
RA File Number	052404000683 AM20
Licence No and<br>Date	0510413419/22/01/2020

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Norms Committee Decision:

Deferred for comments of Department of Biotechnology (DBT).

Case No.	24 / NC/3/MEET/Apr/202223/1
Case Status	Case Rejected
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	018205001847AM21
RA File Number	052304000050 AM21
Licence No and<br>Date	0510414389/12/06/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished reply. Hence, the<br>Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	Case No.	25 / NC/3/MEET/Apr/202223/1	25 / NC/3/MEET/Apr/202223/1
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number			HQRNORM REVIW00287678AM22
RA File Number			039404000227 AM21
Licence No and<br>Date			0310837081/08/07/2020
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and it was decided to revise adhoc norms<br>as under:<br> <br>Sl. No. Export Product<br>Qty.<br>1<br>Desonide Cream 0.05% 15gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.188 Kgs)<br>1 Number<br>2<br>Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)<br>1 Number<br>3<br>Desonide Lotion 0.05% 59ml ( Net Wt. of Desonide USP Micronised (Sicor) is 0.738 Kgs)<br>1 Number
	Sl. No.	Export Product		Qty.
	1	Desonide Cream 0.05% 15gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.188 Kgs)		1 Number
	2	Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)		1 Number
	3	Desonide Lotion 0.05% 59ml ( Net Wt. of Desonide USP Micronised (Sicor) is 0.738 Kgs)		1 Number

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

4	Desonide Lotion 0.05% 118ml ( Net Wt. of Desonide USP Micronised (Sicor) is 1.475 Kgs)	Desonide Lotion 0.05% 118ml ( Net Wt. of Desonide USP Micronised (Sicor) is 1.475 Kgs)	Desonide Lotion 0.05% 118ml ( Net Wt. of Desonide USP Micronised (Sicor) is 1.475 Kgs)	Desonide Lotion 0.05% 118ml ( Net Wt. of Desonide USP Micronised (Sicor) is 1.475 Kgs)	Desonide Lotion 0.05% 118ml ( Net Wt. of Desonide USP Micronised (Sicor) is 1.475 Kgs)	Desonide Lotion 0.05% 118ml ( Net Wt. of Desonide USP Micronised (Sicor) is 1.475 Kgs)	Desonide Lotion 0.05% 118ml ( Net Wt. of Desonide USP Micronised (Sicor) is 1.475 Kgs)	1 Number
5	Desonide Ointment 0.05% 15gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.188 Kgs)							1 Number
6	Desonide Ointment 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)							1 Number

Sl. No.	Import Items	For the Export of 1 No. Pack
		0.05%<br>15 gm pack	0.05%<br>60 gm pack	0.05%<br>59 ml pack	0.05%<br>118 ml pack	0.05%<br>15 gm pack	0.05%<br>60 gm pack
1	Desonide<br>USP<br>Micronised<br>(Sicor)	<br>0.00765 gm	0.0306 gm	0.0301 gm	0.0602 gm	0.00765 gm	0.0306 gm

Case No.	26 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	BIOLOGICAL E. LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	018205001585AM21
RA File Number	092404000253 AM21
Licence No and<br>Date	0910069107/27/08/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis of comments furnished by Department of<br>Biotechnology vide e-mail dated 12.01.2022, the Committee decided to ratify adhoc norms for export product<br>DIPTHERIA AND TETANUS (DT) / TETANUS AND DIPTHERIA (TD) VACCINE ADSORBED 10ML 20<br>DOSES – 50000 kg, allowing wastage as applied by the firm for import item No. 1 to 9, and 13 to 15, however for<br>import item No. 10 to 12, only 2% wastage is allowed.<br> RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda and on the basis of comments furnished by Department of Biotechnology vide e-mail dated 12.01.2022, the Committee decided to ratify adhoc norms for export product DIPTHERIA AND TETANUS (DT) / TETANUS AND DIPTHERIA (TD) VACCINE ADSORBED 10ML 20 DOSES – 50000 kg, allowing wastage as applied by the firm for import item No. 1 to 9, and 13 to 15, however for import item No. 10 to 12, only 2% wastage is allowed.

Case No. 27 / NC/3/MEET/Apr/202223/1

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case Status<br>Case Approved
Party Name<br>ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM REVIW00286536AM22
RA File Number<br>039504000328 AM21
Licence No and<br>Date<br>0310838112/07/09/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07				of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:
Export product	Qty.	Sl. No.	Import items	Qty.
NAS-5((2-DIAZO-1-NAPTHOL-5-	1 kg	1	SULFO TOBIAS ACID	1.798 kg
SULFONIC ACID, SODIUM SALT))
			(Purity 65%)
RA concerned may take further necessary action as per above decision of NC.

Case No.	28 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	018205001858AM21
RA File Number	039404000644 AM21
Licence No and<br>Date	0310839600/19/11/2020
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as<br>i.
per Annexure to Appendix 4E.

i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

Case No.	29 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	TENSHI KAIZEN PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	018205001859AM21
RA File Number	072404000225 AM21
Licence No and<br>Date	0710117295/19/11/2020
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as<br>i.
per Annexure to Appendix 4E.

i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

Meeting Number	Meeting Number	NC/ 3/ MEET/ Ar/ 202223/ 1 and 29/04/2022	NC/ 3/ MEET/ Ar/ 202223/ 1 and 29/04/2022	NC/ 3/ MEET/ Ar/ 202223/ 1 and 29/04/2022	NC/ 3/ MEET/ Ar/ 202223/ 1 and 29/04/2022	NC/ 3/ MEET/ Ar/ 202223/ 1 and 29/04/2022
and Date		p
HQ File Number		018205001859AM21
RA File Number		072404000225 AM21
Licence No and<br>Date		0710117295/19/11/2020
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
<br>/ documents from th		<br>e firm:



Copy of 4.<br>i.		07 application having copy of Advance Authorization alongwith complete technical details as
<br>per Annex		<br>ure to Appendix 4E.



Case No.		30 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		018205001860AM21
RA File Number		039504000530 AM21
Licence No and<br>Date		0310839621/19/11/2020
Norms Committee Decision:<br>Th Citt idd th d d tki f li dii f t dt i
e ommee consere e case as per agena an ang cue rom earer ecson or same expor prouc n<br>Mi N2212214dd212222i d hii N114d 1
eetng o.NC/3		MEET/Feb/0/ ate/0/0 aganst avance autorzaton o.0300568 t.3-06-
<br>2021it was decid		<br>ed to ratif norms under Para 407 of HBP Vol I as per details given below or as applied b the
,		y . . y
firm, whichever is		less:






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



	CLOPIDOGREL	75MG TABLETS	<br>1 Number	1	CLOPIDOGREL	Net content in Exort
	<br>	<br>	<br> <br>		<br>	p<br>
	Clopidogrel Zen<br>Almus / Trom	tiva / Clopidogrel<br>bex (Each Tablet	<br>		BISULFATE FORM II	Description + 2%
	<br>contain 75mg of CLOPIDOGREL<br>BISULFATE FORM II)		<br>



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




Case No.		31 / NC/3/MEET/Apr/202223/1

Case No. 31 / NC/3/MEET/Apr/202223/1

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case Status	Case Deferred
Party Name	FINE ORGANICS
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	018205001867AM21
RA File Number	052304000296 AM21
Licence No and<br>Date	0510415978/24/11/2020
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as<br>i.
per Annexure to Appendix 4E.

i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

Case No.	32 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	018205001869AM21
RA File Number	052404000441 AM21
Licence No and<br>Date	0510415972/24/11/2020
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as<br>i.
per Annexure to Appendix 4E.

i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

Case No.	33 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00233450AM22
RA File Number	302404000083 AM21
Licence No and<br>Date	3010105531/25/11/2020
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

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

i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

Case No.	34 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00233934AM22
RA File Number	072404000233 AM21
Licence No and<br>Date	0710117320/25/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.5/82-ALC4/2020 dated 09.10.2020 against advance authorization No.0710116165 dt. 25.02.2020, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>REBAMIPIDE<br>102.00 mg<br>REBAMIPIDE TABLETS 100MG<br>[53921569 NO.]<br>1 Number Tablet<br>2<br>Ethyl Alcohol 200 Proof<br>(Ethanol)<br>151.00 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	35 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00231954AM22
RA File Number	039404000665 AM21
Licence No and<br>Date	0310839754/26/11/2020

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jun/202122/2 dated 02/07/2021 against advance authorization No. 0311003756 dt. 12-052021 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl.	Import items	Qty.
		No.
Sodium Stearyl Lactylate	1 kg	1	Lactic Acid	0.440 kg
		2	Stearic Acid	0.700 kg

Case No.<br>36 / NC/3/MEET/Apr/202223/1	Case No.<br>36 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>AUROBINDO PHARMA LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00235232AM22
RA File Number<br>092404000485 AM21
Licence No and<br>Date<br>0910069507/26/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.5/82-ALC4/2020 dated 09.10.2020 against advance authorization No.0910067168 dt. 13.02.2019, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied		by the firm,
whichever is less:
	Export product<br>Qty.<br>Sl. No. Import items	Qty.
	1<br>(2S,3S)-1,2-Epoxy-3-(Boc-amino)-4-phenylbutane<br>DARUNAVIR<br>PROPYLENE<br>1 kg	<br>0.587 kg
	(or) BOC-Epoxide<br>GLYCOLATE
	2<br>Activated Carbon (Carbon Enoanticromos)	0.100 kg

Case No.<br>36 / NC/3/MEET/Apr/202223/1	Case No.<br>36 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>AUROBINDO PHARMA LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00235232AM22
RA File Number<br>092404000485 AM21
Licence No and<br>Date<br>0910069507/26/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.5/82-ALC4/2020 dated 09.10.2020 against advance authorization No.0910067168 dt. 13.02.2019, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied		by the firm,
whichever is less:
	Export product<br>Qty.<br>Sl. No. Import items	Qty.
	1<br>(2S,3S)-1,2-Epoxy-3-(Boc-amino)-4-phenylbutane<br>DARUNAVIR<br>PROPYLENE<br>1 kg	<br>0.587 kg
	(or) BOC-Epoxide<br>GLYCOLATE
	2<br>Activated Carbon (Carbon Enoanticromos)	0.100 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

	3	[3R,3aS,6aR]-3-Hydroxyhexahydrofuro[2,3-	0.480 kg
		b]furanyl succicinamidyl carbonate
	4	Isobutylamine	0.330 kg

Case No.<br>37 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00232802AM22
RA File Number<br>039504000555 AM21
Licence No and<br>Date<br>0310839760/26/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.NC/3/MEET/Jul/202122/4 dated 15/07/2021against advance authorization No.0311001140 dt. 21-01-
2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the
firm, whichever is less:
Export product<br>Qty.<br>Sl. No. Import items	Qty.
TOLYLTRIAZOLE (GRANULES)<br>1 kg<br>1<br>TOLYLTRIAZOLE	1.005 kg / kg content in
	the export product
RA concerned may take further necessary action as per above decision of NC.

Case No.	38 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00235562AM22
RA File Number	342404000231 AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Licence No and Date

3410046563/26/11/2020

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.10/82-ALC4/2019 dated 29.11.2019against advance authorization No.3410045527 dt. 10.10.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. PHENOL 1 kg 1 BENZENE 0.87 kg RA concerned may take further necessary action as per above decision of NC.

Case No.	39 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	018205001864AM21
RA File Number	039404000659 AM21
Licence No and<br>Date	0310839748/26/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>COA and purity of export and import item.<br>i.<br>Impurity profile in import and export item.<br>ii.<br>Complete process of manufacturing indicating purity achieved at each step.<br>iii.<br>Production / Consumption data duly certified by GST.<br>iv.<br>Justification for 25% wastage.

Case No.	40 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	VHB MEDI SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	018205001866AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

RA File Number

039504000553 AM21

Licence No and Date

0310839755/26/11/2020

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0310834259 dt. 16.01.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. Colistmethate Sodium for injection BP COLISIN-RD 1 MIU((Net content of Import item = 8.855 kgs)) 115000 Number 1 Colistimethate Sodium Sterile EP 9.027 kg RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	41 / NC/3/MEET/Apr/202223/1	41 / NC/3/MEET/Apr/202223/1	41 / NC/3/MEET/Apr/202223/1	41 / NC/3/MEET/Apr/202223/1	41 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM APPLY 00231953AM22
RA File Number		039404000666 AM21
Licence No and<br>Date		0310839768/27/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.10/82-ALC4/2018 dated 16.10.2018 against advance authorization No.0310819184 dt. 15.02.2018, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>BEHENAMIDE<br>1 kg<br>1<br>BEHENIC ACID<br>1.11 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	BEHENAMIDE		1 kg	1	BEHENIC ACID	1.11 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case No.	42 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	MALWA OXYGEN & INDUSTRIAL GASES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00235076AM22
RA File Number	562404000035 AM21
Licence No and<br>Date	5610006002/27/11/2020
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as<br>i.
per Annexure to Appendix 4E.

i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

Case No.<br>43 / NC/3/MEET/Apr/202223/1	Case No.<br>43 / NC/3/MEET/Apr/202223/1	Case No.<br>43 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>CLARIANT INDIA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00233237AM22
RA File Number<br>039404000660 AM21
Licence No and<br>Date<br>0310839769/27/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier						decision for same export product in
Meeting No.3/82-ALC4/2019 dated 05.07.2019 against advance authorization						No.0310825405 dt.		04.12.2018, it
was decided to ratify norms under Para 4.07 of HBP Vol. I				as per details given below or as applied by the firm,
whichever is less:
	Export product	Qty.	Sl. No.	Import items				Qty.
	EHT (ETHYL HEXYL TRIAZONE) /	1 kg	1	PARA	NITRO	BENZOIC	ACID	<br>1.034 kg
	ETONE			(PNBA)
			2	PERCHLORO ETHYLENE (PCE)				0.606 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

	3	ACETO NITRILE	1.30 kg
	4	CYANURIC CHLORIDE	0.640 kg

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

Case No.	44 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00233238AM22
RA File Number	052404000444 AM21
Licence No and<br>Date	0510415997/27/11/2020
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to call for following information<br>/ documents from the firm:<br>Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as<br>per Annexure to Appendix 4E.<br>i.

i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

Case No.	45 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00234858AM22
RA File Number	092404000482 AM21
Licence No and<br>Date	0910069522/27/11/2020
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to call for following information<br>/ documents from the firm:<br>Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as<br>per Annexure to Appendix 4E.<br>i.

i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case No.	46 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00117698AM21
RA File Number	03AA04033579 AM21
Licence No and<br>Date	0311002962/31/03/2021
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as<br>i.
per Annexure to Appendix 4E.

i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

Case No.	47 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00131778AM22
RA File Number	34AA04004352 AM22
Licence No and<br>Date	3411000801/06/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and reply furnished by the firm on DGFT portal and it was observed
that the firm did not submit proper reply. Hence, it was decided to again call for following information / documents
from the firm:
Commercial value of Residue and Low & High Boiler.<br>i.
Production / Consumption data for last one year duly certified by GST

Case No.	48 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SUVEN PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00133260AM22
RA File Number	09AA04007209 AM22
Licence No and<br>Date	0911001161/07/07/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Norms Committee Decision:

Deferred for comments of TE.

Case No.	49 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SUVEN PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00133263AM22
RA File Number	09AA04003483 AM22
Licence No and<br>Date	0911001162/07/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	50 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00133324AM22
RA File Number	34AA04004084 AM22
Licence No and<br>Date	3411000813/07/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	51 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00134044AM22
RA File Number	31AA04019601 AM22
Licence No and<br>Date	3111000445/08/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Catalogue of import item No. 4 - Morpholine catalyst.<br>i.

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

ii. Whether Hydrogen will be imported or will it be procured indigenously.
iii. Production / Consumption data for last year duly certified by GST Authorities. iv. Percentage yield of reaction.
v. Decision of similar case earlier approved by NC-3.

Case No.	52 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00134197AM22
RA File Number	03AA04035672 AM22
Licence No and<br>Date	0311005214/08/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.

Case No.	Case No.	53 / NC/3/MEET/Apr/202223/1	53 / NC/3/MEET/Apr/202223/1	53 / NC/3/MEET/Apr/202223/1	53 / NC/3/MEET/Apr/202223/1	53 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM APPLY 00135169AM22
RA File Number		03AA04043282 AM22
Licence No and<br>Date		0311005238/09/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2-Amino-3-chloro-5-(TFM)<br>Pyridine<br>1.035 kg<br>8-Chloro-6-(Trifluoromethyl)<br>imidazo<br>[1,2-a]<br>pyridine-2-carboxylic<br>acid<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	8-Chloro-6-(Trifluoromethyl)<br>imidazo<br>[1,2-a]<br>pyridine-2-carboxylic<br>acid		<br> <br>1 kg	1	2-Amino-3-chloro-5-(TFM)<br>Pyridine	1.035 kg

Case No.	Case No.	53 / NC/3/MEET/Apr/202223/1	53 / NC/3/MEET/Apr/202223/1	53 / NC/3/MEET/Apr/202223/1	53 / NC/3/MEET/Apr/202223/1	53 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM APPLY 00135169AM22
RA File Number		03AA04043282 AM22
Licence No and<br>Date		0311005238/09/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2-Amino-3-chloro-5-(TFM)<br>Pyridine<br>1.035 kg<br>8-Chloro-6-(Trifluoromethyl)<br>imidazo<br>[1,2-a]<br>pyridine-2-carboxylic<br>acid<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	8-Chloro-6-(Trifluoromethyl)<br>imidazo<br>[1,2-a]<br>pyridine-2-carboxylic<br>acid		<br> <br>1 kg	1	2-Amino-3-chloro-5-(TFM)<br>Pyridine	1.035 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23


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

Case No.	54 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	CERIGO ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00135220AM22
RA File Number	03AA04027670 AM22
Licence No and<br>Date	0311005241/09/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Percentage yield of reaction at every stage.

Case No.	55 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00135125AM22
RA File Number	30AA04009718 AM22
Licence No and<br>Date	3011000867/09/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case No.	Case No.	56 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ	File Number	HQRNORM APPLY 00136426AM22
RA File Number		03AA04000007 AM22
Licence No and<br>Date		0311005286/11/07/2021
Norms Committee Decision:
The	Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.4/82-ALC4/2020 dated 18.09.2020against advance authorization No.0910065468 dt.				15.09.2017, it
was	decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:
	Export Product	Qty.<br>Sl. No.	Import items	Qty.
	Camphene	1 kg<br>1	Alpha Pinene	1.140 kg
<br>RA	<br>concerned may	take further necessary action as per above decision of NC.

Case No.	57 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00136446AM22
RA File Number	07AA04010172 AM22
Licence No and<br>Date	0711001451/11/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	58 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00137172AM22
RA File Number	08AA04014354 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Licence No and 0811001969/12/07/2021 Date Norms Committee Decision:

Deferred for comments of TE.

Case No.	59 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	BIOMATRIX HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00137175AM22
RA File Number	08AA04014083 AM22
Licence No and<br>Date	0811001973/12/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Mar/202122/15 dated 17/03/2022against advance authorization No.0811000629 dt. 10-<br>02-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Erythromycin Stearate Oral Suspension<br>250mg/5ml(Each 5ml of reconstituted<br>suspension<br>contains<br>Erythromycin<br>Stearate BP Eq. to Erythromycin<br>250mg), 100 ml bottle<br>628500 Number<br>Bottles<br>1<br>Erythromycin Stearate BP<br>4578.4 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	60 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00137286AM22
RA File Number	03AA04025361 AM22
Licence No and<br>Date	0311005326/12/07/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

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

i. Description of all Excipients shown in items to be imported may be furnished as per their chemical name.
ii. Details of Packaging Material may be furnished.
iii. Copy of Master Batch Formula for all export items indicating net content of inputs in each export.

Case No.	61 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00136463AM22
RA File Number	03AA04044012 AM22
Licence No and<br>Date	0311005290/12/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jul/202122/4 dated 15/07/2021 against advance authorization No.0311004815 dt. 22-06-<br>2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>MAP METHYL VINYL PHOSPHATE CAS<br>NO 189188383 4R SS 6S 3 DIPHENYLOXY<br>6 1R HYDROXYETHYL 4 METHYL 7 OXO<br>1 AZABICYCLO 3 2 0<br>457.50 kg<br>DORIPENEM STERILE<br>183 kg<br>2<br>DORIPENEM<br>SIDE<br>CHAIN<br>4<br>NITROBENZYL 2S 4S 4 ACETYLTHIO 2 N<br>SULFAMOYL<br>N<br>TERT<br>BUTOXYCARBONYL<br>AMINO<br>PYRROLIDINE 1 CARBOXYLAT<br>450.50 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 62 / NC/3/MEET/Apr/202223/1

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case Status<br>Case Approved
Party Name<br>MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00136603AM22
RA File Number<br>03AA04022055 AM22
Licence No and<br>Date<br>0311005307/12/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same			export product in
Meeting No.NC/3/MEET/Feb/202122/14 dated 21/02/2022against advance authorization No.0310824148 dt. 03-
10-2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the
firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
SODIUM ACETATE (TRIHYDRATE)<br>1 kg	1	ACETIC ACID	0.463 kg
	2	CAUSTIC ACID	0.568 kg
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	63 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00136846AM22
RA File Number	34AA04005040 AM22
Licence No and<br>Date	3411000829/12/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	64 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00137048AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

RA File Number	34AA04005105 AM22
Licence No and<br>Date	3411000838/12/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	65 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00138116AM22
RA File Number	26AA04002063 AM22
Licence No and<br>Date	2611000198/13/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	66 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00138657AM22
RA File Number	03AA04047965 AM22
Licence No and<br>Date	0311005362/14/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	67 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00139912AM22
RA File Number	03AA04027532 AM22
Licence No and<br>Date	0311005407/15/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

i. Description of all Excipients shown in items to be imported may be furnished as per their chemical name.
ii. Details of Packaging Material may be furnished.
iii. Copy of Master Batch Formula for all export items indicating net content of inputs in each export.

Case No.	68 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	ELIXIR PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00141649AM22
RA File Number	08AA04016381 AM22
Licence No and<br>Date	0811002031/19/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.10/82-ALC4/2018 dated 16.10.2018 against advance authorization No.0810142240 dt. 26.03.2018, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>ISOVALERALDEHYDE<br>0.6068 kg<br>2<br>ETHYL CYANOACETATE<br>0.7814 kg<br>3-ISOBUTYL GLUTARIC ACID<br>(CMH DIACID)<br>1 kg<br>3<br>DIETHYL MALONATE<br>0.90 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	69 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00143189AM22
RA File Number	52AA04009806 AM22
Licence No and	5211001019/20/07/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Date

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 5/82-ALC4/2020 dated 09.10.2020 against advance authorization No. 0310834879 dt. 17.02.2020 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
METHYL PARABEN	1 kg	1	PARA HYDROXY BENZOIC ACID	0.969 kg

Case No.	70 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00143025AM22
RA File Number	07AA04016475 AM22
Licence No and<br>Date	0711001517/20/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	71 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00143924AM22
RA File Number	07AA04016516 AM22
Licence No and<br>Date	0711001521/21/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23


Case No.		72 / NC/3/MEET/Apr/202223/1

Case Status		Case Approved

Party Name		R.L.FINE CHEM PRIVATE LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022

HQ File Number		HQRNORM APPLY 00144650AM22

RA File Number		07AA04016659 AM22

Licence No and<br>Date		0711001528/22/07/2021

Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>1 BROMO 3 CHLORO PROPANE<br>0.95 kg<br>2<br>TETRA HYDRO FURAN<br>0.25 kg<br>CYCLOBENZAPRINE HCL(USP)<br>1 kg<br>3<br>ACETONE<br>0.75 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Q	ty.	Sl.<br>		Import	items	Qty.
					No.
	CYCLOBENZAPRINE HCL(USP)		1	kg	1
							1 BRO	MO 3 CHLORO PROPANE	0.95 kg
					2
							TETRA	HYDRO FURAN	0.25 kg
					3
							ACETO	NE	0.75 kg
	<br>A concerned may take further necessary a			ction as	per a
						bove decision		of NC.

Case No.	73 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00144695AM22
RA File Number	07AA04016662 AM22
Licence No and<br>Date	0711001530/22/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	74 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00145072AM22
RA File Number	05AA04057335 AM22
Licence No and<br>Date	0511003777/22/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	75 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00145203AM22
RA File Number	34AA04005573 AM22
Licence No and<br>Date	3411000885/22/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	76 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00145220AM22
RA File Number	34AA04004907 AM22
Licence No and<br>Date	3411000793/22/07/2021
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following
information / documents from the firm:
Item of import is Propylene, while material balance is given for raw material Benzene. Please give<br>i.
material balance from Propylene.

i. Item of import is Propylene, while material balance is given for raw material Benzene. Please give material balance from Propylene.

Case No.	77 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	MERIDIAN ENTERPRISES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

and Date
HQ File Number	HQRNORM APPLY 00145626AM22
RA File Number	03AA04051822 AM22
Licence No and<br>Date	0311005561/23/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	78 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00146194AM22
RA File Number	03AA04051472 AM22
Licence No and<br>Date	0311005584/23/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	79 / NC/3/MEET/Apr/202223/1	79 / NC/3/MEET/Apr/202223/1	79 / NC/3/MEET/Apr/202223/1	79 / NC/3/MEET/Apr/202223/1	79 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM APPLY 00145549AM22
RA File Number		09AA04008489 AM22
Licence No and<br>Date		0911001257/23/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Oct/202122/10 dated 12/11/2021against advance authorization No.0911000180 dt. 11-<br>01-2021,it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Tolvaptan (Pharmaceutical product)<br>1 kg<br>1<br>7-Chloro-1,2,3,4-tetrahydro-5H-1-<br>Benzazepin-5-one<br>0.96 kg
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	Tolvaptan (Pharmaceutical product)		1 kg	1	7-Chloro-1,2,3,4-tetrahydro-5H-1-<br>Benzazepin-5-one	0.96 kg

Case No.	Case No.	79 / NC/3/MEET/Apr/202223/1	79 / NC/3/MEET/Apr/202223/1	79 / NC/3/MEET/Apr/202223/1	79 / NC/3/MEET/Apr/202223/1	79 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM APPLY 00145549AM22
RA File Number		09AA04008489 AM22
Licence No and<br>Date		0911001257/23/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Oct/202122/10 dated 12/11/2021against advance authorization No.0911000180 dt. 11-<br>01-2021,it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Tolvaptan (Pharmaceutical product)<br>1 kg<br>1<br>7-Chloro-1,2,3,4-tetrahydro-5H-1-<br>Benzazepin-5-one<br>0.96 kg
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	Tolvaptan (Pharmaceutical product)		1 kg	1	7-Chloro-1,2,3,4-tetrahydro-5H-1-<br>Benzazepin-5-one	0.96 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

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

Case No.	80 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00146728AM22
RA File Number	03AA04046766 AM22
Licence No and<br>Date	0311005598/24/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	81 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00146729AM22
RA File Number	03AA04029068 AM22
Licence No and<br>Date	0311005599/24/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	82 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00146743AM22
RA File Number	03AA04045550 AM22
Licence No and<br>Date	0311005604/25/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

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

Case No.	Case No.	Case No.	Case No.	83 / NC/3/MEET/Apr/202223/1	83 / NC/3/MEET/Apr/202223/1	83 / NC/3/MEET/Apr/202223/1	83 / NC/3/MEET/Apr/202223/1	83 / NC/3/MEET/Apr/202223/1
Case Status				Case Approved

Party Name				ZENTIVA PRIVATE LIMITED

Meeting Number an			d
<br>Date				NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number				HQRNORM APPLY 00147236AM22
RA File Number				34AA04005732 AM22

Licence No and Da			te	3411000898/26/07/2021

Norms Committee			Decision:
The Committee co			nsidered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.NC/3/MEET/Oct/202122/10 dated 12/11/2021 against advance authorization No.0311000408 dt. 28-12-<br>2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:

	Sl. No.	Export product<br>			Qty.	Sl. No.	Import items	Qty.
	1	Ramilich / Ramilich Comp /			<br>1 Number	1	Hydrochlorothiazide	12.75 mg / Tablet
		Ramipril HCT ZT/ZTV 5-12.5mg<br>(Net<br>Wt.<br>Hydrochlorothiazide<br>250.000 KGS)			<br>
	2	Ramilich / Ramilich Comp /<br>Ramipril HCT ZT/ZTV 2.5-12.5mg<br>(Net<br>Wt.<br>Hydrochlorothiazide<br>223.650 KGS)			<br> <br> <br>1 Number	1	Hydrochlorothiazide	12.75 mg / Tablet
	3	Ramilich / Ramilich Comp /<br>Ramipril HCT ZT/ZTV 5-25mg			<br> <br>1 Number	1	Hydrochlorothiazide	25.50 mg / Tablet

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

	(Net	Wt.	Hydrochlorothiazide
	535.00	KGS)

Case No.	84 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	CONNEX PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00147368AM22
RA File Number	26AA04002378 AM22
Licence No and<br>Date	2611000203/26/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.10/82-ALC4/2018 dated 16.10.2018 against advance authorization No.3410043944 dt.<br>08.03.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CHLOROMETHYL ISOPROPYL<br>CARBONATE<br>1 kg<br>1<br>METHYLCHLORO FORMATE<br>0.943 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	85 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SYNOKEM PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00147457AM22
RA File Number	05AA04059070 AM22
Licence No and<br>Date	0511003826/26/07/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Norms Committee Decision:

Deferred for comments of TE.

Case No.	86 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00148387AM22
RA File Number	52AA04010429 AM22
Licence No and<br>Date	5211001058/27/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	87 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00148419AM22
RA File Number	31AA04021097 AM22
Licence No and<br>Date	3111000476/27/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	88 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00148633AM22
RA File Number	07AA04017970 AM22
Licence No and<br>Date	0711001564/27/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda it was decided to ratify norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Export product	Qty.	Sl.<br>No.	Import items	Qty.
TRIMIPRAMINE<br>MESYLATE<br>(USP/EP)	<br>1 kg	1	IMINODIBENZYL	0.72 kg
		2	1 BROMO 3 CHLORO 2 METHYL<br>PROPANE	<br>0.53 kg
		3	ACETONE	1.00 kg

Case No.	89 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00148635AM22
RA File Number	07AA04017973 AM22
Licence No and<br>Date	0711001565/27/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	90 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ZEE LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00149067AM22
RA File Number	05AA04057371 AM22
Licence No and<br>Date	0511003868/28/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	91 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00149310AM22
RA File Number	05AA04061858 AM22
Licence No and<br>Date	0511003876/28/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Oct/202122/10 dated 12/11/2021against advance authorization No.0511000307 dt. 21-<br>12-2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Inokain Eye Drops 0.4 Percent 5ml<br>1 Vial<br>1<br>Benoxinate HCL<br>20.4 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	92 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00150128AM22
RA File Number	03AA04054005 AM22
Licence No and<br>Date	0311005722/29/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Overall yield of 47% is low. Please furnish yield at every stage of reaction and justification for the same.<br>i.<br>Appendix 11 A seems to be wrong. Since total consumption shown is 7.315 MT, while it should be 410 MT.<br>Please clarify.<br>ii.<br>Production / Consumption data duly certified by GST.

Case No.	93 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	RAJASTHAN ANTIBIOTICS LTD

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00150875AM22
RA File Number	05AA04055660 AM22
Licence No and<br>Date	0511003910/30/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	94 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	PMC RUBBER CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00272783AM22
RA File Number	02AA04035173 AM22
Licence No and<br>Date	0211001583/02/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	95 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00272834AM22
RA File Number	03AA04014502 AM22
Licence No and<br>Date	0311009117/02/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	96 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00272951AM22
RA File Number	03AA04014150 AM22
Licence No and<br>Date	0311009127/02/12/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Deferred for comments of TE.

Case No.	97 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00272165AM22
RA File Number	03AA040124486 AM22
Licence No and<br>Date	0311009090/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>COA and purity of export and import item.<br>i.<br>Impurity profile in import and export item.<br>ii.<br>Complete process of manufacturing indicating purity achieved at each step.<br>iii.<br>Production / Consumption data duly certified by GST.<br>iv.<br>Justification for 25% wastage.

Case No.	Case No.	98 / NC/3/MEET/Apr/202223/1	98 / NC/3/MEET/Apr/202223/1	98 / NC/3/MEET/Apr/202223/1	98 / NC/3/MEET/Apr/202223/1	98 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM APPLY 00272174AM22
RA File Number		05AA040106672 AM22
Licence No and<br>Date		0511006574/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.7/82-ALC4/2020 dated 04.12.2020against advance authorization No.0510415817 dt. 10.11.2020, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Nepafenac Ophthalmic Suspension, 0.1 Percent<br>w/v NEPALACT Sterile Eye Drops, 5ml)<br>62000 Number<br>1<br>Nepafenac<br>316.2 Gram
	Export Product		Qty.	Sl. No.	Import items	Qty.
	Nepafenac Ophthalmic Suspension, 0.1 Percent<br>w/v NEPALACT Sterile Eye Drops, 5ml)		<br> <br>62000 Number	1	Nepafenac	316.2 Gram

Case No.	Case No.	98 / NC/3/MEET/Apr/202223/1	98 / NC/3/MEET/Apr/202223/1	98 / NC/3/MEET/Apr/202223/1	98 / NC/3/MEET/Apr/202223/1	98 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM APPLY 00272174AM22
RA File Number		05AA040106672 AM22
Licence No and<br>Date		0511006574/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.7/82-ALC4/2020 dated 04.12.2020against advance authorization No.0510415817 dt. 10.11.2020, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Nepafenac Ophthalmic Suspension, 0.1 Percent<br>w/v NEPALACT Sterile Eye Drops, 5ml)<br>62000 Number<br>1<br>Nepafenac<br>316.2 Gram
	Export Product		Qty.	Sl. No.	Import items	Qty.
	Nepafenac Ophthalmic Suspension, 0.1 Percent<br>w/v NEPALACT Sterile Eye Drops, 5ml)		<br> <br>62000 Number	1	Nepafenac	316.2 Gram

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

(PRANAYAM)((Each ml contains Nepafenac 1.0 mg - Equivalent to 310.000 Gram of Bulk Drug))

Case No.	99 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00272724AM22
RA File Number	03AA040127775 AM22
Licence No and<br>Date	0311009114/02/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/ documents from the
firm:
Stoichiometric balance between import and export on molar basis to arrive at the quantity of raw material asked for.

Case No.	100 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	AMARA LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00272745AM22
RA File Number	09AA04018011 AM22
Licence No and<br>Date	0911001982/02/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	101 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00274117AM22
RA File Number	09AA04018279 AM22

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Licence No and<br>Date	Licence No and<br>Date	0911001989/03/12/2021	0911001989/03/12/2021	0911001989/03/12/2021	0911001989/03/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Feb/202122/14dated21/02/2022 against advance authorization No.0911000765dt.06-05-<br>2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>L-(-)MENTHOL (Purity NMT 97%)<br>0.99 kg<br>PURE L-(-)MENTHOL<br>(Chromatographic Purity NLT 99%<br>by G.C.)<br>1 kg<br>2<br>Toluene<br>0.99 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product	Qty.	Sl.<br>No.	Import items	Qty.
	PURE L-(-)MENTHOL<br>(Chromatographic Purity NLT 99%<br>by G.C.)	<br>1 kg	1	L-(-)MENTHOL (Purity NMT 97%)	0.99 kg
			2	Toluene	0.99 kg
			per above decision of NC.

Case No.	102 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00274252AM22
RA File Number	09AA04018274 AM22
Licence No and<br>Date	0911001996/03/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	103 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00274369AM22
RA File Number	09AA04017937 AM22
Licence No and<br>Date	0911001997/03/12/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

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

Export product	Qty.	Sl. No.	Import items	Qty.
TADALAFIL	1 kg	1	Methyl(1R,3R)-1-(benzol(d)(1,3)dioxol-5-yl)-2-(2-<br>chloroacetyl)-2,3,4,9-tetrahydro-1H-Pyrido(3,4-<br>b)indole-3- carboxylate	1.02 kg

Case No.	104 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00273476AM22
RA File Number	34AA04009751 AM22
Licence No and<br>Date	3411001491/03/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	105 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	MAXTAR BIO GENICS
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00273717AM22
RA File Number	05AA040106605 AM22
Licence No and<br>Date	0511006619/03/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br> Strength of Export Product as per DML.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.<br>106 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00273970AM22
RA File Number<br>05AA040108674 AM22
Licence No and<br>Date<br>0511006625/03/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.NC/3/MEET/Oct/202122/10 dated 12/11/2021 against advance authorization No.			0511000306 dt. 21-12-
2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as		per details given below or as applied by the
firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
(Each ml Containing 8 mg Tropicamide)<br>1 Number	1	Tropicamide	40.8 mg / 5 ml vial
RA concerned may take further necessary action as per above decision of		NC.

Case No.	107 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00274052AM22
RA File Number	03AA040121338 AM22
Licence No and<br>Date	0311009169/03/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	108 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00274069AM22
RA File Number	03AA040121871 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Licence No and 0311009171/03/12/2021 Date Norms Committee Decision: Deferred for comments of TE.

Case No.	109 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	RAKSHIT PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00276086AM22
RA File Number	09AA04016769 AM22
Licence No and<br>Date	0911002001/06/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	110 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00276162AM22
RA File Number	03AA040123869 AM22
Licence No and<br>Date	0311009212/06/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	111 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	YASH RASAYAN & CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00276335AM22
RA File Number	34AX04000001 AM22
Licence No and<br>Date	3411001494/06/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Feb/202122/14dated21/02/2022 against advance authorization No.3410044333dt.16-07-<br>2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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firm, whichever is less:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
2 METHOXY BENZOIC ACID	1 kg	1	METHYL SALICYLATE	1.052 kg
		2	DIMETHYL SULPHATE	0.8717 kg

Case No.	112 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00276913AM22
RA File Number	05AA040105427 AM22
Licence No and<br>Date	0511006662/06/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	113 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00276997AM22
RA File Number	30AX04000001 AM22
Licence No and<br>Date	3011001471/06/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	114 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Party Name	AURA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00277561AM22
RA File Number	03AA040123116 AM22
Licence No and<br>Date	0311009243/07/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	115 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00277912AM22
RA File Number	05AA040108247 AM22
Licence No and<br>Date	0511006681/07/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>116 / NC/3/MEET/Apr/202223/1	Case No.<br>116 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00277924AM22
RA File Number<br>05AX04000035 AM22
Licence No and<br>Date<br>0511006685/07/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of				HBP Vol. I as
per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.
	INOKAIN EYE DROPS 0.4 PERCENT 5 ML<br>319424 Vial	1	Benoxinate HCL	6.52 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case No.<br>117 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00277929AM22
RA File Number<br>05AX04000024 AM22
Licence No and<br>Date<br>0511006688/07/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue		from earlier decision for same export product in
Meeting No.2/82-ALC4/2020 dated 10.07.2020 against advance authorization No.0510411666 dt. 28.08.2019, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as	per details given below or as		applied by the firm,
whichever is less:
Export product<br>Qty.<br>Sl. No.		Import items	Qty.
TOBRISS (TOBRAMYCIN 0.3 PERCENT)<br>1 Vial<br>1		Tobramycin Sulphate	19.057 mg/ Vial
EYE DROPS 5 ML VIAL
RA concerned may take further necessary action as per above decision of NC.

Case No.	118 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	ZENTIVA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00277999AM22
RA File Number	03AX04000024 AM22
Licence No and Date	0311009262/07/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Oct/202122/10 dated 12/11/2021 against advance authorization No.0311000408 dt. 28-12-<br>2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
1	Ramilich / Ramilich Comp	/ Ramipril	<br>1 Number	1	Hydrochlorothiazide	12.75 mg /
	HCT ZT/ZTV 5-12.5mg,	(Net Wt.				Tablet
	Hydrochlorothiazide 125.00	KGS)((Net
	Wt. Ramipril 50.00 KGS))			2	Ramipril	5.10 mg
2	Ramilich / Ramilich Comp	/ Ramipril	<br>1 Number	1	Hydrochlorothiazide	12.75 mg /
	HCT ZT/ZTV 2.5-12.5mg	(Net Wt.				Tablet
	Hydrochlorothiazide 125.00	KGS)((Net
	Wt. Ramipril 25.00 KGS))			2	Ramipril	2.55 mg
3	Ramilich / Ramilich Comp	/ Ramipril	<br>1 Number	1	Hydrochlorothiazide	25.50 mg /
	HCT<br>ZT/ZTV<br>5-25mg	(Net<br>Wt.				Tablet
	Hydrochlorothiazide 750.00	KGS)((Net
	Wt. Ramipril 150.00 KGS))			2	Ramipril	5.10 mg

Case No.<br>119 / NC/3/MEET/Apr/202223/1	Case No.<br>119 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>BIOXERA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00279633AM22
RA File Number<br>03AA040131282 AM22
Licence No and<br>Date<br>0311009297/08/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same		export product in
Meeting No.5/82-ALC4/2020 dated 09.10.2020 against advance authorization No.3410045821 dt. 28.01.2020, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:
	Export product<br>Qty.<br>Sl. No.<br>Import items	Qty.
	BENFOTIAMINE<br>1 kg<br>1<br>THIAMINE HYDROCHLORIDE	0.922 kg

Case No.<br>119 / NC/3/MEET/Apr/202223/1	Case No.<br>119 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>BIOXERA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00279633AM22
RA File Number<br>03AA040131282 AM22
Licence No and<br>Date<br>0311009297/08/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same		export product in
Meeting No.5/82-ALC4/2020 dated 09.10.2020 against advance authorization No.3410045821 dt. 28.01.2020, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:
	Export product<br>Qty.<br>Sl. No.<br>Import items	Qty.
	BENFOTIAMINE<br>1 kg<br>1<br>THIAMINE HYDROCHLORIDE	0.922 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case No.	Case No.	Case No.	120 / NC/3/MEET/Apr/202223/1	120 / NC/3/MEET/Apr/202223/1	120 / NC/3/MEET/Apr/202223/1	120 / NC/3/MEET/Apr/202223/1	120 / NC/3/MEET/Apr/202223/1
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number			HQRNORM APPLY 00279782AM22
RA File Number			09AA04011868 AM22
Licence No and<br>Date			0911001516/08/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0910068227 dt.<br>27.11.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Sl. No. Export Product<br>Qty<br>Sl. No. Import Items<br>Qty<br>1<br>Heparin Sodium<br>175.00 mg / vial<br>2<br>Rubber Stoppers<br>Relevant<br>as<br>per<br>packing policy<br>1<br>Heparin Sodium Injection USP,<br>1000 USP Heparin Units/ml 10ml<br>fill in a Vial(Each ml contains<br>Heparin Sodium USP<br>1000 USP Heparin Units (From<br>Porcine<br>intestines),<br>Benzyl<br>alcohol NF 0.01ml, Water for<br>Injection USP q.s.)<br>1 Number<br>3<br>Flip off Seals<br>Relevant<br>as<br>per<br>packing policy<br>1<br>Heparin Sodium<br>291.67 mg / vial<br>2<br>Rubber Stoppers<br>Relevant<br>as<br>per<br>packing policy<br>2<br>Heparin Sodium Injection USP,<br>1000 USP Heparin Units/ml 30ml<br>fill in a Vial(Each ml contains<br>Heparin Sodium USP<br>1000 USP Heparin Units (From<br>Porcine<br>intestines),<br>Benzyl<br>alcohol NF 0.01ml, Water for<br>Injection USP q.s.)<br>1 Number<br>3<br>Flip off Seals<br>Relevant<br>as<br>per<br>packing policy<br>Heparin Sodium Injection USP,<br>Heparin Sodium<br>3<br>1 Number<br>1<br>116.67 mg / vial
	Sl. No.	Export Product		Qty	Sl. No.	Import Items	Qty
	1	Heparin Sodium Injection USP,<br>1000 USP Heparin Units/ml 10ml<br>fill in a Vial(Each ml contains<br>Heparin Sodium USP<br>1000 USP Heparin Units (From<br>Porcine<br>intestines),<br>Benzyl<br>alcohol NF 0.01ml, Water for<br>Injection USP q.s.)		<br> <br> <br> <br> <br> <br>1 Number	1	Heparin Sodium	175.00 mg / vial
					2	Rubber Stoppers	Relevant<br>as<br>per<br>packing policy
					3	Flip off Seals	Relevant<br>as<br>per<br>packing policy
	2	Heparin Sodium Injection USP,<br>1000 USP Heparin Units/ml 30ml<br>fill in a Vial(Each ml contains<br>Heparin Sodium USP<br>1000 USP Heparin Units (From<br>Porcine<br>intestines),<br>Benzyl<br>alcohol NF 0.01ml, Water for<br>Injection USP q.s.)		<br> <br> <br> <br> <br> <br>1 Number	1	Heparin Sodium	291.67 mg / vial
					2	Rubber Stoppers	Relevant<br>as<br>per<br>packing policy
					3	Flip off Seals	Relevant<br>as<br>per<br>packing policy
	3	Heparin Sodium Injection USP,		<br>1 Number	1	Heparin Sodium	116.67 mg / vial

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23


5000 USP Heparin Units/ml 1ml
fill in a Vial(Each ml contains
Heparin Sodium USP	2	Rubber Stoppers	Relevant	as	per
5000 USP Heparin Units (From			packing policy
Porcine<br>intestines),<br>Benzyl
alcohol NF 0.01ml, Water for<br>Injection USP q.s.)	3	Flip off Seals	Relevant<br>as<br>packing policy		per
A concerned may take further necessary action as per above	decision	of NC.

Case No.	121 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00279887AM22
RA File Number	09AA04018537 AM22
Licence No and<br>Date	0911002024/08/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	Case No.	122 / NC/3/MEET/Apr/202223/1	122 / NC/3/MEET/Apr/202223/1	122 / NC/3/MEET/Apr/202223/1	122 / NC/3/MEET/Apr/202223/1	122 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		AARTI INDUSTRIES LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM APPLY 00280152AM22
RA File Number		03AA040121801 AM22
Licence No and<br>Date		0311009305/09/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,3,4 TRI FLUORO ANILINE<br>0.86 kg<br>3,4,5<br>TRIFLUORO<br>BROMO 1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	3,4,5<br>TRIFLUORO<br>BROMO		1 kg	1	2,3,4 TRI FLUORO ANILINE	0.86 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

2<br>SODIUM HYPOPHOSPHITE<br>0.23 kg<br>3<br>BROMINE<br>0.4945 kg<br>BENZENE<br>4<br>HYDROGEN PEROXIDE 50%<br>0.1978 kg<br>RA concerned may take further necessary action as per above decision of NC.	BENZENE		2	SODIUM HYPOPHOSPHITE	0.23 kg
			3	BROMINE	0.4945 kg
			4	HYDROGEN PEROXIDE 50%	0.1978 kg

Case No.	123 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00280232AM22
RA File Number	03AX04000052 AM22
Licence No and<br>Date	0311009315/09/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Dec/202122/12 dated 17/12/2021against advance authorization No.0310839621 dt.<br>19.11.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>CLOPIDOGREL 75MG TABLETS<br>Clopidogrel Zentiva / Clopidogrel<br>Almus<br>/<br>Trombex(Each<br>Tablet<br>contain 75mg of CLOPIDOGREL<br>BISULFATE FORM II<br>1 Number<br>1<br>CLOPIDOGREL<br>BISULFATE FORM II<br>Net content in Export<br>Description + 2%<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	124 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number and	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Date
HQ File Number	HQRNORM APPLY 00280354AM22
RA File Number	03AA040128979 AM22
Licence No and Date	0311009325/09/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Dec/202122/12 dated 17/12/2021against advance authorization No.0311005383 dt. 14-<br>07-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>CHLORAMPHENICOL EYE DROPS 10<br>ML((EACH<br>VIAL<br>CONTAINS<br>CHLORAMPHENICOL<br>MICRONISED<br>0.050GM NET WT OF BULK DRUG IS<br>18.98 KGS))<br>1 Number<br>1<br>Chloramphenicol<br>Micronized<br>51.00 mg /<br>Vial<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	125 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00280355AM22
RA File Number	03AA040124200 AM22
Licence No and<br>Date	0311009326/09/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.

Case No. 126 / NC/3/MEET/Apr/202223/1

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00280583AM22
RA File Number	31AX04000004 AM22
Licence No and<br>Date	3111000770/09/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Dec/202122/12 dated 17/12/2021against advance authorization No.3111000493 dt. 30-<br>07-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,6 xylenol<br>1.06 kg<br>2<br>Paraformaldehyde<br>0.130 kg<br>DNOVO BP818 (Powder)<br>(Tetra Methyl Bisphenol F)<br>1 kg<br>3<br>Methanol<br>0.100 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	127 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00281830AM22
RA File Number	05AX04000037 AM22
Licence No and<br>Date	0511006792/10/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Oct/202122/10 dated 12/11/2021against advance authorization No.0511000310 dt. 21-<br>12-2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Oct/202122/10 dated 12/11/2021 against advance authorization No. 0511000310 dt. 2112-2020 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Brinex / Brinex-M / Brinarga / Brinera<br>(Brinzolamide Opthalmic Suspension 1%)-<br>5ml(Brinex / Brinex-M / Brinarga / Brinera<br>(Brinzolamide Opthalmic Suspension 1%)-<br>5ml)<br>1 Vial<br>1<br>Brinzolamide<br>51.00 mg / Vial<br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.<br>	Sl. No.	Import items	Qty.
	Brinex / Brinex-M / Brinarga / Brinera<br>(Brinzolamide Opthalmic Suspension 1%)-<br>5ml(Brinex / Brinex-M / Brinarga / Brinera<br>(Brinzolamide Opthalmic Suspension 1%)-<br>5ml)	<br> <br> <br> <br>1 Vial<br>	1	Brinzolamide	51.00 mg / Vial

Case No.	128 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00281870AM22
RA File Number	05AX04000039 AM22
Licence No and<br>Date	0511006799/10/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	129 / NC/3/MEET/Apr/202223/1	129 / NC/3/MEET/Apr/202223/1	129 / NC/3/MEET/Apr/202223/1	129 / NC/3/MEET/Apr/202223/1	129 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00283723AM22
RA File Number	07AA04040800 AM22
Licence No and<br>Date	0711002618/13/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.12/82-ALC4/2018 dated 12.12.2018against advance authorization No.0710112292 dt. 23.10.2017, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.
		Qty.	Sl. No.	Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

TIEMONIUM METHYLSULPHATE 1 kg 1 2-ACETYL THIOPHENE 0.75 kg

Case No.	130 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00283764AM22
RA File Number	09AA04017426 AM22
Licence No and<br>Date	0911001978/13/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	131 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00283775AM22
RA File Number	07AA04040754 AM22
Licence No and<br>Date	0711002620/13/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	132 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00283847AM22
RA File Number	03AX04000077 AM22
Licence No and<br>Date	0311009414/13/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case No.	133 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00283891AM22
RA File Number	09AA04018526 AM22
Licence No and<br>Date	0911002040/13/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	134 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00283899AM22
RA File Number	09AX04000002 AM22
Licence No and<br>Date	0911002041/13/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	135 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00283907AM22
RA File Number	09AX04000009 AM22
Licence No and<br>Date	0911002042/13/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	136 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00283711AM22
RA File Number	07AA04040751 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Licence No and 0711002615/13/12/2021 Date Norms Committee Decision: Deferred for comments of TE.

Case No.	137 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00284396AM22
RA File Number	05AX04000058 AM22
Licence No and<br>Date	0511006831/13/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	138 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00285202AM22
RA File Number	09AA04017427 AM22
Licence No and<br>Date	0911002053/14/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	139 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	COMBITIC GLOBAL CAPLET PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00286156AM22
RA File Number	33AA04008791 AM22
Licence No and<br>Date	3311000515/15/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jun/202122/2 dated 02/07/2021 against advance authorization No.3311000189 dt. 19-04-<br>2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

firm, whichever is less:

Export Product	Qty.	Sl. No.	Import items	Qty.
CIPROFLOXACIN TABLETS IP 500MG	1 Number	1	CIPROFLOXACIN<br>HYDROCHLORIDE IP	555 mg /<br>Tablet

Case No.	140 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	GRAMEN BOTANICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00286824AM22
RA File Number	05AA040108712 AM22
Licence No and<br>Date	0511006918/15/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>BERBERINE HYDROCHLORIDE<br>(97 PERCENT)<br>1 kg<br>1<br>BERBERIS ARISTATA EXTRACT<br>0.90 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	141 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00286968AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

RA File Number

13AX04000009 AM22

Licence No and Date

1311000821/15/12/2021

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance authorization No.1311000341 dt. 19-05- 2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export Product Qty. Sl. No. Import items Qty. AZODICARBONAMI DE (BLOWING AGENT), PURITY MINIMUM 99.50 PERCENT, PARTICLE SIZE 4.5 TO 5.5 PERCENT MICRON 200000 kg 1 AZODICARBONAMIDE CRUDE PURITY MINIMUM 97 PERCENT PARTICLE SIZE 13 TO 15 PERCENT MICRON 201000 kg RA concerned may take further necessary action as per above decision of NC.

Case No.	142 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00286998AM22
RA File Number	31AX04000006 AM22
Licence No and<br>Date	3111000788/15/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	143 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	KUSUMA PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00287868AM22
RA File Number	03AX04000216 AM22
Licence No and<br>Date	0311009541/16/12/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Deferred for comments of TE.

Case No.	Case No.	144 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		AMOLI ORGANICS PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM APPLY 00288115AM22
RA File Number		03AA040125782 AM22
Licence No and Date		0311009329/16/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify			norms under Para 4.07 of	HBP Vol. I as
per details given below or as applied by the firm, whichever is less:
	Export Product	Qty.<br>Sl. No. Import items		Qty.
	Rosuvastatin Calcium USP / BP / EP<br>1 kg<br>1<br>Tert-butyl		2-((4R,6S)-6-((E)-2-(4-(4-	1.30 kg
		fluorophenyl)-6-isopropyl-2-(N-
		methylmethylsulfonamido)pyrimidin-5-
		yl)vinyl)-2,2-di	dimethyl-1,3-dioxan-4-
		yl)acetate
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	145 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00288118AM22
RA File Number	03AA040128662 AM22
Licence No and Date	0311009547/16/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Export Product	Qty.	Sl. No.	Import items		Qty.
Rosuvastatin Calcium USP / BP / EP	1 kg	1	Tert-butyl	2-((4R,6S)-6-((E)-2-(4-(4-	1.30 kg
			fluorophenyl)-6-isopropyl-2-(N-
			methylmethylsulfonamido)pyrimidin-5-
			yl)vinyl)-2,2-di	dimethyl-1,3-dioxan-4-
			yl)acetate

Case No.	146 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00287478AM22
RA File Number	03AA040122138 AM22
Licence No and<br>Date	0311009510/16/12/2021
Norms Committee Decision:
Deferred for comments of TE.



Case No.	147 / NC/3/MEET/Apr/202223/1

Case Status	Case Deferred

Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00287541AM22
RA File Number	03AA040131415 AM22
Licence No and<br>Date	0311009528/16/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	148 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

HQ File Number	HQRNORM APPLY 00287549AM22
RA File Number	03AA040130524 AM22
Licence No and<br>Date	0311009529/16/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.

Case No.	149 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00288929AM22
RA File Number	03AA040131485 AM22
Licence No and<br>Date	0311009599/17/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	150 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00288969AM22
RA File Number	05AX04000134 AM22
Licence No and<br>Date	0511006992/17/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	151 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

HQ File Number	HQRNORM APPLY 00289566AM22
RA File Number	34AX04000036 AM22
Licence No and<br>Date	3411001553/17/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	152 / NC/3/MEET/Apr/202223/1	152 / NC/3/MEET/Apr/202223/1

Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED

Meeting Number<br>	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
and Date

HQ File Number	HQRNORM APPLY 00289569AM22
RA File Number	34AX04000035 AM22

Licence No and<br>	3411001554/17/12/2021
Date

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

Case No.	Case No.	Case No.	153 / NC/3/MEET/Apr/202223/1
C	ase Status		Case Deferred
P	arty Name		MAKCUR LABORATORIES LIMITED
M<br>a	eeting Number
	<br>nd Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
H	Q File Numb	er	HQRNORM APPLY 00291474AM22
R	A File Numb	er	08AX04000083 AM22
L<br>D	icence No an<br>ate	d	0811003487/20/12/2021

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

Case No.	154 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00291533AM22
RA File Number	34AX04000052 AM22
Licence No and<br>Date	3411001560/20/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Case No.	155 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00291684AM22
RA File Number	05AX04000180 AM22
Licence No and<br>Date	0511007032/20/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	156 / NC/3/MEET/Apr/202223/1	156 / NC/3/MEET/Apr/202223/1	156 / NC/3/MEET/Apr/202223/1	156 / NC/3/MEET/Apr/202223/1	156 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number		HQRNORM APPLY 00291710AM22
RA File Number		09AA04018176 AM22
Licence No and<br>Date		0911002105/20/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>GLYOXALIC ACID 50PCT<br>0.62 kg<br>2<br>2 5 DIHYDROXY 1 4 DIATHINE<br>0.28 kg<br>3<br>5 FLUOROCYTOSINE<br>0.44 kg<br>4<br>DI METHYL FORMAMIDE<br>0.26 kg<br>5<br>CYTOSINE<br>Not shown in<br>the process or<br>reaction<br>[(2R,5S)-5-(4-Amino-5-fluoro-2-oxo-<br>2h-pyrimidin-1-yl)-[1,3]-oxathiolane-2-<br>carboxylic acid,2s-isopropyl-5r-methyl-<br>1r-<br>([(2R,5S)-5-(4-Amino-5-fluoro-2-<br>oxo-2h-pyrimidin-1-yl)-[1,3]<br>oxathiolane-2-carboxylic<br>acid,<br>s-<br>isopropyl-5r-methyl-1r-<br>cyclohexyl<br>ester)]<br>(FCE))<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	[(2R,5S)-5-(4-Amino-5-fluoro-2-oxo-<br>2h-pyrimidin-1-yl)-[1,3]-oxathiolane-2-<br>carboxylic acid,2s-isopropyl-5r-methyl-<br>1r-<br>([(2R,5S)-5-(4-Amino-5-fluoro-2-<br>oxo-2h-pyrimidin-1-yl)-[1,3]<br>oxathiolane-2-carboxylic<br>acid,<br>s-<br>isopropyl-5r-methyl-1r-<br>cyclohexyl<br>ester)]<br>(FCE))		1 kg	1	GLYOXALIC ACID 50PCT	0.62 kg
				2	2 5 DIHYDROXY 1 4 DIATHINE	0.28 kg
				3	5 FLUOROCYTOSINE	0.44 kg
				4	DI METHYL FORMAMIDE	0.26 kg
				5	CYTOSINE	Not shown in<br>the process or<br>reaction

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

6	HEXA METHYL DISILAZANE	0.29 kg
7	METHYLENE DI CHLORIDE	2.63 kg
8	L MENTHOL FRESH RECOVERY	0.61 kg
9	TRI ETHYL AMINE	0.034 kg
10	TRIPHOSGINE	0.40 kg

Case No.	157 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SUMAR BIOTECH LLP
Meeting Number
and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00291905AM22
RA File Number	08AX04000034 AM22
Licence No and
Date	0811003488/20/12/2021
Norms Committee	Decision:
Deferred for comments of TE.

Case No.	158 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	MELZER CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00291926AM22
RA File Number	31AA04030064 AM22
Licence No and<br>Date	3111000802/20/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	159 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1	and 29/04/2022	and 29/04/2022	and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00291937AM22
RA File Number<br>07AX04000071 AM22
Licence No and<br>Date<br>0711002685/20/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of				HBP	Vol. I as
per details given below or as applied by the firm,	whichever		is less:
Export Product<br>Qty.		Sl. No.	Import items	Qty.
Sodium Chloride Injection USP<br>1 Number		1	10ml Unprinted Clear Glass Vial Empty	Relevant		as
90mg per 10mL Vial.(10mL Vial				per	packing
- filled with 90mg of Sodium				policy
Chloride as bulk drug filled in
10mL Vial and capped with
13mm Grey Serum ChlorobutyI
Rubber Stopper)
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	160 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	INFICHEM PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00291201AM22
RA File Number	52AX04000002 AM22
Licence No and<br>Date	5211001739/20/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	161 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00291953AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

RA File Number	05AX04000176 AM22
Licence No and<br>Date	0511007040/20/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	162 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00292375AM22
RA File Number	03AA040131528 AM22
Licence No and<br>Date	0311009652/21/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	163 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00293146AM22
RA File Number	34AX04000029 AM22
Licence No and<br>Date	3411001569/21/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	164 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00292389AM22
RA File Number	03AA040123994 AM22
Licence No and<br>Date	0311009655/21/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

i. Description of all Excipients shown in items to be imported may be furnished as per their chemical name.
ii. Details of Packaging Material may be furnished.
iii. Copy of Master Batch Formula for all export items indicating net content of inputs in each export.

Case No.	165 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00292436AM22
RA File Number	03AA040114422 AM22
Licence No and<br>Date	0311009656/21/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	166 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00292437AM22
RA File Number	03AX04000252 AM22
Licence No and<br>Date	0311009654/21/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>i.
name.
Details of Packaging Material may be furnished.<br>ii.
Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.

Case No.	167 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00292805AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

RA File Number

31AX04000016 AM22

Licence No and Date

3111000805/21/12/2021

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: Step wise manufacturing process. i. Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis. ii. Complete technical details as per Annexure to Appendix 4E for chemical products. iii. Stoichiometric balance between import and export on molar basis.

Case No.	168 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00292962AM22
RA File Number	09AA04017854 AM22
Licence No and<br>Date	0911002118/21/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	169 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	NATCO PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00293027AM22
RA File Number	09AX04000043 AM22
Licence No and<br>Date	0911002121/21/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	170 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

HQ File Number	HQRNORM APPLY 00293142AM22
RA File Number	05AX04000189 AM22
Licence No and<br>Date	0511007079/21/12/2021
Norms Committee Decision:
Deferred for comments of TE

Case No.	171 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00293646AM22
RA File Number	03AX04000320 AM22
Licence No and<br>Date	0311009690/22/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	172 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00293897AM22
RA File Number	31AX04000017 AM22
Licence No and<br>Date	3111000824/22/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	173 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00293951AM22
RA File Number	34AX04000070 AM22
Licence No and<br>Date	3411001584/22/12/2021
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

information / documents from the firm:

i. Quantity and Commercial Value of co-product Acetone obtained in manufacturing process.

Case No.	174 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00294320AM22
RA File Number	09AA04010826 AM22
Licence No and<br>Date	0911002135/22/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>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>Cytidine<br>1.35 kg<br>2<br>2,2-Dimethoxy propane<br>3.00 kg<br>3<br>DBU (1, 8-diazabicyclo [5.4. 0] undec-7-ene<br>1.50 kg<br>4<br>Isobutyric anhydride<br>0.90 kg<br>Molnupiravir<br>1 kg<br>5<br>Isopropyl alcohol<br>5.00 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	175 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00295585AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

RA File Number<br>03AX04000358 AM22
Licence No and<br>Date<br>0311009732/23/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.NC/3/MEET/Jul/202122/4 dated 15/07/2021 against advance authorization No.0311002953dt.30-03-
2021, it was decided to ratify norms under Para	4.07 of HBP Vol. I as per details given below or as			applied by the
firm, whichever is less:
Export product	Qty.	Sl. No.	Import items	Qty.
DOXYLEB CAPSULES (DOXYCYCLINE	<br>7905982 Number	1	DOXYCYCLINE	912.35 kg
HYCLATE<br>CAPSULES<br>BP)100MG(IN			HYCLATE BP
PACKINGS<br>OF<br>10X10s,10X100s<br>&
1000s.QTY CONSUMED OF EXEMPT
MATERIAL DOXYCYCLINE HYCLATE
BP 117MG / CAPSULE.)
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>176 / NC/3/MEET/Apr/202223/1	Case No.<br>176 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00295676AM22
RA File Number<br>05AX04000265 AM22
Licence No and<br>Date<br>0511007189/23/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same			export product in
Meeting No.NC/3/MEET/Jan/202122/13dated21/01/2022 against advance authorization No.0510413971dt.13-04-
2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or			as applied by the
firm, whichever is less:
	Sl. No. Export product<br>Qty.<br>Sl. No.	Import Items	Qty.
			(for 1 Number,

Case No.<br>176 / NC/3/MEET/Apr/202223/1	Case No.<br>176 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00295676AM22
RA File Number<br>05AX04000265 AM22
Licence No and<br>Date<br>0511007189/23/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same			export product in
Meeting No.NC/3/MEET/Jan/202122/13dated21/01/2022 against advance authorization No.0510413971dt.13-04-
2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or			as applied by the
firm, whichever is less:
	Sl. No. Export product<br>Qty.<br>Sl. No.	Import Items	Qty.
			(for 1 Number,

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

					100 ml Bottle)
1	Nurofen<br>For<br>Children<br>Orange((Total qty in ML =<br>26,40,00,000 ML))	<br> <br>1 Number	1	Ibuprofen	2.10 gram
			2	Tween 80 (Polysorbate 80)	0.01 gram
			3	Glycerine	12.616 gram
			4	Lycasin 80/55 (Maltotol)	46.30 gram
			5	Sodium Saccharin 40/80	0.20 gram
			6	Citric Acid Monohydrate	0.40 gram
			7	Tri Sodium Citrate Dihydrate	0.509 gram
			8	Xanthan Gum	0.75 gram
			9	Sodium Chloride	0.11 gram
			10	Orange flavour	0.25 gram
			11	Domiphen Bromide (BP)	0.01 gram
			12	987 PP28mm M-LOC H&A White<br>T/E	Relevant as per<br>packing policy
			13	A001 5ML Syrnge
			14	0195 NRFN SYRNG PLG
			15	Pet Bottle

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

16<br>Ibuprofen<br>2.10 gram<br>17<br>Tween 80 (Polysorbate 80)<br>0.01 gram<br>18<br>Glycerine<br>12.616 gram<br>19<br>Lycasin 80/55 (Maltotol)<br>46.30 gram<br>20<br>Sodium Saccharin 40/80<br>0.20 gram<br>21<br>Citric Acid Monohydrate<br>0.40 gram<br>22<br>Tri Sodium Citrate Dihydrate<br>0.509 gram<br>23<br>Xanthan Gum<br>0.75 gram<br>24<br>Sodium Chloride<br>0.11 gram<br>25<br>Straw flav KOSHER PHL-142134<br>0.25 gram<br>26<br>Domiphen Bromide (BP)<br>0.01 gram<br>27<br>987 PP28mm M-LOC H&A White<br>T/E<br>28<br>A001 5ML Syrnge<br>29<br>0195 NRFN SYRNG PLG<br>2<br>Nurofen For Children<br>Strawberry((Total qty in<br>ML = 3,60,00,000 ML) )<br>1 Number<br>30<br>Pet Bottle<br>Relevant as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC.	Nurofen For Children<br>Strawberry((Total qty in<br>ML = 3,60,00,000 ML) )	16	Ibuprofen	2.10 gram
		17	Tween 80 (Polysorbate 80)	0.01 gram
		18	Glycerine	12.616 gram
		19	Lycasin 80/55 (Maltotol)	46.30 gram
		20	Sodium Saccharin 40/80	0.20 gram
		21	Citric Acid Monohydrate	0.40 gram
		22	Tri Sodium Citrate Dihydrate	0.509 gram
		23	Xanthan Gum	0.75 gram
		24	Sodium Chloride	0.11 gram
		25	Straw flav KOSHER PHL-142134	0.25 gram
		26	Domiphen Bromide (BP)	0.01 gram
		27	987 PP28mm M-LOC H&A White<br>T/E	Relevant as per<br>packing policy
		28	A001 5ML Syrnge
		29	0195 NRFN SYRNG PLG
		30	Pet Bottle

Case No.	177 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

HQ File Number<br>HQRNORM APPLY	00295722AM22	00295722AM22
RA File Number<br>52AX04000016 AM22
Licence No and<br>Date<br>5211001759/23/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it			was decided to ratify norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:
Export product	Qty.	Sl. No.	Import items	Qty.
1-(3-CHLORO<br>PHENYL)4-(3-	1 kg	1	1,3-BROMO CHLORO PROPANE 99% min	0.924 kg
CHLORO PROPYL) PIPERAZINE
HCL
RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	178 / NC/3/MEET/Apr/202223/1	178 / NC/3/MEET/Apr/202223/1
Case Status		Case Approved
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202223/ 1	and 29/04/2022
HQ File Number		HQRNORM APPLY 00295371AM22
RA File Number		03AX04000239 AM22
Licence No and<br>Date		0311009726/23/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07						of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:
	Export product		Qty.	Sl. No.	Import items	Qty.
	Doxycycline Hyclate DR Tablets USP 100 mg		<br>2970000	1	Doxycyclin e Hyclate USP	342.74 kg
	, 100'S US((29,700 Bottles X 100 Per Bottles		<br>Tablets
	= 29,70,000 Tablets) (Total Weight of Export
	Product = 297.00 Kgs) (Net Content weight of
	Import Product = 351.83 kgs))

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

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

Case No.	179 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00295564AM22
RA File Number	09AX04000038 AM22
Licence No and<br>Date	0911002144/23/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	180 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00295569AM22
RA File Number	09AX04000039 AM22
Licence No and<br>Date	0911002145/23/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	181 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00296310AM22
RA File Number	03AX04000251 AM22
Licence No and<br>Date	0311009744/24/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>name.<br>i.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

ii. Details of Packaging Material may be furnished. iii. Copy of Master Batch Formula for all export items indicating net content of inputs in each export.

Case No.	182 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00296314AM22
RA File Number	03AX04000229 AM22
Licence No and<br>Date	0311009746/24/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>i.
name.
Details of Packaging Material may be furnished.<br>ii.
Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.

Case No.	183 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	NEXUS PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00296625AM22
RA File Number	08AX04000128 AM22
Licence No and<br>Date	0811003535/24/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	184 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	LARK LABORATORIES (INDIA) LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00296972AM22
RA File Number	05AX04000299 AM22
Licence No and<br>Date	0511007234/24/12/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Norms Committee Decision:

Deferred for comments of TE.

Norms Committee	Decision:
Dfd f	t f TE
eerre or comm	ns o .

Case No.	185 / NC/3/MEET/Apr/202223/1

Case Status	Case Deferred

Party Name	INTAS PHARMACEUTICALS LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022

HQ File Number	HQRNORM APPLY 00298292AM22
RA File Number	08AX04000091 AM22
Licence No and<br>Date	0811003537/27/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	186 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00298304AM22
RA File Number	05AX04000086 AM22
Licence No and<br>Date	0511007243/27/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.<br>187 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00298421AM22
RA File Number<br>07AX04000126 AM22
Licence No and<br>Date<br>0711002728/27/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.NC/3/MEET/Dec/202122/12 dated 17.12.2021 against advance authorization No.0711001465 dt.
12.07.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by
the firm, whichever is less:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Dec/202122/12 dated 17.12.2021 against advance authorization No. 0711001465 dt. 12.07.2021 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23


Export Product		Qty.	Sl. No.	Import items	Qty.
Sodium Chloride Injection USP		<br>1 Number	1	13mm Grey Serum ChlorobutyI R/S-RFS-	Relevant		as
90mg per 10mL Vial.(10mL Vial				C14226422GS6TP3	per	packing
- filled with 90mg	of Sodium				policy
Chloride as bulk drug
filled in 10mL Vial	and capped
with<br>13mm	GreySerum
ChlorobutyI Rubber Stopper)
<br>A concerned may take	further necessary action as per above decision of NC

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

Case No.	188 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	SAVLA CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00298647AM22
RA File Number	03AX04000385 AM22
Licence No and<br>Date	0311009839/27/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	189 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	BIOXERA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00298677AM22
RA File Number	03AX04000380 AM22
Licence No and<br>Date	0311009845/27/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.5/82-ALC4/2020 dated 09.10.2020 against advance authorization No.3410045821 dt. 28.01.2020, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 5/82-ALC4/2020 dated 09.10.2020 against advance authorization No. 3410045821 dt. 28.01.2020 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Export product	Qty.	Sl. No.	Import items	Qty.
BENFOTIAMINE	1 kg	1	THIAMINE HYDROCHLORIDE	0.922 kg

Case No.	190 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00298723AM22
RA File Number	09AX04000092 AM22
Licence No and<br>Date	0911002161/27/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.03/AM21 dated 02/09/2020against advance authorization No.0910068027 dated 23.09.2019, it was<br>decided to ratify 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. Import items<br>Qty.<br>IBREXAFUNGERP CITRATE<br>1 kg<br>1<br>ENFUMAFUNGIN<br>4.55 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	191 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00298757AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

RA File Number<br>09AX04000091 AM22
Licence No and<br>Date<br>0911002165/27/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same			export product in
Meeting No.03/AM21 dated 02/09/2020	against advance	authorization No.0910068027 dated 23.09.2019, it was
decided to ratify norms under Para 4.07 of	HBP Vol. I as per details given below or as applied by the firm, whichever
is less:
Export product	Qty.<br>Sl. No.	Import items	Qty.
IBREXAFUNGERP CITRATE	1 kg<br>1	ENFUMAFUNGIN	4.55 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	192 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00298219AM22
RA File Number	03AX04000256 AM22
Licence No and<br>Date	0311009818/27/12/2021
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
Percentage API in the export product supported by DML.

Case No.	193 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00298924AM22
RA File Number	05AA04092052 AM22
Licence No and<br>Date	0511007259/27/12/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Dec/202122/12 dated 17/12/2021 against advance authorization No. 6110001561 dated 28-11-2018 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
1	Inj. Fentanyl Citrate eqv. to Fentanyl 50		<br>3950070	1	Fentanyl Citrate	682.18 gram
	mcg/ml,<br>2	ml<br>Ampoule(Finished	<br>Number
	formulation of	Fentanyl Citrate)
2	Inj. Fentanyl Citrate eqv. to Fentanyl 50		289000	1	Fentanyl Citrate	249.60 gram
	mcg/ml,<br>10	ml<br>Ampoule(Finished	Number
	formulation of	Fentanyl Citrate)

Case No.	194 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00299344AM22
RA File Number	07AA04038998 AM22
Licence No and<br>Date	0711002737/28/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	195 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	MAHARASHTRA ALDEHYDES AND CHEMICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00299560AM22
RA File Number	03AX04000272 AM22
Licence No and<br>Date	0311009857/28/12/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

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

i. Step wise manufacturing process.
ii. Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis.
iii. Complete technical details as per Annexure to Appendix 4E for chemical products.

Stoichiometric balance between import and export on molar basis.

Case No.	196 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	MAHARASHTRA ALDEHYDES AND CHEMICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00299562AM22
RA File Number	03AX04000273 AM22
Licence No and<br>Date	0311009858/28/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage<br>ii.
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.

Case No.	197 / NC/3/MEET/Apr/202223/1
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00299664AM22
RA File Number	09AX04000084 AM22
Licence No and<br>Date	0911002182/28/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.NC/3/MEET/Mar/202122/15 dated 17/03/2022against advance authorization No.0911001083 dated
22-06-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
4-chlorobutyryl chloride	1 kg	1	Gama butyrolactone	0.754 kg
		2	Thionyl Chloride	1.210 kg

Case No.<br>198 / NC/3/MEET/Apr/202223/1
Case Status<br>Case Approved
Party Name<br>AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number<br>HQRNORM APPLY 00299884AM22
RA File Number<br>34AX04000084 AM22
Licence No and<br>Date<br>3411001595/28/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same	export product in
Meeting No.5/82-ALC4/2020 dated 09.10.2020 against advance authorization No.3410045821 dt. 28.01.2020, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:
Export product<br>Qty.<br>Sl. No.<br>Import items	Qty.
BENFOTIAMINE<br>1 kg<br>1<br>THIAMINE HYDROCHLORIDE	0.922 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	199 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00101508AM23

and Date
HQ File Number	HQRNORM APPLY 00299896AM22
RA File Number	34AX04000090 AM22
Licence No and<br>Date	3411001598/28/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	200 / NC/3/MEET/Apr/202223/1
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202223/ 1 and 29/04/2022
HQ File Number	HQRNORM APPLY 00299954AM22
RA File Number	09AX04000070 AM22
Licence No and<br>Date	0911002189/28/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Jun-2022 13:51:24 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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