IN FORCE Advance Authorisation

DGFT Minutes

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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/Aug/202223/6 DATED: 09/09/2022

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/Aug/202223/6 dated 09/09/2022 of Norms Committee - III for the year 2022-23 was held on 09/09/2022 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

	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/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED

This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00041071AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	2 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018305000820AM13
RA File Number	039504000284 AM13
Licence No and<br>Date	0310716659/07/12/2012
Norms Committee Decision:
The firm vide e-mail dated 13.07.2022 has enclosed a copy of Surrender Letter of subject Advance Authorization.
In view of above e-mail of firm, the Committee decided towithdrawthe case.

|The firm vide e-mail dated 13.07.2022 has enclosed a copy of Surrender Letter of subject Advance Authorization.|| |In view of above e-mail of firm, the Committee decided towithdrawthe case.||

Case No.<br>3 / NC/3/MEET/Aug/202223/6	Case No.<br>3 / NC/3/MEET/Aug/202223/6
Case Status<br>Case Approved
Party Name<br>U SQUARE LIFESCIENCE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number<br>HQRNORM REVIW00268752AM22
RA File Number<br>082404000306 AM16
Licence No and<br>Date<br>0810136712/11/12/2015
Norms Committee Decision:
The Committee considered the request of firm for review of norms and			taking cue from earlier	decision for same
export product / import item in Meeting No.4/82-ALC4/2020 dated 18.09.2020against advance				authorization No.
0810144243 dt. 07.01.2019, it was decided to revise adhoc norms		as under
	Export product<br>Qty.	Sl. No.	Import items		Qty.
	CLINDAMYCIN INJECTION 600 mg / 4ml<br>1 Number	1	CLINDAMYCIN		831.13 mg
			PHOSPHATE USP

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

INDAMYCIN INJECTION 600 mg / 4ml 1 Number|1|CLINDAMYCIN||831.13 mg|| ||||PHOSPHATE USP||||

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

Case No.	4 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM REVIW00349952AM22
RA File Number	522404000042 AM17
Licence No and<br>Date	5210042032/30/09/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and taking cue from earlier decision for same<br>export product / import item in Meeting No.NC/3/MEET/May/202223/4 dated 17.06.2022against advance<br>authorization No.5210042570 dt. 20.03.2018, it was decided to revise adhoc norms as under<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>DI- Tert Butyl Dicarbonate<br>2.00 kg<br>TERT-<br>BUTYL<br>1-PIPERAZINE<br>CARBOXYLATE (1-BOC PIPERAZINE)<br>1 kg<br>2<br>PIPERAZINE ANHYDROUS<br>0.80 kg<br>RA concerned may take further necessary action as per above decision of NC.

r>TERT- BUTYL 1-PIPERAZINE CARBOXYLATE (1-BOC PIPERAZINE) 1 kg 2 PIPERAZINE ANHYDROUS 0.80 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	5 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM REVIW00342368AM22
RA File Number	039404001099 AM17
Licence No and<br>Date	0310811662/07/03/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and it was observed that the firm still has not furnished<br>its reply on DGFT Portal. Hence, the Committee decided torejectthe case.

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Case No.	6 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM REVIW00354679AM22
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 review of norms and as per GST Certificate furnished by the firm for<br>the year 2018-19, 2019-20 and 2020-21, it was decided to revise adhoc norms as under<br>Export product<br>Qty.<br>Sl. No.

for review of norms and as per GST Certificate furnished by the firm for the year 2018-19, 2019-20 and 2020-21, it was decided to revise adhoc norms as under Export product Qty. Sl. No. Import items Qty. Noscapine BP USP Ph.Eur JP CP / Noscapine Hydrochloride BP Ph.Eur 1 kg 1 Noscapine Crude Content 95% 1.158 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	7 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	AVA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
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 review of norms and it was observed that the firm still has not furnished<br>its reply on DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC

Case No.	8 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected

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t**the case. RA concerned may take further necessary action as per above decision of NC||

Case No.	8 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected

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Party Name	KUSUMA PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
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 review of norms and it was observed that there is not much<br>difference in COA of import and export. Hence, it was decided torejectthe case maintaining the status quo.<br> RA concerned may take further necessary action as per above decision of NC.

The Committee considered the request of firm for review of norms and it was observed that there is not much difference in COA of import and export. Hence, it was decided to reject the case maintaining the status quo.

the request of firm for review of norms and it was observed that there is not much difference in COA of import and export. Hence, it was decided to reject the case maintaining the status quo.

Case No.	9 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
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 review of norms and as per GST Certificate furnished by the firm for<br>the year 2018-19, 2019-20 and 2020-21, it was decided to revise adhoc norms as under<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Noscapine BP USP Ph.Eur JP CP / Noscapine<br>Hydrochloride BP Ph.Eur<br>1 kg<br>1<br>Noscapine Crude Content 95%<br>1.158 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	10 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	U SQUARE LIFESCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM REVIW00296493AM22
RA File Number	082404000329 AM19
Licence No and	0810144243/07/01/2019

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Date

Norms Committee Decision:

The Committee considered the request of firm for review of norms and taking cue from earlier decision for same export product / import item in Meeting No. 4/82-ALC4/2020 dated 18.09.2020 against advance authorization No. 0810144243 dt. 07.01.2019 , it was decided to revise adhoc norms as under

810144243 dt. 07.01.2019, it was decided to revis	e adhoc norms	as under
Export product	Qty.	Sl. No.	Import items	Qty.
CLINDAMYCIN INJECTION 600 mg / 4 ml	1 Number	1	CLINDAMYCIN	831.13 mg
			PHOSPHATE USP

Case No.<br>11 / NC/3/MEET/Aug/202223/6
Case Status<br>Case Approved
Party Name<br>SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number<br>HQRNORM REVIW00354703AM22
RA File Number<br>022404000173 AM19
Licence No and<br>Date<br>0210209010/26/02/2019
Norms Committee Decision:
The Committee considered the request of firm for review of norms and as per GST Certificate furnished			by the firm for
the year 2018-19, 2019-20 and 2020-21, it was decided to revise adhoc norms as under
Export product<br>Qty.	Sl. No.	Import items	Qty.
Noscapine BP USP Ph.Eur JP CP / Noscapine<br>1 kg	1	Noscapine Crude Content 95%	1.158 kg
Hydrochloride BP Ph.Eur
RA concerned may take further necessary action as per above decision		of NC

apine BP USP Ph.Eur JP CP / Noscapine 1 kg|1|Noscapine Crude Content 95%|1.158 kg|| |Hydrochloride BP Ph.Eur||||| |RA concerned may take further necessary action as per above decision||of NC|||

Case No.	12 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM REVIW00288853AM22

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RA File Number	022404000076 AM20
Licence No and<br>Date	0210209378/16/08/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and as per GST Certificate furnished by the firm for<br>the year 2018-19, 2019-20 and 2020-21, it was decided to revise adhoc norms as under<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Noscapine BP USP Ph.Eur JP CP / Noscapine<br>Hydrochloride BP Ph.Eur<br>1 kg<br>1<br>Noscapine Crude Content 95%<br>1.158 kg<br>RA concerned may take further necessary action as per above decision of NC.

RA File Number

022404000076 AM20

Licence No and Date

0210209378/16/08/2019

Norms Committee Decision: The Committee considered the request of firm for review of norms and as per GST Certificate furnished by the firm for the year 2018-19, 2019-20 and 2020-21, it was decided to revise adhoc norms as under Export product Qty. Sl. No. Import items Qty. Noscapine BP USP Ph.Eur JP CP / Noscapine Hydrochloride BP Ph.Eur 1 kg 1 Noscapine Crude Content 95% 1.158 kg RA concerned may take further necessary action as per above decision of NC.

BP USP Ph.Eur JP CP / Noscapine Hydrochloride BP Ph.Eur 1 kg 1 Noscapine Crude Content 95% 1.158 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	13 / NC/3/MEET/Aug/202223/6	13 / NC/3/MEET/Aug/202223/6	13 / NC/3/MEET/Aug/202223/6
Case Status		Case Approved
Party Name		PANACEA BIOTEC LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number		HQRNORM REVIW00348357AM22
RA File Number		052404000683 AM20
Licence No and<br>Date		0510413419/22/01/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and on the basis of written comments furnished by<br>Department of Biotechnology vide D.O. Letter No. PID-13011(15)/1/2021-PPB-DBT dated 05.08.2022, it was decided<br>to revise norms as under:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Purified Diptheria Toxoid Concentrate<br>Antigen Bulk @2050 Lf/ml<br>13.33 Litre<br>2<br>Purified Tetanus Toxoid Concentrate<br>Antigen @1900 Lf/ml<br>5.23 Litre<br>3<br>Inactivated Whole Cell Pertussis Bulk<br>@192 OU/ml<br>86.46 Litre<br>Easy Five TT Vaccine<br>DTwP-Hep<br>B-Hib-<br>Pentavalent Vaccine (Each<br>vial of 0.5 ml contains 1<br>dose)<br>1<br>Million<br>Vials
	Export product<br>Easy Five TT Vaccine<br>DTwP-Hep<br>B-Hib-<br>Pentavalent Vaccine (Each<br>vial of 0.5 ml contains 1<br>dose)		Qty.	Sl.

0.5 ml contains 1 dose) 1 Million Vials||||||| ||Export product Easy Five TT Vaccine DTwP-Hep B-Hib- Pentavalent Vaccine (Each vial of 0.5 ml contains 1 dose)||Qty.|Sl. No.|Import items|Qty.| |||| 1 Million Vials|1 |Purified Diptheria Toxoid Concentrate Antigen Bulk @2050 Lf/ml|13.33 Litre| |||||2|Purified Tetanus Toxoid Concentrate Antigen @1900 Lf/ml|5.23 Litre| |||||3|Inactivated Whole Cell Pertussis Bulk @192 OU/ml| 86.46 Litre|

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4<br>Rubber Stopper<br>1010000 Numbers<br>5<br>AGS HB Purification MABS Column<br>5.4 Litre<br>6<br>Tetanus Toxoid for conjugation<br>6.15 Litre<br>RA concerned may take further necessary action as per above decision of NC.			4	Rubber Stopper	1010000 Numbers
			5	AGS HB Purification MABS Column	5.4 Litre
			6	Tetanus Toxoid for conjugation	6.15 Litre

Case No.	14 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001749AM21
RA File Number	039404001019 AM20
Licence No and<br>Date	0310838949/16/10/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

RA File Number|039404001019 AM20| |Licence No and Date|0310838949/16/10/2020| |Norms Committee Decision: The reply submitted by the firm is under examination. Deferred for comments of TE.||

Case No.	15 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001750AM21
RA File Number	039404000978 AM20
Licence No and<br>Date	0310838950/16/10/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	16 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001751AM21
RA File Number	039404000297 AM21
Licence No and	0310838951/16/10/2020

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Date

The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	17 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001753AM21
RA File Number	039404000524 AM21
Licence No and<br>Date	0310838953/16/10/2020
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	18 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001755AM21
RA File Number	039404000184 AM21
Licence No and<br>Date	0310838958/16/10/2020
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	19 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001745AM21
RA File Number	039404000392 AM21
Licence No and<br>Date	0310838931/16/10/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE

Case No.	20 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred

UDIN00208504AM23

ion: The reply submitted by the firm is under examination. Deferred for comments of TE||

Case No.	20 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred

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Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001746AM21
RA File Number	039404000516 AM21
Licence No and<br>Date	0310838932/16/10/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	21 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001758AM21
RA File Number	039404000525 AM21
Licence No and<br>Date	0310838974/19/10/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	22 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001759AM21
RA File Number	039404000528 AM21
Licence No and<br>Date	0310838975/19/10/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

RA File Number|039404000528 AM21| |Licence No and Date|0310838975/19/10/2020| |Norms Committee Decision: The reply submitted by the firm is under examination. Deferred for comments of TE.||

Case No.	23 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001767AM21
RA File Number	039404000526 AM21
Licence No and<br>Date	0310839001/20/10/2020

10 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	24 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001769AM21
RA File Number	039404000527 AM21
Licence No and<br>Date	0310839017/20/10/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE

Case No.	25 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001766AM21
RA File Number	039404000548 AM21
Licence No and<br>Date	0310839000/20/10/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE

|RA File Number|039404000548 AM21| |Licence No and Date|0310839000/20/10/2020| |Norms Committee Decision: The reply submitted by the firm is under examination. Deferred for comments of TE||

Case No.	26 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001778AM21
RA File Number	039404000412 AM21
Licence No and<br>Date	0310839084/23/10/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	27 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
PartyName	AARTI DRUGS LIMITED

11 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001779AM21
RA File Number	039404000411 AM21
Licence No and<br>Date	0310839085/23/10/2020
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	28 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001788AM21
RA File Number	039404000410 AM21
Licence No and<br>Date	0310839173/28/10/2020
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

RA File Number|039404000410 AM21| |Licence No and Date|0310839173/28/10/2020| |Norms Committee Decision:|| |The reply submitted by the firm is under examination. Deferred for comments of TE.||

Case No.	29 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001789AM21
RA File Number	039404000346 AM21
Licence No and<br>Date	0310839184/28/10/2020
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE

Case No.	30 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001818AM21
RA File Number	039404001085 AM20
Licence No and<br>Date	0310839307/04/11/2020
Norms Committee Decision:

12 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	31 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001827AM21
RA File Number	039404000597 AM21
Licence No and<br>Date	0310839362/05/11/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

RA File Number|039404000597 AM21| |Licence No and Date|0310839362/05/11/2020| |Norms Committee Decision: The reply submitted by the firm is under examination. Deferred for comments of TE.||

Case No.	32 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001826AM21
RA File Number	039404000596 AM21
Licence No and<br>Date	0310839361/05/11/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	33 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001844AM21
RA File Number	039404000423 AM21
Licence No and<br>Date	0310839485/11/11/2020
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	34 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	TENSHI KAIZEN PRIVATE LIMITED

13 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

|---| |Case Status|Case Rejected| |Party Name|TENSHI KAIZEN PRIVATE LIMITED|

13 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001859AM21
RA File Number	072404000225 AM21
Licence No and<br>Date	0710117295/19/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	35 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	FINE ORGANICS
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	018205001867AM21
RA File Number	052304000296 AM21
Licence No and<br>Date	0510415978/24/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	36 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00233450AM22
RA File Number	302404000083 AM21
Licence No and<br>Date	3010105531/25/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.

14 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Case No.	37 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00234858AM22
RA File Number	092404000482 AM21
Licence No and<br>Date	0910069522/27/11/2020
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00234858AM22| |RA File Number|092404000482 AM21| |Licence No and Date|0910069522/27/11/2020| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	38 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
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 case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	39 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00063660AM21
RA File Number	03AA04018890 AM21
Licence No and<br>Date	0311001030/16/01/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

15 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

submitted by the firm is under examination. Deferred for comments of TE.||

15 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Case No.	40 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00067209AM21
RA File Number	03AA04019643 AM21
Licence No and<br>Date	0311001122/21/01/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE

Case No.	41 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00067214AM21
RA File Number	03AA04019645 AM21
Licence No and<br>Date	0311001129/21/01/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	42 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00067215AM21
RA File Number	03AA04019655 AM21
Licence No and<br>Date	0311001134/21/01/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

RA File Number|03AA04019655 AM21| |Licence No and Date|0311001134/21/01/2021| |Norms Committee Decision: The reply submitted by the firm is under examination. Deferred for comments of TE.||

Case No.	43 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00067217AM21
RA File Number	03AA04019654 AM21

16 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Licence No and 0311001138/21/01/2021 Date Norms Committee Decision: The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	44 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00068219AM21
RA File Number	03AA04020020 AM21
Licence No and<br>Date	0311001191/22/01/2021
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	45 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00068617AM21
RA File Number	03AA04020063 AM21
Licence No and<br>Date	0311001190/22/01/2021
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

RA File Number|03AA04020063 AM21| |Licence No and Date|0311001190/22/01/2021| |Norms Committee Decision:|| |The reply submitted by the firm is under examination. Deferred for comments of TE.||

Case No.	46 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00069628AM21
RA File Number	03AA04020216 AM21
Licence No and<br>Date	0311001225/25/01/2021
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No. 47 / NC/3/MEET/Aug/202223/6

17 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00075441AM21
RA File Number	03AA04021687 AM21
Licence No and<br>Date	0311001421/02/02/2021
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	48 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00093160AM21
RA File Number	03AA04024760 AM21
Licence No and<br>Date	0311001926/26/02/2021
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

|RA File Number|03AA04024760 AM21| |Licence No and Date|0311001926/26/02/2021| |Norms Committee Decision:|| |The reply submitted by the firm is under examination. Deferred for comments of TE.||

Case No.	49 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00094934AM21
RA File Number	03AA04026242 AM21
Licence No and<br>Date	0311002125/02/03/2021
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	50 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00096069AM21
RA File Number	03AA04027466 AM21
Licence No and	0311002195/03/03/2021

18 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Date

The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	51 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00097305AM21
RA File Number	039404000673 AM21
Licence No and<br>Date	0311001441/04/03/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	52 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00098942AM21
RA File Number	03AA04022238 AM21
Licence No and<br>Date	0311001500/08/03/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	53 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00100472AM21
RA File Number	03AA04028410 AM21
Licence No and<br>Date	0311002393/10/03/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	54 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred

UDIN00208504AM23

n: The reply submitted by the firm is under examination. Deferred for comments of TE.||

Case No.	54 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred

UDIN00208504AM23

Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00100470AM21
RA File Number	03AA04028406 AM21
Licence No and<br>Date	0311002391/10/03/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	55 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00108415AM21
RA File Number	03AA04028192 AM21
Licence No and<br>Date	0311002303/22/03/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	56 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00108766AM21
RA File Number	039404000652 AM21
Licence No and<br>Date	0311002733/22/03/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

RA File Number|039404000652 AM21| |Licence No and Date|0311002733/22/03/2021| |Norms Committee Decision: The reply submitted by the firm is under examination. Deferred for comments of TE.||

Case No.	57 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00003027AM22
RA File Number	03AA04031763 AM21
Licence No and<br>Date	0311002768/05/04/2021

20 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Norms Committee Decision:

The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	58 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00003031AM22
RA File Number	039404000229 AM21
Licence No and<br>Date	0311002737/05/04/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	59 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00047353AM22
RA File Number	03AA04031724 AM21
Licence No and<br>Date	0311002771/21/05/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	60 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
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 observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC

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

21 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Case No.	61 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00137286AM22
RA File Number	03AA04025361 AM22
Licence No and<br>Date	0311005326/12/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	62 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00139912AM22
RA File Number	03AA04027532 AM22
Licence No and<br>Date	0311005407/15/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC

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

Case No.	63 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00147545AM22
RA File Number	52AA04008175 AM22
Licence No and<br>Date	5211001047/26/07/2021
Norms Committee Decision:

22 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

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

Case No.	64 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00184798AM22
RA File Number	03AA04091486 AM22
Licence No and<br>Date	0311007000/15/09/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE

|RA File Number|03AA04091486 AM22| |Licence No and Date|0311007000/15/09/2021| |Norms Committee Decision: The reply submitted by the firm is under examination. Deferred for comments of TE||

Case No.	65 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00207439AM22
RA File Number	03AA040109530 AM22
Licence No and<br>Date	0311007595/08/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	66 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00208598AM22
RA File Number	03AA040109754 AM22
Licence No and<br>Date	0311007605/10/10/2021

23 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Norms Committee Decision:

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

Case No.	67 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00211144AM22
RA File Number	03AA040110377 AM22
Licence No and<br>Date	0311007674/13/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	68 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	BIODEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00218076AM22
RA File Number	05AA04090221 AM22
Licence No and<br>Date	0511005461/20/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

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

Case No.	69 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022

UDIN00208504AM23

and Date
HQ File Number	HQRNORM APPLY 00221840AM22
RA File Number	05AA04092995 AM22
Licence No and<br>Date	0511005572/22/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	70 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00224720AM22
RA File Number	31AA04028703 AM22
Licence No and<br>Date	3111000643/25/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	71 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	BAZAYAN ENTERPRISES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00235681AM22
RA File Number	03AA04078009 AM22
Licence No and<br>Date	0311008047/29/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

25 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Case No.	72 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00239687AM22
RA File Number	03AA040115878 AM22
Licence No and<br>Date	0311008179/02/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	73 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00255256AM22
RA File Number	03AA040120589 AM22
Licence No and<br>Date	0311008617/17/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC

Case No.	74 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	BIODEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00265372AM22
RA File Number	05AA040103458 AM22
Licence No and<br>Date	0511006452/25/11/2021
Norms Committee Decision:

26 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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

504AM23

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

Case No.	75 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00271106AM22
RA File Number	03AA040124209 AM22
Licence No and<br>Date	0311009064/01/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	76 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	MAXTAR BIO GENICS
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
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 observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	77 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022

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

Case No.	78 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	GRAMEN BOTANICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM REVIW00001479AM23
RA File Number	05AA040108712 AM22
Licence No and<br>Date	0511006918/15/12/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and taking cue from earlier decision for same<br>export product / import item in Meeting No.NC/3/MEET/May/202223/4 dated 17.06.2022against advance<br>authorization No.**0511002405 dt.

ew of norms and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/May/202223/4 dated 17.06.2022against advance authorization No.0511002405 dt. 04.05.2021, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. BERBERINE HYDROCHLORIDE (97 PERCENT) 1 kg 1 BERBERIS ARISTATA EXTRACT (Assay 90% +/- 1%) 1.00 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	79 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00287541AM22
RA File Number	03AA040131415 AM22
Licence No and<br>Date	0311009528/16/12/2021

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The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	80 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00287549AM22
RA File Number	03AA040130524 AM22
Licence No and<br>Date	0311009529/16/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC

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

Case No.	81 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00292375AM22
RA File Number	03AA040131528 AM22
Licence No and<br>Date	0311009652/21/12/2021
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE

Case No.	82 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00292389AM22
RA File Number	03AA040123994 AM22
Licence No and<br>Date	0311009655/21/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on

29 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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

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

Director on 16-09-2022 19:15:47.

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

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

Case No.	83 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
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 observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	84 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00292805AM22
RA File Number	31AX04000016 AM22
Licence No and<br>Date	3111000805/21/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

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

Case No.	85 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00296310AM22

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

Case No.	86 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00296314AM22
RA File Number	03AX04000229 AM22
Licence No and<br>Date	0311009746/24/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

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

Case No.	87 / NC/3/MEET/Aug/202223/6
Case Status	Case Rejected
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00298219AM22
RA File Number	03AX04000256 AM22
Licence No and<br>Date	0311009818/27/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No. 88 / NC/3/MEET/Aug/202223/6

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Case Status	Case Deferred
Party Name	OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00300023AM22
RA File Number	08AX04000140 AM22
Licence No and<br>Date	0811003577/28/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Copy of DML showing Approved Composition.<br>i.
Master Batch Formula for each export.<br>ii.
iii COA of import item from foreign supplier

ation / documents|| |from the firm:|| |Copy of DML showing Approved Composition. i.|| |Master Batch Formula for each export. ii.|| |iii COA of import item from foreign supplier||

Case No.	89 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00300536AM22
RA File Number	03AX04000446 AM22
Licence No and<br>Date	0311009872/29/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	90 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	DANOPHARM CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00300557AM22
RA File Number	03AA04012793 AM21
Licence No and<br>Date	0311000604/29/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Aug/202122/7 dated 13.08.2021against advance authorization No.
0310831769 dt. 24.09.2019, 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:

32 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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

32 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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Export product	Qty.	Sl. No.	Import items	Qty.
Alpha-(2,4dichlorophenyl)-1H-<br>Imidazole-1-ethanol(ANTI<br>INFLAMMATORY)	1 kg	1	2,2,4 Trichloro Acetophenone	1.45 kg
		2	Imidazole	0.53 kg
		3	Sodium Borohydride	0.10 kg
		4	Dimethyl Sulphoxide	0.42 kg

Case No.	91 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00300612AM22
RA File Number	03AX04000458 AM22
Licence No and<br>Date	0311009880/29/12/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

RA File Number|03AX04000458 AM22| |Licence No and Date|0311009880/29/12/2021| |Norms Committee Decision: The reply submitted by the firm is under examination. Deferred for comments of TE.||

Case No.	92 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00300738AM22
RA File Number	03AX04000454 AM22
Licence No and<br>Date	0311009888/29/12/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	93 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	SATYADIVIS PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022

UDIN00208504AM23

HQ File Number	HQRNORM APPLY 00300935AM22
RA File Number	09AA04018000 AM22
Licence No and<br>Date	0911002190/29/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	94 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00301053AM22
RA File Number	34AX04000076 AM22
Licence No and<br>Date	3411001604/29/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00301053AM22| |RA File Number|34AX04000076 AM22| |Licence No and Date|3411001604/29/12/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	95 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	HAFFKINE BIO PHARMACEUTICAL CORPORATION LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00301796AM22
RA File Number	03AX04000434 AM22
Licence No and<br>Date	0311009905/30/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology<br>(DBT) for obtaining their comments.

Case No.	96 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00302605AM22
RA File Number	09AX04000087 AM22
Licence No and<br>Date	0911002204/30/12/2021
Norms Committee Decision:

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Deferred for comments of TE.

2204/30/12/2021| |Norms Committee Decision:||

34 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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Deferred for comments of TE.

Case No.	97 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00301808AM22
RA File Number	03AX04000439 AM22
Licence No and<br>Date	0311009908/30/12/2021
Norms Committee Decision:<br>The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	Case No.	98 / NC/3/MEET/Aug/202223/6	98 / NC/3/MEET/Aug/202223/6	98 / NC/3/MEET/Aug/202223/6	98 / NC/3/MEET/Aug/202223/6	98 / NC/3/MEET/Aug/202223/6
Case Status		Case Approved
Party Name		SMS PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number		HQRNORM APPLY 00302722AM22
RA File Number		09AX04000056 AM22
Licence No and Date		0911002206/30/12/2021
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.

he 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 (R)-3-((TERT-BUTOXYCARBONYL) AMINO)-4-(2,4,5- TRIFLUOROPHENYL) BUTANOIC ACID (SG04) 0.985 kg 2 1,1-CARBONYLDIIMIDAZOLE 0.50 kg 3 3-(TRIFLUOROMETHYL)-5,6,7,8- TETRAHYDRI-[1,2,4]TRIAZOLO[4,3- a]PYRAZINE HYDROCHLORIDE 0.75 kg 4 TETRAHYDROFURAN 5.00 kg 5 METHYLENE DICHLORIDE 15.00 kg SITAGLIPTIN HYDROCHLORIDE 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||SITAGLIPTIN HYDROCHLORIDE||1 kg|1|(R)-3-((TERT-BUTOXYCARBONYL) AMINO)-4-(2,4,5- TRIFLUOROPHENYL) BUTANOIC ACID (SG04)|0.985 kg| |||||2|1,1-CARBONYLDIIMIDAZOLE|0.50 kg| |||||3|3-(TRIFLUOROMETHYL)-5,6,7,8- TETRAHYDRI-[1,2,4]TRIAZOLO[4,3- a]PYRAZINE HYDROCHLORIDE|0.75 kg| |||||4|TETRAHYDROFURAN|5.00 kg| |||||5|METHYLENE DICHLORIDE|15.00 kg|

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6 ISO PROPYL ALCOHOL 5.00 kg

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

Case No.	99 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	KRUNAL INDUSTRIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00301989AM22
RA File Number	08AX04000162 AM22
Licence No and<br>Date	0811003592/30/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00301989AM22| |RA File Number|08AX04000162 AM22| |Licence No and Date|0811003592/30/12/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	100 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00302256AM22
RA File Number	03AX04000499 AM22
Licence No and<br>Date	0311009919/30/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	101 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00302260AM22
RA File Number	03AX04000308 AM22
Licence No and<br>Date	0311009920/30/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

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|HQRNORM APPLY 00302260AM22| |RA File Number|03AX04000308 AM22| |Licence No and Date|0311009920/30/12/2021| |Norms Committee Decision: Deferred for comments of TE.||

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Case No.	Case No.	Case No.	102 / NC/3/MEET/Aug/202223/6	102 / NC/3/MEET/Aug/202223/6	102 / NC/3/MEET/Aug/202223/6
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number			HQRNORM APPLY 00302268AM22
RA File Number			03AX04000340 AM22
Licence No and<br>Date			0311009921/30/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08.07.2022against advance authorization No.<br>0311002213 dt. 08.07.2022, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>S. No.<br>Export Product<br>Qty.
	S. No.	Export Product			Qty.


	1.	Medical<br>content	Creams & Ointments(Clotrimazole 1 Percentage Cream 10 Gm tubeLabe<br>Clotrimazole 1 Percentae W/W Brand Canesten or an other Tot Wt 3340	led<br>s	1 Number
		<br>(Net Co	g y .

edical content|Creams & Ointments(Clotrimazole 1 Percentage Cream 10 Gm tubeLabe Clotrimazole 1 Percentae W/W Brand Canesten or an other Tot Wt 3340||led s|1 Number| ||| (Net Co|g y . . nt: Clotri 33.40Kgs Oct 450.90Kgs Cetyl 100.20Kgs Ceto 334Kgs Emp tubes||g|| ||| 334000|, , , , Nos))|||| |||||||| |||||||| ||2.|Medical|Creams & Ointments( Clotrimazole 1 Percentage Vaginal cream 35Gm Tube w||ith|1 Number| ||| 6 Appli Tot Wt.| catorLabelled content Clotrimazole1 Percentage W/W Brand Canesten or any ot 2999.85Kgs (Net Cont: Clotri 30Kgs, Oct 404.98Kgs, Cetyl 90Kgs, Ceto|| her|| ||| 299.99Kgs, Emp tubes 85710Nos))||||| ||3.|Medical Creams & Ointments(Clotrimazole1 PercentageCream 100 Gm Tube Label content Clotrimazole1 Percentage W/W Brand Canesten or any other Tot Wt. 2000 (Net Cont: Clotri 20Kgs, Oct 270Kgs, Cetyl 60Kgs, Ceto 200Kgs, Emp tubes 20000Nos|||led Kgs ))|1 Number| ||4.|Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 20Gm.Tube Labelled content Clotrimazole1 PercentageW/W Brand Canesten or any other Tot Wt. 4540Kgs (Net Cont: Clotri 45.40Kgs, Oct 612.90Kgs, Cetyl 136.20Kgs, Ceto 454Kgs, Emp tubes 227000Nos) )||||1 Number| |||||||| ||5.|Medical Creams & Ointments(Clotrimazole 1 PercentageCream 50 Gm.Tube Labelled||||1 Number| ||| content Clotri|| mazole1 PercentageW/W Brand Canesten or any other. Tot Wt. 12420Kgs||| ||| (Net Cont: Cl|| otri 124.20Kgs, Oct 1676.70Kgs, Cetyl 372.60Kgs, Ceto 1242Kgs, Emp||| |||tubes 248400N||os) )||| |||||||| ||||||||

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any other. Tot Wt. 12420Kgs||| ||| (Net Cont: Cl|| otri 124.20Kgs, Oct 1676.70Kgs, Cetyl 372.60Kgs, Ceto 1242Kgs, Emp||| |||tubes 248400N||os) )||| |||||||| ||||||||

UDIN00208504AM23

||6.|Medical Creams & Ointments(Clotrimazole 2 Percentage Vaginal Cream 20 Gm.Tube with 3 ApplicatorLabelled content Clotrimazole 2 PercentageW/W Brand Canesten or any other. Tot Wt. 2000Kgs (Net Cont: Clotri 40Kgs, Oct 270Kgs, Cetyl 60Kgs, Ceto 200Kgs, Emp100000Nos, Appl 300000Nos)|Medical Creams & Ointments(Clotrimazole 2 Percentage Vaginal Cream 20 Gm.Tube with 3 ApplicatorLabelled content Clotrimazole 2 PercentageW/W Brand Canesten or any other. Tot Wt. 2000Kgs (Net Cont: Clotri 40Kgs, Oct 270Kgs, Cetyl 60Kgs, Ceto 200Kgs, Emp100000Nos, Appl 300000Nos)|Medical Creams & Ointments(Clotrimazole 2 Percentage Vaginal Cream 20 Gm.Tube with 3 ApplicatorLabelled content Clotrimazole 2 PercentageW/W Brand Canesten or any other. Tot Wt. 2000Kgs (Net Cont: Clotri 40Kgs, Oct 270Kgs, Cetyl 60Kgs, Ceto 200Kgs, Emp100000Nos, Appl 300000Nos)|Medical Creams & Ointments(Clotrimazole 2 Percentage Vaginal Cream 20 Gm.Tube with 3 ApplicatorLabelled content Clotrimazole 2 PercentageW/W Brand Canesten or any other. Tot Wt. 2000Kgs (Net Cont: Clotri 40Kgs, Oct 270Kgs, Cetyl 60Kgs, Ceto 200Kgs, Emp100000Nos, Appl 300000Nos)|Medical Creams & Ointments(Clotrimazole 2 Percentage Vaginal Cream 20 Gm.Tube with 3 ApplicatorLabelled content Clotrimazole 2 PercentageW/W Brand Canesten or any other. Tot Wt.

Appl 300000Nos)|Medical Creams & Ointments(Clotrimazole 2 Percentage Vaginal Cream 20 Gm.Tube with 3 ApplicatorLabelled content Clotrimazole 2 PercentageW/W Brand Canesten or any other. Tot Wt. 2000Kgs (Net Cont: Clotri 40Kgs, Oct 270Kgs, Cetyl 60Kgs, Ceto 200Kgs, Emp100000Nos, Appl 300000Nos)|1 Number| |---|---|---|---|---|---|---|---| ||7.|Medical Creams & Ointments(Clotrimazole10 PercentageVaginal cream 5 Gm Tube with 1 Applicator. Labelled content Clotrimazole 10 Percentage W/W;Brand Canesten or any other Tot Wt. 100Kgs (Net Cont: Clotri 10Kgs, Cetyl 3Kgs, Ceto 3.50Kgs, Emp tubes 20000Nos, Applicator 20000Nos))|||||1 Number| ||8.|Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 5 Gm.Tube Labelled content Clotrimazole 1 Percentage W/W Brand Canesten or any other. Tot Wt. 1750Kgs (Net Cont: Clotri 17.50Kgs, Oct 236.25Kgs, Cetyl 52.50Kgs, Ceto 175Kgs, Emp tubes 350000Nos) )|||||1 Number| ||9.|Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 3 Gm. Tube Labelled content Clotrimazole 1 Percentage W/W Brand Canesten or any other Tot Wt. 1500Kgs (Net Cont: Clotri 15Kgs, Oct 202.50Kgs, Cetyl 45Kgs, Ceto 150Kgs, Emp tubes 500000Nos) )|||||1 Number| ||For Export Product No. 2, 6 and 7||||||| ||S. No.||Import Item|For Export of 1 No.

s (Net Cont: Clotri 15Kgs, Oct 202.50Kgs, Cetyl 45Kgs, Ceto 150Kgs, Emp tubes 500000Nos) )|||||1 Number| ||For Export Product No. 2, 6 and 7||||||| ||S. No.||Import Item|For Export of 1 No. Clotrimazole Vaginal Cream|||| |||||1%, 35 gm tube|2%, 20 gm tube|10%, 5 gm tube|| ||1.||Clotrimazole|0.357 gm|0.408 gm|0.510 gm|| ||2.||Octyldodecanol|4.725 gm|2.70 gm|--|| ||3.||Cetyl Palmated|1.05 gm|0.60 gm|0.150 gm|| ||4.||Cetostearyl Alcohol|3.50 gm|2.00 gm|0.173 gm|| ||5.||Empty Aluminium Collapsible Tube|Relevant, as per packing policy||||

UDIN00208504AM23

Plastic Applicator

For Export Product No. 1, 3, 4, 5, 8 and 9

S.<br>No	Import Item	For Export of 1 No. Clotrimazole 1% cream, 100 gm pack
1.	Clotrimazole	1.02 gm
2.	Octyldodecanol	13.50 gm
3.	Cetyl Palmated	3.00 gm
4.	Cetostearyl Alcohol	10.00 gm
5.	Empty Aluminium Collapsible Tube	Relevant, as per packing policy

For different pack sizes, RA may work out norms on pro-rata basis.

etyl Palmated|3.00 gm| |4.|Cetostearyl Alcohol|10.00 gm| |5.|Empty Aluminium Collapsible Tube|Relevant, as per packing policy|

For different pack sizes, RA may work out norms on pro-rata basis.

Case No.	103 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00302379AM22
RA File Number	03AX04000490 AM22
Licence No and<br>Date	0311009926/30/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jan/202122/13 dated 21.01.2022against advance authorization No.<br>0311005777 dt. 31.07.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Jan/202122/13 dated 21.01.2022 against advance authorization No. 0311005777 dt. 31.07.2021 , 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:

UDIN00208504AM23

No. 0311005777 dt. 31.07.2021 , 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:

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Export product	Qty.	Sl. No.	Import items	Qty.
Fenofibrate Bulk Granulate	1 kg	1	Fenofibrate Micronized IH/Ph. Eur	0.3155 kg
		2	Hypromellose (2910, 3 cps) Ph. Eur	0.0625 kg
		3	Docusate Sodium Ph. Eur	0.0062 kg
		4	Sucrose Ph. Eur	0.3124 kg
		5	Sodium Lauril Sulfate Ph. Eur	0.0216 kg
		6	Lactose Monohydrate Ph. Eur	0.2804 kg

10, 3 cps) Ph. Eur|0.0625 kg| ||||3|Docusate Sodium Ph. Eur|0.0062 kg| ||||4|Sucrose Ph. Eur|0.3124 kg| ||||5|Sodium Lauril Sulfate Ph. Eur|0.0216 kg| ||||6|Lactose Monohydrate Ph. Eur|0.2804 kg|

Case No.	Case No.	Case No.	104 / NC/3/MEET/Aug/202223/6	104 / NC/3/MEET/Aug/202223/6	104 / NC/3/MEET/Aug/202223/6
Case Status			Case Approved
Party Name			MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number			HQRNORM APPLY 00302477AM22
RA File Number			07AX04000138 AM22
Licence No and<br>Date			0711002764/30/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Furosemide Injection 10mg/mL -<br>2mL Vial(2mL Vial - filled with<br>20mg of furosemide as bulk drug<br>mixed in water for injection and<br>filled in 2mL Vial and capped with<br>13mm chlorobutyle Rubber Stopper)<br>1 Number<br>1<br>Grey Westar RS SIL 1 (13mm<br>Chlorobutyle Rubber Stopper<br>Grey RFS)<br>Relevant as<br>per packing<br>policy<br>Furosemide Injection 10mg/mL -<br>Grey Westar RS SIL 1 Relevant as<br>2<br>1 Number<br>2
	Sl. No.	Export product		Qty.	Sl.

ber Stopper Grey RFS) Relevant as per packing policy Furosemide Injection 10mg/mL - Grey Westar RS SIL 1 Relevant as 2 1 Number 2|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Furosemide Injection 10mg/mL - 2mL Vial(2mL Vial - filled with 20mg of furosemide as bulk drug mixed in water for injection and filled in 2mL Vial and capped with 13mm chlorobutyle Rubber Stopper)|| 1 Number|1|Grey Westar RS SIL 1 (13mm Chlorobutyle Rubber Stopper Grey RFS)| Relevant as per packing policy| ||2|Furosemide Injection 10mg/mL -|| 1 Number|2|Grey Westar RS SIL 1|Relevant as|

UDIN00208504AM23

	4mL Vial(4mL Vial - filled with			(13mm Chlorobutyle Rubber	per packing
	40mg of furosemide as bulk drug			Stopper Grey RFS)	policy
	mixed in water for injection and
	filled in 4mL Vial and capped with
	13mm chlorobutyle Rubber Stopper)
3	Prochlorperazine Edisylate Injection	<br>1 Number	3	Grey Westar RS SIL 1	Relevant as
	USP<br>10mg/2mL(2mL<br>Vial<br>-			(13mm Chlorobutyle Rubber	per packing
	Prochlorperazine Edisylate Injection			Stopper Grey RFS)	policy
	USP 10mg/2mL and capped with
	13mm chlorobutyle Rubber Stopper)

Vial -|||(13mm Chlorobutyle Rubber|per packing| ||Prochlorperazine Edisylate Injection|||Stopper Grey RFS)|policy| ||USP 10mg/2mL and capped with||||| ||13mm chlorobutyle Rubber Stopper)|||||

		4mL Vi	al(4mL Vial - filled with	al(4mL Vial - filled with			(13mm Chlorobutyle Rubber	per packing
		40mg o<br>	f furosemide as bulk drug<br>		<br>		Stopper Grey RFS)	policy
		mixed i<br>	n water for injection and<br>		<br>
		filled in<br>13mm c	4mL Vial and capped with<br>hlorobutyle Rubber Stopper)
3<br>Prochlorperazine Edisylate Injection<br>USP<br>10mg/2mL(2mL<br>Vial<br>-<br>Prochlorperazine Edisylate Injection<br>USP 10mg/2mL and capped with<br>13mm chlorobutyle Rubber Stopper)<br>1 Number<br>3<br>Grey Westar RS SIL 1<br>(13mm Chlorobutyle Rubber<br>Stopper Grey RFS)<br>Relevant as<br>per packing<br>policy
	3	Prochlorperazine Edisylate Injection<br>USP<br>10mg/2mL(2mL<br>Vial<br>-<br>Prochlorperazine Edisylate Injection<br>USP 10mg/2mL and capped with<br>13mm chlorobutyle Rubber Stopper)			<br> <br> <br> <br>1 Number<br>	3	Grey Westar RS SIL 1<br>(13mm Chlorobutyle Rubber<br>Stopper Grey RFS)	Relevant as<br>per packing<br>policy

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


Case No.			105 / N	C/3/MEET/Aug/202223/6

cy| |||||||||||||||| |RA concerned may take fu||||rther necessary action as per above decision of NC.||||||||||| |||||||||||||||| |||||||||||||||| |Case No.|||105 / N|C/3/MEET/Aug/202223/6||||||||||| |Case Status|||Case A|pproved||||||||||| |Party Name|||SUN P|HARMACEUTICAL INDUSTRIES LIMITED||||||||||| |Meeting Number|||NC/ 3/|MEET/ Au/ 202223/ 6 and 09/09/2022||||||||||| |and Date||||g||||||||||| |HQ File Number|||HQRNORM APPLY 00303420AM22|||||||||||| |RA File Number|||05AX04000412 AM22|||||||||||| |Licence No and Date|||0511007495/31/12/2021|||||||||||| |N T i 0 o|orms Committee Decision: he Committee considered the case as per agenda mport item in Meeting No.NC/3/MEET/May/ 510413763 dt. 02.03.2020, it was decided to ratif r as applied by the firm, whichever is less:||||||||and taking cue from earlier decision for same export product / 202223/4 dated 17.06.2022against advance authorization No.|||||| |||||||ed s:|to ratif ||y norms un||der Para 4.07 of HBP Vol. I as per de|||tails given below| |||||||||||||||| ||Export product||||Qty.||Sl. No|||||||| ||||||||||.|Import i|tems||Qty.|| ||Valproic Acid||||1 kg||1|||||||| |||||||||||Diethyl|Malonate||1.42 kg|| ||||||||2|||||||| |||||||||||N-Prop|yl Bromide||2.186 k|g| ||||||||3|||||||| |||||||||||Sodium|Hydroxide Flakes||0.88 kg|| ||||||||4|||||||| |||||||||||Tetra B|utyl Ammonium Bromide||0.100 k|g| ||||||||||||||||

UDIN00208504AM23

5 Sulphuric Acid Not an importable item

||||||Sodium|Hydroxide Flakes||0.88 kg|| ||||||||4|||||||| |||||||||||Tetra B|utyl Ammonium Bromide||0.100 k|g| ||||||||||||||||

UDIN00208504AM23

5 Sulphuric Acid Not an importable item

Case No.	106 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00303434AM22
RA File Number	09AX04000074 AM22
Licence No and<br>Date	0911002160/31/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022against advance authorization No.<br>0911001814 dt. 03.11.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>(S,E)-5-AMINO-2-<br>(DIBENZYLAMINO)-1,6-<br>DIPHENYLHEX-4-EN-3-ONE<br>1.77 kg<br>2<br>SODIUM BORO HYDRIDE<br>0.45 kg<br>3<br>TETRA HYDRO FURAN<br>0.48 kg<br>4<br>2,2,2 TRI FLUORO ACETIC ACID<br>2.16 kg<br>(2S,3S,5S)-2-amino-3-hydroxy-5-tert<br>butyl<br>carbonyl<br>amino-1,6-diphenyl-<br>hexane<br>1 kg<br>5<br>DI TERT.BUTYL DI CARBONATE<br>0.92 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	107 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	TADIMETY AROMATICS PRIVATE LIMITED

UDIN00208504AM23

sary action as per above decision of NC.||

Case No.	107 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	TADIMETY AROMATICS PRIVATE LIMITED

UDIN00208504AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00303552AM22
RA File Number	07AX04000082 AM22
Licence No and<br>Date	0711002772/31/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	108 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00303629AM22
RA File Number	03AX04000191 AM22
Licence No and<br>Date	0311009972/31/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	109 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00303773AM22
RA File Number	34AX04000113 AM22
Licence No and<br>Date	3411001626/31/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	110 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	SANOFI INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00303836AM22
RA File Number	03AX04000501 AM22
Licence No and<br>Date	0311009978/31/12/2021
Norms Committee Decision:

/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022| |HQ File Number|HQRNORM APPLY 00303836AM22| |RA File Number|03AX04000501 AM22| |Licence No and Date|0311009978/31/12/2021| |Norms Committee Decision:||

43 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

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.
Ramipril PC Granules 850gm/1KG(Net content: each<br>1gm contains Ramipril 850mg, total net content<br>Ramipril 4250.00kg)	<br> <br>5000 kg	1	Ramipril	4292.50 kg

Case No.	111 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00305636AM22
RA File Number	09AX04000103 AM22
Licence No and<br>Date	0911002212/03/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>0911002182 dt. 28.12.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

02182 dt. 28.12.2021**, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Gama butyrolactone 0.754 kg 4-chlorobutyryl chloride 1 kg 2 Thionyl Chloride 1.210 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	112 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022

UDIN00208504AM23

HQ File Number	HQRNORM APPLY 00305699AM22
RA File Number	03AA040128756 AM22
Licence No and<br>Date	0311009997/03/01/2022
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	113 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	<br>NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00306197AM22
RA File Number	31AX04000033 AM22
Licence No and<br>Date	3111000851/03/01/2022
Norms Committee Decision:
The Committee	considered the case as per agenda and	taking cue from earlier decision for same export product /
import item in	Meeting No.NC/3/MEET/Mar/202122/15 dated 17.03.2022against		advance authorization No.
**3111000142 dt.

enda and|taking cue from earlier decision for same export product /|||| |import item in||Meeting No.NC/3/MEET/Mar/202122/15 dated 17.03.2022against||advance authorization No.||| |3111000142 dt. 03.02.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below||||||| |or as applied by the firm, whichever is less:||||||| ||Export product Qty. Sl. No.||Import items||Qty.|| ||2,6 Xylidine|1 MT 1|2,6 xylenol||1.4 MT|| |RA concerned may take further necessary action as per above decision of NC.|||||||

Case No.	114 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	GRANULES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00306285AM22
RA File Number	26AX04000009 AM22
Licence No and<br>Date	2611000395/03/01/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less:

UDIN00208504AM23

dered 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:||

UDIN00208504AM23

Export product	Qty.	Sl. No.	Import items	Qty.
Losartan Potassium	1 kg	1	4 Bromomethyl 2 Cyanobiphenyl	0.75 kg
		2	Sodium Borohydride	0.048 kg
		3	2 Butyl 4 Chloro 5 Formyl Imidazole	0.50 kg
		4	Acetone	1.45 kg
		5	Methylene Chloride	1.46 kg

Case No.	115 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	GRANULES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00306335AM22
RA File Number	26AX04000010 AM22
Licence No and<br>Date	2611000396/03/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00306335AM22| |RA File Number|26AX04000010 AM22| |Licence No and Date|2611000396/03/01/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	116 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	THEON PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00307355AM22
RA File Number	30AX04000052 AM22
Licence No and<br>Date	3011001623/04/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No. 117 / NC/3/MEET/Aug/202223/6

UDIN00208504AM23

Case Status	Case Approved
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00308001AM22
RA File Number	03AX04000497 AM22
Licence No and<br>Date	0311010100/05/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022against advance authorization No.<br>0310828995 dt. 14.05.2019,it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.

*0310828995 dt. 14.05.2019,**it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 PHENOL 0.557 kg 2 ISODECYL ALCOHOL OR 2 PROPYL HEPTANOL 0.419 kg DIPHENYL ISODECYL PHOSPHITE((DPDP)) 1 kg 3 YELLOW PHOSPHORUS 0.087 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	118 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	NEXUS PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00310237AM22
RA File Number	08AX04000182 AM22
Licence No and<br>Date	0811003688/06/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022against advance authorization No.<br>0811003180 dt. 18.11.2021,it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:

vance authorization No. **0811003180 dt. 18.11.2021,**it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:||

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Mar/202122/16 dated 08.04.2022 against advance authorization No. 0811003180 dt. 18.11.2021, 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:

UDIN00208504AM23

Export product	Qty.	Sl. No.	Import items	Qty.
Clobetasol Propionate USP	1 kg	1	Betamethasone base	1.00 kg

Case No.	119 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00310531AM22
RA File Number	34AX04000034 AM22
Licence No and<br>Date	3411001652/07/01/2022
Norms Committee Decision:
Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00310531AM22| |RA File Number|34AX04000034 AM22| |Licence No and Date|3411001652/07/01/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	Case No.	119 / N	C/3/MEET/Aug/202223/6	C/3/MEET/Aug/202223/6	C/3/MEET/Aug/202223/6	C/3/MEET/Aug/202223/6
Case Status		Case D	eferred
Party Name		BEST	VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/	MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number		HQRN	ORM APPLY 00310531AM22
RA File Number		34AX0	4000034 AM22
Licence No and<br>		341100	1652/07/01/2022
Date
Norms Committee Decision:<br>Deferred for comments of TE.

C	ase No.	120 / NC/3/MEET/Aug/202223/6
C	ase Status	Case Approved
P	arty Name	NEULAND LABORA		TORIES L	TD.
M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Aug/ 20		2223/ 6 an	d 09/09/202	2
H	Q File Number	HQRNORM APPLY 0		0311219A	M22

R	A File Number	09AX04000109 AM22
L<br>D	icence No and<br>ate	0911002250/07/01/202		2

N<br>T<br>i<br>0<br>o	orms Committee Decision:<br>he Committee considered the case as p<br>mport item in Meeting No.NC/3/ME<br>**911002161 dt.

e|0911002250/07/01/202||2|||||||| ||||||||||||| |N T i 0 o|orms Committee Decision: he Committee considered the case as p mport item in Meeting No.NC/3/ME **911002161 dt. 27.12.2021,**it was decid r as applied by the firm, whichever is les|||er agenda ET/Apr/ ed to ratif s:|||||||| |||||||and takin 202223/1 d ||g cue from earlier decision for same ated 29.04.2022against advance a P 407 f HBP Vl I d||export product / uthorization No. il i bl|| |||||||y norms un||er ara . o o. as per e||as gven eow|| ||||||||||||| ||Export product||||Qt||Sl N||It it||Qt| ||||||y.||. o.||mpor ems||y.| ||IBREXAFUNGERP CITRATE||||1 kg||1||ENFUMAFUNGIN||4.55 kg|

UDIN00208504AM23

Case No.	121 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00310549AM22
RA File Number	09AX04000111 AM22
Licence No and<br>Date	0911002242/07/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>0911002135 dt. 22.12.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.

911002135 dt. 22.12.2021**, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Cytidine 1.35 kg 2 2,2-Dimethoxy propane 3.00 kg 3 DBU (1, 8-diazabicyclo [5.4. 0] undec-7-ene 1.50 kg 4 Isobutyric anhydride 0.90 kg Molnupiravir 1 kg 5 Isopropyl alcohol 5.00 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	122 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	SCITECH SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00311328AM22
RA File Number	03AA040131440 AM22

UDIN00208504AM23

Licence No and 0311010245/07/01/2022 Date Norms Committee Decision:

Licence No and<br>Date	Licence No and<br>Date	0311010245/07/01/2022	0311010245/07/01/2022	0311010245/07/01/2022	0311010245/07/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.


C	ase No.	123 / NC/3/MEET/Aug	/202223/6
C	ase Status	Case Approved
P	arty Name	SUN PHARMACEUTI	CAL IND	USTRIES L	IMITED

||||||| |||||||||||||||| |||||||||||||||| |C|ase No.||123 / NC/3/MEET/Aug||/202223/6|||||||||| |C|ase Status||Case Approved|||||||||||| |P|arty Name||SUN PHARMACEUTI||CAL IND||USTRIES L||||IMITED|||| |M a|eeting Number nd Date||NC/ 3/ MEET/ Aug/ 20||2223/ 6 an|||||||||| ||||||||d 09/09/202||||2|||| |H|Q File Number||HQRNORM APPLY 0||0310564A||M22|||||||| |R|A File Number||05AX04000450 AM22|||||||||||| |L D|icence No and ate||0511007696/07/01/202||2|||||||||| |||||||||||||||| |N T i 0 o|orms Committee Decision: he Committee considered the case as p mport item in Meeting No.NC/3/ME 511005404 dt. 13.10.2021, it was decid r as applied by the firm, whichever is les||||er agenda ET/Mar/2 ed to ratif s:|||||||||| ||||||||and takin 02122/16 y norms un||||g cue from earlier decision for same dated 08.04.2022against advance a der Para 4.07 of HBP Vol. I as per det||export product / uthorization No. ails given below|| |||||||||||||||| |||||||||||||||| ||Export product|||||Qty.|||Sl.

08.04.2022**against advance a der Para 4.07 of HBP Vol. I as per det||export product / uthorization No. ails given below|| |||||||||||||||| |||||||||||||||| ||Export product|||||Qty.|||Sl. No.|||Import items||Qty.| ||Brinzolamide Ophthalmic Suspension, 1 Pt / 5l Stil E D||||| 24000 Nb|||1|||Brinzolamide Micronized Sterile||1224 gram| ||ercen wv m ( ere ye rops) (BRINOLAR / BRAZTEC)((Each ml||||| umers||||||||| || contains Brinz|| olamide equivalent to||| ||||||||| ||Brinzolamide M|| icronized Sterile 10 mg|||||||||||| ||(Equivalent to 12||00 Gm of Bulk Drug),)|||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| |RA concerned may|||take further necessary action as per above decision of NC.|||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| |Case No.|||124 / NC/3/MEET/Aug/202223/6|||||||||||| |Case Status|||Case Deferred|||||||||||| |Party Name|||NAARI PHARMA PRIVATE LIMITED|||||||||||| |Meeting Number and Date|||NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022|||||||||||| |H|Q File Number||HQRNORM APPLY 00310736AM22|||||||||||| |R|A File N|umber|05AX04000472 AM|22||||||||||| |L D|icence N t|o and|0511007713/07/01/2|022||||||||||| ||ae|||||||||||||| |N|orms Co|mmittee Decision:||||||||||||| ||||||||||||||||

|||||||| |R|A File N|umber|05AX04000472 AM|22||||||||||| |L D|icence N t|o and|0511007713/07/01/2|022||||||||||| ||ae|||||||||||||| |N|orms Co|mmittee Decision:||||||||||||| ||||||||||||||||

Case No.	124 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00310736AM22
RA File Number	05AX04000472 AM22
Licence No and<br>Date	0511007713/07/01/2022
Norms Committee Decision:

UDIN00208504AM23

Case No.	125 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00310737AM22
RA File Number	05AX04000473 AM22
Licence No and<br>Date	0511007715/07/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	126 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00310788AM22
RA File Number	34AX04000140 AM22
Licence No and<br>Date	3411001662/07/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00310788AM22| |RA File Number|34AX04000140 AM22| |Licence No and Date|3411001662/07/01/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	127 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00311087AM22
RA File Number	52AX04000026 AM22
Licence No and<br>Date	5211001828/07/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>5211001019 dt. 20.07.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:

51 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Export product	Qty.	Sl. No. Import items	Qty.
Methyl Paraben	1 kg	1<br>Para Hydroxy Benzoic Acid	0.969 kg

KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Export product	Qty.	Sl. No. Import items	Qty.
Methyl Paraben	1 kg	1<br>Para Hydroxy Benzoic Acid	0.969 kg

R	Export product	Export product	Export product	Qty.	Sl. No.	Import items	Import items	Qty.
	Methyl	Paraben		1 kg	1	Para Hydroxy Benzo	ic Acid	0.969 kg

	A concer	ned may take further necessary action as per above decision of NC.

Case No.			128 / NC/3/MEET/Aug/202223/6
Case Status			Case Approved
Party Name			YASHO INDUSTRIES LIMITED
Meeting Number
<br>and Date			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022

HQ File Number			HQRNORM APPLY 00311116AM22

RA File Number			03AX04000607 AM22

Licence No and
Date			0311010239/07/01/2022
Norms Committee			Decision:

The Committee co<br>			nsidered the case as per agenda and taking cue from earlier decision for same export product /<br>
import item in M<br>0311004509 dt. 10<br>lid b h			eeting No.NC/3/MEET/May/202223/4 dated 17.06.2022against advance authorization No.<br>.06.2021, it was decided to ratify norms under Para 4.07 of HBP Vol.

0311004509 dt. 10 lid b h|||eeting No.NC/3/MEET/May/202223/4 dated 17.06.2022against advance authorization No. .06.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below fi hih i l||||||||||| |o R|r as appe y te rm, wcever s ess:||||||||||||| ||Export product|||||Qty.|Sl. No.|||Import items||Qty.|| ||DI-NONYLATED DIPHENYLAMINE (YALUB DND)|||||1 kg|1|||DIPHENYLAMINE||0.4134 kg|| ||||||||2|||NONENE||0.4 kg|| ||||||||3|||ACTIVATED CLAY||0.05 kg|| ||A concerned may take further necessary|||action as per ab|||ove dec|ision of NC.|||||| ||||||||||||||| |C|ase No.||||||||||||| ||||129 / NC/3/MEET/Aug/202223/6||||||||||| |C|ase Status||Case Deferred||||||||||| |Party Name|||PIRAMAL PHARMA LIMITED||||||||||| |Meeting Number |||NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022||||||||||| |and Date|||||||||||||| ||||||||||||||| |HQ File Number|||HQRNORM APPLY 00313299AM22||||||||||| ||||||||||||||| |RA File Number|||03AX04000542 AM22||||||||||| |||||||||||||||

Case No.	129 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00313299AM22
RA File Number	03AX04000542 AM22

UDIN00208504AM23

Licence No and 0311010308/10/01/2022 Date Norms Committee Decision:

UDIN00208504AM23

Licence No and 0311010308/10/01/2022 Date Norms Committee Decision:

Case No.	130 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	NOVEL NUTRIENTSS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00313831AM22
RA File Number	07AX04000173 AM22
Licence No and<br>Date	0711002845/10/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/15 dated 17.03.2022against advance authorization No.<br>0511001323 dt. 17.02.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>BERBERINE HCL<br>(Containing Berberis Aristata Extract)<br>1 kg<br>1<br>BERBERIS ARISTATA EXTRACT<br>1.00 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	131 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00313838AM22
RA File Number	08AX04000177 AM22
Licence No and<br>Date	0811003727/10/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00313838AM22| |RA File Number|08AX04000177 AM22| |Licence No and Date|0811003727/10/01/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No. 132 / NC/3/MEET/Aug/202223/6

UDIN00208504AM23

Case Status	Case Deferred
Party Name	ASOJ SOFT CAPS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00313907AM22
RA File Number	34AX04000142 AM22
Licence No and<br>Date	3411001665/10/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	133 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00314623AM22
RA File Number	05AX04000321 AM22
Licence No and<br>Date	0511007823/11/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology<br>(DBT) for obtaining their comments.

/01/2022| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology (DBT) for obtaining their comments.||

Case No.	134 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	UTTAM CAMPHOR WORKS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00315086AM22
RA File Number	06AA04008356 AM22
Licence No and<br>Date	0611001053/11/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete composition of export product.

Case No.	135 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	PORUS LABORATORIES PRIVATE LIMITED

54 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00315693AM22
RA File Number	09AX04000098 AM22
Licence No and<br>Date	0911002275/12/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

|---|---| |HQ File Number|HQRNORM APPLY 00315693AM22| |RA File Number|09AX04000098 AM22| |Licence No and Date|0911002275/12/01/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	136 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00315825AM22
RA File Number	09AX04000108 AM22
Licence No and<br>Date	0911002281/12/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	137 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00316095AM22
RA File Number	03AX04000666 AM22
Licence No and<br>Date	0311010407/12/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jul/202122/4 dated 15.07.2021against advance authorization No.<br>0311001996 dt. 08.03.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Betamethasone Dipropionate (IP/BP/EP/USP)<br>115 kg<br>1<br>Betamethasone<br>99.82 kg<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00208504AM23

. Betamethasone Dipropionate (IP/BP/EP/USP) 115 kg 1 Betamethasone 99.82 kg RA concerned may take further necessary action as per above decision of NC.||

UDIN00208504AM23

Case No.	138 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00316210AM22
RA File Number	09AX04000110 AM22
Licence No and<br>Date	0911002288/12/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>0911002161 dt. 27.12.2021,it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. 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.	139 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00317040AM22
RA File Number	08AX04000199 AM22
Licence No and<br>Date	0811003776/13/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00317040AM22| |RA File Number|08AX04000199 AM22| |Licence No and Date|0811003776/13/01/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	140 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	VISWAAT CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00318314AM22

UDIN00208504AM23

RA File Number	03AX04000704 AM22
Licence No and<br>Date	0311010518/14/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete composition of import item No. 1 – Mixed Terpenes and Terpenoids in Aromatic Solvent [AS/01/31]<br>indicating percentage composition of each component and percentage solid content.

Case No.	141 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00318349AM22
RA File Number	31AX04000040 AM22
Licence No and<br>Date	3111000876/14/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00318349AM22| |RA File Number|31AX04000040 AM22| |Licence No and Date|3111000876/14/01/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	142 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00320005AM22
RA File Number	07AX04000209 AM22
Licence No and<br>Date	0711002880/16/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	143 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00320474AM22
RA File Number	03AA040113369 AM22
Licence No and	0311010560/17/01/2022

57 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Date

The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	144 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00320476AM22
RA File Number	03AX04000684 AM22
Licence No and<br>Date	0311010562/17/01/2022
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE.

Case No.	145 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00320688AM22
RA File Number	31AX04000045 AM22
Licence No and<br>Date	3111000884/17/01/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	146 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00321040AM22
RA File Number	03AX04000043 AM22
Licence No and<br>Date	0311010585/17/01/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	147 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred

UDIN00208504AM23

r>Date|0311010585/17/01/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	147 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred

UDIN00208504AM23

Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00321046AM22
RA File Number	038504000145 AM21
Licence No and<br>Date	0311010587/17/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	148 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00321275AM22
RA File Number	05AX04000573 AM22
Licence No and<br>Date	0511007997/17/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	149 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00321279AM22
RA File Number	05AX04000574 AM22
Licence No and<br>Date	0511007998/17/01/2022
Norms Committee Decision:<br>Deferred for comments of TE

9/09/2022| |HQ File Number|HQRNORM APPLY 00321279AM22| |RA File Number|05AX04000574 AM22| |Licence No and Date|0511007998/17/01/2022| |Norms Committee Decision: Deferred for comments of TE||

Case No.	150 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00321421AM22
RA File Number	34AX04000074 AM22
Licence No and<br>Date	3411001688/17/01/2022

59 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Case No.	151 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00322542AM22
RA File Number	09AX04000129 AM22
Licence No and<br>Date	0911002311/18/01/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	152 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00322636AM22
RA File Number	03AA04044735 AM22
Licence No and<br>Date	0311010626/18/01/2022
Norms Committee Decision:
The reply submitted by the firm is under examination. Deferred for comments of TE

|RA File Number|03AA04044735 AM22| |Licence No and Date|0311010626/18/01/2022| |Norms Committee Decision:|| |The reply submitted by the firm is under examination. Deferred for comments of TE||

Case No.	153 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00323538AM22
RA File Number	09AX04000097 AM22
Licence No and<br>Date	0911002338/19/01/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	154 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
PartyName	SANDHYA ORGANIC CHEMICALS PVT LTD

60 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number		HQRNORM APPLY 00323988AM22
RA File Number		03AX04000730 AM22
Licence No and<br>Date		0311010684/19/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and after comparison from case of M/s Krishna Antioxidants, it was<br>decided to ratify adhoc 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.

Antioxidants, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 PHENOL 0.238 kg 2 ISODECYL ALCOHOL OR 2 PROPYL HEPTANOL 0.734 kg DI ISODECYL PHENYL PHOSPHITE((DDPP)) 1 kg 3 YELLOW PHOSPHORUS 0.075 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||DI ISODECYL PHENYL PHOSPHITE((DDPP))|| 1 kg|1|PHENOL|0.238 kg| |||||2|ISODECYL ALCOHOL OR 2 PROPYL HEPTANOL| 0.734 kg| |||||3|YELLOW PHOSPHORUS|0.075 kg| |||||s per above decision of NC.|||

Case No.	Case No.	155 / NC/3/MEET/Aug/202223/6	155 / NC/3/MEET/Aug/202223/6	155 / NC/3/MEET/Aug/202223/6	155 / NC/3/MEET/Aug/202223/6	155 / NC/3/MEET/Aug/202223/6
Case Status		Case Approved
Party Name		MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number		HQRNORM APPLY 00323997AM22
RA File Number		03AX04000211 AM22
Licence No and Date		0311009569/19/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Oct/202122/9 dated 15.10.2021against advance authorization No.<br>0910058792 dt. 31.12.2013,it was decided to ratify norms under Para 4.07 of HBP Vol.

/ import item in Meeting No.NC/3/MEET/Oct/202122/9 dated 15.10.2021against advance authorization No. **0910058792 dt. 31.12.2013,**it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.|

Case No.	Case No.	155 / NC/3/MEET/Aug/202223/6	155 / NC/3/MEET/Aug/202223/6	155 / NC/3/MEET/Aug/202223/6	155 / NC/3/MEET/Aug/202223/6	155 / NC/3/MEET/Aug/202223/6
Case Status		Case Approved
Party Name		MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number		HQRNORM APPLY 00323997AM22
RA File Number		03AX04000211 AM22
Licence No and Date		0311009569/19/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Oct/202122/9 dated 15.10.2021against advance authorization No.<br>0910058792 dt. 31.12.2013,it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

UDIN00208504AM23

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

UDIN00208504AM23

1	2,7-DICHLORO-9H-FLUORENE (DCF)	0.760 kg
2	N,N-DIBUTYL AMINE (N-DBA)	0.500 kg
3	SODIUM BOROHYDRIDE	0.060 kg
4	METHYLENE DICHLORIDE (MDC)	1.380 kg
5	4-CHLOROBENZALDEHYDE	0.3476 kg

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

Case No.	156 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00324009AM22
RA File Number	03AX04000495 AM22
Licence No and<br>Date	0311010688/19/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00324009AM22| |RA File Number|03AX04000495 AM22| |Licence No and Date|0311010688/19/01/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.	Case No.	157 / NC/3/MEET/Aug/202223/6	157 / NC/3/MEET/Aug/202223/6	157 / NC/3/MEET/Aug/202223/6	157 / NC/3/MEET/Aug/202223/6	157 / NC/3/MEET/Aug/202223/6
Case Status			Case Approved
Party Name			MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number			HQRNORM APPLY 00324894AM22
RA File Number			07AX04000207 AM22
Licence No and<br>Date			0711002867/20/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.

UDIN00208504AM23

pplied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty.|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.|

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1<br>Sodium Chloride Injection USP<br>90mg per 10mL Vial.(10mL Vial -<br>filled with 90mg of Sodium Chloride<br>as bulk drug filled in 10mL Vial and<br>capped with 13mm Rubber Stopper<br>& 13mm White colour Matte finish<br>Seals)<br>1 Number<br>1<br>13FO<br>LQ<br>3766<br>WHITE<br>MATTE TOP<br>Relevant as<br>per packing<br>policy<br>2<br>Sodium<br>Bicarbonate<br>Injection<br>84mg/mL -50mL Vial(50mL Vial -<br>filled with 4200mg of Sodium<br>Bicarbonate as bulk drug filled in<br>50mL Vial and capped with 20mm<br>Rubber Stopper & 20mm Red colour<br>Matte finish Seals)<br>1 Number<br>2<br>20FO<br>LQ<br>3767<br>RED<br>MATTE TOP<br>Relevant as<br>per packing<br>policy<br>RA concerned may take further necessary action as per above decision of NC.	1	Sodium Chloride Injection USP<br>90mg per 10mL Vial.(10mL Vial -<br>filled with 90mg of Sodium Chloride<br>as bulk drug filled in 10mL Vial and<br>capped with 13mm Rubber Stopper<br>& 13mm White colour Matte finish<br>Seals)	<br> <br> <br> <br> <br> <br>1 Number	1	13FO<br>LQ<br>3766<br>WHITE<br>MATTE TOP	<br>Relevant as<br>per packing<br>policy

& 13mm White colour Matte finish Seals)| 1 Number|1|13FO LQ 3766 WHITE MATTE TOP| Relevant as per packing policy| |---|---|---|---|---|---|---| ||2|Sodium Bicarbonate Injection 84mg/mL -50mL Vial(50mL Vial - filled with 4200mg of Sodium Bicarbonate as bulk drug filled in 50mL Vial and capped with 20mm Rubber Stopper & 20mm Red colour Matte finish Seals)| 1 Number|2|20FO LQ 3767 RED MATTE TOP|Relevant as per packing policy|

Case No.	Case No.	Case No.	158 / NC/3/MEET/Aug/202223/6	158 / NC/3/MEET/Aug/202223/6	158 / NC/3/MEET/Aug/202223/6	158 / NC/3/MEET/Aug/202223/6	158 / NC/3/MEET/Aug/202223/6
Case Status			Case Approved
Party Name			J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number			HQRNORM APPLY 00326370AM22
RA File Number			03AX04000650 AM22
Licence No and<br>Date			0311010761/21/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Aug/202122/7 dated 13.08.2021against advance authorization No.<br>0310832013 dt. 04.10.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.

and 09/09/2022| |HQ File Number|HQRNORM APPLY 00333787AM22| |RA File Number|34AX04000203 AM22| |Licence No and Date|3411001739/28/01/2022| |Norms Committee Decision:||

UDIN00208504AM23

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/May/202223/3 dated 27.05.2022 against advance authorization No. 3411000938 dt. 04.08.2021 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
1	CREAM(Lidocaine and Prilocaine Cream USP 2.5<br>percentage and 2.5 percentage 5 gm tube<br>(Net content of API Lidocaine 0.375 kgs. and<br>Prilocaine 0.375 kgs	<br> <br>3000<br>Numbers	1	Lidocaine USP	0.382 kg
			2	Prilocaine Base USP	0.382 kg
2	CREAM(Lidocaine and Prilocaine Cream USP 2.5<br>percentage and 2.5 percentage 30 gm tube<br>(Net content of API Lidocaine 195.75 kgs.

|1|Lidocaine USP|0.382 kg| ||||2|Prilocaine Base USP|0.382 kg| |2|CREAM(Lidocaine and Prilocaine Cream USP 2.5 percentage and 2.5 percentage 30 gm tube (Net content of API Lidocaine 195.75 kgs. and Prilocaine 195.75 kgs)| 261000 Numbers|3|Lidocaine USP|199.6585 kg| ||||4|Prilocaine Base USP|199.6585 kg| |3|OINTMENT(Lidocaine Ointment USP 5 percentage 30 gm tube (Net content of API 1.50 kgs.))| 1000 Numbers|5|Lidocaine USP|1.5295 kg| |4|OINTMENT(Lidocaine Ointment USP 5 percentage 35.44 gm tube (Net content of API 1.77 kgs.))| 1000 Numbers|6|Lidocaine USP|1.807 kg| |5|OINTMENT(Lidocaine Ointment USP 5 percentage 50 gm jar tube (Net content of API 2.5 kgs.))| 1000 Numbers|7|Lidocaine USP|2.55 kg|

Case No.	185 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	SYMED LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00333903AM22
RA File Number	09AX04000106 AM22
Licence No and<br>Date	0911002414/28/01/2022
Norms Committee Decision:

UDIN00208504AM23

and 09/09/2022| |HQ File Number|HQRNORM APPLY 00333903AM22| |RA File Number|09AX04000106 AM22| |Licence No and Date|0911002414/28/01/2022| |Norms Committee Decision:||

UDIN00208504AM23

Case No.	186 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00333910AM22
RA File Number	05AX04000799 AM22
Licence No and<br>Date	0511008302/28/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>0511006792 dt. 04.08.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Brinex / Brinex-M / Brinarga / Brinera (Brinzolamide<br>Opthalmic Suspension 1%)- 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.

Brinarga / Brinera (Brinzolamide Opthalmic Suspension 1%)- 5ml 1 Vial 1 Brinzolamide 51.00 mg / Vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	187 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00334092AM22
RA File Number	08AX04000340 AM22
Licence No and<br>Date	0811003916/28/01/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	188 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED

UDIN00208504AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00334321AM22
RA File Number	52AX04000053 AM22
Licence No and<br>Date	5211001941/28/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>5211001019 dt. 20.07.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Methyl Paraben<br>1 kg<br>1<br>Para Hydroxy Benzoic Acid<br>0.969 kg<br>RA concerned may take further necessary action as per above decision of NC.

uct Qty. Sl. No. Import items Qty. Methyl Paraben 1 kg 1 Para Hydroxy Benzoic Acid 0.969 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	189 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	GRANULES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00334413AM22
RA File Number	26AX04000014 AM22
Licence No and<br>Date	2611000439/28/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.6/82-ALC4/2018 dated 16.08.2019against advance authorization No.0910067616 dt.<br>31.05.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Rifaximin<br>1 kg<br>1<br>Rifamycin O<br>1.50 kg<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00208504AM23

ty. Sl. No. Import items Qty. Rifaximin 1 kg 1 Rifamycin O 1.50 kg RA concerned may take further necessary action as per above decision of NC.||

UDIN00208504AM23

Case No.	190 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	BIODEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00342526AM22
RA File Number	05AX04000785 AM22
Licence No and<br>Date	0511008526/03/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/15 dated 17.03.2022against advance authorization No.<br>0511000932 dt. 02.02.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>NASAL SPRAY(SNAP-ON, S20<br>WHITE<br>SMOOTH,<br>NASAL<br>ADAPTOR & CHEMICALS)<br>127500<br>Number<br>1<br>NASAL ADAPTOR FOR MFG<br>OF NASAL SPRAY<br>Relevant, on Net<br>to Net basis with<br>accountability<br>RA concerned may take further necessary action as per above decision of NC.

r>Number 1 NASAL ADAPTOR FOR MFG OF NASAL SPRAY Relevant, on Net to Net basis with accountability RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	Case No.<br>	Case No.<br>	191 / NC/3/MEET/Aug/202223/6	191 / NC/3/MEET/Aug/202223/6	191 / NC/3/MEET/Aug/202223/6	191 / NC/3/MEET/Aug/202223/6	191 / NC/3/MEET/Aug/202223/6
Case Status<br>			Case Approved
Party Name<br>			MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number<br>			HQRNORM APPLY 00342818AM22
RA File Number<br>			07AX04000330 AM22
Licence No and<br>Date<br>			0711003135/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Furosemide Injection 10mg/mL -<br>2mL Vial(2mL Vial - filled with<br>20mg of furosemide as bulk drug<br>1<br>1 Number<br>1<br>Grey Westar RS SIL 1<br>(13mm Chlorobutyle Rubber<br>Stopper Grey RFS)<br>Relevant as<br>per packing<br>policy
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	Furosemide Injection 10mg/mL -<br>2mL Vial(2mL Vial - filled with<br>20mg of furosemide as bulk drug		<br> <br> <br>1 Number	1	Grey Westar RS SIL 1<br>(13mm Chlorobutyle Rubber<br>Stopper Grey RFS)	<br> <br>Relevant as<br>per packing<br>policy

ial - filled with 20mg of furosemide as bulk drug|| 1 Number|1|Grey Westar RS SIL 1 (13mm Chlorobutyle Rubber Stopper Grey RFS)| Relevant as per packing policy|

Case No.<br>	Case No.<br>	Case No.<br>	191 / NC/3/MEET/Aug/202223/6	191 / NC/3/MEET/Aug/202223/6	191 / NC/3/MEET/Aug/202223/6	191 / NC/3/MEET/Aug/202223/6	191 / NC/3/MEET/Aug/202223/6
Case Status<br>			Case Approved
Party Name<br>			MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number<br>			HQRNORM APPLY 00342818AM22
RA File Number<br>			07AX04000330 AM22
Licence No and<br>Date<br>			0711003135/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Furosemide Injection 10mg/mL -<br>2mL Vial(2mL Vial - filled with<br>20mg of furosemide as bulk drug<br>1<br>1 Number<br>1<br>Grey Westar RS SIL 1<br>(13mm Chlorobutyle Rubber<br>Stopper Grey RFS)<br>Relevant as<br>per packing<br>policy
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	Furosemide Injection 10mg/mL -<br>2mL Vial(2mL Vial - filled with<br>20mg of furosemide as bulk drug		<br> <br> <br>1 Number	1	Grey Westar RS SIL 1<br>(13mm Chlorobutyle Rubber<br>Stopper Grey RFS)	<br> <br>Relevant as<br>per packing<br>policy

ial - filled with 20mg of furosemide as bulk drug|| 1 Number|1|Grey Westar RS SIL 1 (13mm Chlorobutyle Rubber Stopper Grey RFS)| Relevant as per packing policy|

UDIN00208504AM23

mixed in water for injection and<br>filled in 2mL Vial and capped with<br>13mm chlorobutyle Rubber Stopper)<br>2<br>Furosemide Injection 10mg/mL -<br>4mL Vial(4mL Vial - filled with<br>40mg of furosemide as bulk drug<br>mixed in water for injection and<br>filled in 4mL Vial and capped with<br>13mm chlorobutyle Rubber Stopper)<br>1 Number<br>2<br>Grey Westar RS SIL 1<br>(13mm Chlorobutyle Rubber<br>Stopper Grey RFS)<br>Relevant as<br>per packing<br>policy<br>3<br>Prochlorperazine Edisylate Injection<br>USP<br>10mg/2mL(2mL<br>Vial<br>-<br>Prochlorperazine Edisylate Injection<br>USP 10mg/2mL and capped with<br>13mm chlorobutyle Rubber Stopper)<br>1 Number<br>3<br>Grey Westar RS SIL 1<br>(13mm Chlorobutyle Rubber<br>Stopper Grey RFS)<br>Relevant as<br>per packing<br>policy<br>RA concerned may take further necessary action as per above decision of NC.		mixed in water for injection and<br>filled in 2mL Vial and capped with<br>13mm chlorobutyle Rubber Stopper)	<br>

rther necessary action as per above decision of NC.		mixed in water for injection and<br>filled in 2mL Vial and capped with<br>13mm chlorobutyle Rubber Stopper)	<br>
	2	Furosemide Injection 10mg/mL -<br>4mL Vial(4mL Vial - filled with<br>40mg of furosemide as bulk drug<br>mixed in water for injection and<br>filled in 4mL Vial and capped with<br>13mm chlorobutyle Rubber Stopper)	<br> <br> <br> <br> <br>1 Number	2	Grey Westar RS SIL 1<br>(13mm Chlorobutyle Rubber<br>Stopper Grey RFS)	<br> <br>Relevant as<br>per packing<br>policy
	3	Prochlorperazine Edisylate Injection<br>USP<br>10mg/2mL(2mL<br>Vial<br>-<br>Prochlorperazine Edisylate Injection<br>USP 10mg/2mL and capped with<br>13mm chlorobutyle Rubber Stopper)	<br> <br> <br> <br>1 Number	3	Grey Westar RS SIL 1<br>(13mm Chlorobutyle Rubber<br>Stopper Grey RFS)	<br> <br>Relevant as<br>per packing<br>policy

Case No.	192 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	BIOXERA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343396AM22
RA File Number	03AX04001003 AM22
Licence No and<br>Date	0311011012/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.<br>0311009297 dt. 08.12.2021, it was decided to ratify norms under Para 4.07 of HBP Vol.

br>import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No. 0311009297 dt. 08.12.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: (Ask Mathur Sir) Export product Qty. Sl. No. Import items Qty. BENFOTIAMINE 1 kg 1 VITAMIN B1 0.922 kg RA concerned may take further necessary action as per above decision of NC.||

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Case No.	193 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343447AM22
RA File Number	03AX04000901 AM22
Licence No and<br>Date	0311011119/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.5/82-ALC4/2019 dated 02.08.2019against advance authorization No.0310828889 dt.<br>09.05.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Difluprednate<br>Ophthalmic<br>Emulsion<br>0.05%(Each ml contains : Difluprednate<br>0.05%, Sorbic acid NF 0.1%)<br>1 Number<br>1<br>Difluprednate<br>0.00255 gm / 5 ml pack<br>RA concerned may take further necessary action as per above decision of NC.

contains : Difluprednate 0.05%, Sorbic acid NF 0.1%) 1 Number 1 Difluprednate 0.00255 gm / 5 ml pack RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	Case No.<br>	194 / NC/3/MEET/Aug/202223/6	194 / NC/3/MEET/Aug/202223/6	194 / NC/3/MEET/Aug/202223/6	194 / NC/3/MEET/Aug/202223/6	194 / NC/3/MEET/Aug/202223/6
Case Status<br>		Case Approved
Party Name<br>		MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number<br>		HQRNORM APPLY 00342819AM22
RA File Number<br>		07AX04000318 AM22
Licence No and<br>Date<br>		0711003139/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Sodium Chloride Injection USP 90mg per<br>10mL Vial.(10mL Vial - filled with 90mg<br>of Sodium Chloride as bulk drug<br>1 Number<br>1<br>10ml Unprinted Clear Glass Vial Empty Relevant as per<br>packing policy
	Export product		Qty.	Sl. No.	Import items	Qty.
	Sodium Chloride Injection USP 90mg per<br>10mL Vial.(10mL Vial - filled with 90mg<br>of Sodium Chloride as bulk drug		<br> <br>1 Number	1	10ml Unprinted Clear Glass Vial Empty	Relevant as per<br>packing policy

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br>10mL Vial.(10mL Vial - filled with 90mg of Sodium Chloride as bulk drug|| 1 Number|1|10ml Unprinted Clear Glass Vial Empty|Relevant as per packing policy|

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filled in 10mL Vial and capped with 13mm GreySerum ChlorobutyI Rubber Stopper)

Case No.	195 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343414AM22
RA File Number	03AX04001020 AM22
Licence No and<br>Date	0311011104/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.13/82-ALC4/2018 dated 14.01.2019against advance authorization No.0310824646<br>dated 24.10.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Behenic Acid<br>0.546 kg<br>Behenyl Behenate<br>1 kg<br>2<br>Behenyl Alcohol<br>0.524 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	196 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343548AM22
RA File Number	31AX04000047 AM22
Licence No and<br>Date	3111000999/04/02/2022

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Case No.	197 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	NORM APPLY 00343126AM22
RA File Number	31AX04000059 AM22
Licence No and<br>Date	3111000968/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>As per Advance Authorization, the description of Item No. 3 is 1, 4 BUTANEDIOL, however in manufacturing<br>process, the import item is mentioned as Gamma Butyrolactone. Please clarify it.

Case No.	Case No.	Case No.	198 / NC/3/MEET/Aug/202223/6	198 / NC/3/MEET/Aug/202223/6	198 / NC/3/MEET/Aug/202223/6	198 / NC/3/MEET/Aug/202223/6	198 / NC/3/MEET/Aug/202223/6
Case Status			Case Approved
Party Name			MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number			HQRNORM APPLY 00342820AM22
RA File Number			07AX04000317 AM22
Licence No and<br>Date			0711003138/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol.

ence No and Date|||0711003138/04/02/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Sodium Chloride Injection USP 90mg per 10mL Vial.(10mL Vial - filled with 90mg of Sodium Chloride as bulk drug filled in 10mL Vial and capped with 13mm Grey Serum ChlorobutyI Rubber Stopper) 1 Number 1 13mm Grey Serum ChlorobutyI R/S-RFS- C14226422GS6TP3 Relevant as per packing policy|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Sodium Chloride Injection USP 90mg per 10mL Vial.(10mL Vial - filled with 90mg of Sodium Chloride as bulk drug filled in 10mL Vial and capped with 13mm Grey Serum ChlorobutyI Rubber Stopper)|| 1 Number|1|13mm Grey Serum ChlorobutyI R/S-RFS- C14226422GS6TP3| Relevant as per packing policy|

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lorobutyI Rubber Stopper)|| 1 Number|1|13mm Grey Serum ChlorobutyI R/S-RFS- C14226422GS6TP3| Relevant as per packing policy|

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2<br>Sterile Water for Injection 10mL<br>Vial(Sterile Water for injection,<br>filled in 10mL Vial and capped with<br>13mm Grey Serum ChlorobutyI<br>Rubber Stopper)<br>1 Number<br>2<br>13mm<br>Grey<br>Serum<br>ChlorobutyI<br>R/S-RFS-<br>C14226422GS6TP3<br>Relevant as<br>per packing<br>policy<br>RA concerned may take further necessary action as per above decision of NC.	2	Sterile Water for Injection 10mL<br>Vial(Sterile Water for injection,<br>filled in 10mL Vial and capped with<br>13mm Grey Serum ChlorobutyI<br>Rubber Stopper)	<br> <br> <br> <br>1 Number	2	13mm<br>Grey<br>Serum<br>ChlorobutyI<br>R/S-RFS-<br>C14226422GS6TP3	Relevant as<br>per packing<br>policy

Case No.	Case No.	Case No.	199 / NC/3/MEET/Aug/202223/6	199 / NC/3/MEET/Aug/202223/6	199 / NC/3/MEET/Aug/202223/6	199 / NC/3/MEET/Aug/202223/6	199 / NC/3/MEET/Aug/202223/6
Case Status			Case Approved
Party Name			J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number			HQRNORM APPLY 00343419AM22
RA File Number			03AX04001010 AM22
Licence No and<br>Date			0311011108/04/02/2022

Date|||NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022||||| |HQ File Number|||HQRNORM APPLY 00343419AM22||||| |RA File Number|||03AX04001010 AM22||||| |Licence No and Date|||0311011108/04/02/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.5/82-ALC4/2020 dated 09.10.2020against advance authorization No.0310834236 dated 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: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 OXYBUTYNIN CHLORIDE USP 5.10 mg 2 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 32.40 mg 3 SENTRY POLYOX WSR N80 FP NF 80.52 mg 1 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB USP 5 MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.808 Kgs (ii) 535.05 Kgs (iii) 1108.08 Kgs (iv) 565.60 Kgs.) 1 Number 4 SENTRY POLYOX WSR 303 NF 41.10 mg OXYBUTYNIN CHLORIDE OXYBUTYNIN 2 1 Number 5 10.20 mg|||||||| ||Sl. No.|Export product||Qty.|Sl.

s (iv) 565.60 Kgs.) 1 Number 4 SENTRY POLYOX WSR 303 NF 41.10 mg OXYBUTYNIN CHLORIDE OXYBUTYNIN 2 1 Number 5 10.20 mg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB USP 5 MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.808 Kgs (ii) 535.05 Kgs (iii) 1108.08 Kgs (iv) 565.60 Kgs.)||1 Number|1|OXYBUTYNIN CHLORIDE USP|5.10 mg| ||||||2|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 32.40 mg| ||||||3|SENTRY POLYOX WSR N80 FP NF| 80.52 mg| ||||||4|SENTRY POLYOX WSR 303 NF| 41.10 mg| ||2|OXYBUTYNIN CHLORIDE||1 Number|5|OXYBUTYNIN|10.20 mg|

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|CHLORIDE USP 6 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 32.40 mg 7 SENTRY POLYOX WSR N80 FP NF 80.77 mg EXTENDED RELEASE TAB. USP 10 MG. Each tablet contains (i) Oxybutynin Chloride USP- 10mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg.

(i) Oxybutynin Chloride USP- 10mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.807 Kgs (ii) 267.52 Kgs (iii) 555.754 Kgs (iv) 282.80 Kgs.) 8 SENTRY POLYOX WSR 303 NF 41.10 mg 9 OXYBUTYNIN CHLORIDE USP 15.30 mg 10 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 32.40 mg 11 SENTRY POLYOX WSR N80 FP NF 81.02 mg 3 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 15 MG. Each tablet contains (i) Oxybutynin Chloride USP - 15 mg((ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 81.02 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 91.743 Kgs (ii) 237.798 Kgs (iii) 495.535 Kgs (iv) 251.376 Kgs.) 1 Number 12 SENTRY POLYOX WSR 303 NF 41.10 mg RA concerned may take further necessary action as per above decision of NC.||EXTENDED RELEASE TAB. USP 10 MG. Each tablet contains (i) Oxybutynin Chloride USP- 10mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg.

(i) Oxybutynin Chloride USP- 10mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.807 Kgs (ii) 267.52 Kgs (iii) 555.754 Kgs (iv) 282.80 Kgs.)|||CHLORIDE USP|| |---|---|---|---|---|---|---| |||||6|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 32.40 mg| |||||7|SENTRY POLYOX WSR N80 FP NF| 80.77 mg| |||||8|SENTRY POLYOX WSR 303 NF| 41.10 mg| ||3|OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 15 MG. Each tablet contains (i) Oxybutynin Chloride USP - 15 mg((ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 81.02 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 91.743 Kgs (ii) 237.798 Kgs (iii) 495.535 Kgs (iv) 251.376 Kgs.)|1 Number|9|OXYBUTYNIN CHLORIDE USP|15.30 mg| |||||10|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 32.40 mg| |||||11|SENTRY POLYOX WSR N80 FP NF| 81.02 mg| |||||12|SENTRY POLYOX WSR 303 NF| 41.10 mg|

0 mg| |||||10|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 32.40 mg| |||||11|SENTRY POLYOX WSR N80 FP NF| 81.02 mg| |||||12|SENTRY POLYOX WSR 303 NF| 41.10 mg|

Case No.	200 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343700AM22
RA File Number	03AX04001017 AM22
Licence No and<br>Date	0311011123/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Dec/202122/12 dated 17.12.2021against advance authorization No.<br>0311005566 dated 23.07.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Dec/202122/12 dated 17.12.2021 against advance authorization No. 0311005566 dated 23.07.2021 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given

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

0311005566 dated 23.07.2021 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given

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

Export Product	Qty.	Sl. No.	Import items	Qty.
Bempedoic Acid and Ezetimibe Fixed Dose<br>Combination Tablets((Net content of Bempedoic<br>Acid 3195kgs and Ezetimibe 177.5kgs in Total<br>Export Qty) (AA for Free of cost material as per<br>Para 4.11 of HBP & Para 4.19 of FTP & RBI<br>Master Circular C-26 -Disallowing remittances<br>for material being supplied free of cost))	<br> <br> <br> <br> <br> <br>1 Number	1	Bempedoic Acid	189.90 mg
		2	Ezetimibe	10.55 mg
Note: The above norms are valid only for subject to fulfillment of following conditions:<br>Export Product being Patented Medicine, be filed with USFDA as an NDA (New Drug Application.<br>1.<br>Export to USA and Europe only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.

atented Medicine, be filed with USFDA as an NDA (New Drug Application.** 1. Export to USA and Europe only. 2. Firm holding Certificate of Manufacturing Exclusivity. 3.|||||

Case No.	201 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00342844AM22
RA File Number	34AX04000227 AM22
Licence No and<br>Date	3411001756/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/4 dated 17.06.2022against advance authorization No.<br>3410046526 dt. 05.11.2020,it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:

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Export product	Qty.		Sl. No.	Import items	Qty.
Phenol	6511	MT	1	Cumene	5499.92 MT

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

4AM23

Export product	Qty.		Sl. No.	Import items	Qty.
Phenol	6511	MT	1	Cumene	5499.92 MT

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

Case No.	Case No.	Case No.	202 / NC/3/MEET/Aug/202223/6	202 / NC/3/MEET/Aug/202223/6	202 / NC/3/MEET/Aug/202223/6	202 / NC/3/MEET/Aug/202223/6	202 / NC/3/MEET/Aug/202223/6
Case Status			Case Approved
Party Name			J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number			HQRNORM APPLY 00343437AM22
RA File Number			03AX04001016 AM22
Licence No and<br>Date			0311011111/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/May/202223/4 dated 17.06.2022against advance authorization No.<br>0311004497 dated 10.06.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>GLIPIZIDE USP<br>10.20 mg<br>2<br>EASTMAN<br>(TM)<br>CELLULOSE<br>ACETATE<br>(CA 398-10NF/EP)<br>29.70 mg<br>3<br>SENTRY POLYOX WSR<br>N80 FP NF<br>178.10 mg<br>1<br>GLIPIZIDE EXTENDED RELEASE<br>TABLETS 10 MG.

SP 10.20 mg 2 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 29.70 mg 3 SENTRY POLYOX WSR N80 FP NF 178.10 mg 1 GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet contains (i) Glipizide USP- 10 mg (ii) Eastman (TM Cellulose(Acetate (CA 398- 10NF/EP)- 29.70 mg (iii) Sentry Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR 303 NF- 100 mg. Net content (i) 459.46 Kgs (ii) 1364.59 Kgs (iii) 8182.96 Kgs (iv) 4594.59 Kgs.) 1 Number 4 SENTRY POLYOX WSR 303 NF 100.00 mg 5 GLIPIZIDE USP 5.10 mg GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet contains (i) Glipizide USP- 5 mg (ii) Eastman (TM Cellulose Acetate((CA 398- EASTMAN (TM) 2 1 Number 6 20.40 mg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet contains (i) Glipizide USP- 10 mg (ii) Eastman (TM Cellulose(Acetate (CA 398- 10NF/EP)- 29.70 mg (iii) Sentry Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR 303 NF- 100 mg. Net content (i) 459.46 Kgs (ii) 1364.59 Kgs (iii) 8182.96 Kgs (iv) 4594.59 Kgs.)|| 1 Number|1|GLIPIZIDE USP|10.20 mg| ||||||2|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 29.70 mg| ||||||3|SENTRY POLYOX WSR N80 FP NF| 178.10 mg| ||||||4|SENTRY POLYOX WSR 303 NF| 100.00 mg| ||2|GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG.

ACETATE (CA 398-10NF/EP)| 29.70 mg| ||||||3|SENTRY POLYOX WSR N80 FP NF| 178.10 mg| ||||||4|SENTRY POLYOX WSR 303 NF| 100.00 mg| ||2|GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet contains (i) Glipizide USP- 5 mg (ii) Eastman (TM Cellulose Acetate((CA 398-|| 1 Number|5|GLIPIZIDE USP|5.10 mg| ||||||6|EASTMAN (TM)| 20.40 mg|

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|CELLULOSE ACETATE (CA 398-10NF/EP) 7 SENTRY POLYOX WSR N80 FP NF 89.05 mg 10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 182.43 Kgs (ii) 744.32 Kgs (iii) 3249.12 Kgs (iv) 1824.33 Kgs.) 8 SENTRY POLYOX WSR 303 NF 50.00 mg 9 GLIPIZIDE USP 2.55 mg 10 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 20.40 mg 11 SENTRY POLYOX WSR N80 FP NF 89.05 mg 3 GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet contains (i) Glipizide USP- 2.5 mg (ii) Eastman (TM Cellulose(Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 33.78 Kgs (ii) 275.68 Kgs (iii) 1203.38 Kgs (iv) 675.68 Kgs.) 1 Number 12 SENTRY POLYOX WSR 303 NF 50.00 mg RA concerned may take further necessary action as per above decision of NC.||10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg.

	10NF/EP)- 20.40 mg (iii) Sentry Polyox<br>WSR N80 FP NF- 89.05 mg (iv) Sentry<br>Polyox WSR 303 NF- 50 mg. Net<br>content (i) 182.43 Kgs (ii) 744.32 Kgs<br>(iii) 3249.12 Kgs (iv) 1824.33 Kgs.)	<br> <br> <br>		CELLULOSE<br>ACETATE<br>(CA 398-10NF/EP)
			7	SENTRY POLYOX WSR<br>N80 FP NF	<br>89.05 mg
			8	SENTRY POLYOX WSR<br>303 NF	<br>50.00 mg
3	GLIPIZIDE EXTENDED RELEASE<br>TABLETS 2.5 MG. Each tablet<br>contains (i) Glipizide USP- 2.5 mg (ii)<br>Eastman (TM Cellulose(Acetate (CA<br>398-10NF/EP)- 20.40 mg (iii) Sentry<br>Polyox WSR N80 FP NF- 89.05 mg<br>(iv) Sentry Polyox WSR 303 NF- 50<br>mg. Net content (i) 33.78 Kgs (ii)<br>275.68 Kgs (iii) 1203.38 Kgs (iv)<br>675.68 Kgs.)	1 Number	9	GLIPIZIDE USP	2.55 mg
			10	EASTMAN<br>(TM)<br>CELLULOSE<br>ACETATE<br>(CA 398-10NF/EP)	<br> <br>20.40 mg
			11	SENTRY POLYOX WSR<br>N80 FP NF	<br>89.05 mg
			12	SENTRY POLYOX WSR<br>303 NF	<br>50.00 mg

5 mg| |||||10|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 20.40 mg| |||||11|SENTRY POLYOX WSR N80 FP NF| 89.05 mg| |||||12|SENTRY POLYOX WSR 303 NF| 50.00 mg|

Case No.	203 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	SARACA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00342859AM22
RA File Number	09AX04000141 AM22
Licence No and<br>Date	0911002446/04/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.6/82-ALC4/2019 dated 16.08.2019against advance authorization No.0910067656 dated<br>12.06.2019, 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:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. 6/82-ALC4/2019 dated 16.08.2019 against advance authorization No. 0910067656 dated 12.06.2019 , 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:

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Export product	Qty.	Sl. No.	Import	items				Qty.
GABAPENTIN(API)	1 kg	1	1,1	CYCLOHEXANE	DI	ACETIC	ACID	<br>1.630 kg
			MONOAMIDE (CAM)

08504AM23

Export product	Qty.	Sl. No.	Import	items				Qty.
GABAPENTIN(API)	1 kg	1	1,1	CYCLOHEXANE	DI	ACETIC	ACID	<br>1.630 kg
			MONOAMIDE (CAM)

Case No.	204 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	DANOPHARM CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343441AM22
RA File Number	039404000360 AM21
Licence No and<br>Date	0311011114/04/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	205 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00342862AM22
RA File Number	09AX04000195 AM22
Licence No and<br>Date	0911002452/04/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	206 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343443AM22
RA File Number	03AX04000895 AM22
Licence No and<br>Date	0311011115/04/02/2022

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Case No.	207 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343056AM22
RA File Number	34AX04000212 AM22
Licence No and<br>Date	3411001750/04/02/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	208 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343444AM22
RA File Number	03AX04000893 AM22
Licence No and<br>Date	0311011116/04/02/2022
Norms Committee Decision:
Deferred for comments of TE

Case No.	209 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343395AM22
RA File Number	03AX04001061 AM22
Licence No and<br>Date	0311011086/04/02/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	210 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
PartyName	INNOVASSYNTH TECHNOLOGIES(INDIA)LIMITED

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23/6| |---|---| |Case Status|Case Deferred| |PartyName|INNOVASSYNTH TECHNOLOGIES(INDIA)LIMITED|

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Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00343445AM22
RA File Number	03AX04000892 AM22
Licence No and<br>Date	0311011117/04/02/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	211 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00345204AM22
RA File Number	03AX04001106 AM22
Licence No and<br>Date	0311011140/06/02/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	212 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00345730AM22
RA File Number	03AX04000898 AM22
Licence No and<br>Date	0311011149/07/02/2022
Norms Committee Decision:
Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00345730AM22| |RA File Number|03AX04000898 AM22| |Licence No and Date|0311011149/07/02/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	213 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00345828AM22
RA File Number	09AX04000205 AM22
Licence No and<br>Date	0911002465/07/02/2022
Norms Committee Decision:

92 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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Case No.	214 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00345974AM22
RA File Number	03AX04001021 AM22
Licence No and<br>Date	0311010996/07/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	215 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00346268AM22
RA File Number	34AX04000204 AM22
Licence No and<br>Date	3411001767/07/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00346268AM22| |RA File Number|34AX04000204 AM22| |Licence No and Date|3411001767/07/02/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	216 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00346808AM22
RA File Number	09AX04000140 AM22
Licence No and<br>Date	0911002475/08/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.9/82-ALC4/2019 dated 18.10.2019against advance authorization No.0910067680 dt.<br>19.06.2019, 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:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. 9/82-ALC4/2019 dated 18.10.2019 against advance authorization No. 0910067680 dt. 19.06.2019 , 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:

93 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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

93 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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Export product	Qty.	Sl. No.	Import items	Qty.
VALSARTAN	1 kg	1	N-[(2-Cyanobiphenyl-4-methyl)]-[L]-valine methyl	<br>0.85 kg
			ester Hydrochloride

Case No.	217 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00347013AM22
RA File Number	31AX04000060 AM22
Licence No and<br>Date	3111000964/08/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Feb/202122/14 dated 21.02.2022against advance authorization No.<br>3111000350 dt. 24.05.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Phenol<br>0.90 kg<br>Anisole<br>1 kg<br>2<br>Methanol<br>0.350 kg<br>RA concerned may take further necessary action as per above decision of NC.

t Qty. Sl. No. Import items Qty. 1 Phenol 0.90 kg Anisole 1 kg 2 Methanol 0.350 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	218 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00347173AM22
RA File Number	03AX04001053 AM22
Licence No and<br>Date	0311011202/08/02/2022
Norms Committee Decision:

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The Committee considered the case as per agenda and it was decided to ratify adhoc norms as per SION A-412 .

Case No.	219 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00347306AM22
RA File Number	08AX04000205 AM22
Licence No and<br>Date	0811003993/08/02/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	220 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ARKRAY HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00347493AM22
RA File Number	52AX04000059 AM22
Licence No and<br>Date	5211001995/08/02/2022
Norms Committee Decision:
Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00347493AM22| |RA File Number|52AX04000059 AM22| |Licence No and Date|5211001995/08/02/2022| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	221 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00347838AM22
RA File Number	09AX04000179 AM22
Licence No and<br>Date	0911002407/08/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022against advance authorization No.
0911001814 dt. 03.11.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Mar/202122/16 dated 08.04.2022 against advance authorization No. 0911001814 dt. 03.11.2021 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below

95 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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or as applied by the firm, whichever is less:

I as per details given below

95 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

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or as applied by the firm, whichever is less:

Export product		Qty.	Sl. No.	Import items	Qty.
(2S,3S,5S)-2-amino-3-		1 kg	1	(S,E)-5-AMINO-2-(DIBENZYLAMINO)-1,6-	1.77 kg
hydroxy-5-tert	butyl			DIPHENYLHEX-4-EN-3-ONE
carbonyl	amino-1,6-
diphenyl-hexane			2	SODIUM BORO HYDRIDE	0.45 kg
			3	TETRA HYDRO FURAN	0.48 kg
			4	2,2,2 TRI FLUORO ACETIC ACID	2.16 kg
			5	DI TERT.BUTYL DI CARBONATE	0.92 kg

Case No.<br>222 / NC/3/MEET/Aug/202223/6
Case Status<br>Case Approved
Party Name<br>DANOPHARM CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number<br>HQRNORM APPLY 00348263AM22
RA File Number<br>039404000359 AM21
Licence No and<br>Date<br>0311011233/09/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and	taking cue from earlier decision for	same export product /
import item in Meeting No.NC/3/MEET/Aug/202122/7 dated 13.08.2021against advance authorization No.
0310831769 dt. 24.09.2019, 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<br>Qty.<br>Sl.

769 dt. 24.09.2019**, 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. Sl. No.|Import items||Qty.|| |1 Alpha-(2,4-dichlorophenyl)-1H- 1 kg|2,2,4 Trichloro Acetophenone||1.45 kg|| |Imidazole-1-Ethanol||||| |2|Imidazole||0.53 kg||

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	3	Sodium Borohydride	0.10 kg
	4	Dimethyl Sulphoxide (DMSO)	0.42 kg

Case No.	Case No.	223 / NC/3/MEET/Aug/202223/6	223 / NC/3/MEET/Aug/202223/6	223 / NC/3/MEET/Aug/202223/6	223 / NC/3/MEET/Aug/202223/6	223 / NC/3/MEET/Aug/202223/6
Case Status		Case Approved
Party Name		CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number		HQRNORM APPLY 00348935AM22
RA File Number		31AX04000064 AM22
Licence No and<br>Date		3111001078/09/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022against advance authorization No.<br>3111000614 dt. 12.10.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

00614 dt. 12.10.2021**, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Phenol 0.72 kg 2 Methanol 0.276 kg Acetyl Anisole (4 Methoxy Acetophenone) 1 kg 3 Acetic Anhydride Purity 99 Percentage 0.755 kg RA concerned may take further necessary action as per above decision of NC||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Acetyl Anisole (4 Methoxy Acetophenone)||1 kg|1|Phenol|0.72 kg| |||||2|Methanol|0.276 kg| |||||3|Acetic Anhydride Purity 99 Percentage|0.755 kg| |||||as per above decision of NC|||

Case No.	224 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	VENKATA NARAYANA ACTIVE INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00348986AM22
RA File Number	04AX04000023 AM22
Licence No and<br>Date	0411002608/09/02/2022

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Case No.	Case No.	225 / NC/3/MEET/Aug/202223/6	225 / NC/3/MEET/Aug/202223/6	225 / NC/3/MEET/Aug/202223/6
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number		HQRNORM APPLY 00349075AM22
RA File Number		03AX04000842 AM22
Licence No and Date		0311011271/09/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I 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>DOCOSANOL 1H (WATSON – TEVA)<br>0.204 gram<br>Medical<br>Creams<br>&<br>Ointments(DOCOSANOL<br>CREAM 10% 2G Tot Wt:<br>2800Kgs (Net Cont: Docosanol<br>280 Kgs, Tubes 1400000Nos))<br>1 Number<br>2<br>DOCOSANOL 10% CREAM 2G TUBE<br>Relevant as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

) 1 Number 2 DOCOSANOL 10% CREAM 2G TUBE Relevant as per packing policy RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Medical Creams & Ointments(DOCOSANOL CREAM 10% 2G Tot Wt: 2800Kgs (Net Cont: Docosanol 280 Kgs, Tubes 1400000Nos))|| 1 Number|1|DOCOSANOL 1H (WATSON – TEVA)|0.204 gram| |||||2|DOCOSANOL 10% CREAM 2G TUBE|Relevant as per packing policy| |||||as per above decision of NC.|||

Case No.	226 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00348248AM22
RA File Number	03AX04001105 AM22
Licence No and<br>Date	0311011230/09/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>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.

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

i. Details of Packaging Material may be furnished. ii.||

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

Case No.	227 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	DANOPHARM CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00348260AM22
RA File Number	039404000358 AM21
Licence No and<br>Date	0311000653/09/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br> Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per<br>Annexure to Appendix 4E.

Case No.	228 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00350237AM22
RA File Number	05AX04000943 AM22
Licence No and<br>Date	0511008753/10/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00350237AM22| |RA File Number|05AX04000943 AM22| |Licence No and Date|0511008753/10/02/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	229 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved
Party Name	LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00350608AM22
RA File Number	03AX04001220 AM22
Licence No and<br>Date	0311011318/10/02/2022
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/Apr/202223/1 dated 29.04.2022 against advance authorization No.0311009732 dt. 23.12.2<br>021, 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,

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Apr/202223/1 dated 29.04.2022 against advance authorization No. 0311009732 dt. 23.12.2 021 , 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,

99 This document has been digitally signed by AJAY KUMAR, Deputy Director on 16-09-2022 19:15:47.

UDIN00208504AM23

whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
DOXYLEB CAPSULES (DOXYCYCLINE<br>HYCLATE CAPSULES BP) 100MG(IN<br>PACKING OF 10sX10, 10sX100 &1000s.<br>QTY<br>CONSUMED<br>OF<br>EXEMPT<br>MATERIAL DOXYCYCLINE HYCLATE<br>BP 117MG/CAPSULE)	<br> <br> <br> <br> <br>5982906 Number	1	DOXYCYCLINE<br>HYCLATE BP	690.4 kg

Case No.	Case No.	230 / NC/3/MEET/Aug/202223/6	230 / NC/3/MEET/Aug/202223/6	230 / NC/3/MEET/Aug/202223/6
Case Status		Case Approved
Party Name		SMS PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number		HQRNORM APPLY 00352284AM22
RA File Number		09AX04000238 AM22
Licence No and Date		0911002507/11/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I 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>2,4,5<br>TRIFLUOROPHENYLACETIC<br>ACID<br>1.146 kg<br>2<br>MELDRUM ACID<br>0.88 kg<br>3<br>3-(TERIFLUOROMETHYL)-5,6,7,8-<br>TETRAHYDRI-[1,2,4] TRIAZOLO[4,3-a]<br>PYRAZINE HYDROCHLORIDE<br>0.75 kg<br>4<br>DI-TERTIARY BUTYL DICARBONATE<br>(DIBOC)<br>1.50 kg<br>SITAGLIPTIN HYDROCHLORIDE<br>1 kg
	Export product		Qty.	Sl.

RAHYDRI-[1,2,4] TRIAZOLO[4,3-a] PYRAZINE HYDROCHLORIDE 0.75 kg 4 DI-TERTIARY BUTYL DICARBONATE (DIBOC) 1.50 kg SITAGLIPTIN HYDROCHLORIDE 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||SITAGLIPTIN HYDROCHLORIDE||1 kg|1|2,4,5 TRIFLUOROPHENYLACETIC ACID|1.146 kg| |||||2|MELDRUM ACID|0.88 kg| |||||3|3-(TERIFLUOROMETHYL)-5,6,7,8- TETRAHYDRI-[1,2,4] TRIAZOLO[4,3-a] PYRAZINE HYDROCHLORIDE|0.75 kg| |||||4|DI-TERTIARY BUTYL DICARBONATE (DIBOC)|1.50 kg|

100

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5	TETRAHYDROFURAN	1.50 kg
6	ISO PROPYL ALCOHOL	5.50 kg
7	METHYL DI CHLORIDE	12.18 kg
8	METHANOL	3.12 kg
9	N-HEPTANE	1.80 kg
10	TERTIARY BUTANOL (T-BUTANOL)	1.78 kg

Case No.	231 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00351303AM22
RA File Number	09AX04000191 AM22
Licence No and<br>Date	0911002504/11/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/09/2022| |HQ File Number|HQRNORM APPLY 00351303AM22| |RA File Number|09AX04000191 AM22| |Licence No and Date|0911002504/11/02/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	232 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00351870AM22
RA File Number	03AX04000936 AM22
Licence No and<br>Date	0311011342/11/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No. 233 / NC/3/MEET/Aug/202223/6

101

UDIN00208504AM23

Case Status	Case Status		Case Approved
Party Name			UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ	File Number		HQRNORM APPLY 00353423AM22
RA File Number			03AX04001196 AM22
Licence No and<br>Date			0311011360/12/02/2022
Norms Committee Decision:
The Committee		considered the case as per agenda and it was decided to ratify adhoc norms as under:
	Sl. No.	Export Product		SION No.
	1	Erythromycin Base/Erythromycin		A-215
	2	Erythromycin Oxime Base (Erythromycin A-9 Oxime)		A-2244
RA concerned may take further necessary action as per above decision of NC.

No.|| ||1|Erythromycin Base/Erythromycin||A-215|| ||2|Erythromycin Oxime Base (Erythromycin A-9 Oxime)||A-2244|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.<br>234 / NC/3/MEET/Aug/202223/6
Case Status<br>Case Approved
Party Name<br>AMI ORGANICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number<br>HQRNORM APPLY 00354939AM22
RA File Number<br>52AX04000075 AM22
Licence No and<br>Date<br>5211002025/14/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and	taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/May/202223/4 dated 17.06.2022against advance authorization No.
5210042570 dt. 20.03.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
TERT-<br>BUTYL<br>1-PIPERAZINE<br>1 kg	1	DI -TERT BUTYL DICARBONATE	2.00 kg
CARBOXYLATE (1-BOC PIPERAZINE)	2	PIPERAZINE ANHYDROUS	0.80 kg

102

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. No.|Import items|Qty.|| |TERT- BUTYL 1-PIPERAZINE 1 kg|1|DI -TERT BUTYL DICARBONATE|2.00 kg|| |CARBOXYLATE (1-BOC PIPERAZINE)|2|PIPERAZINE ANHYDROUS|0.80 kg||

102

UDIN00208504AM23

Case No.	235 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00356332AM22
RA File Number	08AX04000424 AM22
Licence No and<br>Date	0811004069/15/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	236 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00356333AM22
RA File Number	08AX04000425 AM22
Licence No and<br>Date	0811004071/15/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	237 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00356345AM22
RA File Number	30AX04000119 AM22
Licence No and<br>Date	3011001784/15/02/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	238 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved

103

UDIN00208504AM23

Date|3011001784/15/02/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	238 / NC/3/MEET/Aug/202223/6
Case Status	Case Approved

103

UDIN00208504AM23

Party Name	TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00355947AM22
RA File Number	03AX04001249 AM22
Licence No and<br>Date	0311011408/15/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I 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>ORLISTAT PELLETS 50 %<br>1 kg<br>1<br>ORLISTAT<br>0.50 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	239 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00355978AM22
RA File Number	03AX04001161 AM22
Licence No and<br>Date	0311011414/15/02/2022

| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022| |HQ File Number|HQRNORM APPLY 00355978AM22| |RA File Number|03AX04001161 AM22| |Licence No and Date|0311011414/15/02/2022| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: Description of all Excipients shown in items to be imported may be furnished as per their chemical name. i. Details of Packaging Material may be furnished. ii. Copy of Master Batch Formula for all export items indicating net content of inputs in each export. iii.||

Case No.	240 / NC/3/MEET/Aug/202223/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202223/ 6 and 09/09/2022
HQ File Number	HQRNORM APPLY 00355981AM22

104

UDIN00208504AM23

RA File Number

03AX04001160 AM22

Licence No and Date

0311011415/15/02/2022

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: Description of all Excipients shown in items to be imported may be furnished as per their chemical name. i. Details of Packaging Material may be furnished. ii. Copy of Master Batch Formula for all export items indicating net content of inputs in each export. iii.

Case No.	241 / NC/3/MEET/Aug/202223/6

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