IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2021-08-13

DGFT Committee Minutes

Document text

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Government of India Ministry of Commerce and Industry Department of Commerce

DIRECTORATE GENERAL OF FOREIGN TRADE

(DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Aug/202122/7 DATED: 13/08/2021

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.

Minutes of the Norms Committee – 3 Meeting No. NC/3/MEET/Aug/202122/7 dated 13.08.2021, actually held on 26.08.2021 under the Chairmanship of Shri Vijay Kumar, Addl. DGFT and on 10.09.2021 under the Chairmanship of Dr. Amiya Chandra, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

The following members were present in the meeting:-

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

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signe Name: Ajay Kumar( Deputy Director ) Name: Ajay Kumar( uty Director ) Date: 01-Nov-2021 13:18:50 Date: 01-Nov-2021 #3:18:50 Reason: AJAY.DHIMAN88@GOV.IN Reason: AJAY. IAN88@GOV.IN Location: DGFT(HQ) Location: DGFTIHG)

This document has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 01-Nov-2021.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	ANUPAM RASAYAN INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000924AM10
RA File Number	522404000031 AM10
Licence No and<br>Date	5210029505/27/01/2010
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that Norms Committee -3 in its earlier Meeting No. 46/82-ALC4/2009 dated 09.02.2010 has already transferred this case to Norms Committee – 4.

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

Case No.	2 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001244AM10
RA File Number	092404000546 AM10
Licence No and<br>Date	0910041467/25/03/2010
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 30/82-ALC4/2010 dated 26.10.2020 .

Case No. 3 / NC/3/MEET/Aug/202122/7

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case Status	Case Deferred
Party Name	VASISTA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000814AM13
RA File Number	092404000308 AM13
Licence No and<br>Date	0910053881/21/09/2012

Norms Committee Decision:

Since, the licence is very old, RLA, Hyderabad was requested vide e-mail dated 16.08.2021 to intimate whether the subject Advance Authorization issued to firm has been redeemed or not. Reply awaited from RLA, Hyderabad.

Case No.	4 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	CDYMAX (INDIA) PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001377AM13
RA File Number	072404000317 AM13
Licence No and<br>Date	0710091789/06/11/2012
Norms Committee	Decision:

Since, the licence is very old, RLA, Banglaore was requested vide e-mail dated 16.08.2021 to intimate whether the subject Advance Authorization issued to firm has been redeemed or not. Reply awaited from RLA, Bangalore.

Case No.	5 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	IND SWIFT LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000966AM13
RA File Number	222404000051 AM13
Licence No and<br>Date	2210013450/17/12/2012

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Since, the licence is very old, RLA, Ludhiana was requested vide e-mail dated 16.08.2021 to intimate whether the subject Advance Authorization issued to firm has been redeemed or not. Reply awaited from RLA, Ludhiana.

Case No.	6 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	CHAMPIONX DAI-ICHI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001143AM13
RA File Number	039404000792 AM13
Licence No and<br>Date	0310717692/19/12/2012
Norms Committee	Decision:

Since, the licence is very old, RLA, Mumbai was requested vide e-mail dated 16.08.2021 to intimate whether the subject Advance Authorization issued to firm has been redeemed or not. Reply awaited from RLA, Mumbai.

Case No.	7 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000113AM14
RA File Number	072404000020 AM14
Licence No and<br>Date	0710095227/06/05/2013
Norms Committee	Decision:

Since, the licence is very old, RLA, Bangalore was requested vide e-mail dated 16.08.2021 to intimate whether the subject Advance Authorization issued to firm has been redeemed or not. Reply awaited from RLA, Bangalore.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.	8 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	HESTER BIOSCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000216AM14
RA File Number	082404000081 AM14
Licence No and<br>Date	0810121432/27/05/2013
Norms Committee	Decision:

Since, the licence is very old, RLA, Ahmedabad was requested vide e-mail dated 16.08.2021 to intimate whether the subject Advance Authorization issued to firm has been redeemed or not. Reply awaited from RLA, Ahmedabad.

Case No.	9 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000515AM14
RA File Number	039404000536 AM13
Licence No and<br>Date	0310736143/30/05/2013
Norms Committee	Decision:

Case No.	10 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000714AM14

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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RA File Number	039404000199 AM14
Licence No and<br>Date	0310736614/04/06/2013
Norms Committee	Decision:

Case No.	11 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	VIVIN DRUGS & PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000671AM14
RA File Number	092404000082 AM14
Licence No and<br>Date	0910056266/06/06/2013
Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 16/82-ALC4/2013 dated 21.11.2013 .

Case No.	12 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	BOSTIK INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000495AM14
RA File Number	072404000502 AM13
Licence No and<br>Date	0710096186/25/06/2013
Norms Committee	Decision:

Since, the licence is very old, RLA, Bangalore was requested vide e-mail dated 16.08.2021 to intimate whether the

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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subject Advance Authorization issued to firm has been redeemed or not.

RLA, Bangalore vide e-mail dated 08.09.2021 has informed that the subject Advance Authorization has not been redeemed yet.

Since, NC-3 has no details / information about the case, it was decided to call for following information / documents from the firm:

Complete technical details as per Annexure to Appendix 4E.

Case No.	13 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	WRIGLEY INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001532AM15
RA File Number	072404000535 AM13
Licence No and<br>Date	0710096312/28/06/2013
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that Norms Committee -3 in its earlier Meeting No. 3/82-ALC4/2015 dated 20.05.2015 has already transferred this case to Norms Committee – 6.

Case No.	14 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	INDO PHYTOCHEM PHARMACEUTICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000524AM14
RA File Number	052304000185 AM14

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Licence No and 0510361498/01/08/2013 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 3/82-ALC4/2019 dated 05.07.2019 against advance authorization No. 0310824604 dated 23.10.2018 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export Product	Qty	Sl. No.	Import Items	Qty
YOHIMBINE HYDROCHLORIDE USP<br>USED AS A APHRODISIAC	<br>1 kg	1	YOHIMBE PAUSINYSTALIA BARK<br>OR<br>YOHIMBE<br>BARK<br>OR<br>YOHIMBINE<br>BARK,<br>BARK<br>HAVING BROWN COLOR WITH<br>YOHIMBINE CONTENT NLT 1.0%	<br> <br> <br> <br>100.00 kg

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

Case No.	15 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	THINQ PHARMA-CRO LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000736AM14
RA File Number	039504000432 AM14
Licence No and<br>Date	0310749651/16/09/2013
Norms Committee	Decision:

Case No. 16 / NC/3/MEET/Aug/202122/7

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case Status	Case Withdrawn
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000858AM14
RA File Number	052404000219 AM14
Licence No and<br>Date	0510366235/19/09/2013
Norms Committee	Decision:

CLA, New Delhi vide e-mail dated 27.08.2021 has informed that the subject Advance Authorization was issued to firm on repeat basis as per decision of Norms Committee taken in Meeting No. 24/82-ALC4/2012 dated 15.11.2012 and the licence has already been redeemed.

The Committee considered the above e-mail of CLA, New Delhi and has decided to withdraw the case.

Case No.	17 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000880AM14
RA File Number	039404000591 AM14
Licence No and<br>Date	0310753016/09/10/2013
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 23/82-ALC4/2013 dated 06.03.2014 .

Case No.	18 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	SOMU SOLVENTS PVT. LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

HQ File Number	018205000762AM14
RA File Number	072404000233 AM14
Licence No and<br>Date	0710099060/18/10/2013
Norms Committee	Decision:

Case No.	19 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	BLISS GVS PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000959AM14
RA File Number	039404000687 AM14
Licence No and<br>Date	0310756546/01/11/2013

Case No.	20 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	ATGC BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001228AM14
RA File Number	092404000275 AM14
Licence No and<br>Date	0910058222/13/11/2013
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Hyderabad.

Case No.	21 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	AUCTUS PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000937AM14
RA File Number	092404000436 AM14
Licence No and<br>Date	0910058486/06/12/2013
Norms Committee	Decision:

Case No.	22 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	NECTAR LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000137AM15
RA File Number	222404000096 AM14
Licence No and<br>Date	2210014646/28/02/2014
Norms Committee	Decision:

Case No.	23 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Party Name	VIVIMED LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000965AM15
RA File Number	092404000039 AM15
Licence No and<br>Date	0910059887/28/04/2014

Case No.	24 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000595AM15
RA File Number	052404000144 AM15
Licence No and<br>Date	0510389651/11/07/2014
Norms Committee	Decision:

CLA, New Delhi vide e-mail dated 27.08.2021 has informed that the subject Advance Authorization was surrendered by the firm as it was unutilized.

The Committee considered the above e-mail of CLA, New Delhi and has decided to withdraw the case.

Case No.	25 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000677AM15
RA File Number	092404000324 AM15
Licence No and<br>Date	0910060989/17/09/2014

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 9/82-ALC4/2015 dated 30.09.2015 .

Case No.	26 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	INDOFIL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001195AM15
RA File Number	039404000539 AM15
Licence No and<br>Date	0310789636/24/09/2014

Case No.	27 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001151AM15
RA File Number	072404000208 AM15
Licence No and<br>Date	0710106752/24/09/2014
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	28 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001155AM15
RA File Number	039404000692 AM15
Licence No and<br>Date	0310790392/20/10/2014
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 3/82-ALC4/2015 dated 20.05.2015 .

Case No.	29 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000448AM16
RA File Number	052404000511 AM15
Licence No and<br>Date	0510393355/25/02/2015
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 12/82-ALC4/2015 dated 18.11.2015 .

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	30 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	KRISHNA ANTIOXIDANTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000554AM16
RA File Number	039404001090 AM15
Licence No and<br>Date	0310794291/02/03/2015

Case No.	31 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	WANBURY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000547AM16
RA File Number	039504000934 AM15
Licence No and<br>Date	0310794735/20/03/2015
Norms Committee	Decision:

Case No.	32 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Party Name	IND SWIFT LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000785AM16
RA File Number	222404000007 AM16
Licence No and<br>Date	2210015238/25/05/2015

Case No.	33 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	ORION CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000914AM16
RA File Number	039504000337 AM16
Licence No and<br>Date	0310797764/28/07/2015

Case No.	34 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001419AM16
RA File Number	318304000084 AM16

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Licence No and 3110065720/23/10/2015 Date Norms Committee Decision:

Case No.	35 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001545AM16
RA File Number	039404000240 AM16
Licence No and<br>Date	0310799907/30/10/2015
Norms Committee	Decision:

Case No.	36 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001506AM16
RA File Number	318304000103 AM16
Licence No and<br>Date	3110065750/05/11/2015
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 19/82-ALC4/2015 dated 25.02.2016 .

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	37 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	CDYMAX (INDIA) PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000348AM17
RA File Number	072404000115 AM17
Licence No and<br>Date	0710110184/29/07/2016
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 5/82-ALC4/2017 dated 25.10.2017 .

Case No.	38 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001733AM19
RA File Number	052304000561 AM17
Licence No and<br>Date	0510401758/22/02/2017
Norms Committee	Decision:

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

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

DML.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	39 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001784AM19
RA File Number	052304000268 AM18
Licence No and<br>Date	0510404290/13/10/2017
Norms Committee	Decision:

The firm vide letter dated 11.02.2020 has informed that they have not utilized the subject Advance Authorization and hence, they have surrendered the same to CLA, New Delhi. Accordingly, the firm has requested to withdraw the case.

Case No.	40 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001785AM19
RA File Number	052304000266 AM18
Licence No and<br>Date	0510404285/13/10/2017
Norms Committee	Decision:

i. Copy of DML for each export item.

Copy of Master Batch Formula for each export item.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	41 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001786AM19
RA File Number	052304000267 AM18
Licence No and<br>Date	0510404287/13/10/2017
Norms Committee	Decision:

i. DML for each export item.

Master Batch Formula for each export item.

Case No.	42 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000454AM20
RA File Number	522404000059 AM18
Licence No and<br>Date	5210042473/01/01/2018
Norms Committee	Decision:

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

Case No.	43 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

HQ File Number	018205001830AM19
RA File Number	072404000046 AM19
Licence No and<br>Date	0710113330/25/05/2018
Norms Committee	Decision:

The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Rose Crystals Ex Benzaldehyde	1 kg	1	Benzaldehyde	0.416 kg
(Trichloro Phenyl Methyl Carbinyl acetate)

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

Case No.	44 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001835AM19
RA File Number	052304000080 AM19
Licence No and<br>Date	0510406733/05/06/2018
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	45 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001836AM19
RA File Number	052304000070 AM19
Licence No and<br>Date	0510406734/05/06/2018
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that a copy of Show Cause Notice dated 10.10.2019 issued to firm alongwith a copy of reply dated 22.12.2019 received from the firm were forwarded to CLA, New Delhi on 16.03.2021, followed by Reminder on 27.08.2021 with the request to examine the reply of firm in response to the Show Cause Notice and furnish their reply as per Annexure B. The requisite reply is still awaited from CLA, New Delhi. Hence, the Committee decided to defer the case.

Case No.	46 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001837AM19
RA File Number	052304000022 AM19
Licence No and<br>Date	0510406736/05/06/2018
Norms Committee	Decision:

Case No.	47 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

HQ File Number	018205001840AM19
RA File Number	052304000121 AM19
Licence No and<br>Date	0510406800/08/06/2018
Norms Committee	Decision:

Case No.	48 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001842AM19
RA File Number	052304000501 AM18
Licence No and<br>Date	0510406802/08/06/2018

Case No.	49 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001875AM19
RA File Number	052304000163 AM19
Licence No and<br>Date	0510407077/04/07/2018
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	50 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001876AM19
RA File Number	052304000164 AM19
Licence No and<br>Date	0510407078/04/07/2018

Case No.	51 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002074AM19
RA File Number	052304000166 AM19
Licence No and<br>Date	0510407070/04/07/2018
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	52 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001846AM19
RA File Number	082404000030 AM19
Licence No and<br>Date	0810142955/04/07/2018
Norms Committee	Decision:

Manufacturing process with molecular weight and percentage yield from starting raw material, i.e. Methanol.

Case No.	53 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001874AM19
RA File Number	052304000167 AM19
Licence No and<br>Date	0510407069/04/07/2018
Norms Committee	Decision:

Case No.	54 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001503AM19
RA File Number	092404000181 AM19
Licence No and<br>Date	0910066442/11/07/2018

i. Export description is not matching with DML.

ii. Import item No.2 description is confusing and is not matching with process details and DML.

Case No.	55 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001889AM19
RA File Number	052304000183 AM19
Licence No and<br>Date	0510407217/17/07/2018
Norms Committee	Decision:

Case No.	56 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001905AM19
RA File Number	092404000200 AM19

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Licence No and 0910066511/24/07/2018 Date Norms Committee Decision:

Export product		Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
CEFUROXIME	AXETIL	<br>1 kg	1	7-Amino Cephalosporanic Acid (7-ACA)	0.544 kg
POVIDONE MIXTURE
			2	Acetone	3.91 kg
			3	Activated Carbon (Carbon Enoanticromos)	0.0686 kg
			4	Chlorosulfonyl Isocyanate (CSI)	0.374 kg
			5	Di Isopropyl Ether (or) Iso Propyl Ether	0.410 kg
			6	Methanol (Methyl Alcohol)	0.88 kg
			7	Methylenechloride (MDC)	0.94 kg
			8	N,N-Dimethyl Acetamide	1.66 kg
			9	(Z)-2-Methoxy Imino(Furyl- 2-YL) Acetic Acid	<br>0.438 kg
				Ammonium Salt (SMIA)

Case No.	57 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

HQ File Number	018205001217AM19
RA File Number	039404000390 AM19
Licence No and<br>Date	0310822723/31/07/2018
Norms Committee	Decision:

i. CA has certified production in 2017-18, while CGST has certified NIL production submitted vide your letter dated 11.07.2019. Please clarify and produce GST certified data for last Production / Consumption.

Commercial value of By-Product –other fractions obtained in distillation.

Case No.	58 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001150AM19
RA File Number	342404000094 AM19
Licence No and<br>Date	3410044399/08/08/2018
Norms Committee	Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 against advance authorization No. 3410045217 dated 18.06.2019 , 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:

Export	Product		Qty	Sl. No.	Import Items	Qty
Rose	Oxide	(Tetrahydro-4-Methyl-2-(2-Methyl	<br>1 kg	1	Citral Synthetic	3.454 kg
Propenyl) 2 H Pyron

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	59 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001112AM19
RA File Number	039504000445 AM19
Licence No and<br>Date	0310822942/09/08/2018
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the information submitted vide letter dated 04.03.2021 by the firm is not legible, also complete chemistry, percentage yield and material balance is not given. Hence, the decided to call for following information from the firm:

i. Complete chemistry, percentage yield, material balance.

Case No.	60 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001927AM19
RA File Number	052304000232 AM19
Licence No and<br>Date	0510407550/20/08/2018
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	61 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001928AM19
RA File Number	052304000231 AM19
Licence No and<br>Date	0510407551/20/08/2018
Norms Committee	Decision:

Case No.	62 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	DANOPHARM CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001346AM19
RA File Number	039404000340 AM19
Licence No and<br>Date	0310823354/28/08/2018
Norms Committee	Decision:

Export product<br>	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
Alpha-(2,4- dichlorophenyl)- 1H-	1 kg	1	2,2,4 Trichloro Acetophenone	1.45 kg
imidazole-1-ethanol
		2	Imidazole	0.53 kg
		3	Sodium Carbonate	Not shown in the process

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

4	Sodium Borohydride	0.10 kg
5	Iso Propyl Alcohol	0.42 kg
6	Toluene	0.45 kg
7	Sodium Hydroxide	0.10 kg
8	Activated Carbon	0.050 kg

Case No.	63 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	DANOPHARM CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001347AM19
RA File Number	039404000413 AM19
Licence No and<br>Date	0310823358/28/08/2018

Export product	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
5-Chloro-2- Methyl Amino	1 kg	1	2-Amino-5- Chloro Benzophenone	1.257 kg
Benzophenone
		2	Potassium Carbonate	0.75 kg
		3	Dimethyl Sulphate	0.823 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

4	Toluene	0.50 kg
5	Iso Propyl Alcohol	0.75 kg
6	Tetrabutyl Ammonium Hydrogen Sulphate	0.10 kg
7	Caustic Soda	0.50 kg
8	Activated Carbon	0.05 kg

Case No.	64 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001062AM19
RA File Number	092404000251 AM19
Licence No and<br>Date	0910066620/03/09/2018
Norms Committee	Decision:

Past Production Consumption data duly certified by Central Taxes and GST Authorities.

Case No.	65 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SUVEN LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001959AM19

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

RA File Number 092404000260 AM19 Licence No and 0910066621/03/09/2018 Date Norms Committee Decision:

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

Export Product	Qty.	Sl.<br>No.	Import items	Qty.
1-(2-FLUORO-6-<br>TRIFLUOROMETHYL)BENZYL)-5-<br>IODO-6-METHYLPYRIMIDINE<br>-2,<br>4<br>(1H,3H)-DIONE	<br>1 kg	1	3-FLUORO BENZOTRIFLUORIDE	1.011 kg
		2	DIMETHYL FORMAMIDE	0.472 kg
		3	TETRAHYDROFURAN	0.80 kg
		4	METHYL-1-t-BUTYLETHER(MTBE)	0.255 kg
		5	IODINE MONOCHLORIDE	0.411 kg

Case No.	66 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	DCM SHRIRAM INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001413AM19
RA File Number	052304000242 AM19
Licence No and<br>Date	0510407689/05/09/2018
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Complete technical details as per Annexure to Appendix 4E.

Case No.	67 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001378AM19
RA File Number	039404000504 AM19
Licence No and<br>Date	0310823779/17/09/2018

Sl. No.	Export product			Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
							(for export of 1
							Number
							Lozenges)
1	Benzydamine	Hydrochloride	<br>And	<br>1 Number	1	Benzydamine Hydrochloride	3.06 mg
	Cetylpyridinium	<br>Chloride	Anti-
	Inflammatory And Antiseptic		Lozenges
	Sugar Free and all				2	Cetylpyridinium Chloride	1.33 mg
	(other flavours.	Each lozenge contains (i)
	Benzydamine<br>Cetylpyridinium	Hydrochloride-3mg<br>(ii)<br>Chloride- 1.33mg (iii)		<br>	3	Isomalt ST-M	2586.00 mg
	Isomalt ST-M - 2586mg. Net content (i)
	43.796 Kgs (ii) 19.416 Kgs (iii) 37751.835
	Kgs)
2	Benzydamine	Hydrochloride,	<br>2,4-	1 Number	4	Benzydamine Hydrochloride	3.06 mg
	Dichlorobenzyl	Alcohol And	Lidocaine
	Hydrochloride	Anaesthetic,	Anti-
	Inflammatory,	(Anti-Bacterial	Lozenges		5	Isomalt ST-M	2586.00 mg
	Sugar Free. Each lozenge contains (i)
	Benzydamine Hydrochloride -		3mg (ii)
	Isomalt ST-M-	2586mg. Net content (i)
	21.898 Kgs. (ii) 18875.897 Kgs.)

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

6<br>Benzydamine Hydrochloride<br>3.06 mg<br>3<br>Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free. Each<br>lozenge<br>contains<br>((i)<br>Benzydamine<br>Hydrochloride- 3mg (ii) Isomalt ST-M -<br>2595mg. Net content (i) 14.234 Kgs. (ii)<br>12312.05 Kgs.)<br>7<br>Isomalt ST-M<br>2595.00 mg<br>8<br>Cetylpyridinium Chloride<br>1.33 mg<br>4<br>Cetylpyridinium Chloride And Bromhexine<br>Hydrochloride Antiseptic Lozenges Sugar<br>Free and all other flavours. (Each lozenge<br>contains (i) Cetylpyridinium Chloride -<br>1.33mg (ii) Isomalt ST-M - 2576mg. Net<br>content (i) 1.873 Kgs. (ii) 3628.141 Kgs.)<br>1 Number<br>9<br>Isomalt ST-M<br>2576.00 mg<br>10<br>Cetylpyridinium Chloride<br>1.00 mg<br>5<br>Cetylpyridinium Chloride And Benzydamine<br>Hydrochloride Antiseptic Lozenges Suger<br>Free.<br>Each<br>lozenge<br>contains<br>((i)<br>Cetylpyridinium Chloride- 1mg (ii) Isomalt<br>ST-M - 2595mg. Net content (i) 1.408 Kgs<br>(ii) 3654.923 Kgs.)<br>1 Number<br>11<br>Isomalt ST-M<br>2595.00 mg<br>6<br>Zecuf Herbal Cough Lozenges Sugar Free.<br>Each lozenge contains<br>((i) Isomalt ST-M - 3015.82mg. Net content<br>(i) 4247.626 Kgs.)<br>1 Number<br>12<br>Isomalt ST-M<br>3015.82 mg<br>7<br>Vicks Vapo Drops+Cough Orange Menthol/<br>Lemon Menthol, Sugar Free Lozenges. Each<br>lozenge contains<br>((i) Isomalt ST-M - 2786.80mg. Net content<br>(i) 3925.063 Kgs.)<br>1 Number<br>13<br>Isomalt ST-M<br>2786.80 mg<br>RA concerned may take further necessary action as per above decision of NC.	6<br>Benzydamine Hydrochloride<br>3.06 mg<br>3<br>Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free. Each<br>lozenge<br>contains<br>((i)<br>Benzydamine<br>Hydrochloride- 3mg (ii) Isomalt ST-M -<br>2595mg. Net content (i) 14.234 Kgs. (ii)<br>12312.05 Kgs.)<br>7<br>Isomalt ST-M<br>2595.00 mg<br>8<br>Cetylpyridinium Chloride<br>1.33 mg<br>4<br>Cetylpyridinium Chloride And Bromhexine<br>Hydrochloride Antiseptic Lozenges Sugar<br>Free and all other flavours. (Each lozenge<br>contains (i) Cetylpyridinium Chloride -<br>1.33mg (ii) Isomalt ST-M - 2576mg. Net<br>content (i) 1.873 Kgs. (ii) 3628.141 Kgs.)<br>1 Number<br>9<br>Isomalt ST-M<br>2576.00 mg<br>10<br>Cetylpyridinium Chloride<br>1.00 mg<br>5<br>Cetylpyridinium Chloride And Benzydamine<br>Hydrochloride Antiseptic Lozenges Suger<br>Free.<br>Each<br>lozenge<br>contains<br>((i)<br>Cetylpyridinium Chloride- 1mg (ii) Isomalt<br>ST-M - 2595mg. Net content (i) 1.408 Kgs<br>(ii) 3654.923 Kgs.)<br>1 Number<br>11<br>Isomalt ST-M<br>2595.00 mg<br>6<br>Zecuf Herbal Cough Lozenges Sugar Free.<br>Each lozenge contains<br>((i) Isomalt ST-M - 3015.82mg. Net content<br>(i) 4247.626 Kgs.)<br>1 Number<br>12<br>Isomalt ST-M<br>3015.82 mg<br>7<br>Vicks Vapo Drops+Cough Orange Menthol/<br>Lemon Menthol, Sugar Free Lozenges. Each<br>lozenge contains<br>((i) Isomalt ST-M - 2786.80mg. Net content<br>(i) 3925.063 Kgs.)<br>1 Number<br>13<br>Isomalt ST-M<br>2786.80 mg<br>RA concerned may take further necessary action as per above decision of NC.	6<br>Benzydamine Hydrochloride<br>3.06 mg<br>3<br>Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free. Each<br>lozenge<br>contains<br>((i)<br>Benzydamine<br>Hydrochloride- 3mg (ii) Isomalt ST-M -<br>2595mg. Net content (i) 14.234 Kgs. (ii)<br>12312.05 Kgs.)<br>7<br>Isomalt ST-M<br>2595.00 mg<br>8<br>Cetylpyridinium Chloride<br>1.33 mg<br>4<br>Cetylpyridinium Chloride And Bromhexine<br>Hydrochloride Antiseptic Lozenges Sugar<br>Free and all other flavours. (Each lozenge<br>contains (i) Cetylpyridinium Chloride -<br>1.33mg (ii) Isomalt ST-M - 2576mg. Net<br>content (i) 1.873 Kgs. (ii) 3628.141 Kgs.)<br>1 Number<br>9<br>Isomalt ST-M<br>2576.00 mg<br>10<br>Cetylpyridinium Chloride<br>1.00 mg<br>5<br>Cetylpyridinium Chloride And Benzydamine<br>Hydrochloride Antiseptic Lozenges Suger<br>Free.<br>Each<br>lozenge<br>contains<br>((i)<br>Cetylpyridinium Chloride- 1mg (ii) Isomalt<br>ST-M - 2595mg. Net content (i) 1.408 Kgs<br>(ii) 3654.923 Kgs.)<br>1 Number<br>11<br>Isomalt ST-M<br>2595.00 mg<br>6<br>Zecuf Herbal Cough Lozenges Sugar Free.<br>Each lozenge contains<br>((i) Isomalt ST-M - 3015.82mg. Net content<br>(i) 4247.626 Kgs.)<br>1 Number<br>12<br>Isomalt ST-M<br>3015.82 mg<br>7<br>Vicks Vapo Drops+Cough Orange Menthol/<br>Lemon Menthol, Sugar Free Lozenges. Each<br>lozenge contains<br>((i) Isomalt ST-M - 2786.80mg. Net content<br>(i) 3925.063 Kgs.)<br>1 Number<br>13<br>Isomalt ST-M<br>2786.80 mg<br>RA concerned may take further necessary action as per above decision of NC.
6<br>Benzydamine Hydrochloride<br>3.06 mg<br>3<br>Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free. Each<br>lozenge<br>contains<br>((i)<br>Benzydamine<br>Hydrochloride- 3mg (ii) Isomalt ST-M -<br>2595mg. Net content (i) 14.234 Kgs. (ii)<br>12312.05 Kgs.)<br>7<br>Isomalt ST-M<br>2595.00 mg<br>8<br>Cetylpyridinium Chloride<br>1.33 mg<br>4<br>Cetylpyridinium Chloride And Bromhexine<br>Hydrochloride Antiseptic Lozenges Sugar<br>Free and all other flavours. (Each lozenge<br>contains (i) Cetylpyridinium Chloride -<br>1.33mg (ii) Isomalt ST-M - 2576mg. Net<br>content (i) 1.873 Kgs. (ii) 3628.141 Kgs.)<br>1 Number<br>9<br>Isomalt ST-M<br>2576.00 mg<br>10<br>Cetylpyridinium Chloride<br>1.00 mg<br>5<br>Cetylpyridinium Chloride And Benzydamine<br>Hydrochloride Antiseptic Lozenges Suger<br>Free.<br>Each<br>lozenge<br>contains<br>((i)<br>Cetylpyridinium Chloride- 1mg (ii) Isomalt<br>ST-M - 2595mg. Net content (i) 1.408 Kgs<br>(ii) 3654.923 Kgs.)<br>1 Number<br>11<br>Isomalt ST-M<br>2595.00 mg<br>6<br>Zecuf Herbal Cough Lozenges Sugar Free.<br>Each lozenge contains<br>((i) Isomalt ST-M - 3015.82mg. Net content<br>(i) 4247.626 Kgs.)<br>1 Number<br>12<br>Isomalt ST-M<br>3015.82 mg<br>7<br>Vicks Vapo Drops+Cough Orange Menthol/<br>Lemon Menthol, Sugar Free Lozenges. Each<br>lozenge contains<br>((i) Isomalt ST-M - 2786.80mg. Net content<br>(i) 3925.063 Kgs.)<br>1 Number<br>13<br>Isomalt ST-M<br>2786.80 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	68 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SUVEN LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001976AM19
RA File Number	092404000288 AM19
Licence No and<br>Date	0910066679/18/09/2018

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Norms Committee Decision:

Export product		Qty.	Sl.	Import items	Qty.
			No.
1-[2-FLUORO-6-(TRIFLUOROMETHYL)		1 kg	1	3-FLUORO BENZOTRIFLUORIDE	1.011 kg
BENZYL]	-5-IODO-6-
METHYLPYRIMIDINE-2,4<br>DIONE	(1H,3H)-		2	DIMETHYL FORMAMIDE	0.472 kg
			3	TETRAHYDROFURAN	0.80 kg
			4	METHYL-1-t-BUTYLETHER	0.255 kg
				(MTBE)
			5	IODINE MONOCHLORIDE	0.411 kg
			6	MALONIC ACID	1.04 kg
			7	ACETONE	0.50 kg
			8	HEPTANE	0.32 kg

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

Case No.	69 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SHILPA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001982AM19
RA File Number	072404000164 AM19
Licence No and<br>Date	0710113890/25/09/2018

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Norms Committee Decision:

Export product	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
GEMCITABINE HCL	1 kg	1	2-Deoxy-2,2- Difluoro-D- Erythro- Pentafuranous-	1-<br>4.78 kg
			Ulose-3,5-Dibenzoate
		2	Tetra Hydro Furan	4.60 kg
		3	Methylene Dichloride	6.20 kg
		4	N-Acetyl Cytosine	2.92 kg
		5	Trimethyl Silyl Trifluoromethane Sulfonate	4.23 kg
		6	Methanol	6.20 kg

Case No.	70 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	VOVANTIS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001154AM19
RA File Number	342404000145 AM19
Licence No and<br>Date	3410044518/26/09/2018
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Drug Manufacturing Licence (DML).

Case No.	71 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001383AM19
RA File Number	039404000568 AM19
Licence No and<br>Date	0310824072/28/09/2018
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that NC-3 in its Meeting No. 4/82-ALC4/2019 dated 19.07.2019 has already rejected the case.

Case No.	72 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002024AM19
RA File Number	612404000009 AM19
Licence No and<br>Date	6110001546/04/10/2018
Norms Committee	Decision:

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

1	Inj. Methadone HCL 10 mg	1 Number	1	METHADONE HCL	11.00<br>mg	/
					injection
2	Tab. Methadone HCl 10 mg	1 Number	1	METHADONE HCL	10.20 mg /	10
					mg Tablet
3	Tab. Methadone HCl 5 mg	1 Number	1	METHADONE HCL	5.10 mg /
					5 mg Tablet

Case No.	73 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002026AM19
RA File Number	052304000297 AM19
Licence No and<br>Date	0510408024/08/10/2018
Norms Committee	Decision:

Case No.	74 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002027AM19
RA File Number	052304000295 AM19

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Licence No and 0510408025/08/10/2018 Date Norms Committee Decision:

Case No.	75 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	ASTRAL STERITECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001202AM19
RA File Number	342404000225 AM19
Licence No and<br>Date	3410044573/10/10/2018
Norms Committee	Decision:

Sl. No.	Export product	Export product				Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
1	Oxacillin	for	Injection		USP	100000	1	STERILE OXACILLIN SODIUM	<br>231.00 kg
	2gm.(Each	Vials	Contains Oxacillin			Numbers		(Sterile Bulk)
	Sodium	Equivalent		to	2gm
	Oxacillin.)
							2	Glass Bottles 0077047005 Antibiotic	Relevant as per
								10ml Clear Glass Type-1.	packing policy
							3	Rubber Stopper C14746720gc 6tp3	<br>Relevant as per
								20mm Injection Stopper Bromo Butyl	<br>packing policy
								Grey Ultra.
2	Oxacillin	for	Injection		USP	<br>16000	4	STERILE OXACILLIN SODIUM	<br>184.80 kg
	10gm.(Each Vial		Contains Oxaxillin			<br>Numbers		(Sterile Bulk)
	Sodium	Equivalent		to	10gm
	Oxacillin.)
							5	Glass Bottles 2047201005 Infusion	Relevant as per

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Clear Choice- P 100ml Clear Glass packing policy Type-1. 6 Rubber Stopper C16436720gc Relevant as per packing policy 6tp3 28mm Infusion Stopper Bromo Butyl Grey Ultra.

Case No.	76 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	MACSON PRODUCTS
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002039AM19
RA File Number	522404000039 AM19
Licence No and<br>Date	5210042796/11/10/2018
Norms Committee	Decision:

The firm vide e-mail dated 05.02.2020 has enclosed a copy of Non-Utilization Certificate received from Office of Commissioner of Customs, Nhava-Sheva, Maharashtra and has stated that they have not taken any benefit against the subject Advance Authorization. In view of that, the firm has requested to convert it into Duty Drawnback Scheme.

The Committee considered the request of the firm and it was observed that it is not possible to covert the Advance Authorization to Duty Drawback Sceme. Accordingly, the Committee decided to withdraw the case.

Case No.	77 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002047AM19
RA File Number	612404000011 AM19
Licence No and	6110001553/11/10/2018

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Date

Export product	Qty.	Sl. No.	Import items	Qty.
Tab. Naltrexone HCl 50mg	1 Number	1	Naltrexone HCL USP/BP	51.00 mg

Case No.	78 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	SPC LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001147AM19
RA File Number	342404000211 AM19
Licence No and<br>Date	3410044586/12/10/2018
Norms Committee	Decision:

i. End use of export product.
ii. Stoichiometric balance on molar basis for chemical reaction indicating percentage yield at each stage.
iii. Last two years Production / Consumption data duly certified by GST.

Copy of earlier Norms Committee decision.

Case No. 79 / NC/3/MEET/Aug/202122/7 Case Status Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Party Name	SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002049AM19
RA File Number	092404000338 AM19
Licence No and<br>Date	0910066753/16/10/2018
Norms Committee	Decision:

The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is less:

Export Product	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
(1S, 4R)-4-Amino-2- cyclopentene-1-	<br>1 kg	1	2-Azabicylo [2.2.1] hept- 5-ene-2-one	1.337 kg
methanol D (-) tartarate (CAP-II)			(Vincelactam)
		2	Sodium borohydride	0.214 kg
		3	D (-) tartaric acid	0.742 kg
		4	L(+) Tartaric acid	0.90 kg

Case No.	80 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	WOCKHARDT LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001626AM19
RA File Number	039504000755 AM19
Licence No and<br>Date	0310824651/24/10/2018
Norms Committee	Decision:

The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is less:

Export Product Qty. Sl. Import items Qty. No. SUMATRIPTAN SUCCINATE INJ 1 Number 1 SUMATRIPTAN SUCCINATE 9.24 mg 6MG/0.5ML (5 VIAL PACK) EACH VIAL Vial CONTAINS (SUMATRIPTAN SUCCINATE 8.4MG EQUIVALENT TO SUMATRIPTAN 6MG (Total 60085 Vials and Total Net Content of Sumatriptan succinate upto 0.707 KGS))

Case No.	81 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002054AM19
RA File Number	092404000345 AM19
Licence No and<br>Date	0910066762/25/10/2018
Norms Committee	Decision:

i. Export Product description is not matching with DML. ii. All import quantity applied are disproportional to export. iii. Import Item No. 5 is confusing and is not confirming to process and DML.

Case No. 82 / NC/3/MEET/Aug/202122/7 Case Status Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Party Name GLAND PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205002059AM19 RA File Number 092404000229 AM19 Licence No and 0910066775/26/10/2018 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 against advance authorization No. 0910067519 dated 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:

Party Name	Party Name	Party Name	GLAND PHARMA LIMITED	GLAND PHARMA LIMITED	GLAND PHARMA LIMITED	GLAND PHARMA LIMITED	GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number			018205002059AM19
RA File Number			092404000229 AM19
Licence No and<br>Date			0910066775/26/10/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0910067519 dated<br>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<br>the firm, whichever is less:<br>Sl. No. Export Product<br>Qty<br>Sl.<br>No.<br>Import Items<br>Qty<br>1<br>Heparin Sodium<br>39.733 mg<br>2<br>Barrel Syringes<br>Net to Net<br>3<br>Needle Shield<br>Net to Net<br>4<br>Plunger Stoppers<br>Net to Net<br>5<br>Plunger Rods<br>Net to Net<br>1<br>Enoxaparin<br>Sodium<br>Injection<br>20mg<br>Pre-<br>filled Syringes<br>1 Number<br>6<br>Preventis Needle Shielding System<br>Net to Net<br>1<br>Heparin Sodium<br>79.466 mg<br>2<br>Barrel Syringes<br>Net to Net<br>3<br>Needle Shield<br>Net to Net<br>4<br>Plunger Stoppers<br>Net to Net<br>5<br>Plunger Rods<br>Net to Net<br>2<br>Enoxaparin<br>Sodium<br>Injection<br>40mg<br>Pre-<br>filled Syringes<br>1 Number
	Sl. No.	Export Product		Qty	Sl.<br>No.	Import Items	Qty
	1	Enoxaparin<br>Sodium<br>Injection<br>20mg<br>Pre-<br>filled Syringes		<br>1 Number	1	Heparin Sodium	39.733 mg
					2	Barrel Syringes	Net to Net
					3	Needle Shield	Net to Net
					4	Plunger Stoppers	Net to Net
					5	Plunger Rods	Net to Net
					6	Preventis Needle Shielding System	Net to Net
	2	Enoxaparin<br>Sodium<br>Injection<br>40mg<br>Pre-<br>filled Syringes		<br>1 Number	1	Heparin Sodium	79.466 mg
					2	Barrel Syringes	Net to Net
					3	Needle Shield	Net to Net
					4	Plunger Stoppers	Net to Net
					5	Plunger Rods	Net to Net

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22


					6	Preventis Needle Shielding System	Net to Net

3	Enoxap	arin<br>Sodium	<br>1 Number		1	Heparin Sodium	119.187 mg
	<br>Injectio	<br> <br>n<br>60mg<br>Pre-	<br>
	<br>filled S	<br> <br>yringes			2	Barrel Syringes	Net to Net

					3	Needle Shield	Net to Net
					4	Plunger Stoppers	Net to Net

					5	Plunger Rods	Net to Net

					6	Preventis Needle Shielding System	Net to Net
4	Enoxaparin<br>Sodium<br>Injection<br>80mg<br>Pre-<br>filled Syringes		<br>1 N	umber
					1	Heparin Sodium	158.93 mg

					2	Barrel Syringes	Net to Net

					3	Needle Shield	Net to Net

					4	Plunger Stoppers	Net to Net
					5	Plunger Rods	Net to Net

					6	Preventis Needle Shielding System	Net to Net
5	Enoxaparin<br>Sodium		<br>1 Number		1	Heparin Sodium	23840 mg
	<br>Injectio	<br> <br>n 120mg Pre-	<br>				.
	<br>filled S	<br>yringes
					2	Barrel Syringes	Net to Net

					3	Needle Shield	Net to Net

					4	Pl S	N N
						unger toppers	et to et

					5	Plunger Rods	Net to Net
					6	Preventis Needle Shielding System	Net to Net

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Enoxaparin	1	Heparin Sodium	298.00 mg
Injection 150mg Pre-
filled Syringes	2	Barrel Syringes	Net to Net
	3	Needle Shield	Net to Net
	4	Plunger Stoppers	Net to Net
	5	Plunger Rods	Net to Net
	6	Preventis Needle Shielding System	Net to Net

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

Case No.	83 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SUVEN LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002062AM19
RA File Number	092404000354 AM19
Licence No and<br>Date	0910066781/26/10/2018
Norms Committee	Decision:

Export product	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
1-[2-FLUORO-6-	1 kg	1	3-FLUORO BENZOTRIFLUORIDE	1.011 kg
(TRIFLUOROMETHYL)BENZYL]-5-
IODO-6-METHYLPYRIMIDINE-2,4		2	DIMETHYL FORMAMIDE	0.472 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

3	TETRAHYDROFURAN	0.80 kg
4	METHYL-1-t-BUTYLETHER (MTBE) 0.255 kg
5	IODINE MONOCHLORIDE	0.411 kg
6	MALONIC ACID	1.04 kg
7	ACETONE	0.50 kg
8	HEPTANE	0.32 kg

Case No.	84 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	MACSON PRODUCTS
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002065AM19
RA File Number	522404000058 AM19
Licence No and<br>Date	5210042821/26/10/2018
Norms Committee	Decision:

Case No. 85 / NC/3/MEET/Aug/202122/7

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case Status	Case Approved
Party Name	PHAROSE REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001161AM19
RA File Number	302404000032 AM19
Licence No and<br>Date	3010104485/31/10/2018
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:


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:

	Export Product		Qty	Sl. No.	Import Items	Qty

						<br>
	ALPHA KETO<br>+ ESSENTIAL	NALOGUE<br>AMINO ACIDS FILM	1180000<br>Numbers	1	L-LYSINE ACETATE BULK DRUG. -<br>IMPORT ITEMS NO.01 TO 10 WITH<br>CONDITION :-THE IMPORT OF DRUGS	<br> <br> <br>126.00 kg
	COATED TAB<br>	LET wei 1150.5 kgs.The<br>			FROM UNREGISTERED SOURCES
	weight of eac<br>	h tables will be 975<br>f i N 1 105

	mg.(cont.content<br>mg (2) 53 mg<br>30mg.(6) 59 mg	s o tems o. () as<br>(3) 23mg (4) 38mg (5)<br>. (7) 67mg. (8)101mg.(9)		2	L-THREONINE	63.00 kg
	8mg. &10) 86mg.resp.)			3	L-TRYPTOPHAN	27.00 kg

				4	L-HISTIDINE	45.00 kg
				5	L-TYROSINE	36.00 kg

				6	D,<br>L-<br>ALPHA-	71.00 kg
					<br>HYDROXYMETHIONINE, CALCIUM
					SALT

				7	D,<br>L-<br>ALPHA-KETOISOLEUCINE,	<br>80.64 kg
					CALCIUM
					SALT


				8	ALPHA KETOLEUCIN CALCIUM<br>SALT	121.56 kg
				9	ALPHA KETOPHENY CALCIUM<br>SALT	81.84 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

10 ALPHA-KETOVALIN SALT 103.51 kg

Case No. 86 / NC/3/MEET/Aug/202122/7 Case Status Case Approved Party Name PUNJAB CHEMICALS AND CROP PROTECTION LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205001568AM19 RA File Number 039504000709 AM19 Licence No and 0310824946/12/11/2018 Date Norms Committee Decision:

==> picture [450 x 137] intentionally omitted <==

----- Start of picture text ----- Export product Qty. Sl. Import items Qty. No. M325 (BENZENE ACETIC ACID, 2- 1 kg 1 3-ISOCHROMANONE 99 % MIN. 0.505 kg [[[6-(TRIFLUOROMETHYL)-2- PYRIDINYL]OXY]METHYL]-, 2 2-HYDROXY-6-(TRIFLUOROMETHYL) 0.528 kg METHYL ESTER) PYRIDINE 99 % MIN. 3 DIMETHYL ACETAMIDE 99.5 % MIN. 0.15 kg ----- End of picture text -----

Case No. 87 / NC/3/MEET/Aug/202122/7

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002084AM19
RA File Number	092404000382 AM19
Licence No and<br>Date	0910066853/15/11/2018
Norms Committee	Decision:

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

Export Product	Qty	Sl. No.	Import Items	Qty
LOPINAVIR	1 kg	1	L-Valine	0.74 kg
		2	Methanol (Methyl Alcohol)	13.18 kg
		3	Methylene Chloride	5.23 kg
		4	Isopropyl Alcohol (IPA)	3.20 kg
		5	Acetone	0.04 kg
		6	Toluene	0.19 kg
		7	Activated Carbon (Carbon Enoanticromos)	0.10 kg
		8	Methanesulfonic Acid	1.82 kg
		9	Monoethylene Glycol Dimethyl Ether (Monoglyme)	6.35 kg
		10	Sodium Borohydride	0.80 kg
		11	N-N-Carbonyl Di Imidazole	0.60 kg
		12	5% Palladium on Charcoal / Carbon (Catalyst- type 5T39<br>Paste)	<br>0.007 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

	13	L-Pyroglutamic Acid	0.31 kg
	14	Dimethylformamide (D M F)	2.49 kg
	15	N-Heptane	0.07 kg

Case No. 88 / NC/3/MEET/Aug/202122/7 Case Status Case Approved Party Name VIVIN DRUGS & PHARMACEUTICALS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205002087AM19 RA File Number 092404000391 AM19 Licence No and 0910066856/15/11/2018 Date

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	Sl. No. Import items	Qty.
(2R,CIS)-5-<br>FLUORO(4-	<br>AMINO-1,2-<br>1 kg	1	GLYOXYLIC ACID 50 PERCENT	0.62 kg
DIHYDRO-2- OXO-1- PYRIMIDINYL- 1,
3-OXATHIOLANE(<br>2-<br>CARBOXYLIC<br>ACID (2R,5R)-MENTHYLESTER (FCE)		2	2,5 DI HYDROXY 1,4 DITHIANE	0.28 kg
OR FCN OR FCME OR
FCM)		3	5-FLUORO CYTOSINE	0.44 kg
		4	HEXAMETHYL DISILAZANE	0.29 kg
		5	METHYLENE CHLORIDE	3.00 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

6	L-MENTHOL	0.61 kg
7	TRIPHOSGENE	0.40 kg
8	ETHYL ACETATE	1.00 kg
9	N-HEXANE	2.60 kg
10	TOLUENE	2.50 kg

Case No.	89 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002095AM19
RA File Number	092404000386 AM19
Licence No and<br>Date	0910066874/20/11/2018
Norms Committee	Decision:

i. Export Product description does not match with DML.
ii. Description of import item No. 5 does not match with process details and DML.

Case No.	90 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	CADILA HEALTHCARE LIMITED
Meeting Number	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

and Date
HQ File Number	018205002096AM19
RA File Number	082404000187 AM19
Licence No and<br>Date	0810143923/20/11/2018
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:

Sl. No.	Export product						Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
1	AZITHROMYCIN					ORAL	<br>1 Number	1	AZITHROMYCIN DIHYDRATE	330.12 mg
	SUSPENSION	USP 100MG /				5ML
	(300MG/15ML		BOTTLE)((ACTIVE						USP (This Licence is issued with
	INGREDIENT	:	<br>AZITHROMYCIN						condition that import of any Drug
	DIHYDRATE	USP		-	NET	<br>WT.			against this Licence will be allowed
	203.857 KGS))								through Registered Sources as per
									provision laid down in Drug &
									Cosmetic Act and as per Para 4.07 of
									HBP 2015-20 subject to fixation of
									norms by ACL, New Delhi
								2	SUCROSE<br>NF<br>FINE<br>GRADE	<br>11616.00 mg
									(COMPRESSUC PS)
2	AZITHROMYCIN					ORAL	<br>1 Number	1	AZITHROMYCIN DIHYDRATE	660.24 mg
	SUSPENSION	USP 200MG /				5ML
	(600MG/15ML		BOTTLE)((ACTIVE						USP (This Licence is issued with
	INGREDIENT	:	<br>AZITHROMYCIN						condition that import of any Drug
	DIHYDRATE	USP		-	NET	<br>WT.			against this Licence will be allowed
	731.939 KGS))								through Registered Sources as per
									provision laid down in Drug &
									Cosmetic Act and as per Para 4.07 of
									HBP 2015-20 subject to fixation of
									norms by ACL, New Delhi
								2	SUCROSE<br>NF<br>FINE<br>GRADE	<br>11616.00 mg
									(COMPRESSUC PS)
3	AZITHROMYCIN					ORAL	<br>1 Number	1	AZITHROMYCIN DIHYDRATE	990.36 mg
	SUSPENSION		USP		200MG/5ML
	(900MG		/		22.5ML				USP (This Licence is issued with
	BOTTLE)((ACTIVE INGREDIENT :								condition that import of any Drug
	AZITHROMYCIN DIHYDRATE USP								against this Licence will be allowed
	- NET WT. 711.410 KGS))								through Registered Sources as per
									provision laid down in Drug &
									Cosmetic Act and as per Para 4.07 of
									HBP 2015-20 subject to fixation of

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

									norms by ACL, New Delhi
								2	SUCROSE<br>NF<br>FINE<br>GRADE	<br>17424.00 mg
									(COMPRESSUC PS)
4	AZITHROMYCIN					ORAL	<br>1 Number	1	AZITHROMYCIN DIHYDRATE	1320.48 mg
	SUSPENSION		USP		200MG/5ML
	(1200MG / 30ML		BOTTLE)((ACTIVE						USP (This Licence is issued with
	INGREDIENT	:	<br>AZITHROMYCIN						condition that import of any Drug
	DIHYDRATE	USP		-	NET	<br>WT.			against this Licence will be allowed
	809.024 KGS))								through Registered Sources as per
									provision laid down in Drug &
									Cosmetic Act and as per Para 4.07 of
									HBP 2015-20 subject to fixation of
									norms by ACL, New Delhi
								2	SUCROSE<br>NF<br>FINE<br>GRADE	<br>23232.00 mg
									(COMPRESSUC PS)

Case No.	91 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	GLOBE TROTTERS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002106AM19
RA File Number	039404000713 AM19
Licence No and<br>Date	0310825212/26/11/2018
Norms Committee	Decision:

Complete technical details as per Annexure to Appendix 4E.

Case No. 92 / NC/3/MEET/Aug/202122/7

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case Status	Case Approved
Party Name	INDIA GLYCOLS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001441AM19
RA File Number	052304000359 AM19
Licence No and<br>Date	0510408634/26/11/2018
Norms Committee	Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 2/AM21 dated 24.07.2020 against advance authorization No. 0510405825 dated 09.03.2018 and also from Catalogue of Silver Catalyst and Production / Consumption data duly certified by GST submitted by the firm vide letter dated 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. Mono Ethylene Glycol (MEG) 1 kg 1 Denatured Ethyl Alcohol 1.123 kg 2 Silver Catalyst (Activity 29-30%) 0.000284 kg 3 Alumina Catalyst 0.000362 kg

Case No.	93 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002130AM19
RA File Number	612404000018 AM19
Licence No and<br>Date	6110001564/28/11/2018
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that DML given by the firm does not contain

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

export item. Hence, it was decided to call for following information from the firm:

DML for the export item with approved composition.

Case No.	94 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002116AM19
RA File Number	092404000410 AM19
Licence No and<br>Date	0910066905/28/11/2018

Export product	Qty.	Sl.	Import items	Qty.
		No.
Sultamicillin Base / Sultamicillin	1 kg	1	6-Amino Penicillanic Acid (6-APA)	0.60 kg
		2	Acetonitrile	1.24 kg
		3	Activated Carbon (Carbon Enoanticromos)	0.07 kg
		4	D(-) Alpha Phenyl Glycine Base	0.472 kg
		5	Dimethylformamide (D M F)	1.00 kg
		6	Isopropyl Alcohol (IPA)	2.85 kg
		7	Methanol (Methyl Alcohol)	0.25 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

8	Methyl Acetoacetate (MAA)	0.523 kg
9	Penicillin G Amidase (Particle size 250 – 500	0.0014 kg
	micron, Creamish to Brown regularly shaped
	beads)
10	Potassium Carbonate (Anhydrous)	0.27 kg
11	Iodomethyl Sulbactam	0.87 kg
12	Toluene	0.10 kg

Case No.	95 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002131AM19
RA File Number	612404000017 AM19
Licence No and<br>Date	6110001565/28/11/2018

Export product	Qty.	Sl. No.	Import items	Qty.
Inj. Sufentanil Citrate 50mcg/ml, 1 ml	51245 Numbers	1	Sufentanil Citrate	4.22 grams

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	96 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002121AM19
RA File Number	092404000358 AM19
Licence No and<br>Date	0910066915/28/11/2018
Norms Committee	Decision:

Export product	Qty.	Sl. No.	Import items	Qty.
1-Bromo-3,5- Dimethyl Adamantane	1 kg	1	1,3-Dimethyl adamantane	0.769 kg

Case No.	97 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002132AM19
RA File Number	612404000016 AM19
Licence No and<br>Date	6110001566/28/11/2018
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Copy of DML for all the export items.

Case No.	98 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002126AM19
RA File Number	612404000012 AM19
Licence No and<br>Date	6110001560/28/11/2018
Norms Committee	Decision:

Export product	Qty.	Sl. No.	Import items	Qty.
Tab. Buprenorphine 2 mg	415000 Number	1	Buprenorphine HCL BP/USP	0.9126 kg

Case No.	99 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002127AM19
RA File Number	612404000013 AM19
Licence No and<br>Date	6110001561/28/11/2018

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Copy of DML for each export item showing approved composition.

Case No.	100 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002128AM19
RA File Number	612404000014 AM19
Licence No and<br>Date	6110001562/28/11/2018
Norms Committee	Decision:

Sl. No.	Export product<br>	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
1	Tab. Oxycodone HCL 5mg	1 Number	1	Oxycodone HCL (EP/BP/USP)	5.10 mg /
					5 mg Tablet
2	Tab. Oxycodone HCL 10mg	<br>1 Number	1	Oxycodone HCL (EP/BP/USP)	10.20	mg
	(NR/ER/PR)				/ 10	mg
					Tablet
3	Tab. Oxycodone HCL 20mg	<br>1 Number	1	Oxycodone HCL (EP/BP/USP)	20.40 mg /
	(NR/ER/PR)				20 mg Tablet
4	Tab. Oxycodone HCL 40mg	<br>1 Number	1	Oxycodone HCL (EP/BP/USP)	40.80 mg /
	(NR/ER/PR)				40 mg Tablet

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	101 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002129AM19
RA File Number	612404000015 AM19
Licence No and<br>Date	6110001563/28/11/2018
Norms Committee	Decision:

Copy of DML for each export item showing approved composition.

Case No.	102 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	CADILA HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002125AM19
RA File Number	082404000264 AM19
Licence No and<br>Date	0810143988/29/11/2018
Norms Committee	Decision:

i. Net weight of one Empty Capsule in each export item alongwith size and specification of empty capsules. ii. Consumption of Glycerine in each capsule. iii. Consumption of Gelatin in each capsule.

Whether capsule size and specification is same for export item No. 3 and 4 with justification.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	103 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002145AM19
RA File Number	052304000385 AM19
Licence No and<br>Date	0510408748/04/12/2018
Norms Committee	Decision:

Case No.	104 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002153AM19
RA File Number	092404000436 AM19
Licence No and<br>Date	0910066944/05/12/2018
Norms Committee	Decision:

Export product	Qty.	Sl. No.	Import items	Qty.
FONDAPARINUX SODIUM	1 kg	1	N-3 intermediate of Fondaparinux	2.05 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	105 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	VISION DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002155AM19
RA File Number	092404000412 AM19
Licence No and<br>Date	0910066949/06/12/2018

Export product	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
3,4-Dimthoxyphenethylamine (HVA)	1 kg	1	Veratrole	1.44 kg
		2	Sodium Cyanide	0.50 kg
		3	Methanol	1.40 kg

Case No.	106 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	DCM SHRIRAM INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001444AM19

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

RA File Number 052304000376 AM19 Licence No and 0510408809/06/12/2018 Date Norms Committee Decision:

Export product Qty. Sl. No. Import items Qty. Valine Hydantoin (Synonym : 5- Isopropyl 1 kg 1 Isobutyraldehyde 0.555 kg Hydantoin) 2 Sodium Cyanide 0.383 kg RA concerned may take further necessary action as per above decision of NC. Case No. 107 / NC/3/MEET/Aug/202122/7 Case Status Case Approved Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205001545AM19 RA File Number 039404000774 AM19 Licence No and 0310825559/10/12/2018 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 against advance authorization No. 0310836157dated 11.05.2020 , 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.	Export Product	Qty	Sl.	Import Items	Qty
No.			No.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

1	Cetylpyridinium<br>Chloride,<br>Benzydamine<br>Hydrochloride and Pholcodine Lozenges Sugar<br>Free Blackcurrant/ Pineapple & Lime/<br>Honey,Lemon & Ginger/ Other Flavours. Each<br>Lozenge<br>contains<br>(i)Pholcodine<br>5.50mg<br>(ii)Benzydamine<br>Hydrochloride<br>1.50mg<br>(iii)Cetylpyridinium Chloride 1.33mg(iv)Isomalt<br>ST-M<br>2595.67mg.<br>Net<br>Content(i)76.923<br>kgs(ii)20.979kgs(iii)18.601kgs(iv)36303.103kgs.	<br> <br> <br> <br> <br> <br> <br>1 Number	1	Pholcodine	5.61 mg
			2	Benzydamine<br>Hydrochloride	1.53 mg
			3	Cetylpyridinium Chloride	1.357 mg
			4	Isomalt ST-M	2583.0 mg
2	Pholcodine<br>and<br>Cetylpyridinium<br>Chloride<br>Lozenges Sugar Free Orange / Lemon and Other<br>Flavours. Each Lozenge contains<br>(i)Pholcodine<br>5.50<br>mg<br>(ii)Cetylpyridinium<br>Chloride 1.33 mg (iii)Isomalt ST-M 2591.86 mg.<br>Net Content (i) Pholcodine 31.539 kgs (ii)<br>Cetylpyridinium Chloride 7.627 kgs (iii) Isomalt<br>ST-M 14862.492 kgs.	<br> <br> <br> <br> <br> <br>1 Number	5	Pholcodine	5.61 mg
			6	Cetylpyridinium Chloride	1.357 mg
			7	Isomalt ST-M	2579.0 mg

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

Case No.	108 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	MALLADI DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002172AM19
RA File Number	042404000143 AM19
Licence No and<br>Date	0410164962/10/12/2018
Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the import quantity have no relevance with the quantity of export and also Value Addition mentioned against the subject Advance Authorization is unrealistic. Hence, the Committee decided to reject the case.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	109 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SUVEN LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002168AM19
RA File Number	092404000441 AM19
Licence No and<br>Date	0910066959/11/12/2018
Norms Committee	Decision:

Export product Qty. Sl. No. Import items Qty. ETHYL 6-FLUOROBENZOFURAN -71 kg 1 HEPTANE 0.152 kg CARBOXYLATE 2 METHYL TERT-BUTYL 3.23 kg ETHER 3 SODIUM BOROHYDRIDE 0.392 kg 4 2,6-DIFLUORO BENZOIC 1.813 kg ACID 5 DIMETHYL FORMAMIDE 0.653 kg

Case No.	110 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001596AM19

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

RA File Number 039504000889 AM19 Licence No and 0310825587/11/12/2018 Date Norms Committee Decision:

Copy of Master Batch Formula for each export item showing net content of each input.

Case No.	111 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002178AM19
RA File Number	612404000020 AM19
Licence No and<br>Date	6110001570/13/12/2018
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the list approved items in DML provided by the firm does not contain 10 ml injection of relevant API. Accordingly, it was decided to call for following information from the firm:

DML for export item.

Case No.	112 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	TATA CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001646AM19
RA File Number	039504000901 AM19
Licence No and<br>Date	0310825645/13/12/2018
Norms Committee	Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

The Committee considered the case as per agenda and it was observed that Norms Committee -3 in its Meeting No. 7/82-ALC4/2019 dated 06.09.2019 has already decided to transfer the case to Norms Committee-6 as the export product – Fossence (Oligofructose / FOS ) Powder P 90 / Liquid L95 comes under Food category, not pharmaceutical.

Case No.	113 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	NATCO PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002183AM19
RA File Number	092404000417 AM19
Licence No and<br>Date	0910066973/18/12/2018
Norms Committee	Decision:

(i) Copy of Master Batch Formula for each export item.

Case No.	114 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002184AM19
RA File Number	092404000443 AM19
Licence No and<br>Date	0910066974/18/12/2018
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Export product	Qty.	Sl. No.	Import items	Qty.
DULOXETINE HYDROCHLORIDE	1 kg	1	N-Methyl Duloxetine Oxalate	1.485 kg

Case No.	115 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002193AM19
RA File Number	522404000068 AM19
Licence No and<br>Date	5210042870/18/12/2018

Export product	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
4-HYDROXY COUMARIN	1 kg	1	Acetyl Salicylic Acid (For Industrial Use)	1.37 kg
(by Acetyl Salicylic Acid route)
		2	Ethyl Aceto Acetate	0.89 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No. 116 / NC/3/MEET/Aug/202122/7 Case Status Case Deferred Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205001556AM19 RA File Number 052404000503 AM19 Licence No and 0510408988/19/12/2018 Date Norms Committee Decision:

i. Complete and balanced chemical reactions showing molecular weight of each reactant.
ii. Percentage yield on molar basis for each step.
iii. Requirement and recovery of solvents at each step.

Production / Consumption data duly certified by GST.

Case No.	117 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	VIVIMED LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002195AM19
RA File Number	092404000460 AM19
Licence No and<br>Date	0910066983/19/12/2018
Norms Committee	Decision:

(i) Exact Chemical Name of Export product and its specification with percentage purity.

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

Case No. 118 / NC/3/MEET/Aug/202122/7 Case Status Case Withdrawn

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002199AM19
RA File Number	342404000295 AM19
Licence No and<br>Date	3410044774/20/12/2018

RLA, Vadodara vide e-mail dated 22.10.2020 has confirmed that the subject Advance Authorization was issued under Para 4.07 A of FTP (Self Ratification) as per the attached Condition Sheet and the licence has been exempted from approval of Norms Committee.

Case No.	119 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002209AM19
RA File Number	082404000303 AM19
Licence No and<br>Date	0810144142/21/12/2018
Norms Committee	Decision:

i. Chemistry, material balance and yield starting from Methanol.

ii. Details given are from starting raw material as Formaldehyde. Please clarify it.

Case No.	120 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	SUVEN LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002232AM19

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

RA File Number 092404000482 AM19 Licence No and 0910067014/31/12/2018 Date Norms Committee Decision:

i. Copy of the Guaranteed Norms given by the Foreign Collaborator.
ii. Complete chemical description of import item No. 4 (XTAFLUOR-E), its chemical structure, molecular weight and specific use in step II.

End-use of the export item.

Case No.	121 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	MALLADI DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002529AM19
RA File Number	042404000218 AM19
Licence No and<br>Date	0410165065/04/01/2019

Export product	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
Trioxabicyclooctane	1 kg	1	Cis-2-butane-1,4-diol	1.02 kg
		2	Methanol	1.07 kg
		3	2,2-Dimethoxy Propane	1.32 kg
		4	Acetonitrile	1.42 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

5 Methylene di chloride RA concerned may take further necessary action as per above decision of NC.

Methylene di chloride 1.25 kg

Case No. 122 / NC/3/MEET/Aug/202122/7 Case Status Case Approved Party Name REYAANSH HEALTHCARE Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205001580AM19 RA File Number 039504001019 AM19 Licence No and 0310826282/10/01/2019 Date

Sl. No. Export product Qty. Sl. No. Import items Qty. 1 SELAMECTIN SIX PERCENT 100 Number 1 SELAMECTIN 1.53 gram SPOT ON 0.25 ML TUBE. NET QUANTITY OF SELAMECTIN 0.99 KGS 2 SELAMECTIN SIX PERCENT 100 Number 1 SELAMECTIN 3.06 gram SPOT ON 0.50 ML TUBE NET QUANTITY OF SELAMECTIN 3.96 KGS. 3 SELAMECTIN SIX PERCENT 100 Number 1 SELAMECTIN 4.59 gram SPOT ON 0.75ML TUBE NET QUANTITY OF SELAMECTIN 5.94 KGS 4 SELAMECTIN SIX PERCENT 100 Number 1 SELAMECTIN 6.12 gram

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

SPOT ON 1 ML TUBE NET QUANTITY OF SELAMECTIN 3.96 KGS

Case No.	123 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	S.M. HERBALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002299AM19
RA File Number	052404000602 AM19
Licence No and<br>Date	0510409465/24/01/2019

The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

i. Content of 10-DAB III in the imported Twig and Leaf supported by COA from foreign supplier. ii. Content of 10-DAB-III in the export item supported by COA.

iii. Stepwise process details with wastage in each step of active ingredient.

Whether norms applied at Appendix 4E justify the import requirements

Case No.	124 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	LIRICON TRADING
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002304AM19
RA File Number	039504001055 AM19
Licence No and<br>Date	0310826653/25/01/2019
Norms Committee	Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

The Committee considered the case as per agenda and it was observed that the description of export product, net content on Bulk Drug in the export and import quantity applied are largely mismatching and the firm has not given any explanation for this. Hence, the Committee decided to reject the case.

Case No.	125 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	MAHESHRAJ CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002340AM19
RA File Number	082404000374 AM19
Licence No and<br>Date	0810144562/08/02/2019

The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

i. Complete technical details as for Annexure to Appendix 4E.

(ii) Complete technical details like chemistry, material balance and percentage yield.

Case No.	126 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	GELTEC PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002348AM19
RA File Number	039404000970 AM19
Licence No and<br>Date	0310826970/11/02/2019
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Sl. No.	Export product			Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
1	DOLORAZ	400<br>CAPSULES	(EACH	<br>1 Number	1	IBUPROFEN	408.00 mg
	CAPSULE	CONTAIN	400MG	<br>Capsule
	IBUPROFEN & 455MG GELATIN)				2	GELATIN	257.73 mg
2	IBUPROFEN	200 MG CAPSULES	(EACH	<br>1 Number	1	IBUPROFEN	204.00 mg
	CAPSULE	CONTAIN	200MG	<br>Capsule
	IBUPROFEN AND 205MG GELATIN
					2	GELATIN	125.43 mg
3	RAFEN<br>GEL<br>CAPSULES		(EACH	<br>1 Number	1	IBUPROFEN	204.00 mg
	CAPSULE	CONTAIN<br>200	MG	<br>Capsule
	IBUPROFEN AND 205MG GELATIN)				2	GELATIN	125.43 mg

Case No.	127 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002360AM19
RA File Number	039504001113 AM19
Licence No and<br>Date	0310827030/14/02/2019
Norms Committee	Decision:

Sl. No.	Export product	Qty.
1	Phytosterol Natural Refined Phytosterol 95%	60000 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

2<br>Natural Mixed Tocopherol 70%<br>27500 kg	2<br>Natural Mixed Tocopherol 70%<br>27500 kg	2<br>Natural Mixed Tocopherol 70%<br>27500 kg
Sl. No.	Import items	Qty.
1	Fatty Acid Distillate / Deoderised Distillate	921250 kg
1	Acetone	44000 kg
2	Heptane-S	94050 kg

Case No.	128 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002362AM19
RA File Number	052304000508 AM19
Licence No and<br>Date	0510409675/15/02/2019
Norms Committee	Decision:

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

DML.

Case No. 129 / NC/3/MEET/Aug/202122/7

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002363AM19
RA File Number	052304000507 AM19
Licence No and<br>Date	0510409676/15/02/2019
Norms Committee	Decision:

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

DML.

Case No.	130 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002364AM19
RA File Number	092404000515 AM19
Licence No and<br>Date	0910067181/15/02/2019
Norms Committee	Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

i. Complete chemical description of import item No. 1.
ii. COA of import item No. 1 from foreign supplier.

(iii) Whether import item No. 2 is Pt Metal or 5% Pt on carbon.

Case No.	131 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	THINQ PHARMA-CRO LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205002386AM19 RA File Number 039504001186 AM19 Licence No and 0310827227/22/02/2019 Date Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the requisite information as asked for by NC-3 in its Meeting Nos. 13/82ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020 and letter dated 07.08.2020 and e-mail dated 19.11.2020.

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

Case No.	132 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	SHANKUS PHARMACEUTICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002574AM19
RA File Number	082404000430 AM19
Licence No and<br>Date	0810144782/18/03/2019
Norms Committee	Decision:

The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020 , followed by Reminder on 03.09.2020 and 11.12.2020 :

i. Complete chemistry, molecular weight as per Appendix 4E.

In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.

Case No. 133 / NC/3/MEET/Aug/202122/7

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case Status	Case Rejected
Party Name	DINAKARA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002576AM19
RA File Number	092404000571 AM19
Licence No and<br>Date	0910067285/18/03/2019
Norms Committee	Decision:

Case No.	134 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205002606AM19
RA File Number	092404000633 AM19
Licence No and<br>Date	0910067303/20/03/2019
Norms Committee	Decision:

Case No. 135 / NC/3/MEET/Aug/202122/7 Case Status Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Party Name JODAS EXPOIM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205000042AM20 RA File Number 052304000015 AM20 Licence No and 0510410233/15/04/2019 Date Norms Committee Decision:

Sl.	No. Export product		Qty.	Sl.	Import items		Qty.
				No.
1	Ampicillin<br>&<br>Sulbactam	<br>for	<br>666667	1	SULBACTAM	SODIUM	<br>96.17 kg
	Injection 375mg. Import & Export to		<br>Number		RELEVANT BULK
	be governed as per P/C 9	dated
	30.06.2003 as amended				DRUG. Import & Export to be
					governed as per P/C	9 dated
					30.06.2003 as
					amended
2	Ampicillin<br>&<br>Sulbactam	<br>for	<br>333333	1	SULBACTAM	SODIUM	<br>96.17 kg
	Injection 750mg. Import & Export to		<br>Number		RELEVANT BULK
	be governed as per P/C 9	dated
	30.06.2003 as amended				DRUG. Import & Export to be
					governed as per P/C	9 dated
					30.06.2003 as
					amended
3	Ampicillin<br>&<br>Sulbactam	for	3000000	1	SULBACTAM	SODIUM	<br>1730.94 kg
	Injection 1500mg. Import & Export		Number		RELEVANT BULK
	to be governed as per P/C 9 dated
	30.06.2003 as amended				DRUG. Import & Export to be
					governed as per P/C	9 dated
					30.06.2003 as
					amended

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	136 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000086AM20
RA File Number	082404000005 AM20
Licence No and<br>Date	0810145144/01/05/2019
Norms Committee	Decision:

i. Complete technical details as for Annexure to Appendix 4E.
ii. Chemistry, molecular weight, percentage yield of reaction.
iii. Stoichiometric balance on molar basis of chemical reaction.

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

Case No.	137 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000101AM20
RA File Number	052304000048 AM20
Licence No and<br>Date	0510410475/03/05/2019
Norms Committee	Decision:

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Ertapenem for Injection 1g/Vial,	ERTAPENEM	SODIUM	RELEVANT
20 ml vial. Import & Export to be	BULK DRUG.	Import &	Export to be
governed as per P/C 9 dated	governed as per	P/C 9 dated	30.06.2003 as
30.06.2003 as amended	amended

Case No.	138 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	PRACHEM LABORATORIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000106AM20
RA File Number	082404000003 AM20
Licence No and<br>Date	0810145205/08/05/2019
Norms Committee	Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the requisite information as asked for by NC-3 in its Meeting Nos. 11/82ALC4/2019 dated 03.01.2020, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020 and e-mail dated 16.01.2020.

Case No.	139 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000109AM20
RA File Number	222404000011 AM20
Licence No and<br>Date	2210016146/10/05/2019
Norms Committee	Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Export product	Qty.	Sl. No.	Import items	Qty.
KETOPROFEN	1 kg	1	3-(1-cyanoethyl)benzoic acid	1.034 kg

Case No. 140 / NC/3/MEET/Aug/202122/7 Case Status Case Deferred Party Name SALVI CHEMICAL INDUSTRIES LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205000191AM20 RA File Number 039504000157 AM20 Licence No and 0310829190/22/05/2019 Date Norms Committee Decision:

i. Detailed chemistry.
ii. Stoichiometric balance on molar basis.

Percentage yield at every stage of manufacturing.

Case No.	141 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

HQ File Number 018205000207AM20 RA File Number 039404000134 AM20 Licence No and 0310829265/27/05/2019 Date Norms Committee Decision:

i. Step-wise complete reactions item percentage yield on molar basis.
ii. Copy of technical literature in support of yield envisaged.

Production / Consumption data duly certified by GST.

Case No.	142 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	RESONANCE SPECIALTIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001006AM20
RA File Number	039504000166 AM20
Licence No and<br>Date	0310829318/29/05/2019
Norms Committee	Decision:

Case No.	143 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000226AM20

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

RA File Number	342404000036 AM20
Licence No and<br>Date	3410045179/30/05/2019
Norms Committee	Decision:

The Committee considered the case as per agenda and it was decided to ratify adhoc norms as per SION A-3679.

Case No.	144 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	RAVESHIA ORGANICS LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000225AM20
RA File Number	039504000204 AM20
Licence No and<br>Date	0310829355/30/05/2019
Norms Committee	Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the requisite information as asked for by NC-3 in its Meeting Nos. 14/82ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020 and e- mail dated 10.09.2020.

Case No.	145 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000279AM20
RA File Number	039404000201 AM20
Licence No and<br>Date	0310829703/17/06/2019
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

i. Production / Consumption for licensing period data duly certified by GST.

Percentage purity of export item.

Case No.	146 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	CONCORD BIOTECH LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000319AM20
RA File Number	082404000101 AM20
Licence No and<br>Date	0810145581/27/06/2019
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the firm has made the request twice for amendment in the export product / import items and the details are all mixed up.

In view of above, the Committee decided to call for following information from the firm:

The firm is advised to first get its Advance Authorization amended from RLA and then submit the revised Appendix 4E with all technical details for further examination of its case.

Case No.	147 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	NOCIL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001639AM21
RA File Number	039504000284 AM20
Licence No and<br>Date	0310829992/28/06/2019
Norms Committee	Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 1/82-ALC4/2018 dated 01.05.2018 against advance authorization No. 0310811898 dated 17.03.2017 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product			Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
N-(Cyclohexyl	thio-)	Phthalimide	1 kg	1	Phthalic Anyhdride (PAN)	0.603 kg
(Our Brand name:PILGARD PVI)
				2	DiCycloHexyl Disulphide (DCDS)	0.486 kg
				3	Caustic Potash Flakes (Potassium Hydroxide)	<br>0.020 kg
					(KOH)

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

Case No.	148 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000329AM20
RA File Number	092404000146 AM20
Licence No and<br>Date	0910067735/02/07/2019
Norms Committee	Decision:

Export product Qty. Sl. Import items Qty. No. (S)-METHYL-3-METHYL-2-(N-((21 kg 1 2-Cyano-4-Methyl Biphenyl (or) 4-Methyl-20.74 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

(1-TRITYL-1H-TETRAZOLE-5-YL)	(1-TRITYL-1H-TETRAZOLE-5-YL)		Cyano Biphenyl (OTBN)
BIPHENYL-4-YL)	<br>METHYL)
PENTANAMIDO)	BUTANOATE	2	L-Valine	0.27 kg
		3	Methylene dichloride	4.00 kg

Case No.	149 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000340AM20
RA File Number	039504000318 AM20
Licence No and<br>Date	0310830043/03/07/2019
Norms Committee	Decision:

i. Copy of Master Batch Formula showing net content in export product.

ii. Percentage overages applied in each import.

Copy of COA of Eudragit L 30 D55.

Case No.	150 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000343AM20
RA File Number	092404000172 AM20
Licence No and<br>Date	0910067749/03/07/2019

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

i. End use of Export Product.
ii. Catalogue of import item.

Production / Consumption data for last one year duly certified by GST.

Case No.	151 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	PROLIFE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000348AM20
RA File Number	039504000329 AM20
Licence No and<br>Date	0310830123/05/07/2019

The Committee considered case as per agenda in the presence of the technical experts and on the basis of two stage reaction and taking overall yield of 71%, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
P-CRESIDINE SULFONIC ACID	1 kg	1	2-NITRO PARA CRESOL	1.00 kg

Case No. 152 / NC/3/MEET/Aug/202122/7 Case Status Case Approved Party Name ACME GENERICS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

and Date
HQ File Number	018205000356AM20
RA File Number	222404000026 AM20
Licence No and<br>Date	2210016194/08/07/2019
Norms Committee	Decision:

Sl. No. Export product Qty. Sl. Import items Qty. No. 1 Ferrous Fumarate Tablet 200 mg 1 Number 1 Ferrous Fumarate 204.00 mg / (Each Tablet contain Ferrous Fumarate Powder Tablet Powder 207mg) 2 Ferrous Fumarate + Folic Acid Tablet 1 Number 1 Ferrous Fumarate 316.20 mg/ (310mg+350mcg) (Each Tablet contain Powder Tablet Ferrous Fumarate Powder 320.85mg)

Case No.	153 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	LACTOSE (INDIA) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000370AM20
RA File Number	039504000296 AM20
Licence No and<br>Date	0310830184/09/07/2019
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Export product	Qty.	Sl.<br>No.	Import items	Qty.
LACTULOSE<br>CONCENTRATE<br>USP/EP/LACTULOSE<br>SOLUTION<br>USP/EP/LACTULOSE<br>FOOD<br>GRADE<br>(Assay NLT 99%)	<br> <br> <br>100 MT	1	Food<br>Grade<br>Lactose/<br>Edible<br>Grade Lactose/ Refined Edible<br>Grade<br>lactose<br>/<br>lactose<br>Monohydrate BP/EP/USP-NF	<br> <br> <br>100 MT

Case No.	154 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	MAHARSHI PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000371AM20
RA File Number	082404000114 AM20
Licence No and<br>Date	0810145666/09/07/2019
Norms Committee	Decision:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
Betamethasone Sodium Phosphate	1 kg	1	17 Alpha 21- Dihydroxy- 16-Beta Methyl-9-<br>Beta-11- Beta-Epoxy Pregna-1, 4-Diene-3,<br>20- Dione (DB-XI)	0.72 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	155 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	MAHARSHI PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000376AM20
RA File Number	082404000116 AM20
Licence No and<br>Date	0810145668/09/07/2019
Norms Committee	Decision:

(i) Complete and balanced chemical reaction with molecular weight.

Percentage yield on molar basis for each step.

Case No.	156 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	MAHARSHI PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000377AM20
RA File Number	082404000117 AM20
Licence No and<br>Date	0810145669/09/07/2019
Norms Committee	Decision:

Export product	Qty.	Sl. No.	Import items	Qty.
Betamethasone Dipropionate	1 kg	1	17 Alpha-21 Dihydroxy- 16-A-Methyl-9- Beta-	1.10 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

11-Beta Epoxy Pregna-1, 4-Dione, 3, 20- Dione (DB-X1)

Case No.	157 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	THINQ PHARMA-CRO LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000374AM20
RA File Number	039504000338 AM20
Licence No and<br>Date	0310830207/10/07/2019
Norms Committee	Decision:

i. Percentage yield on molar basis alongwith copy of technical literature in support of yields.

Specify the API / End-use of export item.

Case No.	158 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000381AM20
RA File Number	039504000335 AM20
Licence No and<br>Date	0310830246/12/07/2019
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper as the firm still has not furnished percentage yield of reaction. Hence, the Committee decided to call for

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

following information from the firm:

Percentage yield of reaction.

Case No.	159 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	PRACHEM LABORATORIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000395AM20
RA File Number	082404000123 AM20
Licence No and<br>Date	0810145731/17/07/2019

Complete technical details as for Annexure to Appendix 4E.

Case No.	160 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205001597AM21
RA File Number	092404000642 AM19
Licence No and<br>Date	0910067796/19/07/2019
Norms Committee	Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the requisite information as asked for by NC-3 in its Meeting Nos. 4/82ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020 and e-mail dated 16.10.2020.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	161 / NC/3/MEET/Aug/202122/7	161 / NC/3/MEET/Aug/202122/7
Case Status	Case Withdrawn
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000441AM20
RA File Number	318304000047 AM20
Licence No and<br>Date	3110067483/24/07/2019
Norms Committee Decision:<br>The firm vide e-mail dated25.08.2021has informed that they have surrendered the subject Advance Authorization<br>and hence there is no need to fix the input-output norms.<br>The Committee considered the request of the firm and has decided towithdrawthe case.

Case No.	162 / NC/3/MEET/Aug/202122/7	162 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	ACME GENERICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000462AM20
RA File Number	222404000031 AM20
Licence No and<br>Date	2210016214/26/07/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:

i. Content of Aspirin in import item. Copy of COA of import item from foreign supplier.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	163 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	ACME GENERICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000463AM20
RA File Number	222404000030 AM20
Licence No and<br>Date	2210016215/26/07/2019
Norms Committee	Decision:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
Acetylsalicylic<br>Asid<br>(ASA)<br>Chewable Tablets 80mg<br>(Each<br>Tablet<br>contain<br>ACETYLSALICYLIC<br>ACID<br>(ASPIRIN) USP 20-60M - 81.70<br>mg)	<br> <br> <br> <br>1<br>Number<br>Tablet	1	ACETYLSALICYLIC ACID (ASPIRIN)<br>USP 20-60M	81.6 mg

Case No.	164 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	WOCKHARDT LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000464AM20
RA File Number	039504000426 AM20
Licence No and	0310830632/29/07/2019

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Date

Export product	Qty.	Sl.<br>No.	Import items	Qty.
SUMATRIPTAN SUCCINATE INJ<br>6MG/0.5ML (5 VIAL PACK), EACH<br>VIAL CONTAINS SUMATRIPTAN<br>SUCCINATE 8.4MG EQUIVALENT<br>TO SUMATRIPTAN 6MG (Total<br>60085 Vials and Total Net Content of<br>Sumatriptan<br>succinate<br>upto<br>0.707<br>KGS)	<br> <br> <br> <br> <br> <br> <br>1 Number Vial	1	SUMATRIPTAN SUCCINATE	9.24 mg

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

Case No.	165 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	MAHAVIR SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000469AM20
RA File Number	522404000023 AM20
Licence No and<br>Date	5210043127/29/07/2019
Norms Committee	Decision:

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

K - ACID K/NA SALT (2-NAPHTHYLAMINE -	<br>1 kg	1	K - ACID	1.10 kg
3.6.8 - TRISULFONIC ACID K/NA - SALT)

Case No.	166 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000475AM20
RA File Number	092404000232 AM20
Licence No and<br>Date	0910067851/30/07/2019

Export product	Qty.	Sl.	Import items		Qty.
		No.
DULOXETINE	1 kg	1	(S)-3-METHYLAMINO	-1-(THIOPHENE-2-YL)-	0.676 kg
HYDROCHLORIDE			PROPAN-1-OL (or) (1S)-3-(METHYLAMINO)-1-
			(THIOPHENE-2-YL)PROPAN-1-OL)
		2	1-Fluoronaphthalene		0.751 kg
		3	Dimethyl Sulfoxide (DMSO)		2.274 kg
		4	Activated Carbon (Carbon	Enoanticromos)	0.040 kg
		5	Isopropyl Alcohol		3.440 kg
		6	Toluene		2.623 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	167 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000490AM20
RA File Number	318304000051 AM20
Licence No and<br>Date	3110067490/02/08/2019
Norms Committee	Decision:

i. As per details given by the firm, the percentage of yield is low, that is 69%, 74% and 45%, please furnish justification for the same.
ii. Production / Consumption data for last one year for all raw material and catalyst duly certified by GST.

Catalogue of catalyst to be imported and its name.

Case No.	168 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SUVEN LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000488AM20
RA File Number	092404000244 AM20
Licence No and<br>Date	0910067866/05/08/2019
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Export product	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
CHLOROACETIC ANHYDRIDE	1 kg	1	CHLOROACETIC ACID	0.558 kg
		2	CHLOROACETYL CHLORIDE	0.734 kg

Case No.	169 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000533AM20
RA File Number	039404000397 AM20
Licence No and<br>Date	0310831038/16/08/2019
Norms Committee	Decision:

Case No.	170 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000540AM20

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

RA File Number 292404000010 AM20 Licence No and 2910025424/19/08/2019 Date Norms Committee Decision:

Case No.	171 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000554AM20
RA File Number	072404000117 AM20
Licence No and<br>Date	0710115318/22/08/2019
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that as per details furnished by the firm, yields are on lower side, that is 66.67%, 72.5%, 55.5% and 41.64%, hence it was decided to call for following information from the firm:

Production / Consumption data for last one year duly certified by GST.

Case No.	172 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000566AM20
RA File Number	092404000275 AM20
Licence No and	0910067938/27/08/2019

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Date

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

Percentage strength of import item and its COA.

Case No.	173 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	MALLADI DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000575AM20
RA File Number	042404000089 AM20
Licence No and<br>Date	0410166026/29/08/2019

Export product	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
Trioxabicyclooctane	1 kg	1	Cis-2-butane-1,4-diol	1.02 kg
		2	Methanol	1.07 kg
		3	2,2-Dimethoxy Propane	1.32 kg
		4	Acetonitrile	1.42 kg
		5	Methylene di chloride	1.25 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	174 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000589AM20
RA File Number	092404000304 AM20
Licence No and<br>Date	0910067970/05/09/2019

Export product		Qty.	Sl.	Import items	Qty.
			No.
HYDROXY	CHLOROQUINE	<br>1 kg	1	4,7-DICHLORO QUINOLINE	0.723 kg
SULFATE USP
			2	4-AMINO-N-ETHYL(2 HYDROXY ETHYL)-	<br>0.671 kg
				PENTY LAMINE
			3	SODIUM HYDROXIDE MICRO PEARLS	0.750 kg

Case No.	175 / NC/3/MEET/Aug/202122/7	175 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	VIVIN DRUGS & PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

HQ File Number 018205000590AM20 RA File Number 092404000289 AM20 Licence No and 0910067973/05/09/2019 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the requisite information as asked for by NC-3 in its Meeting Nos. 14/82ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020 and letter dated 14.08.2020 and e-mail dated 06.10.2020.

Case No. 176 / NC/3/MEET/Aug/202122/7 Case Status Case Approved Party Name CADILA PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205000592AM20 RA File Number 082404000175 AM20 Licence No and 0810146100/05/09/2019 Date Norms Committee Decision:

The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is less:

Export product Qty. Sl. Import items Qty. No. TOBRAMYCIN AND 1 Number 1 TOBRAMYCIN SULPHATE USP 18.513 mg DEXAMETHASONE OPTHALMIC Vial SOLUTION (EACH 5 ML VIAL CONTAINING TOBRAMYCIN 2 DEXAMETHASONE SODIUM 5.10 mg PHOSPHATE USP SULPHATE CONSUMED INCLUDING WASTAGE 28.15 MG & DEXAMETHASONE SODIUM PHOSPHATE USP IS 7.15 MG ) ( NET CONTENT OF TOBRAMYCIN

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

SULPHATE IS 5.630 KGS DEXAMETHASONE SODIUM PHOSPHATE USP IS 1.430 KGS)

Case No.	177 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	HIMALAYAN PRODUCTS AND INDUSTRIES CORPN PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000601AM20
RA File Number	612404000007 AM20
Licence No and<br>Date	6110001614/06/09/2019
Norms Committee Decision:

i. Percentage content of active ingredient (a.i.) in import and export.
ii. COA of import item from foreign supplier.

Complete technical details as per Annexure to Appendix 4E.

Case No.	178 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000602AM20
RA File Number	052404000296 AM20
Licence No and<br>Date	0510411778/06/09/2019
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Complete technical details as per Annexure to Appendix 4E.

Case No.	179 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	SUVEN LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000605AM20
RA File Number	092404000307 AM20
Licence No and<br>Date	0910067982/09/09/2019

Export product<br>	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
ETHYL-6-FLUOROBENZOFURAN-7-	1 kg	1	HEPTANE	0.152 kg
CARBOXYLATE
		2	METHYL TERT-BUTYL ETHER	3.23 kg
		3	SODIUM BOROHYDRIDE	0.392 kg
		4	2,6-DIFLUOROBENZOIC ACID	1.813 kg
		5	DIMETHYL FORMAMIDE	0.653 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	180 / NC/3/MEET/Aug/202122/7	180 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000612AM20
RA File Number	039404000455 AM20
Licence No and<br>Date	0310831483/11/09/2019
Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 against advance authorization No. 0310836157 dated 11.05.2020 , 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	Cetylpyridinium Chloride, Benzydamine<br>Hydrochloride and Pholcodine Lozenges<br>Sugar Free Blackcurrant/ Pineapple<br>& Ginger/ Other Flavours. Each Lozenge<br>contains<br>(i)<br>Pholcodine<br>5.50mg<br>(ii)<br>Benzydamine Hydrochloride 1.50mg (iii)<br>Cetylpyridinium Chloride 1.33mg (iv)<br>Isomalt ST-M 2595.67mg. Net Content (i)<br>43.624kg (ii) 11.898kg (iii) 10.549kg (iv)<br>20588.045kg	<br> <br> <br> <br> <br> <br> <br> <br>1 Number	1	Pholcodine	5.61 mg
			2	Benzydamine Hydrochloride	1.53 mg
			3	Cetylpyridinium Chloride	1.357 mg
			4	Isomalt ST-M	2583.0 mg
2	Pholcodine and Cetylpyridinium Chloride<br>Lozenges Sugar Free Orange / Lemon and<br>Other Flavours. Each Lozenge contains (i)<br>Pholcodine 5.50 mg (ii) Cetylpyridinium<br>Chloride 1.33 mg (iii) Isomalt ST-M<br>2591.86 mg. Net Content (i) Pholcodine<br>23.49 kg (ii) Cetylpyridinium Chloride<br>5.68 kg (iii) Isomalt ST-M 11069.627 kg.	<br> <br> <br> <br> <br> <br> <br>1 Number	5	Pholcodine	5.61 mg
			6	Cetylpyridinium Chloride	1.357 mg
			7	Isomalt ST-M<br>Items Nos. 1,2,3,5,6, (other than<br>Isomalt ST-M ) are drugs as per<br>declaration of the firm.	<br> <br>2579.0 mg

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	181 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000617AM20
RA File Number	039404000462 AM20
Licence No and<br>Date	0310831524/13/09/2019
Norms Committee	Decision:

i. Complete technical details as per Annexure to Appendix 4E.
ii. Manufacturing process in details.
iii. Exact chemical name of export and import item.

COA of import item from foreign supplier.

	182 / NC/3/MEET/Aug/202122/7	182 / NC/3/MEET/Aug/202122/7
Case No.	182 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000625AM20
RA File Number	092404000313 AM20
Licence No and<br>Date	0910067997/13/09/2019
Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the applied norms are more than 10 times higher than the approved quantity given in the Mater Batch Formula. As such no norms can be recommended for this case in its present form. Hence, the Committee decided to reject the case.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	183 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	THERAPIVA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000644AM20
RA File Number	092404000294 AM20
Licence No and<br>Date	0910068000/16/09/2019
Norms Committee	Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the requisite information as asked for by NC-3 in its Meeting Nos. 14/82ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020 and letters dated 14.08.2020 and 06.10.2020.

Case No.	184 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	RENOWN PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000637AM20
RA File Number	342404000182 AM20
Licence No and<br>Date	3410045458/17/09/2019
Norms Committee Decision:

Export product	Qty.	Sl. No.	Import items	Qty.
SOFT<br>GELATIN<br>CAPSULES<br>(ITC(HS)<br>CODE<br>30045090/30045039)<br>NET<br>CONTENT : 1)GELATIN 175	<br> <br> <br> <br>34035800.000<br>Number	1	GELATIN 175 BLOOM 5-15 MESH	10080 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

BLOOM 5-15 MESH :9,600.000 KILOGRAM

Case No.	185 / NC/3/MEET/Aug/202122/7
Case Status	Case Rejected
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000647AM20
RA File Number	318204000056 AM20
Licence No and<br>Date	3110067535/19/09/2019
Norms Committee	Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the requisite information as asked for by NC-3 in its Meeting Nos. 14/82ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020 and letter dated 14.08.2020 and e-mail dated 06.10.2020.

Case No.	186 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000652AM20
RA File Number	039504000621 AM20
Licence No and<br>Date	0310831732/23/09/2019
Norms Committee	Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Export product Qty. Sl. No. Import items Qty. PSC1164 / JAC21 (Blended product) 118000.000 kg 1 NEO FATTY ACID C10-20 64900.000 kg (containing 55% Neo Fatty Acid and 35% Tallow Amine 2 TALLOW DIAMINE 41300.000 kg

Case No. 187 / NC/3/MEET/Aug/202122/7 Case Status Case Deferred Party Name SUVEN LIFE SCIENCES LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205000750AM20 RA File Number 092404000322 AM20 Licence No and 0910068026/23/09/2019 Date Norms Committee Decision:

i. Copy of the Guaranteed Norms given by the Foreign Collaborator.
ii. Complete chemical description of import item No. 4 (XTAFLUOR-E), its chemical structure, molecular weight and specific-wise in step II.

End-use of the export item.

Case No. 188 / NC/3/MEET/Aug/202122/7 Case Status Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Party Name	DANOPHARM CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000656AM20
RA File Number	039404000422 AM20
Licence No and<br>Date	0310831769/24/09/2019
Norms Committee	Decision:

Export product	Qty.	Sl. No. Import items	Sl. No. Import items	Qty.
Alpha-(2,4-dichlorophenyl)-1H-	1 kg	1	2,2,4 Trichloro Acetophenone	1.45 kg
imidazole-1-ethanol
		2	Imidazole	0.53 kg
		3	Sodium Carbonate	Not shown in
				the process
		4	Sodium Borohydride	0.10 kg
		5	Dimethyl Sulphoxide (DMSO)	0.42 kg
		6	Toluene	0.45 kg
		7	Sodium Hydroxide (NaOH)	0.10 kg
		8	Activated Carbon	0.050 kg

Case No. 189 / NC/3/MEET/Aug/202122/7 Case Status Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Party Name OPES HEALTH CARE PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021 and Date HQ File Number 018205000661AM20 RA File Number 082404000202 AM20 Licence No and 0810146231/25/09/2019 Date Norms Committee Decision:

i. The firm is claiming extra wastage of 14.50% due to loss on drying in the imported drug. However, the import item description does not indicate any such moisture content or loss in Drying. Please clarify it.

Case No.	190 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	AVIK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000677AM20
RA File Number	039404000494 AM20
Licence No and<br>Date	0310831896/27/09/2019
Norms Committee	Decision:

Export Product	Qty	Sl. No.	Import Items	Qty
Budesonide Micronized<br>(IP/EP/BP/USP)	1 kg	1	16 Alpha-Hydroxyprednisolone (16-HPN)	0.972 kg

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	191 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	GOPINATH CHEM-TECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000684AM20
RA File Number	082404000190 AM20
Licence No and<br>Date	0810146246/27/09/2019
Norms Committee	Decision:

(i) Percentage purity of import and export item

i. Impurity profile in import and export item.

COA of import item indicating purity and impurity level.

Case No.	192 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000670AM20
RA File Number	039404000484 AM20
Licence No and<br>Date	0310831860/27/09/2019
Norms Committee	Decision:

i. Percentage purity of export item.
ii. COA of import item from foreign supplier.
iii. COA of export item from the firm.

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Case No.	193 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000671AM20
RA File Number	039404000485 AM20
Licence No and<br>Date	0310831861/27/09/2019
Norms Committee	Decision:

i. Percentage purity of import item.

COA of import item from foreign supplier.

Case No.	194 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000672AM20
RA File Number	039504000625 AM20
Licence No and<br>Date	0310831873/27/09/2019
Norms Committee	Decision:

The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 3/82ALC4/2020 dated 07.08.2020 , followed by Reminder on 06.10.2020 :

i. Justification for quantity asked for import item No. 3 -5% Palladium on Carbon Paste Type 87, 5R 487 (Pd/C) on Dry Basis.
ii. Material balance on % metal content for export product No. 2 – Palladium Metal Sponge and import item No. 4 - RECOVERABLE WASTAGE GENERATED FROM 5% PALLADIUM ON CARBON PASTE TYPE 487,5R 487 (Pd/C) ON DRY BASIS.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

iii. Production / Consumption Data till date for both export products separately duly certified by GST.

In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.

Case No.	195 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000687AM20
RA File Number	039504000340 AM20
Licence No and<br>Date	0310831915/30/09/2019
Norms Committee	Decision:

The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 3/82ALC4/2020 dated 07.08.2020 , followed by Reminder on 06.10.2020 :

i. Recovery of Methanol and its Commercial Value for in production of Export Product No. 1 - STEROCARE CMEA (Coco Mono Ethanol Amide).

In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.

Case No.	196 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000688AM20
RA File Number	039504000135 AM20
Licence No and<br>Date	0310831916/30/09/2019

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Norms Committee Decision:

The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 3/82ALC4/2020 dated 07.08.2020 , followed by Reminder on 06.10.2020 :

i. Blend ratio of Export Product No. 3 - M 2653 (OXYALKYLATED NONYL PHENOL+pTERT.BUTYL PHENOL FORMADEHYDE RESIN).

In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.

Case No.	197 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000689AM20
RA File Number	318304000087 AM20
Licence No and<br>Date	3110067548/30/09/2019
Norms Committee	Decision:

i. Exact Chemical Name of Export Product.
ii. Exact chemical name of Import Item No. 1 – OCP 50 and its catalogue from foreign supplier.
iii. Quantity, value and name of By-Products obtained.

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

Case No.	198 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000696AM20

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

RA File Number 039404000514 AM20 Licence No and 0310832013/04/10/2019 Date Norms Committee Decision:

Sl. No.	Export product	Qty.	Sl. No. Import items	Sl. No. Import items			Qty.
1	Nifedipine Extended-Release Tablets	1 Number	1	Sentry Polyox WSR Coagulant NF			56.8 mg
	30mg.
	Each tablet contains (i) Sentry
	Polyox WSR Coagulant NF - 56.80		2	EASTMAN	(TM)	CELLULOSE	<br>33.12 mg
	mg (ii) Eastman (TM Cellulose			ACETATE (CA 398-10NF/EP)
	Acetate (CA 398-10NF/EP)- 33.12
	mg (iii) SENTRY POLYOX WSR<br>N80 FP NF - 118.40 mg. Net content		3	SENTRY POLYOX WSR		N80 FP NF	118.40 mg
	(i) 148.335 Kgs (ii) 86.494 Kgs (iii)
	309.205 Kgs
2	Nifedipine Extended-Release Tablets	<br>1 Number	4	Sentry Polyox WSR Coagulant NF			113.60 mg
	60mg.
	Each tablet contains (i) Sentry Polyox
	WSR Coagulant NF - 113.60 mg (ii)		5	EASTMAN	(TM)	CELLULOSE	<br>42.32 mg
	Eastman (TM Cellulose Acetate (CA			ACETATE (CA 398-10NF/EP)
	398-10NF/EP)-<br>42.32<br>mg<br>(iii)
	SENTRY POLYOX WSR N80 FP
	NF - 236.80 mg. Net content (i)		6	SENTRY POLYOX WSR		N80 FP NF	236.80 mg
	235.718 Kgs (ii) 87.813 Kgs (iii)
	491.355 Kgs

Case No.	199 / NC/3/MEET/Aug/202122/7
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000721AM20
RA File Number	039404000541 AM20

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

Licence No and 0310832145/11/10/2019 Date Norms Committee Decision:

Licence No and Date

0310832145/11/10/2019

Norms Committee Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Mirapezol 0.7mg Tablets (Pramipexole) (Pack 30 Tabs.) (0.7 mg Pramipexole equi. to Pramipexole DI-HCL-H2O 1.0 mg) ( Net Wt. of Import is 0.300Kgs.) 1 Number Tablet 1 Pramipexole DI-HCL-H2O 1.02 mg 2 Glepark 0.7mg Tablets (Pramipexole) (Pack 30 Tabs.) (0.7 mg Pramipexole equi. to Pramipexole DI-HCL-H2O 1.0 mg) ( Net Wt. of Import is 1.500 Kgs.) 1 Number Tablet 1 Pramipexole DI-HCL-H2O 1.02 mg 3 Glepark 0.7mg Tablets (Pramipexole) (Pack 100 Tabs.) (0.7 mg Pramipexole equi. to Pramipexole DI-HCL-H2O 1.0 mg) ( Net Wt. of Import is 5.000 Kgs.) 1 Number Tablet 1 Pramipexole DI-HCL-H2O 1.02 mg 4 Pramifer 0.7mg Tablets (Pramipexole) (Pack 100 Tabs.) (0.7 mg Pramipexole equi. to Pramipexole DI-HCL-H2O 1.0 mg) ( Net Wt. of Import is 1.000 Kgs.) 1 Number Tablet 1 Pramipexole DI-HCL-H2O 1.02 mg 5 Pramipexole 0.7mg Tablets (Pramipexole) (Pack 100 Tabs.) (0.7 mg Pramipexole equi. to Pramipexole DI-HCL-H2O 1.0 mg) ( Net Wt. of Import is 2.000 Kgs.) 1 Number Tablet 1 Pramipexole DI-HCL-H2O 1.02 mg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

6	Pramipexole Glenmark 0.18mg Tablets	Pramipexole Glenmark 0.18mg Tablets	<br>1 Number	1	Pramipexole DI-HCL-H2O 0.255 mg
	(Pramipexole) (Pack 30 Tabs.) (0.18	mg	<br>Tablet
	Pramipexole equi. to Pramipexole	DI-
	HCL-H2O 0.25 mg )
	( Net Wt. of Import is 0.075 Kgs.)
7	Glenmark 0.18mg Tablets (Pramipexole)		<br>1 Number	1	Pramipexole DI-HCL-H2O 0.255 mg
	(Pack 30 Tabs.)		Tablet
	(0.18<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.25 mg )
	( Net Wt. of Import is 0.375 Kgs.)
8	Pramifer 0.18mg Tablets (Pramipexole)		<br>1 Number	1	Pramipexole DI-HCL-H2O 0.255 mg
	(Pack 30 Tabs.)		Tablet
	(0.18<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.25 mg )
	( Net Wt. of Import is 0.075 Kgs.)
9	Mirapezol 0.18mg Tablets (Pramipexole)		<br>1 Number	1	Pramipexole DI-HCL-H2O 0.255 mg
	(Pack 30 Tabs.)		Tablet
	(0.18<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.25 mg )
	( Net Wt. of Import is 0.075 Kgs.)
10	Glepark 0.18mg Tablets (Pramipexole)		<br>1 Number	1	Pramipexole DI-HCL-H2O 0.255 mg
	(Pack 100 Tabs.)		Tablet
	(0.18<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.25 mg )
	( Net Wt. of Import is 1.750 Kgs.)
11	Pramifer 0.18mg Tablets (Pramipexole)		<br>1 Number	1	Pramipexole DI-HCL-H2O 0.255 mg
	(Pack 100 Tabs.)		Tablet
	(0.18<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.25 mg )
	( Net Wt. of Import is 0.375 Kgs.)
12	Pramipexole 0.18mg Tablets (Pack	100	<br>1 Number	1	Pramipexole DI-HCL-H2O 0.255 mg
	Tabs.) (0.18 mg Pramipexole equi.	to	<br>Tablet
	Pramipexole DI-HCL-H2O 0.25 mg )
	( Net Wt. of Import is 0.375 Kgs.)

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

13	Glepark 0.088 mg Tablets (Pramipexole)	Glepark 0.088 mg Tablets (Pramipexole)	<br>1 Number	1	Pramipexole DI-HCL-H2O 0.1275 mg
	(Pack 30 Tabs.)		Tablet
	(0.088<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.125 mg )
	( Net Wt. of Import is 0.206 Kgs.)
14	Pramipexole<br>0.088<br>mg<br>Tablets		<br>1 Number	1	Pramipexole DI-HCL-H2O 0.1275 mg
	(Pramipexole) (Pack 30 Tabs.)		Tablet
	(0.088<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.125 mg )
	( Net Wt. of Import is 0.038 Kgs.)
15	Glepark 0.088 mg Tablets (Pramipexole)		<br>1 Number	1	Pramipexole DI-HCL-H2O 0.1275 mg
	(Pack 100 Tabs.)		Tablet
	(0.088<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.125 mg )
	( Net Wt. of Import is 0.625 Kgs.)
16	Glepark 0.35 mg Tablets (Pramipexole)		<br>1 Number	1	Pramipexole DI-HCL-H2O 0.51 mg
	(Pack 30 Tabs.)		Tablet
	(0.35<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.50 mg)
	( Net Wt. of Import is 0.300 Kgs.)
17	Glepark 0.35 mg Tablets (Pramipexole)		<br>1 Number	1	Pramipexole DI-HCL-H2O 0.51 mg
	(Pack 100 Tabs.)		Tablet
	(0.35<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.50 mg)
	( Net Wt. of Import is 2.500 Kgs.)
18	Pramipexole<br>0.35<br>mg<br>Tablets		<br>1 Number	1	Pramipexole DI-HCL-H2O 0.51 mg
	(Pramipexole) (Pack 100 Tabs.)		Tablet
	(0.35<br>mg<br>Pramipexole<br>equi.	to
	Pramipexole DI-HCL-H2O 0.500 mg)
	( Net Wt. of Import is 0.750 Kgs.)
19	Pramipexole 0.125 mg Tablets (Pack	90	<br>1 Number	1	Pramipexole DI-HCL-H2O 0.1275 mg
	Tabs.) (equi. to Pramipexole DI-HCL-H2O		<br>Tablet
	0.125 mg ) ( Net Wt. of Import is 0.011
	Kgs.)

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

20	Pramipexole 0.25 mg Tablets (Pack 90	<br>1 Number	1	Pramipexole DI-HCL-H2O 0.255 mg
	Tabs.) (equi. to Pramipexole DI-HCL-H2O	<br>Tablet
	0.25 mg )
	( Net Wt. of Import is 0.180 Kgs.)
21	Pramipexole 0.500 mg Tablets (Pack 90	<br>1 Number	1	Pramipexole DI-HCL-H2O 0.51 mg
	Tabs.) (equi. to Pramipexole DI-HCL-H2O	<br>Tablet
	0.50 mg )
	( Net Wt. of Import is 0.225 Kgs.)
22	Pramipexole 1.000 mg Tablets (Pack 90	<br>1 Number	1	Pramipexole DI-HCL-H2O 1.02 mg
	Tabs.) (equi. to Pramipexole DI-HCL-H2O	<br>Tablet
	1.000 mg )
	( Net Wt. of Import is 0.720 Kgs.)
23	Pramipexole 1.500 mg Tablets (Pack 90	<br>1 Number	1	Pramipexole DI-HCL-H2O 1.53 mg
	Tabs.) (equi. to Pramipexole DI-HCL-H2O	<br>Tablet
	1.500 mg )
	( Net Wt. of Import is 1.350 Kgs.)

Case No.	200 / NC/3/MEET/Aug/202122/7
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202122/ 7 and 13/08/2021
HQ File Number	018205000765AM20
RA File Number	039404000526 AM20
Licence No and<br>Date	0310832396/23/10/2019
Norms Committee	Decision:

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00155926AM22

i. The firm has applied for import of Propylene Glycol in all the export items. However, as per DML furnished by the firm, Propylene Glycol is shown in the composition of Ivermectin Injection only as per DML. Technical justification may be furnished in this regard.

Copy of Master Batch Formula for each export item may be furnished.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 01-Nov-2021 13:18:50 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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