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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/Jan/202122/13 DATED: 21/01/2022

Please Note

  • I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in

  • II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.

  • III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.

Meeting No. NC/3/MEET/Jan/202122/13 dated 21/01/2022 of Norms Committee - III for the year 2021-22 was actually held on 04.02.2022 under the Chairmanship of Amiya Chandra,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

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

,Deputy Director|Directorate General of Foreign Trade, Delhi| |3||SHAISH KUMAR,Technical Authority|Technical Consultant,DGFT| |4||DINESHNARAIN MATHUR,Technical 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: 11-Feb-2022 16:55:21 Date: 11-Feb-2022 f6:55:21 Reason: AJAY.DHIMAN88@GOV.IN Reason: AJAY. IAN88@GOV.IN Location: DGFT(HQ) Location: DGFT)

This document has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.

Case Details and Decision(s):

Case No. 1 / NC/3/MEET/Jan/202122/13
Case Status Case Rejected
Party Name VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205002080AM19
RA File Number 092404000363 AM19
Licence No and<br>Date 0910066851/14/11/2018
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished the requisite reply / information on portal. Hence, the Committee decided
torejectthe case.
Case No. 2 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name CADILA HEALTHCARE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205002125AM19
RA File Number 082404000264 AM19
Licence No and<br>Date 0810143988/29/11/2018
Norms Committee Decision:
The Committee considered the reply submitted by the firm on DGFT portal and it was observed that the reply received from the firm was very confusing. For example, the net weight
of 10 mg capsule is given 110.0 mg whereas Gelatin consumption is shown as 440.64 mg and Glycerine as 201.28 mg totaling to 641.92 mg of these two inputs. This data appears to
be confusing and perhaps incorrect.
In view of above, the Committee decided to call the firm forPersonal Hearing<br> alongwith following documents / information:

data appears to||| |be confusing and perhaps incorrect.||| |In view of above, the Committee decided to call the firm forPersonal Hearing<br>||alongwith following documents / information:| ||||

The Committee considered the reply submitted by the firm on DGFT portal and it was observed that the reply received from the firm was very confusing. For example, the net weight of 10 mg capsule is given 110.0 mg whereas Gelatin consumption is shown as 440.64 mg and Glycerine as 201.28 mg totaling to 641.92 mg of these two inputs. This data appears to be confusing and perhaps incorrect.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

  • i. Net weight of Empty Soft Gelatin Capsule Shell in each export item.

  • ii. Net content of Gelatin in each Soft Gelatin Capsule Shell.

  • iii. Net weight of Glycerine in each Soft Gelatin Capsule Shell.

  • iv. Stepwise process details for manufacturing Empty Soft Gelatin Capsule Shell with percentage wastage.

  • v. Complete material balance for point (iv) above showing Recovery, Re-use or Sale-Value of these two inputs recovered in the process.

Soft Gelatin Capsule Shell with percentage wastage.**

  • v. Complete material balance for point (iv) above showing Recovery, Re-use or Sale-Value of these two inputs recovered in the process.
Case No. 3 / NC/3/MEET/Jan/202122/13
Case Status Case Rejected
Party Name GLAND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205002142AM19
RA File Number 092404000420 AM19
Licence No and<br>Date 0910066931/03/12/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished the requisite reply / information on portal. Hence, the Committee decided<br>torejectthe case.
Case No. 4 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name NATCO PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205002183AM19
RA File Number 092404000417 AM19
Licence No and 0910066973/18/12/2018<br>Sinature Not Verified
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>g

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

Norms Committee Decision:

The firm vide its reply submitted on DGFT portal has stated that they are going to surrender the subject Advance Authorization as the same has not been utilized by them.

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

Case No. 5 / NC/3/MEET/Jan/202122/13
Case Status Case Rejected
Party Name R CHEM (SOMANAHALLI) PVT.LTD,
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205002287AM19
RA File Number 092404000516 AM19
Licence No and<br>Date 0910067074/18/01/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished the requisite reply / information on portal. Hence, the Committee decided
torejectthe case.
Case No. 6 / NC/3/MEET/Jan/202122/13
Case Status Case Rejected
Party Name ASTRAL STERITECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205002391AM19
RA File Number 342404000356 AM19
Licence No and 3410044929/22/02/2019

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the firm still has not furnished the requisite reply / information on portal. Hence, the Committee decided to reject the case.

Case No. 7 / NC/3/MEET/Jan/202122/13
Case Status Case Rejected
Party Name ASTRAL STERITECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205002392AM19
RA File Number 342404000355 AM19
Licence No and<br>Date 3410044930/22/02/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished the requisite reply / information on portal. Hence, the Committee decided<br>torejectthe case.
Case No. 8 / NC/3/MEET/Jan/202122/13
Case Status Case Rejected
Party Name SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205002490AM19
RA File Number 092404000591 AM19
Licence No and<br>Date 0910067219/26/02/2019
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee considered the case as per agenda and it was observed that the firm still has not furnished the requisite reply / information on portal. Hence, the Committee decided to reject the case.

Case No. 9 / NC/3/MEET/Jan/202122/13
Case Status Case Rejected
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205002562AM19
RA File Number 092404000612 AM19
Licence No and<br>Date 0910067275/13/03/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished the requisite reply / information on portal. Hence, the Committee decided<br>torejectthe case.
Case No. 10 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205000386AM20
RA File Number 039504000363 AM20
Licence No and<br>Date 0310830298/15/07/2019
Norms Committee Decision:<br>Deferred for comments of TE.<br>Si N Vifid
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>gnature ot ere

or,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>gnature ot ere||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 11 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205000429AM20
RA File Number 342404000069 AM20
Licence No and<br>Date 3410045298/18/07/2019
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 12 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205000442AM20
RA File Number 039504000413 AM20
Licence No and<br>Date 0310830547/24/07/2019
Norms Committee Decision:<br>Deferred for comments of TE.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 13 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205000490AM20
RA File Number 318304000051 AM20
Licence No and<br>Date 3110067490/02/08/2019
Norms Committee Decision:<br>Deferred for comments of TE.
Case No.<br> 14 / NC/3/MEET/Jan/202122/13
Case Status<br> Case Deferred
Party Name<br> AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number<br> 018205000528AM20
RA File Number<br> 522104000085 AM20
Licence No and<br>Date<br> 5210043146/14/08/2019
Norms Committee Decision:<br>The Committee considered the reply furnished by the firm and it was observed that the reply furnished by the firm was not proper. Hence, it was decided to again call for following<br>information from the firm:<br>Molecular weight of export product.<br>i.<br>(ii) Production / Consumption data for the last two years duly certified by GST.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 15 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205000529AM20
RA File Number 522104000086 AM20
Licence No and<br>Date 5210043147/14/08/2019
Norms Committee Decision:<br>The Committee considered the reply furnished by the firm and it was observed that the reply furnished by the firm was not proper. Hence, it was decided to again call for following<br>information from the firm:<br>Calculation sheet to arrive at the quantity of raw material obtained on the basis of Stoichiometric balance and yield.<br>i.<br>Recovery of solvent.<br>ii.<br>Production / Consumption data for last two years duly certified by GST.
Case No. 16 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name GOPINATH CHEM-TECH LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205000684AM20
RA File Number 082404000190 AM20
Licence No and<br>Date 0810146246/27/09/2019
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

7/09/2019| |Norms Committee Decision:||

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee considered the case as per agenda and taking 95% yield, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl. No. Import items Qty.
META UREIDO ANILINE (PURIFIED) (Purity Min. 99%) 9500 kg 1 META UREIDO ANILINE (Purity Max. 84.77%) 10000 kg

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

Case No. 17 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205000689AM20
RA File Number 318304000087 AM20
Licence No and<br>Date 3110067548/30/09/2019
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 18 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name PANACEA BIOTEC LIMITED
Meeting Number NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

a
nd Date
H Q File Number 018205000753AM20
R A File Number 052404000410 AM20
L<br>D icence No and<br>ate 0510412195/21/10/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc<br>whichever is less: orms Committee Decision:
norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
Export product Qty. Sl. No. Import items Qty.
Easy Five TT<br>(Each vial of 0.5 Vaccine DTwP-Hep B-Hib-Pentavalent Vaccine<br>ml contains 1 dose) <br>1 Million Vials 1 Purified Diptheria Toxoid Concentrate Antigen Bulk<br>@2050 Lf/ml <br>13.64 Litre
2 Purified Tetanus Toxoid Concentrate Antien @1900 <br>523 Litre
g<br>Lf/ml <br>.
3 Inactivated Whole Cell Pertussis Bulk @192 OU/ml 86.46 Litre
4 Rubber Stopper 1010000 Numbers
5 AGS HB Purification MABS Column 5.4 Litre
RA concerned may take further necessary action as per above decision of NC.
Case No. 19 / NC/3/MEET/Jan/202122/13

necessary action as per above decision of NC.||||||||||||| |||||||||||||| |||||||||||||| |||||||||||||| |||||||||||||| |||||||||||||| |||||||||||||| |Case No.||19 / NC/3/MEET/Jan/202122/13||||||||||| |||||||||||||| |Case Status||Case Deferred||||||||||| |||||||||||||| |Party Name||MANGALAM ORGANICS LIMITED<br>||||||||||| |ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Sig<br>Name: Ajay<br>Date: 11-Fe<br>Reason: AJ<br>Location: D<br>Signat|||||||||ned.<br>Kumar( Dep<br>b-2022 16:5<br>AY.DHIMAN<br>GFT(HQ)<br>ure Not|uty Director )<br>5:21<br>88@GOV.IN<br>Verified|||

Case No. 19 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name MANGALAM ORGANICS LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205000854AM20
RA File Number 039504000790 AM20
Licence No and<br>Date 0310832931/21/11/2019
Norms Committee Decision:<br>The Committee considered the reply furnished by the firm and it was observed that the reply furnished by the firm was not proper. Hence, it was decided to again call for following<br>information from the firm:<br>**As per application, quantity of import item – Gum Turpentine Oil required is 1.12 kg / kg, however as per Appendix 4E the required quantity is 0.50 kg / kg.

llowing<br>information from the firm:<br>As per application, quantity of import item – Gum Turpentine Oil required is 1.12 kg / kg, however as per Appendix 4E the required quantity is 0.50 kg / kg. Please explain.<br>i.<br>Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as per Annexure to Appendix 4E.<br>ii.||

Case No. 20 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205000947AM20
RA File Number 052404000601 AM20
Licence No and<br>Date 0510413159/01/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of Advance Authorization.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. Case No. 21 / NC/3/MEET/Jan/202122/13 21 / NC/3/MEET/Jan/202122/13 21 / NC/3/MEET/Jan/202122/13 21 / NC/3/MEET/Jan/202122/13 21 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name TINA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205000993AM20
RA File Number 052404000633 AM20
Licence No and<br>Date 0510413266/09/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking 95% yield, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied<br>by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>ORTHO ISOPROPYL PHENOL<br>LIQUID STANDARD<br>0.950 kg<br>ISOPROPYLATED<br>PHENYL<br>PHOSPHATE<br>(LIQUID STANDARD)<br>1kg<br>2<br>PHOSPHOROUS YELLOW SOLID STANDARD<br>0.079 kg<br>RA concerned may take further necessary action as per above decision of NC.
Export product Qty. Sl. No. Import items Qty.
ISOPROPYLATED<br>PHENYL<br>PHOSPHATE<br>(LIQUID STANDARD) <br>1kg 1 ORTHO ISOPROPYL PHENOL<br>LIQUID STANDARD 0.950 kg
2 PHOSPHOROUS YELLOW SOLID STANDARD 0.079 kg
of NC.

s|Qty.| ||ISOPROPYLATED<br>PHENYL<br>PHOSPHATE<br>(LIQUID STANDARD)||<br>1kg|1|ORTHO ISOPROPYL PHENOL<br>LIQUID STANDARD|0.950 kg| |||||2|PHOSPHOROUS YELLOW SOLID STANDARD|0.079 kg| |||||of NC.|||

Case No. 22 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name LACTOSE (INDIA) LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

HQ File Number 018205001043AM20
RA File Number 039504001033 AM20
Licence No and<br>Date 0310834414/23/01/2020
Norms Committee Decision:<br>The Committee considered the reply submitted by the firm on DGFT portal and it was observed that as per COA given by the firm for each export item, % Lactulose differs in each<br>export item. Accordingly, the Committee decided to call for following information from the firm:<br>Each export item description with percentage content of Lactulose and export quantity of each export item separately.<br>i.<br>Corresponding import requirement for each export item.

The Committee considered the reply submitted by the firm on DGFT portal and it was observed that as per COA given by the firm for each export item, % Lactulose differs in each export item. Accordingly, the Committee decided to call for following information from the firm:

it was observed that as per COA given by the firm for each export item, % Lactulose differs in each export item. Accordingly, the Committee decided to call for following information from the firm:

Case No. 23 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205001129AM20
RA File Number 039504001078 AM20
Licence No and<br>Date 0310835280/06/03/2020
Norms Committee Decision:<br>The Committee considered the reply furnished by the firm and it was observed that the reply furnished by the firm was not proper. Hence, it was decided to again call for following<br>information from the firm:<br>Commercial value of By-Product Dipentene.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. Case No. 24 / NC/3/MEET/Jan/202122/13 24 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205001140AM20
RA File Number 092404000613 AM20
Licence No and<br>Date 0910068574/13/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms<br>whichever is less:<br> <br>Export product<br>Qty.<br>Propyl Hydroxy Benzonate BP/ Propyl Paraben<br>1 kg<br>RA concerned may take further necessary action as per above decision of NC. under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
Export product Qty. Sl. No. Import items Qty.
Propyl Hydroxy Benzonate BP/ Propyl Paraben 1 kg 1 Parahydroxy Benzoic Acid 0.80 kg
2 N-Propanol 0.347 kg
Case No.<br> 25 / NC/3/MEET/Jan/202122/13
Case Status<br> Case Approved
Party Name<br> SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number<br> 018205001141AM20
RA File Number<br> 092404000614 AM20
Licence No and<br> 0910068575/13/03/2020

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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. 2/82-ALC4/2018 dated 16.05.2018 against advance authorization No. 0910064645 dt. 06.02.2017 , 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 Qty.
Dimethyl Dimethylol Hydantoin Liquid 1 kg 1 5.5 Dimethyl Hydanton White Fine / Crystaline <br>0.37 kg
Powder
Case No. 26 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205001176AM21
RA File Number 052404000007 AM21
Licence No and<br>Date 0510413971/13/04/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:
Sl. No. Export product Qty. Sl. No. Import Items Qty.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

15 0195 NRFN SYRNG PLG
16 Pet Bottle
2 Nurofen For Children Strawberry 1 Number 1 Ibuprofen 2.10 gram
2 Tween 80 (Polysorbate 80) 0.01 gram
3 Glycerine 12.616 gram
4 Lycasin 80/55 (Maltotol) 46.30 gram
5 Sodium Saccharin 40/80 0.20 gram
6 Citric Acid Monohydrate 0.40 gram
7 Tri Sodium Citrate Dihydrate 0.509 gram
8 Xanthan Gum 0.75 gram
9 Sodium Chloride 0.11 gram
11 Domiphen Bromide (BP) 0.01 gram
12 Straw flav KOSHER PHL-142134 0.25 gram
13 987 PP28mm M-LOC H&A White T/E Relevant as per packing<br>policy
14 A001 5ML Syrnge

gram| |||||11|Domiphen Bromide (BP)|0.01 gram| |||||12|Straw flav KOSHER PHL-142134|0.25 gram| |||||13|987 PP28mm M-LOC H&A White T/E|Relevant as per packing<br>policy| |||||14|A001 5ML Syrnge||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

15<br>0195 NRFN SYRNG PLG<br>16<br>Pet Bottle<br>RA concerned may take further necessary action as per above decision of NC. 15 0195 NRFN SYRNG PLG
16 Pet Bottle
Case No. 27 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205001196AM21
RA File Number 052404000013 AM21
Licence No and<br>Date 0510414035/20/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Meropenem Buffered (Bulk Drug / Pharmacopeal Grade)<br>1 kg<br>1<br>(4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-<br>hydroxyethyl]<br>0.8278 kg<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

ay take further necessary action as per above decision of NC.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 28 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name NATURAL AND ESSENTIAL OILS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205001323AM21
RA File Number 072404000051 AM21
Licence No and<br>Date 0710116493/26/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Caffeine<br>51.7 kg<br>2<br>Coffee Extracts<br>35.00 kg<br>1<br>Crude Caffeine (Decaffeination from green coffee) Purity 50.21 %<br>100 kg<br>3<br>Caffeine<br>59.6 kg<br>4<br>Coffee Extracts<br>40.37 kg<br>2<br>Crude Caffeine (Decaffeination from green coffee)Purity 51.96 %<br>100 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 29 / NC/3/MEET/Jan/202122/13

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

above decision of NC.||

Case No. 29 / NC/3/MEET/Jan/202122/13

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case Status Case Status Case Status Case Approved Case Approved Case Approved Case Approved Case Approved Case Approved Case Approved Case Approved Case Approved
Party Name TINA ORGANICS PRIVATE LIMITED
Meeting Number
and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205001602AM21
RA File Number 052404000252 AM21
Licence No and 0510415052/31/08/2020
Date
Norms Committee Decision:
The Committee co nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against
<br>advance authorizat<br>is less: <br>ion No.0510409855 dt. 06.03.2019, 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
Export product Qty. Sl.

decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Export product||||Qty.|Sl. No.||Import items|||Qty.| |<br> <br>TRI XYLENYL PHOSPHATE(ADDITIVE FOR LUBRICATING OIL)<br>1 kg<br>RA concerned may take further necessary action as per above decision of NC.|||||||||||| ||TRI XYLENYL PHOSPHATE(ADDITIVE FOR LUBRICATING OIL)||||1 kg|1||MIXED XYLENOL LIQUID|||0.939 kg| |||||||2||PHOSPHOROUS YELLOW SOLID (P4)|||0.087 kg| |||concerned may take further necessary action as per above decision of NC.|||||||||| ||||||||||||| ||||||||||||| |Ca||se No.|30 / NC/3/MEET/Jan/202122/13||||||||| ||||||||||||| |Ca||se Status|Case Deferred||||||||| |Par||ty Name|SHANKAR NUTRICON PRIVATE LIMITED||||||||| |Meeting Number<br>and Date|||NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022||||||||| ||||||||||||| |HQ File Number|||018205001861AM21||||||||| ||||||||||||| |RA File Number|||562404000032 AM21||||||||| ||||||||||||| |Licence No and|||5610005989/19/11/2020||||||||| ||||||||||||| ||||Signature Not Verified||||||||| |ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>||||||||||||

ty Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>||||||||||||

Case No. 30 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SHANKAR NUTRICON PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205001861AM21
RA File Number 562404000032 AM21
Licence No and 5610005989/19/11/2020

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

Norms Committee Decision:

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

  • i. COA of import item from foreign supplier showing purity and impurity profile.

  • ii. COA of export item showing purity and impurity profile.

  • iii. Whether export item conform to any Pharmaceutical specifications for medicinal use.

  • iv. Please indicate export and import quantity of Soya and Sunflower Lecithin separately in the Advance Authorization.

Case No. Case No. 31 / NC/3/MEET/Jan/202122/13 31 / NC/3/MEET/Jan/202122/13 31 / NC/3/MEET/Jan/202122/13 31 / NC/3/MEET/Jan/202122/13 31 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name NEULAND LABORATORIES LTD.
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205001875AM21
RA File Number 092404000452 AM21
Licence No and<br>Date 0910069497/19/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl.

s per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Ethyl isobutyrate<br>0.78 kg<br>2<br>1-Bromo-5-chloropentane<br>1.10 kg<br>Diethyl-2,2,14,14-tetramethyl-8-oxopentadecanediote<br>(Drug<br>Intermediate of Bempedoic Acid)<br>1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Diethyl-2,2,14,14-tetramethyl-8-oxopentadecanediote<br>(Drug<br>Intermediate of Bempedoic Acid)||<br>1 kg|1|Ethyl isobutyrate|0.78 kg| |||||2|1-Bromo-5-chloropentane|1.10 kg|

Case No. Case No. 31 / NC/3/MEET/Jan/202122/13 31 / NC/3/MEET/Jan/202122/13 31 / NC/3/MEET/Jan/202122/13 31 / NC/3/MEET/Jan/202122/13 31 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name NEULAND LABORATORIES LTD.
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number 018205001875AM21
RA File Number 092404000452 AM21
Licence No and<br>Date 0910069497/19/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl.

s per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Ethyl isobutyrate<br>0.78 kg<br>2<br>1-Bromo-5-chloropentane<br>1.10 kg<br>Diethyl-2,2,14,14-tetramethyl-8-oxopentadecanediote<br>(Drug<br>Intermediate of Bempedoic Acid)<br>1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Diethyl-2,2,14,14-tetramethyl-8-oxopentadecanediote<br>(Drug<br>Intermediate of Bempedoic Acid)||<br>1 kg|1|Ethyl isobutyrate|0.78 kg| |||||2|1-Bromo-5-chloropentane|1.10 kg|

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Toluenesulfonylmethyl isocyanide

3

0.56 kg

Case No. 32 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00076701AM21
RA File Number 03AA04021304 AM21
Licence No and<br>Date 0311001426/04/02/2021
Norms Committee Decision:<br>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.<br>NC/3/MEET/Jul/202122/4 dated 15.07.2021.<br>In view of above, the Committee decided towithdrawthe case.
Case No. 33 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00084155AM21
RA File Number 09AA04004523 AM21
Licence No and<br>Date 0911000350/15/02/2021<br>Si N Vifi
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>gnature ot ered

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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. NC/3/MEET/Jul/202122/4 dated 15.07.2021.

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

Case No. 34 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00103221AM21
RA File Number 07AA04009852 AM21
Licence No and<br>Date 0711000657/15/03/2021
Norms Committee Decision:<br>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.<br>NC/3/MEET/Jul/202122/4 dated 15.07.2021.<br>In view of above, the Committee decided towithdrawthe case.

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. NC/3/MEET/Jul/202122/4 dated 15.07.2021.

ed 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. NC/3/MEET/Jul/202122/4 dated 15.07.2021.

Case No. 35 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name GLOBE CHEMIE
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00116704AM21
RA File Number 31AA04006841 AM21
Licence No and 3111000253/30/03/2021<br>Sintr Nt Vrifid

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date Norms Committee Decision: Deferred for comments of TE.

Dat e
No<br>De rms Committee Decision:
ferred for comments of TE.
Case No. 36 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name MAIVA PHARMA PRIVATE LIMITED
Meeting Number 22122 1 d 211222
and Date NC/ 3/ MEET/ Jan/ 0/ 3 an /0/0
HQ File Number HQRNORM APPLY 00008718AM22
RA File Number 07AA04011194 AM21
Licence No and 1164221
Date 0700089/09/0/0
Norms Committee Decision:<br>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.<br>NC/3/MEET/Jun/202122/2 dated 02.07.2021.<br>In view of above, the Committee decided towithdrawthe case.

ization have already been ratified by NC-3 in its Meeting No.<br>NC/3/MEET/Jun/202122/2 dated 02.07.2021.<br>In view of above, the Committee decided towithdrawthe case.||||||| ||||||||

Case No. 37 / NC/3/MEET/Jan/202122/13
C S C Ad
ase tatus ase pprove
P N CADILA HEALTHCARE LIMITED
arty ame
Mi Nb
eetng umer<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
H Fil Nb HRNORM APPLY 00009477AM22
Q e umer Q
RA File Number 08AA04012364 AM21
Licence No and<br>Date 0811001230/10/04/2021
Norms Committee Decision:<br>Signature Not Verified
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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. NC/3/MEET/Jun/202122/2 dated 02.07.2021.

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

Case No. 38 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00024975AM22
RA File Number 34AA04000433 AM22
Licence No and<br>Date 3411000488/23/04/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 39 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name SAGA LIFESCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00045089AM22
RA File Number 08AA04003764 AM22
Licence No and<br>Date 0811001516/18/05/2021
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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. NC/3/MEET/Jun/202122/2 dated 02.07.2021.

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

Case No. 40 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00046134AM22
RA File Number 13AA04002353 AM22
Licence No and<br>Date 1311000341/19/05/2021
Norms Committee Decision:<br>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.<br>NC/3/MEET/Jun/202122/2 dated 02.07.2021.<br>In view of above, the Committee decided towithdrawthe case.

Advance Authorization have already been ratified by NC-3 in its Meeting No.<br>NC/3/MEET/Jun/202122/2 dated 02.07.2021.<br>In view of above, the Committee decided towithdrawthe case.||

Case No. 41 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00150724AM22<br>Sit Nt Vifid
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>gnaure o ere

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 07AA04019266 AM22
Licence No and<br>Date 0711001603/30/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 42 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BALAJI SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00151178AM22
RA File Number 31AA04001432 AM22
Licence No and<br>Date 3111000494/30/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 43 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name CIPLA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00151180AM22
RA File Number 03AA04012474 AM22
Licence No and<br>Date 0311005772/30/07/2021
Norms Committee Decision:<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

|The Committee co<br>|The Committee co<br>|The Committee co<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for sam

king cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case

2.2021**against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>|nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>| |---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---| |advance authorization No.0310836755 dt. 19.06.2020, 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<br>is less:|||||||||||||||||||||| ||||||||||||||||||||||| ||||||||||||||||||||||| ||||||||||||||||||||||| ||||||||||||||||||||||| ||||||||||||||||||||||| ||||||||||||||||||||||| |||||||||||||||||||It it|||t| ||Sl N|Et dt|||||||||t||||Sl N||||||| ||. o.|xpor prouc|||||||||Qy.||||.

||||||||||||||||||||||| ||||||||||||||||||||||| ||||||||||||||||||||||| ||||||||||||||||||||||| |||||||||||||||||||It it|||t| ||Sl N|Et dt|||||||||t||||Sl N||||||| ||. o.|xpor prouc|||||||||Qy.||||. o.|||mpor ems|||Qy.| ||||||||||||||||||||||| ||1|Telmisartan and A<br>||mlodipine Tablets 40/10mg / Each uncoated tablets<br>|||||||<br> <br>1 Number||||1|||Telmisartan Granules|||68.034 mg| |||contains : Telmisartan 40 mg(Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg Net wt of Telmisartan Granules is 466.805<br>Kgs.Net wt of Amlodipine Besilate is 70.620 Kgs.)|||||||||<br> <br>||||||||||| ||||||||||||||||2|||Amlodipine Besilate|||10.20 mg| ||2|Telmisartan and Amlodipine T||||ablets 80/1||0mg / E||ach uncoated tablets|<br>1 Number||||3|||Telmisartan Granules|||136.07 mg| |||contains : Telmisartan 80||||mg(Telmisa||rtan 80||mg equivalent to|||||||||||| |||<br>Telmisartan granules 134.72m<br>Amlodipine USP 10mg Net w||||<br>g Amlodi<br>t of Telm||<br>pine B<br>isartan||<br>esilate equivalent to<br>ranules is 2517917|<br> <br>||||4|||Am|lodipine Besilate||10.20 mg| ||3|<br>Kgs.

134.72m<br>Amlodipine USP 10mg Net w||||<br>g Amlodi<br>t of Telm||<br>pine B<br>isartan||<br>esilate equivalent to<br>ranules is 2517917|<br> <br>||||4|||Am|lodipine Besilate||10.20 mg| ||3|<br>Kgs. Net wt of Amlodipine Bes||||<br>ilate is 190.||<br>460 K||.<br>)|||||||||||| |||||||||g||.|||||||||||| |||Telmisartan and Amlodipine T<br>contains : Telmisartan 40 mg(T<br>il Tli||||ablets 40/<br>elmisartan<br>l 67||/ E||h td tblt|<br>1 N|b|||5||||||| |||||||||||||||||||Te|lmisartan Granules||68.034 mg| |||||||||mg<br>40 mg<br>36||ac uncoae aes<br>ldii Bil|<br> <br>um|er|||||||||| ||||||||||||||||6||||||| |||||||||||||||||||Am|lodipine Besilate||5.10 mg| |||equvaent to emsartan granues<br>equivalent to Amlodipine USP 5mg Net<br>||||||.mg mopne esate<br>wt of Telmisartan Granules is<br>|||<br>||||||||||| |||1471.142 Kgs. Net wt of Amlodipine Besilate is 111.280 Kgs.)|||||||||||||||||||| ||||||||||||<br>|||||||Telmisartan Granules|||136.07 mg| ||4|Telmisartan and Amlodipine Tablets 80/5mg / Each uncoated tablets<br>|||||||||<br> <br>1 Number||||7||||||| |||conta|ins : Telmisartan 80 mg(Telmisartan 80 mg equivalent to||||||||||||||||||| |||Tl|it l 13472 Aldii Bilt ilt t||||||||||||||||||| |||e|saran granues .mg mopne esae equvaen o||||||||||||||||||| |||Aml|odipine USP 5mg Net wt of Telmisartan Granules is 2517917 Kgs||||||||||||8|||Amlodipine Besilate|||5.10 mg| ||||.

||||||||||||||| |||e|saran granues .mg mopne esae equvaen o||||||||||||||||||| |||Aml|odipine USP 5mg Net wt of Telmisartan Granules is 2517917 Kgs||||||||||||8|||Amlodipine Besilate|||5.10 mg| ||||. .||||||||||||||||||| |||Net|wt of Amlodipine Besilate is 95.230 Kgs.)||||||||||||||||||| ||||||||||||||||||||||| ||||||||||||||||||||||| ||||||||||||||||||||||| ||||Signat|||||||||||||ure Not|||||| ||||<br>|||||||||||||<br>|||||| |ument has been digital|||ly signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Sig<br>Name: Ajay<br>Date: 11-Fe<br>|||||||||||||ned.<br>Kumar( Dep<br>b-2022 16:5<br>|ut<br>5:<br>||||| ||||Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)|||||||||||||AY.DHIMAN<br>GFT(HQ)|||||| ||||||||||||||||||||||| ||||||||||||||||||||||| |||||||||||||||||||||||

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. Case No. 44 / NC/3/MEET/Jan/202122/13 44 / NC/3/MEET/Jan/202122/13 44 / NC/3/MEET/Jan/202122/13 44 / NC/3/MEET/Jan/202122/13 44 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00151772AM22
RA File Number 03AA04042035 AM22
Licence No and<br>Date 0311005777/31/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Fenofibrate Micronized IH/Ph. Eur<br>0.3155 kg<br>2<br>Hypromellose (2910, 3 cps) Ph. Eur<br>0.0625 kg<br>3<br>Docusate Sodium Ph. Eur<br>0.0062 kg<br>4<br>Sucrose Ph. Eur<br>0.3124 kg<br>Fenofibrate Bulk Granulate<br>1 kg
Export product Qty. Sl. No. Import items Qty.
Fenofibrate Bulk Granulate 1 kg 1 Fenofibrate Micronized IH/Ph. Eur 0.3155 kg
2 Hypromellose (2910, 3 cps) Ph. Eur 0.0625 kg
3 Docusate Sodium Ph. Eur 0.0062 kg
4 Sucrose Ph. Eur 0.3124 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

ate Sodium Ph. Eur|0.0062 kg| |||||4|Sucrose Ph. Eur|0.3124 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

5 Sodium Lauril Sulfate Ph. Eur 0.0216 kg
6 Lactose Monohydrate Ph. Eur 0.2804 kg
Case No. 45 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name INDOCO REMEDIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00151775AM22
RA File Number 03AA04057326 AM22
Licence No and<br>Date 0311005778/31/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 46 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name CIPLA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00151854AM22
RA File Number 03AA04012476 AM22

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0311005784/01/08/2021 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. 0310836755 dt. 19.06.2020 , 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:

Licence No and<br>Date Licence No and<br>Date Licence No and<br>Date 0311005784/01/08/2021 0311005784/01/08/2021 0311005784/01/08/2021 0311005784/01/08/2021 0311005784/01/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>advance authorization No.0310836755 dt. 19.06.2020, 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<br>is less: <br>Sl. No.<br>Export product<br>Qty.<br>Sl.

19.06.2020**, 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<br>is less: <br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Telmisartan Granules<br>68.034 mg<br>1<br>Telmisartan and Amlodipine Tablets 40/10mg / Each<br>uncoated tablets contains : Telmisartan 40 mg(Telmisartan 40<br>mg equivalent to Telmisartan granules 67.36mg Amlodipine<br>Besilate equivalent to Amlodipine USP 10mg Net wt of<br>Telmisartan Granules is 1598.453 Kgs. Net wt of Amlodipine<br>Besilate is 241.820 Kgs.)<br>1 Number<br>2<br>Amlodipine Besilate<br>10.20 mg<br>3<br>Telmisartan Granules<br>136.07 mg<br>2<br>Telmisartan and Amlodipine Tablets 80/10mg / Each<br>uncoated tablets contains : Telmisartan 80 mg(Telmisartan 80<br>mg equivalent to Telmisartan granules 134.72mg Amlodipine<br>Besilate equivalent to Amlodipine USP 10mg Net wt of<br>Telmisartan Granules is 8614.670 Kgs. Net wt of Amlodipine<br>Besilate is 651.630 Kgs.)<br>1 Number<br>4<br>Amlodipine Besilate<br>10.20 mg<br>5<br>Telmisartan Granules<br>68.034 mg<br>3<br>Telmisartan and Amlodipine Tablets 40/5mg / Each uncoated<br>tablets contains : Telmisartan 40 mg(Telmisartan 40 mg<br>equivalent to Telmisartan granules 67.36mg Amlodipine<br>Besilate equivalent to Amlodipine USP 5mg Net wt of<br>Telmisartan Granules is 5028.761 Kgs.

contains : Telmisartan 40 mg(Telmisartan 40 mg<br>equivalent to Telmisartan granules 67.36mg Amlodipine<br>Besilate equivalent to Amlodipine USP 5mg Net wt of<br>Telmisartan Granules is 5028.761 Kgs. Net wt of Amlodipine<br>Besilate is 380.385 Kgs.)<br>6<br>Amlodipine Besilate<br>5.10 mg<br>7<br>Telmisartan Granules<br>136.07 mg<br>4<br>Telmisartan and Amlodipine Tablets 80/5mg / Each uncoated<br>tablets contains : Telmisartan 80 mg(Telmisartan 80 mg<br>equivalent to Telmisartan granules 134.72mg Amlodipine<br>Besilate equivalent to Amlodipine USP 5mg Net wt of<br>Telmisartan Granules is 8614.670 Kgs. Net wt of Amlodipine<br>Besilate is 325.815 Kgs.)<br>8<br>Amlodipine Besilate<br>5.10 mg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Telmisartan and Amlodipine Tablets 40/10mg / Each<br>uncoated tablets contains : Telmisartan 40 mg(Telmisartan 40<br>mg equivalent to Telmisartan granules 67.36mg Amlodipine<br>Besilate equivalent to Amlodipine USP 10mg Net wt of<br>Telmisartan Granules is 1598.453 Kgs. Net wt of Amlodipine<br>Besilate is 241.820 Kgs.)||1 Number|1|Telmisartan Granules|68.034 mg| ||||||2|Amlodipine Besilate|10.20 mg| ||2|Telmisartan and Amlodipine Tablets 80/10mg / Each<br>uncoated tablets contains : Telmisartan 80 mg(Telmisartan 80<br>mg equivalent to Telmisartan granules 134.72mg Amlodipine<br>Besilate equivalent to Amlodipine USP 10mg Net wt of<br>Telmisartan Granules is 8614.670 Kgs.

ntains : Telmisartan 80 mg(Telmisartan 80<br>mg equivalent to Telmisartan granules 134.72mg Amlodipine<br>Besilate equivalent to Amlodipine USP 10mg Net wt of<br>Telmisartan Granules is 8614.670 Kgs. Net wt of Amlodipine<br>Besilate is 651.630 Kgs.)||1 Number|3|Telmisartan Granules|136.07 mg| ||||||4|Amlodipine Besilate|10.20 mg| ||3|Telmisartan and Amlodipine Tablets 40/5mg / Each uncoated<br>tablets contains : Telmisartan 40 mg(Telmisartan 40 mg<br>equivalent to Telmisartan granules 67.36mg Amlodipine<br>Besilate equivalent to Amlodipine USP 5mg Net wt of<br>Telmisartan Granules is 5028.761 Kgs. Net wt of Amlodipine<br>Besilate is 380.385 Kgs.)||<br> <br> <br> <br>|5|Telmisartan Granules|68.034 mg| ||||||6|Amlodipine Besilate|5.10 mg| ||4|Telmisartan and Amlodipine Tablets 80/5mg / Each uncoated<br>tablets contains : Telmisartan 80 mg(Telmisartan 80 mg<br>equivalent to Telmisartan granules 134.72mg Amlodipine<br>Besilate equivalent to Amlodipine USP 5mg Net wt of<br>Telmisartan Granules is 8614.670 Kgs. Net wt of Amlodipine<br>Besilate is 325.815 Kgs.)|||7|Telmisartan Granules|136.07 mg| ||||||8|Amlodipine Besilate|5.10 mg|

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 47 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00151855AM22
RA File Number 03AA04054480 AM22
Licence No and<br>Date 0311005785/01/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.4/82-ALC4/2018 dated 19/06/2018against advance<br>authorization No.0310819057 dt. 09.02.2018, 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:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>ERYTHROMYCIN OXIME BASE ALTERNATE NAME (ERYTHROMYCIN<br>A-9 OXIME))<br>1 kg<br>1<br>ERYTHROMYCIN THIOCYANATE 1.20 kg<br>RA concerned may take further necessary action as per above decision of NC.

RYTHROMYCIN OXIME BASE ALTERNATE NAME (ERYTHROMYCIN<br>A-9 OXIME))<br>1 kg<br>1<br>ERYTHROMYCIN THIOCYANATE 1.20 kg<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 47 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00151855AM22
RA File Number 03AA04054480 AM22
Licence No and<br>Date 0311005785/01/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.4/82-ALC4/2018 dated 19/06/2018against advance<br>authorization No.0310819057 dt. 09.02.2018, 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:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>ERYTHROMYCIN OXIME BASE ALTERNATE NAME (ERYTHROMYCIN<br>A-9 OXIME))<br>1 kg<br>1<br>ERYTHROMYCIN THIOCYANATE 1.20 kg<br>RA concerned may take further necessary action as per above decision of NC.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. Case No. Case No. 48 / NC/3/MEET/Jan/202122/13 48 / NC/3/MEET/Jan/202122/13 48 / NC/3/MEET/Jan/202122/13 48 / NC/3/MEET/Jan/202122/13 48 / NC/3/MEET/Jan/202122/13 48 / NC/3/MEET/Jan/202122/13 48 / NC/3/MEET/Jan/202122/13 48 / NC/3/MEET/Jan/202122/13 48 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br> NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
and Date
HQ File Number HQRNORM APPLY 00152486AM22
RA File Number 05AA04061893 AM22
Licence No and<br>Date 0511003964/02/08/2021
Norms Committee Decision:
The Committee co nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12/02/2021against
<br>advance authorizat<br>is less: <br>ion No.0510414103 dt. 04.05.2020, 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
Export product Qty. Sl.

0**, 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||||||||| ||||||||||||| ||||||||||||| |||Export product||||Qty.||Sl. No.|Import items|Qty.|| ||||||||||||| ||||||||||||| |||Brinex / Brine|x-M / Brinarga / Brinera (Brinzolamide Opthalmic Suspension|||<br>1 Vial||1|Brinzolamide|51.00 mg|| |||<br>1Percent) 5ml(|<br>Brinex / Brinex-M / Brinarga / Brinera (Brinzolamide Opthalmic|||<br>|||||| |||Suspension 1P|ercent) 5ml)||||||||| ||||||||||||| ||||||||||||| |RA concerned may|||take further necessary action as per above decision of NC.||||||||| ||||||||||||| |C|ase No.||49 / NC/3/MEET/Jan/202122/13||||||||| |C|ase Status||Case Deferred||||||||| |P|art Name||TOPNOTCH CHEMICALS PVT LTD||||||||| ||y||||||||||| |M<br>a|eeting Number<br>nd Date||NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/20|22|||||||| |HQ File Number|||HQRNORM APPLY 00151931AM22|||||||||

Case No. 49 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name TOPNOTCH CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00151931AM22

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 03AA04052617 AM22
Licence No and<br>Date 0311005794/02/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 50 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00152053AM22
RA File Number 34AA04005925 AM22
Licence No and<br>Date 3411000923/02/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 51 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00152085AM22
RA File Number 34AA04005924 AM22
Licence No and<br>Date 3411000924/02/08/2021
Norms Committee Decision:<br>

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Deferred for comments of TE.

Case No. 52 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SPANSULES FORMULATIONS
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00152429AM22
RA File Number 09AA04008677 AM22
Licence No and<br>Date 0911001300/02/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 53 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name ALKALI METALS LTD.
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00152742AM22
RA File Number 09AA04009415 AM22
Licence No and<br>Date 0911001301/03/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 54 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name MONTAGE LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00153154AM22
RA File Number 08AA04019635 AM22
Licence No and<br>Date 0811002200/03/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2022| |HQ File Number|HQRNORM APPLY 00153154AM22| |RA File Number|08AA04019635 AM22| |Licence No and<br>Date|0811002200/03/08/2021| |Norms Committee Decision:<br>Deferred for comments of TE.||

Case No. 55 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00153334AM22
RA File Number 03AA04058605 AM22
Licence No and<br>Date 0311005851/03/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Molecular formula.<br>i.<br>Structural formula.<br>ii.<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Molecular weight with catalogue of Export Product.

Case No. 56 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00153854AM22
RA File Number 03AA04059410 AM22
Licence No and<br>Date 0311005889/04/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.5/82-ALC4/2018 dated 25/07/2018against advance<br>authorization No.0310816195 dt. 06.10.2017, it was decided to ratify norms under Para 4.07 of HBP Vol.

for same export product in Meeting No.5/82-ALC4/2018 dated 25/07/2018against advance<br>authorization No.0310816195 dt. 06.10.2017, 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:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>SECNIDAZOLE TASTE MASKED PELLETS<br>1 kg<br>1<br>SECNIDAZOLE IH<br>1.01 kg/ kg content in the export product as<br>per DML<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 57 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00154003AM22
RA File Number 34AA04004194 AM22
Licence No and<br>Date 3411000938/04/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 58 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SCAN BIOTECH LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00154224AM22
RA File Number 56AA04003167 AM22
Licence No and<br>Date 5611000412/04/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2022| |HQ File Number|HQRNORM APPLY 00154224AM22| |RA File Number|56AA04003167 AM22| |Licence No and<br>Date|5611000412/04/08/2021| |Norms Committee Decision:<br>Deferred for comments of TE.||

Case No. 59 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00153478AM22<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 03AA04050763 AM22
Licence No and<br>Date 0311005861/04/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 03AA04050763 AM22
Licence No and<br>Date 0311005861/04/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. Case No. Case No. 60 / NC/3/MEET/Jan/202122/13 60 / NC/3/MEET/Jan/202122/13 60 / NC/3/MEET/Jan/202122/13 60 / NC/3/MEET/Jan/202122/13 60 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00153479AM22
RA File Number 03AA04044498 AM22
Licence No and<br>Date 0311005862/04/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Aug/2021/22/7 dated 13/08/2021<br>against advance authorization No.0310832013 dt. 04.10.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>SENTRY POLYOX WSR COAGULANT NF<br>56.8 mg<br>2<br>EASTMAN (TM) CELLULOSE ACETATE (CA 398-<br>10NF/EP)<br>33.12 mg<br>Nifedipine Extended-Release Tablets 30mg. Each tablet<br>contains (i) Sentry Polyox WSR Coagulant NF - 56.80<br>mg((ii) Eastman (TM Cellulose Acetate (CA 398-<br>10NF/EP)- 33.12 mg (iii) SENTRY POLYOX WSR<br>N80 FP NF - 118.40 mg.

lets 30mg. Each tablet<br>contains (i) Sentry Polyox WSR Coagulant NF - 56.80<br>mg((ii) Eastman (TM Cellulose Acetate (CA 398-<br>10NF/EP)- 33.12 mg (iii) SENTRY POLYOX WSR<br>N80 FP NF - 118.40 mg. Net content (i) 864 Kgs<br>1<br>1 Number|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Nifedipine Extended-Release Tablets 30mg. Each tablet<br>contains (i) Sentry Polyox WSR Coagulant NF - 56.80<br>mg((ii) Eastman (TM Cellulose Acetate (CA 398-<br>10NF/EP)- 33.12 mg (iii) SENTRY POLYOX WSR<br>N80 FP NF - 118.40 mg. Net content (i) 864 Kgs||<br> <br> <br>1 Number|1|SENTRY POLYOX WSR COAGULANT NF|56.8 mg| ||||||2|EASTMAN (TM) CELLULOSE ACETATE (CA 398-<br>10NF/EP)|33.12 mg|

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

(ii) 503.80 Kgs (iii) 1801.02 Kgs)<br>3<br>SENTRY POLYOX WSR N80 FP NF<br>118.40 mg<br>4<br>SENTRY POLYOX WSR COAGULANT NF<br>113.60 mg<br>5<br>EASTMAN (TM) CELLULOSE ACETATE (CA 398-<br>10NF/EP)<br>42.32 mg<br>2<br>Nifedipine Extended-Release Tablets 60mg. Each tablet<br>contains (i) Sentry Polyox WSR Coagulant NF - 113.60<br>mg((ii) Eastman (TM Cellulose Acetate (CA 398-<br>10NF/EP)- 42.32 mg (iii) SENTRY POLYOX WSR<br>N80 FP NF - 236.80 mg. Net content (i) 406 Kgs<br>(ii) 151.25 Kgs (iii) 846.31 Kgs)<br>1 Number<br>6<br>SENTRY POLYOX WSR N80 FP NF<br>236.80 mg<br>RA concerned may take further necessary action as per above decision of NC. (ii) 503.80 Kgs (iii) 1801.02 Kgs) 3 SENTRY POLYOX WSR N80 FP NF 118.40 mg
2 Nifedipine Extended-Release Tablets 60mg. Each tablet<br>contains (i) Sentry Polyox WSR Coagulant NF - 113.60<br>mg((ii) Eastman (TM Cellulose Acetate (CA 398-<br>10NF/EP)- 42.32 mg (iii) SENTRY POLYOX WSR<br>N80 FP NF - 236.80 mg. Net content (i) 406 Kgs<br>(ii) 151.25 Kgs (iii) 846.31 Kgs) <br> <br> <br>1 Number 4 SENTRY POLYOX WSR COAGULANT NF 113.60 mg
5 EASTMAN (TM) CELLULOSE ACETATE (CA 398-<br>10NF/EP) 42.32 mg
6 SENTRY POLYOX WSR N80 FP NF 236.80 mg

) 846.31 Kgs)|<br> <br> <br>1 Number|4|SENTRY POLYOX WSR COAGULANT NF|113.60 mg| |||||5|EASTMAN (TM) CELLULOSE ACETATE (CA 398-<br>10NF/EP)|42.32 mg| |||||6|SENTRY POLYOX WSR N80 FP NF|236.80 mg|

Case No. 61 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name STANEX DRUGS AND CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00153599AM22
RA File Number 09AA04003901 AM22
Licence No and<br>Date 0911001307/04/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 62 / NC/3/MEET/Jan/202122/13
Case Status Case Approved<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00153812AM22
RA File Number 08AA04017921 AM22
Licence No and<br>Date 0811002234/04/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl.

s per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>BIVALIRUDIN FOR INJECTION 250 MG/VIAL (5ML VIAL)(EACH VIAL<br>CONTAINS: BIVALIRUDIN 250 MG [IN<br>WHICH ACTIVE INGREDIENT BIVALIRUDIN USED IS 13190.000 GRAMS])<br>1 Number<br>1<br>Bivalirudin<br>275 mg<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 63 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00154532AM22
RA File Number 342404000041 AM21
Licence No and<br>Date 3411000939/05/08/2021<br>Sinature Not Verified
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>g

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Norms Committee Decision: Deferred for comments of TE.

Case No. 64 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00154546AM22
RA File Number 03AA04058773 AM22
Licence No and<br>Date 0311005930/05/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for Personal Hearing before Norms Committee alongwith following information / documents:<br>Production / Consumption data duly certified by GST Authorities.<br>i.
Case No. Case No. Case No. 65 / NC/3/MEET/Jan/202122/13 65 / NC/3/MEET/Jan/202122/13 65 / NC/3/MEET/Jan/202122/13
Case Status Case Rejected
Par ty Name AETHER INDUSTRIES LIMITED
Me<br>and eting Number<br>Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ
File Number HQRNORM APPLY 00154857AM22
RA File Number 52AA04012264 AM22
Lic<br>Dat ence No and<br> 5211001107/05/08/2021
e
No rms Committee Decision:<br>Si N Vifid

umber||HQRNORM APPLY 00154857AM22||| |RA|File Number||52AA04012264 AM22||| ||||||| |Lic<br>Dat|ence No and<br>||5211001107/05/08/2021||| ||e||||| |No|rms Committee Decision:<br>Si||||N Vifid| |ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>gnature ot ere|nt has been digit|ally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2||022.<br>Digitally Signe<br>Name: Aja K<br>gnatu||

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee considered the case as per agenda and it was observed that export product is not specific and too generic in nature. Hence, the Committee decided to reject the case.

Case No. 66 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SHITAL CHEMICAL INDUSTRIES
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00154910AM22
RA File Number 34AA04006318 AM22
Licence No and<br>Date 3411000943/05/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 67 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name EMMENNAR PHARMA PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00155992AM22
RA File Number 26AA04001564 AM21
Licence No and Date 2611000214/06/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Dec/202122/12 dated 17/12/2021<br>against advance authorization No.0911001258 dt. 23.07.2021, it was decided to ratify norms under Para 4.07 of HBP Vol.

xport product in Meeting No.NC/3/MEET/Dec/202122/12 dated 17/12/2021<br>against advance authorization No.0911001258 dt. 23.07.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>|| |ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>PROPIONALDEHYDE<br>1.66 kg<br>2<br>SODIUM CYANIDE<br>1.40 kg<br>3<br>L(+) TARTARIC ACID<br>1.45 kg<br>4<br>METHYLENE DICHLORIDE<br>1.12 kg<br>5<br>ACETONE<br>1.795 kg<br>S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE<br>1 kg<br>6<br>METHANOL<br>1.39 kg<br>RA concerned may take further necessary action as per above decision of NC. Export product Qty. Sl. No. Import items Qty.
S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE 1 kg 1 PROPIONALDEHYDE 1.66 kg
2 SODIUM CYANIDE 1.40 kg
3 L(+) TARTARIC ACID 1.45 kg
4 METHYLENE DICHLORIDE 1.12 kg
5 ACETONE 1.795 kg
6 METHANOL 1.39 kg

HYDROCHLORIDE|1 kg|1|PROPIONALDEHYDE|1.66 kg| ||||2|SODIUM CYANIDE|1.40 kg| ||||3|L(+) TARTARIC ACID|1.45 kg| ||||4|METHYLENE DICHLORIDE|1.12 kg| ||||5|ACETONE|1.795 kg| ||||6|METHANOL|1.39 kg|

Case No. 68 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00155896AM22
RA File Number 03AA04059396 AM22
Licence No and<br>Date 0311005991/06/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.5/82-ALC4/2018 dated 25/07/2018against advance<br>Signature Not Verified
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

authorization No. 0310816195 dt. 06.10.2017 , 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:

DGFT(HQ)

authorization No. 0310816195 dt. 06.10.2017 , 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:

au<br> <br>RA thorization No.0310816195 dt. 06.10.2017, 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: <br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>SECNIDAZOLE TASTE MASKED PELLETS<br>1 kg<br>1<br>SECNIDAZOLE IH<br>1.01 kg/ kg content in the export product as per<br>DML.<br>concerned may take further necessary action as per above decision of NC.
Case No. Case No. Case No. 69 / NC/3/MEET/Jan/202122/13 69 / NC/3/MEET/Jan/202122/13 69 / NC/3/MEET/Jan/202122/13 69 / NC/3/MEET/Jan/202122/13 69 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00157001AM22
RA File Number 07AA04021708 AM22
Licence No and<br>Date 0711001669/09/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jun/202122/2 dated 02/07/2021against<br>advance authorization No.0711000869 dt. 09.04.2021, it was decided to ratify norms under Para 4.07 of HBP Vol.

export product in Meeting No.NC/3/MEET/Jun/202122/2 dated 02/07/2021against<br>advance authorization No.0711000869 dt. 09.04.2021, 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<br>is less:<br> <br>Sl.<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.|||||||| ||Sl.|Export Product||Qty.|Sl. No.|Import items|Qty.|

Case No. Case No. Case No. 69 / NC/3/MEET/Jan/202122/13 69 / NC/3/MEET/Jan/202122/13 69 / NC/3/MEET/Jan/202122/13 69 / NC/3/MEET/Jan/202122/13 69 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00157001AM22
RA File Number 07AA04021708 AM22
Licence No and<br>Date 0711001669/09/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jun/202122/2 dated 02/07/2021against<br>advance authorization No.0711000869 dt. 09.04.2021, 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<br>is less:<br> <br>Sl.<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
Sl. Export Product Qty. Sl. No. Import items Qty.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

No.<br>1<br>Bumetanide Injection USP 0.25mg for mL, 4mL fill in 5mL<br>Vial(Bumetanide filled as bulk drug for 4mL Vial in 5mL Vial and<br>capped with 13mm RFS -V-35 4416/50 GRY SIL3 WESTAR<br>RS/SP02-R/S)<br>540000<br>Numbers<br>1<br>13mm RFS -V-35 4416/50 GRY SIL3<br>WESTAR RS/SP02-R/S<br>Relevant as per packing policy<br>2<br>Bumetanide Injection USP 0.25mg for mL, 10 mL Vial(Bumetanide<br>filled as bulk drug for 10mL Vial and capped with 13mm RFS -V-35<br>4416/50 GRY SIL3 WESTAR RS/SP02-R/S)<br>450000<br>Numbers<br>2<br>13mm RFS -V-35 4416/50 GRY SIL3<br>WESTAR RS/SP02-R/S<br>Relevant as per packing policy<br>3<br>Famotidine Injection USP 10mg for mL, 2 mL Vial(Famotidine<br>filled as bulk drug for 2mL Vial and capped with 13mm RFS -V-35<br>4416/50 GRY SIL3 WESTAR RS/SP02-R/S)<br>540000<br>Numbers<br>3<br>13mm RFS -V-35 4416/50 GRY SIL3<br>WESTAR RS/SP02-R/S<br>Relevant as per packing policy<br>RA concerned may take further necessary action as per above decision of NC. No.
1 Bumetanide Injection USP 0.25mg for mL, 4mL fill in 5mL<br>Vial(Bumetanide filled as bulk drug for 4mL Vial in 5mL Vial and<br>capped with 13mm RFS -V-35 4416/50 GRY SIL3 WESTAR<br>RS/SP02-R/S) <br> <br> <br>540000<br>Numbers 1 13mm RFS -V-35 4416/50 GRY SIL3<br>WESTAR RS/SP02-R/S <br>Relevant as per packing policy

l and<br>capped with 13mm RFS -V-35 4416/50 GRY SIL3 WESTAR<br>RS/SP02-R/S)|<br> <br> <br>540000<br>Numbers|1|13mm RFS -V-35 4416/50 GRY SIL3<br>WESTAR RS/SP02-R/S|<br>Relevant as per packing policy| ||2|Bumetanide Injection USP 0.25mg for mL, 10 mL Vial(Bumetanide<br>filled as bulk drug for 10mL Vial and capped with 13mm RFS -V-35<br>4416/50 GRY SIL3 WESTAR RS/SP02-R/S)|<br> <br>450000<br>Numbers|2|13mm RFS -V-35 4416/50 GRY SIL3<br>WESTAR RS/SP02-R/S|<br>Relevant as per packing policy| ||3|Famotidine Injection USP 10mg for mL, 2 mL Vial(Famotidine<br>filled as bulk drug for 2mL Vial and capped with 13mm RFS -V-35<br>4416/50 GRY SIL3 WESTAR RS/SP02-R/S)|<br> <br>540000<br>Numbers|3|13mm RFS -V-35 4416/50 GRY SIL3<br>WESTAR RS/SP02-R/S|Relevant as per packing policy| ||||||||

Case No. 70 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00157208AM22
RA File Number 03AA04061662 AM22
Licence No and<br>Date 0311006047/09/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for Personal Hearing before Norms Committee alongwith following information / documents:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

i. Production / Consumption data duly certified by GST Authorities.

lly Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

i. Production / Consumption data duly certified by GST Authorities.

Case No. Case No. 71 / NC/3/MEET/Jan/202122/13 71 / NC/3/MEET/Jan/202122/13 71 / NC/3/MEET/Jan/202122/13 71 / NC/3/MEET/Jan/202122/13 71 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00157298AM22
RA File Number 08AA04018596 AM22
Licence No and<br>Date 0811002277/09/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Taxus Baccata<br>1340.00 kg<br>Docetaxel<br>1 kg<br>2<br>1,5-bis[di isopropyl-(+)- 4'-phenyl-2'-azetidinone-3'-hydroxy-silyl]pentane<br>0.888 kg<br>RA concerned may take further necessary action as per above decision of NC. 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,
Export product Qty. Sl. No. Import items Qty.
Docetaxel 1 kg 1 Taxus Baccata 1340.00 kg
2 1,5-bis[di isopropyl-(+)- 4'-phenyl-2'-azetidinone-3'-hydroxy-silyl]pentane 0.888 kg

rm,||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Docetaxel||1 kg|1|Taxus Baccata|1340.00 kg| |||||2|1,5-bis[di isopropyl-(+)- 4'-phenyl-2'-azetidinone-3'-hydroxy-silyl]pentane|0.888 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 72 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00157355AM22
RA File Number 08AA04018916 AM22
Licence No and<br>Date 0811002280/09/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>NALTREXONE HYDROCHLORIDE TABLETS 50 MG(EACH<br>FILM<br>COATED<br>TABLET<br>CONTAINS:<br>NALTREXONE<br>HYDROCHLORIDE PH. EUR. 50 MG [IN WHICH ACTIVE<br>INGREDIENT NALTREXONE HYDROCHLORIDE USED IS<br>135.000 KGS.])<br>1 Number<br>1<br>NALTREXONE HYDROCHLORIDE EP / BP / IP /<br>USP / PH. EUR<br>51.00 mg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 73 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name AARTI DRUGS LIMITED
Meeting Number NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022 Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

and Date
HQ File Number HQRNORM APPLY 00158859AM22
RA File Number 03AA04062552 AM22
Licence No and<br>Date 0311006072/10/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for Personal Hearing before Norms Committee alongwith following information / documents:<br>Production / Consumption data duly certified by GST Authorities.<br>i.
Case No. Case No. 74 / NC/3/MEET/Jan/202122/13 74 / NC/3/MEET/Jan/202122/13 74 / NC/3/MEET/Jan/202122/13 74 / NC/3/MEET/Jan/202122/13 74 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name ADCOCK INGRAM LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00159124AM22
RA File Number 07AA04022482 AM22
Licence No and Date 0711001689/10/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jun/202122/2 dated 02/07/2021against<br>advance authorization No.0711000843 dt. 06.04.2021, 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<br>is less:<br> <br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>DOXYLAMINE SUCCINATE USP /Ph.

.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:<br> <br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>DOXYLAMINE SUCCINATE USP /Ph. Eur<br>Grade<br>306 kg<br>ACURATE<br>TABLETS((Paracetamol<br>450mg+Doxylamine<br>Succinate 5mg+Caffeine 30mg+Codeine Phosphate 10mg+Colour<br>6,00,00,000 Number<br>||||||| ||Export Product||Qty.|Sl. No.|Import items|Qty.| ||ACURATE<br>TABLETS((Paracetamol<br>450mg+Doxylamine<br>Succinate 5mg+Caffeine 30mg+Codeine Phosphate 10mg+Colour||<br> <br>6,00,00,000 Number|1<br>|DOXYLAMINE SUCCINATE USP /Ph. Eur<br>Grade<br>|<br>306 kg|

Signature Not Verified Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Quinoline Yellow 2Mg) (Para -27000.000+Doxy-300.000+Caffeine-<br>1800.000+Codeine-600.000+Colour-120.000Kgs)(No. of<br>Tablets 60000000))<br> <br>RA concerned may take further necessary action as per above decision of NC. Quinoline Yellow 2Mg) (Para -27000.000+Doxy-300.000+Caffeine-<br>1800.000+Codeine-600.000+Colour-120.000Kgs)(No. of<br>Tablets 60000000)) 2 CAFFEINE<br>ANHYDROUS<br>BP2010/USP/EP/PH.EUR/BP <br>1836 kg
3 CODEINE PHOSPHATE BP/USP/EP/PH.EUR 612 kg
4 COLOUR QUINOLINE YELLOW CI 47005<br>(SPECTRACOL) <br>120 kg

r>BP2010/USP/EP/PH.EUR/BP|<br>1836 kg| |---|---|---|---|---|---| ||||3|CODEINE PHOSPHATE BP/USP/EP/PH.EUR|612 kg| ||||4|COLOUR QUINOLINE YELLOW CI 47005<br>(SPECTRACOL)|<br>120 kg| ||||||| |||||||

Case No. 75 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name AMI ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00159245AM22
RA File Number 52AA04010432 AM22
Licence No and<br>Date 5211001134/10/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.6/82-ALC4/2018 dated 26/07/2018against advance<br>authorization No.0310811363 dt. 22.02.2017, 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:<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export Product Qty. Sl. No. Import items Qty.
Propyl Paraben 1 kg 1 Para Hydroxy Benzoic Acid 0.850 kg
Case No. 76 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name MEGHMANI NOVOTECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00160149AM22
RA File Number 08AA04019584 AM22
Licence No and<br>Date 0811002298/11/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2022| |HQ File Number|HQRNORM APPLY 00160149AM22| |RA File Number|08AA04019584 AM22| |Licence No and<br>Date|0811002298/11/08/2021| |Norms Committee Decision:<br>Deferred for comments of TE.||

Case No. 77 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00161177AM22
RA File Number 32AA04016546 AM22

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and<br>Date 3211001412/12/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.10/82-ALC4/2018 dated 16.10.2018against advance<br>authorization No.3210078439 dt. 02.04.2018, 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:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Secondary Butyl Quinoline<br>1 kg<br>1<br>Glycerine<br>2.748 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 78 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name AMI ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00161263AM22
RA File Number 52AA04010591 AM22
Licence No and<br>Date 5211001166/12/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 79 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00161419AM22
RA File Number 03AA04060738 AM22
Licence No and<br>Date 0311006129/13/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No.<br> Case No.<br> 80 / NC/3/MEET/Jan/202122/13 80 / NC/3/MEET/Jan/202122/13 80 / NC/3/MEET/Jan/202122/13 80 / NC/3/MEET/Jan/202122/13 80 / NC/3/MEET/Jan/202122/13
Case Status<br> Case Approved
Party Name<br> CROPNOSYS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number<br> HQRNORM APPLY 00162232AM22
RA File Number<br> 03AA04062018 AM22
Licence No and<br>Date<br> 0311006154/13/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Oct/202122/9 dated 15.10.2021against<br>advance authorization No.0310823957 dt. 24.09.2018 and 0310811611 dt. 03.03.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Export product<br>Qty.<br>**Sl.

dt. 03.03.2017**, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>2-AMINO-3-CHLORO-5-<br>1 kg<br>1<br>2,3-Dichloro-5-Trifluoromethyl Pyridine 98 percent<br>1.20 kg<br>Si N Vifid||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||2-AMINO-3-CHLORO-5-||1 kg|1|2,3-Dichloro-5-Trifluoromethyl Pyridine 98 percent<br>Si N Vifid|1.20 kg| |ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>gnature ot ere|||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

TRIFLUOROMETHYL(TFM) PYRIDINE(SOLID)

Case No. 81 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00163778AM22
RA File Number 07AA04019274 AM22
Licence No and<br>Date 0711001720/16/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 82 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name MILAN LABORATORIES (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00163823AM22
RA File Number 03AA04064805 AM22
Licence No and<br>Date 0311006209/16/08/2021
Norms Committee Decision:<br>Sinature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Deferred for comments of TE.

Case No. 83 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SUNDYOTA NUMANDIS PROBIOCEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00163360AM22
RA File Number 08AA04021121 AM22
Licence No and<br>Date 0811002324/16/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 84 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name MEHK CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00163371AM22
RA File Number 03AA04061020 AM22
Licence No and<br>Date 0311006197/16/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. Case No. 85 / NC/3/MEET/Jan/202122/13 85 / NC/3/MEET/Jan/202122/13 85 / NC/3/MEET/Jan/202122/13 85 / NC/3/MEET/Jan/202122/13 85 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00163767AM22
RA File Number 05AA04069779 AM22
Licence No and<br>Date 0511004139/16/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>advance authorization No.0510413496 dt. 31.01.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>CITRIC ACID<br>0.726 kg<br>2<br>DENATURED ETHYL ALCOHOL<br>0.526 kg<br>TRI ETHYL CITRATE (TEC)(TRI ETHYL CITRATE (TEC)<br>(PACKED IN 400 NOS. OF HM-HDPE DRUMS MADE OF HDPE<br>GRANULES (3,400.000 KGS.

CITRIC ACID<br>0.726 kg<br>2<br>DENATURED ETHYL ALCOHOL<br>0.526 kg<br>TRI ETHYL CITRATE (TEC)(TRI ETHYL CITRATE (TEC)<br>(PACKED IN 400 NOS. OF HM-HDPE DRUMS MADE OF HDPE<br>GRANULES (3,400.000 KGS. WITHOUT WASTAGE)) (EACH<br>DRUM SHALL WEIGHT 8.5 KG AND STORAGE CAPACITY<br>250.000 KGS.)<br>1 kg<br>3<br>HDPE GRANULES (TOTAL WEIGHT =<br>3,570.000 KGS.)<br>Relevant as per packing policy<br>RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||TRI ETHYL CITRATE (TEC)(TRI ETHYL CITRATE (TEC)<br>(PACKED IN 400 NOS. OF HM-HDPE DRUMS MADE OF HDPE<br>GRANULES (3,400.000 KGS. WITHOUT WASTAGE)) (EACH<br>DRUM SHALL WEIGHT 8.5 KG AND STORAGE CAPACITY<br>250.000 KGS.)||1 kg|1|CITRIC ACID|0.726 kg| |||||2|DENATURED ETHYL ALCOHOL|0.526 kg| |||||3|HDPE GRANULES (TOTAL WEIGHT =<br>3,570.000 KGS.)|<br>Relevant as per packing policy| ||||||||

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 86 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00164102AM22
RA File Number 03AA04065031 AM22
Licence No and<br>Date 0311006216/17/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 87 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00164145AM22
RA File Number 34AA04006527 AM22
Licence No and<br>Date 3411000984/17/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 88 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00165816AM22
RA File Number 05AA04070414 AM22
Licence No and<br>Date 0511004197/18/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2022| |HQ File Number|HQRNORM APPLY 00165816AM22| |RA File Number|05AA04070414 AM22| |Licence No and<br>Date|0511004197/18/08/2021| |Norms Committee Decision:<br>Deferred for comments of TE.||

Case No. 89 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00164975AM22
RA File Number 34AA04006491 AM22
Licence No and<br>Date 3411000985/18/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 90 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name ANTILA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00165364AM22<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 08AA04018980 AM22
Licence No and<br>Date 0811002348/18/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 08AA04018980 AM22
Licence No and<br>Date 0811002348/18/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 91 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00165403AM22
RA File Number 05AA04062260 AM22
Licence No and<br>Date 0511004178/18/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 92 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00165623AM22
RA File Number 05AA04070539 AM22
Licence No and<br>Date 0511004189/18/08/2021
Norms Committee Decision:<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

|The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>(for 1 Number,<br>100 ml Bottle)<br>1<br>Ibuprofen<br>2.10 gram<br>2<br>Tween 80 (Polysorbate 80)<br>0.01 gram<br>3<br>Glycerine<br>12.616 gram<br>4<br>Lycasin 80/55 (Maltotol)<br>46.30 gram<br>5<br>Sodium Saccharin 40/80<br>0.20 gram<br>6<br>Citric Acid Monohydrate<br>0.40 gram<br>7<br>Tri Sodium Citrate Dihydrate<br>0.509 gram<br>8<br>Xanthan Gum<br>0.75 gram<br>9<br>Sodium Chloride<br>0.11 gram<br>10<br>Orange flavour<br>0.25 gram<br>11<br>Domiphen Bromide (BP)<br>0.01 gram<br>1<br>Nurofen For Children Orange<br>1 Number|The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl.

agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>(for 1 Number,<br>100 ml Bottle)<br>1<br>Ibuprofen<br>2.10 gram<br>2<br>Tween 80 (Polysorbate 80)<br>0.01 gram<br>3<br>Glycerine<br>12.616 gram<br>4<br>Lycasin 80/55 (Maltotol)<br>46.30 gram<br>5<br>Sodium Saccharin 40/80<br>0.20 gram<br>6<br>Citric Acid Monohydrate<br>0.40 gram<br>7<br>Tri Sodium Citrate Dihydrate<br>0.509 gram<br>8<br>Xanthan Gum<br>0.75 gram<br>9<br>Sodium Chloride<br>0.11 gram<br>10<br>Orange flavour<br>0.25 gram<br>11<br>Domiphen Bromide (BP)<br>0.01 gram<br>1<br>Nurofen For Children Orange<br>1 Number|The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl.

agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>(for 1 Number,<br>100 ml Bottle)<br>1<br>Ibuprofen<br>2.10 gram<br>2<br>Tween 80 (Polysorbate 80)<br>0.01 gram<br>3<br>Glycerine<br>12.616 gram<br>4<br>Lycasin 80/55 (Maltotol)<br>46.30 gram<br>5<br>Sodium Saccharin 40/80<br>0.20 gram<br>6<br>Citric Acid Monohydrate<br>0.40 gram<br>7<br>Tri Sodium Citrate Dihydrate<br>0.509 gram<br>8<br>Xanthan Gum<br>0.75 gram<br>9<br>Sodium Chloride<br>0.11 gram<br>10<br>Orange flavour<br>0.25 gram<br>11<br>Domiphen Bromide (BP)<br>0.01 gram<br>1<br>Nurofen For Children Orange<br>1 Number|The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl.

agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>(for 1 Number,<br>100 ml Bottle)<br>1<br>Ibuprofen<br>2.10 gram<br>2<br>Tween 80 (Polysorbate 80)<br>0.01 gram<br>3<br>Glycerine<br>12.616 gram<br>4<br>Lycasin 80/55 (Maltotol)<br>46.30 gram<br>5<br>Sodium Saccharin 40/80<br>0.20 gram<br>6<br>Citric Acid Monohydrate<br>0.40 gram<br>7<br>Tri Sodium Citrate Dihydrate<br>0.509 gram<br>8<br>Xanthan Gum<br>0.75 gram<br>9<br>Sodium Chloride<br>0.11 gram<br>10<br>Orange flavour<br>0.25 gram<br>11<br>Domiphen Bromide (BP)<br>0.01 gram<br>1<br>Nurofen For Children Orange<br>1 Number|The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl.

agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>(for 1 Number,<br>100 ml Bottle)<br>1<br>Ibuprofen<br>2.10 gram<br>2<br>Tween 80 (Polysorbate 80)<br>0.01 gram<br>3<br>Glycerine<br>12.616 gram<br>4<br>Lycasin 80/55 (Maltotol)<br>46.30 gram<br>5<br>Sodium Saccharin 40/80<br>0.20 gram<br>6<br>Citric Acid Monohydrate<br>0.40 gram<br>7<br>Tri Sodium Citrate Dihydrate<br>0.509 gram<br>8<br>Xanthan Gum<br>0.75 gram<br>9<br>Sodium Chloride<br>0.11 gram<br>10<br>Orange flavour<br>0.25 gram<br>11<br>Domiphen Bromide (BP)<br>0.01 gram<br>1<br>Nurofen For Children Orange<br>1 Number|The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl.

agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>(for 1 Number,<br>100 ml Bottle)<br>1<br>Ibuprofen<br>2.10 gram<br>2<br>Tween 80 (Polysorbate 80)<br>0.01 gram<br>3<br>Glycerine<br>12.616 gram<br>4<br>Lycasin 80/55 (Maltotol)<br>46.30 gram<br>5<br>Sodium Saccharin 40/80<br>0.20 gram<br>6<br>Citric Acid Monohydrate<br>0.40 gram<br>7<br>Tri Sodium Citrate Dihydrate<br>0.509 gram<br>8<br>Xanthan Gum<br>0.75 gram<br>9<br>Sodium Chloride<br>0.11 gram<br>10<br>Orange flavour<br>0.25 gram<br>11<br>Domiphen Bromide (BP)<br>0.01 gram<br>1<br>Nurofen For Children Orange<br>1 Number|The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>(for 1 Number,<br>100 ml Bottle)<br>1<br>Ibuprofen<br>2.10 gram<br>2<br>Tween 80 (Polysorbate 80)<br>0.01 gram<br>3<br>Glycerine<br>12.616 gram<br>4<br>Lycasin 80/55 (Maltotol)<br>46.30 gram<br>5<br>Sodium Saccharin 40/80<br>0.20 gram<br>6<br>Citric Acid Monohydrate<br>0.40 gram<br>7<br>Tri Sodium Citrate Dihydrate<br>0.509 gram<br>8<br>Xanthan Gum<br>0.75 gram<br>9<br>Sodium Chloride<br>0.11 gram<br>10<br>Orange flavour<br>0.25 gram<br>11<br>Domiphen Bromide (BP)<br>0.01 gram<br>1<br>Nurofen For Children Orange<br>1 Number| |---|---|---|---|---|---|---| ||Sl.

<br>Deferred for comments of TE.<br>Sinature Not Verified||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 127 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SUPREET CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00172393AM22
RA File Number 52AA04014297 AM22
Licence No and<br>Date 5211001238/27/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>COA of import item from foreign supplier.<br>i.<br>COA of Export item.<br>ii.<br>Process description.<br>iii.
Case No. 128 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name OSMED FORMULATIONS PVT. LTD.,
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00172452AM22
RA File Number 56AA04003575 AM22
Licence No and<br>Date 5611000465/27/08/2021
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Deferred for comments of TE.

Case No. 129 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name IPCA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00172940AM22
RA File Number 03AA04051423 AM22
Licence No and<br>Date 0311006518/28/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 130 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00173288AM22
RA File Number 03AA04074480 AM22
Licence No and<br>Date 0311006526/29/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for Personal Hearing before Norms Committee alongwith following information / documents:<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

i. Production / Consumption data duly certified by GST Authorities.

Case No. 131 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00173524AM22
RA File Number 09AA04010645 AM22
Licence No and<br>Date 0911001444/30/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 132 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00173574AM22
RA File Number 09AA04010955 AM22
Licence No and<br>Date 0911001455/30/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 133 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BALAJI SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00173361AM22
RA File Number 31AA04025739 AM22
Licence No and<br>Date 3111000553/30/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2022| |HQ File Number|HQRNORM APPLY 00173361AM22| |RA File Number|31AA04025739 AM22| |Licence No and<br>Date|3111000553/30/08/2021| |Norms Committee Decision:<br>Deferred for comments of TE.||

Case No. 134 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00174053AM22
RA File Number 08AA04023464 AM22
Licence No and<br>Date 0811002450/31/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>NALTREXONE<br>HYDROCHLORIDE<br>TABLETS<br>50<br>MG(EACH<br>FILM<br>COATED<br>TABLET<br>CONTAINS:<br>NALTREXONE HYDROCHLORIDE PH. EUR. 50 MG [IN<br>WHICH<br>ACTIVE<br>INGREDIENT<br>NALTREXONE<br>HYDROCHLORIDE USED<br>IS 39.000 KGS.])<br>1 Number<br>1<br>NALTREXONE HYDROCHLORIDE EP / BP / IP / USP / PH.<br>EUR<br>51.00 mg / Tablet<br>RA concerned may take further necessary action as per above decision of NC. Export product Qty. Sl. No. Import items Qty.
NALTREXONE<br>HYDROCHLORIDE<br>TABLETS<br>50<br>MG(EACH<br>FILM<br>COATED<br>TABLET<br>CONTAINS:<br>NALTREXONE HYDROCHLORIDE PH. EUR.

oduct|Qty.|Sl. No.|Import items|Qty.| |---|---|---|---|---|---| ||NALTREXONE<br>HYDROCHLORIDE<br>TABLETS<br>50<br>MG(EACH<br>FILM<br>COATED<br>TABLET<br>CONTAINS:<br>NALTREXONE HYDROCHLORIDE PH. EUR. 50 MG [IN<br>WHICH<br>ACTIVE<br>INGREDIENT<br>NALTREXONE<br>HYDROCHLORIDE USED<br>IS 39.000 KGS.])|<br> <br> <br> <br>1 Number|1|NALTREXONE HYDROCHLORIDE EP / BP / IP / USP / PH.<br>EUR|<br>51.00 mg / Tablet|

Case No. Case No. Case No. 135 / NC/3/MEET/Jan/202122/13 135 / NC/3/MEET/Jan/202122/13 135 / NC/3/MEET/Jan/202122/13 135 / NC/3/MEET/Jan/202122/13 135 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00174577AM22
RA File Number 03AA04066488 AM22
Licence No and<br>Date 0311006599/01/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
Sl.<br>No. Export product Qty. Sl. No.<br> Import items Qty.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

1 Alverine Citrate 120mg Hard Capsules 1 Number 1 Alverine Citrate 122.40 mg / Capsule
2 Alverine Citrate 60mg Hard Capsules 1 Number 2 Alverine Citrate 61.20 mg / Capsule
Case No. 136 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00174578AM22
RA File Number 03AA04066551 AM22
Licence No and<br>Date 0311006600/01/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12/02/2021against<br>advance authorization No.0310835417 dt. 17.03.2020, 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<br>is less:<br>Export Product<br>Qty<br>Sl. No.<br>Import Items<br>Qty<br>MEBEVERINE<br>HYDROCHLORIDE<br>135MG<br>FILM<br>COATED<br>TABLETS<br>1 Number<br>1<br>MEBEVERINE HYDROCHLORIDE<br>137.70 mg<br>

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. Case No. 137 / NC/3/MEET/Jan/202122/13 137 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00174957AM22
RA File Number 31AA04025974 AM22
Licence No and<br>Date 3111000556/01/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Phenol<br>0.72 kg<br>2<br>Methanol<br>0.276 kg<br>Acetyl Anisole (4 Methoxy Acetophenone)<br>1 kg<br>3<br>Acetic Anhydride PURITY 99 Percentage<br>0.755 kg<br>RA concerned may take further necessary action as per above decision of NC. ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
Export product Qty. Sl. No. Import items Qty.
Acetyl Anisole (4 Methoxy Acetophenone) 1 kg 1 Phenol 0.72 kg
2 Methanol 0.276 kg
3 Acetic Anhydride PURITY 99 Percentage 0.755 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

.276 kg| |||||3|Acetic Anhydride PURITY 99 Percentage|0.755 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 138 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00175282AM22
RA File Number 03AA04068130 AM22
Licence No and<br>Date 0311006626/01/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>All excipients should be given in chemical name.<br>i.<br>Details of Packaging Material.<br>ii.<br>Copy of Master Batch Formula for each export item showing Net content of each input in export item and wastage claimed.
Case No. 139 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00175833AM22
RA File Number 34AA04005756 AM22
Licence No and<br>Date 3411001056/02/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 140 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00175852AM22
RA File Number 34AA04006370 AM22
Licence No and<br>Date 3411000952/02/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 141 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BHARAT PARENTERALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00175489AM22
RA File Number 34AA04006862 AM22
Licence No and<br>Date 3411001052/02/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 142 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00176177AM22
RA File Number 03AA04077623 AM22
Licence No and<br>Date 0311006660/03/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No.<br> Case No.<br> 143 / NC/3/MEET/Jan/202122/13 143 / NC/3/MEET/Jan/202122/13 143 / NC/3/MEET/Jan/202122/13 143 / NC/3/MEET/Jan/202122/13 143 / NC/3/MEET/Jan/202122/13
Case Status<br> Case Approved
Party Name<br> HONOUR LAB LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number<br> HQRNORM APPLY 00176303AM22
RA File Number<br> 09AA04010932 AM22
Licence No and<br>Date<br> 0911001485/03/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Glycine Ethyl-Ester Hydro Chloride<br>0.967 kg<br>Gemifloxacin Mesylate<br>1 kg
Export product Qty. Sl. No. Import items Qty.
Gemifloxacin Mesylate 1 kg 1 Glycine Ethyl-Ester Hydro Chloride 0.967 kg

r Hydro Chloride<br>0.967 kg<br>Gemifloxacin Mesylate<br>1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Gemifloxacin Mesylate||1 kg|1|Glycine Ethyl-Ester Hydro Chloride|0.967 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

2 3-Cyano 2,6-Dichloro-5-Fluoro Pyridine (DCFPC) RA concerned may take further necessary action as per above decision of NC.

0.834 kg

Case No. 144 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00176436AM22
RA File Number 09AA04010830 AM22
Licence No and<br>Date 0911001493/03/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Percentage yield on molar basis for each step.<br>i.<br>Production / Consumption data duly certified by GST Authorities.<br>ii.<br>End – use of export item.
Case No. 145 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SV PLASTOCHEM PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022<br>

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

and Date
HQ File Number HQRNORM APPLY 00176504AM22
RA File Number 31AA04025900 AM22
Licence No and<br>Date 3111000564/03/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 146 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name TRANSPEK INDUSTRY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00177367AM22
RA File Number 34AA04006865 AM22
Licence No and<br>Date 3411001062/06/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.1/82-ALC4/2019 dated 03.06.2019against advance<br>authorization No.3410044409 dt. 09.08.2018, 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:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>2-ETHYL HEXANOYL CHLORIDE<br>1 kg<br>1<br>2 ETHYL HEXANOIC ACID<br>0.952 kg<br>RA concerned may take further necessary action as per above decision of NC.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 147 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00177439AM22
RA File Number 09AA04011018 AM22
Licence No and<br>Date 0911001497/06/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 148 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name CADILA HEALTHCARE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00177562AM22
RA File Number 08AA04023793 AM22
Licence No and<br>Date 0811002515/06/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 149 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00177709AM22
RA File Number 05AA04075717 AM22
Licence No and<br>Date 0511004534/06/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Budesonide Suspension For Inhalation , 0.125 mg / ml 2ml<br>Ampoule ) (Each ml contains Budesonide 0.125 mg((Equivalent to<br>0.055 Kg of Bulk Drug))<br>220000 Number<br>1<br>Budesonide<br>0.05775 kg<br>2<br>Budesonide Suspension For Inhalation , 0.25 mg / ml ( 2 ml<br>Ampoule ) (Each ml contains Budesonide 0.250 mg ((Equivalent to<br>2.970 Kg. of Bulk Drug))<br>5940000 Number<br>1<br>Budesonide<br>3.1185 kg<br>3<br>Budesonide Suspension For Inhalation , 0.5 mg / ml ( 2 ml Ampoule<br>) (Each ml contains Budesonide 0.5 mg( (Equivalent to 4.400 Kg. of<br>Bulk Drug) Total Bulk Drug Qty. 7.425 Kg.)<br>4400000 Number<br>1<br>Budesonide<br>4.62 kg<br>RA concerned may take further necessary action as per above decision of NC.

lent to 4.400 Kg. of<br>Bulk Drug) Total Bulk Drug Qty. 7.425 Kg.)<br>4400000 Number<br>1<br>Budesonide<br>4.62 kg<br>RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 150 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00177855AM22
RA File Number 08AA04025507 AM22
Licence No and<br>Date 0811002517/06/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>BIVALIRUDIN FOR INJECTION 250 MG/VIAL (5ML VIAL)(EACH<br>VIAL CONTAINS: BIVALIRUDIN 250 MG [IN WHICH ACTIVE<br>INGREDIENT BIVALIRUDIN USED IS 14705.000 GRAMS])<br>58820 Number<br>1<br>BIVALIRUDIN<br>16175.50 gram<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 151 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SRF LIMITED

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00177945AM22
RA File Number 05AA04070230 AM22
Licence No and<br>Date 0511004557/06/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. Case No. 152 / NC/3/MEET/Jan/202122/13 152 / NC/3/MEET/Jan/202122/13 152 / NC/3/MEET/Jan/202122/13 152 / NC/3/MEET/Jan/202122/13 152 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00177145AM22
RA File Number 08AA04022429 AM22
Licence No and<br>Date 0811002501/06/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>BIVALIRUDIN<br>FOR<br>INJECTION<br>250<br>MG/VIAL<br>(5ML<br>VIAL)(EACH VIAL CONTAINS: BIVALIRUDIN 250 MG<br>[IN WHICH ACTIVE INGREDIENT BIVALIRUDIN USED IS<br>3720.000 GRAMS])<br>14880 Number<br>1<br>BIVALIRUDIN<br>4092.00 gram
Export product Qty. Sl.

L)(EACH VIAL CONTAINS: BIVALIRUDIN 250 MG<br>[IN WHICH ACTIVE INGREDIENT BIVALIRUDIN USED IS<br>3720.000 GRAMS])<br>14880 Number<br>1<br>BIVALIRUDIN<br>4092.00 gram||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||BIVALIRUDIN<br>FOR<br>INJECTION<br>250<br>MG/VIAL<br>(5ML<br>VIAL)(EACH VIAL CONTAINS: BIVALIRUDIN 250 MG<br>[IN WHICH ACTIVE INGREDIENT BIVALIRUDIN USED IS<br>3720.000 GRAMS])||<br> <br>14880 Number|1|BIVALIRUDIN|4092.00 gram|

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 153 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00177182AM22
RA File Number 05AA04076110 AM22
Licence No and<br>Date 0511004515/06/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 154 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00178977AM22
RA File Number 08AA04026034 AM22
Licence No and<br>Date 0811002528/07/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 155 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DORF-KETAL CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00178330AM22
RA File Number 03AA04067379 AM22
Licence No and<br>Date 0311006748/07/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2022| |HQ File Number|HQRNORM APPLY 00178330AM22| |RA File Number|03AA04067379 AM22| |Licence No and<br>Date|0311006748/07/09/2021| |Norms Committee Decision:<br>Deferred for comments of TE.||

Case No. 156 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00178872AM22
RA File Number 34AA04007161 AM22
Licence No and<br>Date 3411001079/07/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 157 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00179282AM22
RA File Number 03AA04080758 AM22
Licence No and<br>Date 0311006784/08/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 158 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00179705AM22
RA File Number 05AA04071036 AM22
Licence No and<br>Date 0511004601/08/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 159 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

and Date
HQ File Number HQRNORM APPLY 00179714AM22
RA File Number 03AA04074695 AM22
Licence No and<br>Date 0311006805/08/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Description of all Excipients shown in items to be imported may be furnished as per their chemical name.<br>i.
Details of Packaging Material may be furnished.<br>ii.
Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.
Case No. Case No. 160 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name EMCURE PHARMACEUTICALS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00179720AM22
RA File Number 31AA04026637 AM22
Licence No and Date 3111000570/08/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.15/82-ALC4/2018 dated 22/03/2019against advance
authorization No.3110067194 dt. 10.10.2018, it was decided to ratify norms under Para 4.07 of HBP Vol.

xport product in Meeting No.15/82-ALC4/2018 dated 22/03/2019against advance||||| |authorization No.3110067194||dt. 10.10.2018, 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.|Import items|Qty.|| ||||No.||||

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

CIPROBIOTIC FORTE [CIPROFLOXACIN<br>TABLETS 500 MG](EACH FILM COATED<br>TABLET<br>CONTAIN<br>:<br>CIPROFLOXACIN<br>HYDROCHLORIDE USP EQUIVALENT TO<br>CIPROFLOXACIN 500 MG [NET WEIGHT<br>2663.25 KG])<br>1 Number<br>1.<br>CIPROFLOXACIN HYDROCHLORIDE<br>USP<br>555.00mg<br> RA concerned may take further necessary action as per above decision of NC. CIPROBIOTIC FORTE [CIPROFLOXACIN<br>TABLETS 500 MG](EACH FILM COATED<br>TABLET<br>CONTAIN<br>:<br>CIPROFLOXACIN<br>HYDROCHLORIDE USP EQUIVALENT TO<br>CIPROFLOXACIN 500 MG [NET WEIGHT<br>2663.25 KG]) <br> <br> <br> <br> <br>1 Number 1. CIPROFLOXACIN HYDROCHLORIDE<br>USP <br>555.00mg
Case No. 161 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00180144AM22
RA File Number 05AA04077131 AM22
Licence No and<br>Date 0511004616/08/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 162 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

HQ File Number HQRNORM APPLY 00180145AM22
RA File Number 05AA04077016 AM22
Licence No and<br>Date 0511004617/08/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 163 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00180146AM22
RA File Number 05AA04073979 AM22
Licence No and<br>Date 0511004618/08/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 164 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name HONOUR LAB LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00180405AM22
RA File Number 09AA04012030 AM22
Licence No and<br>Date 0911001527/09/09/2021<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Norms Committee Decision: Deferred for comments of TE.

Case No. 165 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name REYAANSH HEALTHCARE
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00180436AM22
RA File Number 03AA04081342 AM22
Licence No and
Date 0311006829/09/09/2021
Norms Committee<br> Decision:<br> ing No.NC/3/MEET/Aug/202122/7 dated 13/08/2021against<br>s per details given below or as applied by the firm, whichever
The Committee co<br>d hi nsidered the case as per agenda and taking cue from earlier decision for same export product in Meet<br>N0310826282 dt 10012019i didd if d P 407 f HBP Vl I
avance autorzat<br>is less: on o.. .., t was ece to raty norms uner ara . o o.
Sl. No. Export product Qty. Sl.

9i didd if d P 407 f HBP Vl I|||||||| |avance autorzat<br>is less:|||on o.. ..**, t was ece to raty norms uner ara . o o.|||||||| |||||||||||| |||||||||||| ||Sl. No.|Export product||Qty.|Sl. No.||||Import items|Qty.| ||1|SELAMECTIN(6 PERCENT SPOT ON 0.25 ML TUBE)||100 Number|1||||SELAMECTIN|1.53 gram| ||2|SELAMECTIN(6 PERCENT SPOT ON 0.50 ML||100 Number|1||||SELAMECTIN|3.06 gram| |||TUBE)||||||||| |||||||||||| ||||||||||SELAMECTIN|4.59 gram| ||3|SEL|AMECTIN(6 PERCENT SPOT ON 0.75 ML|100 Number|1|||||| |||<br>TU|<br>BE)|||||||| |||||||||||| ||||||||||SELAMECTIN<br>ifid|6.12 gram| ||4|SE|AMECTIN(6 PERCENT SPOT ON 1 ML TUBE)|100 Number|1|||||| |||||Si|N|||||| ||||gnature ot|||||ere||| |||||||||y Director )<br>21<br>@GOV.IN||| |ument has been digital|||ly signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 11-Feb-2022 16:55:<br>Reason: AJAY.DHIMAN88|||||||| |Location: DGFT||||||(HQ|)|||| ||||||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

5 SELAMECTIN(6 PERCENT SPOT ON 2 ML TUBE) 100 Number 1 SELAMECTIN 12.24 gram
6 SELAMECTIN(6 PERCENT SPOT ON 4 ML TUBE) 100 Number 1 SELAMECTIN 24.48 gram

ECTIN(6|PERCENT SPOT ON|2|ML TUBE)|100|Number|1|SELAMECTIN|12.24|gram| |---|---|---|---|---|---|---|---|---|---|---| |6|SELAMECTIN(6|PERCENT SPOT ON|4|ML TUBE)|100|Number|1|SELAMECTIN|24.48|gram|

Case No. 166 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00181385AM22
RA File Number 08AA04024263 AM22
Licence No and<br>Date 0811002550/10/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 167 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BIOMATRIX HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00181484AM22
RA File Number 08AA04023562 AM22

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0811002557/10/09/2021 Date Norms Committee Decision: Deferred for comments of TE.

Case No. 168 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00181607AM22
RA File Number 05AA04061713 AM22
Licence No and<br>Date 0511004657/10/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 169 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00181671AM22
RA File Number 34AA04006805 AM22
Licence No and<br>Date 3411001099/10/09/2021
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Deferred for comments of TE.

Case No. 170 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00181768AM22
RA File Number 03AA04010926 AM22
Licence No and<br>Date 0311006852/10/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Description of all Excipients shown in items to be imported may be furnished as per their chemical name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.
Case No. 171 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name CROPNOSYS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00182220AM22
RA File Number 03AA04081999 AM22
Licence No and<br>Date 0311006854/11/09/2021<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Oct/202122/9 dated 15.10.2021 against advance authorization No. 0310823957 dt. 24.09.2018 and 0310811611 dt. 03.03.2017 , 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 Qty.
2-Amino-3-Chloro-5-Trifluoromethyl(TFM) Pyridine 1 kg 1 2,3-Dichloro-5-Trifluoromethyl Pyridine 98 Percent min 1.20 kg
Case No. 172 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00183041AM22
RA File Number 03AA04090257 AM22
Licence No and<br>Date 0311006909/13/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No. 173 / NC/3/MEET/Jan/202122/13

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

for comments of TE.||

Case No. 173 / NC/3/MEET/Jan/202122/13

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case Status Case Status Case Approved Case Approved Case Approved Case Approved Case Approved
Party Name INDOCO REMEDIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00183067AM22
RA File Number 03AA04085131 AM22
Licence No and<br>Date 0311006912/13/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Oct/202122/9 dated 15/10/2021against<br>advance authorization No.0310837582 dt. 10.08.2020, 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<br>is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Ciprofloxacin HCL<br>18.1125.kg<br>2<br>Dexamethasone<br>5.5125 kg<br>3<br>Ear Drop Bottle<br>Relevant as per packing policy<br>4<br>Ear Drop Caps<br>Relevant as per packing policy<br>Ciprofloxacin and Dexamethasone Suspension USP ( 0.3 / 0.1<br>percentage ) 7.5ml Bottle.((Each ml Contains: CIPROFLOXACIN<br>HYDROCHLORIDE EQU TO CIPROFLOXACIN BASE 3mg and<br>DEXAMETHASONE 1mg per bottle of 7.5ml) (Each 7.5 ml Contains:<br>Ciprofloxacin 22.5mg & Dexamethasone 7.5 mg) Net wt.

ml Contains: CIPROFLOXACIN<br>HYDROCHLORIDE EQU TO CIPROFLOXACIN BASE 3mg and<br>DEXAMETHASONE 1mg per bottle of 7.5ml) (Each 7.5 ml Contains:<br>Ciprofloxacin 22.5mg & Dexamethasone 7.5 mg) Net wt. Ciprofloxacin<br>HCL 15.750kgs & Dexamethasone 5.250kgs)<br>700000<br>Number<br>5<br>Ear Drop Insert<br>Relevant as per packing policy<br> <br>RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin and Dexamethasone Suspension USP ( 0.3 / 0.1<br>percentage ) 7.5ml Bottle.((Each ml Contains: CIPROFLOXACIN<br>HYDROCHLORIDE EQU TO CIPROFLOXACIN BASE 3mg and<br>DEXAMETHASONE 1mg per bottle of 7.5ml) (Each 7.5 ml Contains:<br>Ciprofloxacin 22.5mg & Dexamethasone 7.5 mg) Net wt. Ciprofloxacin<br>HCL 15.750kgs & Dexamethasone 5.250kgs)||<br> <br> <br> <br> <br>700000<br>Number|1|Ciprofloxacin HCL|18.1125.kg| |||||2|Dexamethasone|5.5125 kg| |||||3|Ear Drop Bottle|Relevant as per packing policy| |||||4|Ear Drop Caps|Relevant as per packing policy| |||||5|Ear Drop Insert|Relevant as per packing policy| ||||||||

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 174 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00183913AM22
RA File Number 05AA04078246 AM22
Licence No and<br>Date 0511004729/14/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 175 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00184798AM22
RA File Number 03AA04091486 AM22
Licence No and<br>Date 0311007000/15/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for Personal Hearing before Norms Committee alongwith following information / documents:<br>Production / Consumption data duly certified by GST Authorities.<br>i.

Case No. 176 / NC/3/MEET/Jan/202122/13

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Authorities.**<br>i.||

Case No. 176 / NC/3/MEET/Jan/202122/13

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case Status Case Deferred
Party Name DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00184161AM22
RA File Number 34AA04007354 AM22
Licence No and<br>Date 3411001111/15/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 177 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00184484AM22
RA File Number 05AA04076999 AM22
Licence No and<br>Date 0511004742/15/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 178 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name CUCKOS PHARMACEUTICAL PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

HQ File Number HQRNORM APPLY 00184568AM22
RA File Number 33AA04006480 AM22
Licence No and<br>Date 3311000430/15/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
HQ File Number HQRNORM APPLY 00184568AM22
RA File Number 33AA04006480 AM22
Licence No and<br>Date 3311000430/15/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 179 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00184658AM22
RA File Number 05AA04081685 AM22
Licence No and<br>Date 0511004757/15/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 180 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00184742AM22
RA File Number 05AA04079139 AM22
Licence No and<br>Date 0511004763/15/09/2021<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Norms Committee Decision: Deferred for comments of TE.

ed~~||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Norms Committee Decision: Deferred for comments of TE.

Case No. 181 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SANOFI INDIA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00185047AM22
RA File Number 03AA04082679 AM22
Licence No and<br>Date 0311007007/16/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 182 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00185161AM22
RA File Number 13AA04016708 AM22
Licence No and<br>Date 1311000571/16/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 183 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00185253AM22
RA File Number 34AA04007093 AM22
Licence No and<br>Date 3411001118/16/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.5/82-ALC4/2020 dated 09/10/2020against advance<br>authorization No.3410045821 dt. 28.01.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Benfotiamine<br>1 kg<br>1<br>Thiamine Mononitrate<br>0.922 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

==> picture [738 x 68] intentionally omitted <==

----- Start of picture text -----<br> Case No. 184 / NC/3/MEET/Jan/202122/13<br>Case Status Case Deferred<br>Party Name BALAJI SPECIALITY CHEMICALS PRIVATE LIMITED<br>Meeting Number NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022<br>Signature Not Verified<br>----- End of picture text -----<br>

ferred<br>Party Name BALAJI SPECIALITY CHEMICALS PRIVATE LIMITED<br>Meeting Number NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022<br>Signature Not Verified<br>----- End of picture text -----<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

and Date
HQ File Number HQRNORM APPLY 00185282AM22
RA File Number 31AA04026965 AM22
Licence No and<br>Date 3111000573/16/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 185 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00185767AM22
RA File Number 03AA04011760 AM22
Licence No and<br>Date 0311007030/16/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 186 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00186512AM22
RA File Number 09AA04012487 AM22
Licence No and 0911001571/17/09/2021<br>

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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/Sep/202122/8 dated 24/09/2021 against advance authorization No. 0910068744 dt. 12.05.2020 , 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 Aztreonam for Injection USP 1 Gram(( Contains <br>1 Number 1 Aztreonam and Arginine 1.10 gram / vial
a blend of Sterile Aztreonam 56 percent and
Arginine 44 percent ))
2 Aztreonam for Injection USP 500 mg(( Contains <br>1 Number 2 Aztreonam and Arginine 0.55 gram / vial
a blend of Sterile Aztreonam 56 percent and
Arginine 44 percent ))
Case No. 187 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name VINEET LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00186138AM22
RA File Number 09AA04014031 AM22
Licence No and<br>Date 0911001559/17/09/2021
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Deferred for comments of TE.

Case No. 188 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name SANOFI INDIA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00186395AM22
RA File Number 03AA04094137 AM22
Licence No and<br>Date 0311007049/17/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 189 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name GANGWAL CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00187865AM22
RA File Number 03AA04083531 AM22
Licence No and<br>Date 0311007077/20/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 190 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00187904AM22
RA File Number 08AA04029099 AM22
Licence No and<br>Date 0811002644/20/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2022| |HQ File Number|HQRNORM APPLY 00187904AM22| |RA File Number|08AA04029099 AM22| |Licence No and<br>Date|0811002644/20/09/2021| |Norms Committee Decision:<br>Deferred for comments of TE.||

Case No. 191 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00187990AM22
RA File Number 07AA04024759 AM22
Licence No and<br>Date 0711001935/20/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 192 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00188549AM22
RA File Number 31AA04024656 AM22
Licence No and<br>Date 3111000586/20/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No.<br> Case No.<br> 193 / NC/3/MEET/Jan/202122/13 193 / NC/3/MEET/Jan/202122/13 193 / NC/3/MEET/Jan/202122/13 193 / NC/3/MEET/Jan/202122/13 193 / NC/3/MEET/Jan/202122/13
Case Status<br> Case Approved
Party Name<br> CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number<br> HQRNORM APPLY 00188559AM22
RA File Number<br> 31AA04027260 AM22
Licence No and<br>Date<br> 3111000588/20/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Phenol<br>0.93 kg<br>Guaiacol<br>1 kg
Export product Qty. Sl. No. Import items Qty.
Guaiacol 1 kg 1 Phenol 0.93 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

2 Methanol 0.36 kg
3 Hydrogen Peroxide PURITY 60 Percentage 0.687 kg
Acetone (Solvent) 0.09 kg
4<br>Acetone (Solvent) 4 Acetone (Solvent)
Case No. 194 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name RUSAN PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00188589AM22
RA File Number 03AA04091430 AM22
Licence No and<br>Date 0311007109/20/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:<br>
Sl. No. Export product Qty. Sl. No. Import items Qty.
1 ENOXAPARIN SODIUM INJECTION BP 40 MG 0.4 ML PRE- 1 Number 1 ENOXAPARIN SODIUM 44.00 mg
FILLED SYRINGE (RUPARIN 40) (BP/EP/USP)

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

2 ENOXAPARIN SODIUM INJECTION BP 60 MG 0.6 ML PRE- 1 Number 2 ENOXAPARIN SODIUM 66.00 mg
FILLED SYRINGE (RUPARIN 60) (BP/EP/USP)
Case No. 195 / NC/3/MEET/Jan/202122/13
Case Status Case Rejected
Party Name ASOJ SOFT CAPS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00190573AM22
RA File Number 34AA04007764 AM22
Licence No and<br>Date 3411001147/22/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that one of the import items namelyFish Oil (30 percentage) 18:12) (Fish Lipid Oil)having ITC HS Code –<br>15042020, which comes under Chapter 15 and as per para 4.11 (a) (i) of theFTP 2015-20<br> , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import<br>on self- declaration basis under para 4.07 of the FTP.<br>In view of above, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

lf- declaration basis under para 4.07 of the FTP.<br>In view of above, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.|||

The Committee considered the case as per agenda and it was observed that one of the import items namely Fish Oil (30 percentage) 18:12) (Fish Lipid Oil) having ITC HS Code – 15042020, which comes under Chapter 15 and as per para 4.11 (a) (i) of the FTP 2015-20 , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self- declaration basis under para 4.07 of the FTP.

Case No. 196 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name ASOJ SOFT CAPS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00190578AM22
RA File Number 34AA04007816 AM22
Licence No and<br>Date 3411001148/22/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 197 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00190805AM22
RA File Number 04AA04015436 AM22
Licence No and<br>Date 0411001511/22/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/01/2022| |HQ File Number|HQRNORM APPLY 00190805AM22| |RA File Number|04AA04015436 AM22| |Licence No and<br>Date|0411001511/22/09/2021| |Norms Committee Decision:<br>Deferred for comments of TE.||

Case No. 198 / NC/3/MEET/Jan/202122/13
Case Status Case Approved
Party Name NATCO PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00190278AM22<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 11-Feb-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 11-Feb-2022 16:55:21<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number RA File Number RA File Number 09AA04011759 AM22 09AA04011759 AM22
Licence No and<br>Date 0911001583/22/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms<br>whichever is less:<br> <br>Sl.

ce No and<br>Date|||0911001583/22/09/2021||||| |Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms<br>whichever is less:<br> <br>Sl. No.<br>Export product<br>Qty.<br>1<br>NITROGLYCERIN SUBLINGUAL TABLETS USP 0.3 mg<br>Each Tablet contains Nitroglycerin USP 0.3 mg (2x1,80,000<br>=3,60,000 Tablets)(Raw Material)<br>1 Number Tablet<br>2<br>NITROGLYCERIN SUBLINGUAL TABLETS USP 0.4mg,<br>Each Tablet contains Nitroglycerin USP 0.4mg<br>(5x12,00,000=60,00,000 Tablets)(Raw Material)<br>1 Number Tablet<br>RA concerned may take further necessary action as per above decision of NC.|||||under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|NITROGLYCERIN SUBLINGUAL TABLETS USP 0.3 mg<br>Each Tablet contains Nitroglycerin USP 0.3 mg (2x1,80,000<br>=3,60,000 Tablets)(Raw Material)||<br> <br>1 Number Tablet|1|DILUTED NITROGLYCERIN USP 1.95 percent|15.70 mg| ||||||2|Glyceryl Monosterate (Imwitor 491 powder)|1.60 mg| ||2|NITROGLYCERIN SUBLINGUAL TABLETS USP 0.4mg,<br>Each Tablet contains Nitroglycerin USP 0.4mg<br>(5x12,00,000=60,00,000 Tablets)(Raw Material)||<br>1 Number Tablet|3|DILUTED NITROGLYCERIN USP 1.95 percent|20.93 mg| ||||||4|Glyceryl Monosterate (Imwitor 491 powder)|1.60 mg| |||||||||

0.4mg<br>(5x12,00,000=60,00,000 Tablets)(Raw Material)||<br>1 Number Tablet|3|DILUTED NITROGLYCERIN USP 1.95 percent|20.93 mg| ||||||4|Glyceryl Monosterate (Imwitor 491 powder)|1.60 mg| |||||||||

Case No. 199 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name INDO AMINES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00191007AM22
RA File Number 03AA040103017 AM22
Licence No and 0311007156/23/09/2021

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 11-Feb-2022 16:55:21 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date Norms Committee Decision: Deferred for comments of TE.

Case No. 200 / NC/3/MEET/Jan/202122/13
Case Status Case Deferred
Party Name GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202122/ 13 and 21/01/2022
HQ File Number HQRNORM APPLY 00191008AM22
RA File Number 03AA040103051 AM22
Licence No and<br>Date 0311007157/23/09/2021
Norms Committee Deci

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