IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2026-06-22

DGFT Committee Minutes

Document text

1 Government of India / भारत सरकार Ministry of Commerce and Industry / वाणिज्य और उद्योग मंत्रालय Department of Commerce / वाणिज्‍य विभाग Directorate General of Foreign Trade, Delhi / विदेश व्यापार महानिदेशालय, दिल्ली VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वाणिज्य भवन, अकबर रोड, नई दिल्ली

(DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Jun/202627/4 DATED: 22/06/2026

Minutes of the Norms Committee–3 Meeting NC/3/MEET/Jun/202627/4 dated 22/06/2026 under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of the Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under Chapter 29 and 30. 2. The following members were present in the Meeting:-

Sl. No. Name & Designation Department 1 Shri Dinesh Narain Mathur, Technical Expert Consultant (Pharma) 2 Shri Shaish Kumar, Technical Expert Consultant (Chemical) 3 Shri Raman Kumar, Joint DGFT DGFT (HQ) 4 Smt. Skina Rani, FTDO DGFT (HQ) 3. The Norms Committee has taken decisions only with respect to technical aspect/ UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

2 wastage aspect/ wastage norms. While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure, including those in notifications, public notices and policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularisation of the case. 4. RAs shall ensure compliance with SION, General Notes and Chapter Notes wherever applicable. 5. RAs shall also ensure that authorization is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard, full compliance with the provisions of Para 4.12 of FTP, Para 4.16, Para 4.21, and Para 4.51 of HBP shall be made. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

3 Case Details and Decision(s): Case No. 1 / NC/3/MEET/Jun/202627/4 Case Status Case Rejected Party Name AUROBINDO PHARMA LTD Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00000124AM26 RA File Number NA Licence No and Date NA Norms Committee Decision: The representative of the firm appeared for the personal hearing and requested the fixation of norms in respect of Advance Authorisation No. 0910069488 dated 17/11/2020. The Norms Committee observed that the present application had been submitted under Para 4.06 of the HBP for the fixation of norms for the aforesaid authorisation, which was issued under Para 4.07 of the HBP.

After detailed deliberation, the Committee decided to close the present application and call for a report from the concerned RA regarding the reasons for the non-fixation of norms in respect of Advance Authorisation No. 0910069488 dated 17/11/2020. The RA was further requested to furnish details of the imports and exports undertaken under the said authorisation to facilitate further examination of the matter.

Case No. 2 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name SIGACHI INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00000805AM27 RA File Number NA Licence No and Date NA Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Copy of Drug Manufacturing Licence (DML) showing approved composition of export item. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Case No. 3 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name SIGACHI INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00000806AM27 RA File Number NA Licence No and Date NA Norms Committee Decision:

The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Copy of Drug Manufacturing Licence (DML) showing approved composition of export item.

Case No. 4 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name AGROCEL INDUSTRIES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001050AM27 RA File Number NA Licence No and Date NA Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Complete chemistry, chemical reaction, Stichometric balance on molar basis with molecular weight and percentage yield for each step of reaction. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Case No. 5 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name AGROCEL INDUSTRIES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001054AM27 RA File Number NA Licence No and Date NA Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Complete chemistry, chemical reaction, Stichometric balance on molar basis with molecular weight and percentage yield for each step of reaction.

Case No. 6 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name AGROCEL INDUSTRIES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001067AM27 RA File Number NA Licence No and Date NA Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Complete chemistry, chemical reaction, Stichometric balance on molar basis with molecular weight and percentage yield for each step of reaction. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Case No. 7 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name ORIENTAL AROMATICS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001217AM27 RA File Number NA Licence No and Date NA Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Percentage purity of import and export item with Certificate of Analysis (CoA). 1. Molecular weight of import and export and percentage yield of conversion. 2.

Case No. 8 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name LINCOLN PHARMACEUTICALS LTD Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001324AM27 RA File Number NA Licence No and Date NA Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Description of export product not matching with Drug Manufacturing Licence (DML). Norms can not be fixed in its present form. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Case No. 9 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name BIOLOGICAL E. LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00005879AM25 RA File Number NA Licence No and Date NA Norms Committee Decision: The case is under consideration, and the Technical Expert of DBT was requested to expedite his comments.

Case No. 10 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name PUROGENE LABS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00006919AM25 RA File Number NA Licence No and Date NA Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 2-Thiouracil 0.57 kg. 2 Diglyme 0.57 kg. Rilpivirine Hydrochloride (RIN-I) Intermediate 1 kg. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

8 3 Tetra Hydro Furan 0.48 kg. 4 Methanol(Solvent) 6.23 kg. 5 Caustic Soda Lye 48% 0.82 kg. 6 4-Iodo-2, 6-Dimethyl Benzenamine 1.29 kg.

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

Case No. 11 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name HONOUR LAB LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00003500AM26 RA File Number 092404000369 AM19 Licence No and Date 0910066835/13/11/2018 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 N,N-Dimethyl Formamide (DMF) 0.25 kg. 2 Hexamethyl disilazane 0.730 kg. (1R, 2S, 5R)-2-Isopropyl-5- methylcyclohexyl (2R, 5S)-5-(4- amino-2-oxopyrimidin-1(2H)- yl)-1,3-oxathiolane-2- 1 kg. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

9 3 Cytosine 0.478 kg. carboxylate 4 Triphosgene 0.500 kg.

Note:

The above norms are for regularisation and closure purposes only. 1. The Regional Authority (RA) shall not issue any further Authorisations on the basis of the above-mentioned norms on repeat basis. 2.

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

Case No. 12 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name HONOUR LAB LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00003501AM26 RA File Number 092404000534 AM19 Licence No and Date 0910067129/04/02/2019 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 N,N-Dimethyl Formamide (DMF) 0.25 kg. (1R, 2S, 5R)-2-Isopropyl-5- methylcyclohexyl (2R, 5S)-5-(4- 1 kg. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

10 2 Hexamethyl disilazane 0.730 kg. 3 Cytosine 0.478 kg. amino-2-oxopyrimidin-1(2H)- yl)-1,3-oxathiolane-2- carboxylate 4 Triphosgene 0.500 kg.

Note: The above norms are for regularisation and closure purposes only. I. The Regional Authority (RA) shall not issue any further Authorisations on the basis of the above-mentioned norms on repeat basis. II.

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

Case No. 13 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ALPHAMED FORMULATIONS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00006048AM26 RA File Number 092404000605 AM20 Licence No and Date 0910068804/27/05/2020 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jan/202021/4 dated 12/02/2021
against advance authorization No. 0910067120 dated 31/01/2019, it was decided to fix ad-hoc 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 Item Qty. allowed. Ulsanic 1G Effervescent Tablets Sucralfate (Aluminium 1 Number 1 1.02 gm. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

11 (Each Tablet Contains -1000 mg of Sucralfate ) Sucrose Sulphate with Aluminium Assay 18.8% and LOD 11.4%)

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

Case No. 14 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name LAZERHEAD LIFESCIENCES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00004743AM26 RA File Number 09AA04012424 AM22 Licence No and Date 0911001950/26/11/2021 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Ovaplant 250 mcg (Salmon Gonadotropin Releasing Hormone Analogue Implant) 18706 Numbers 1 Salmon Gonadorelin 4.723 gm. Ovaprime 10 ml. Vial 20 mcg/ml (Salmon Gonadotropin Releasing Hormone Analogue Implant) 37976 Numbers 2 Salmon Gonadorelin 7.671 gm.

RA concerned may take further necessary action as per above decision of NC.
UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Case No. 15 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name STERLING AUXILIARIES PVT LTD Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00005178AM25 RA File Number 03AX04002204 AM23 Licence No and Date 0311016388/15/07/2022 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Manufacturing process and complete chemistry with material balance.

Case No. 16 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00002872AM26 RA File Number 03AX04002399 AM23 Licence No and Date 0311017082/10/08/2022 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Master-Batch formula for each export product.

UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

13 Case No. 17 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name LOZEN PHARMA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00008339AM24 RA File Number 03AX04004941 AM24 Licence No and Date 0311030679/05/02/2024 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 Isomalt 4821.68 mg. Soothing Throat pops or Pops (Each Pop Contains 4821.68 Mg of Isomalt, 45 mg Wellmune Dispersible Powder & 58.82 mg of Acerola ) (Net Content of Isomalt - 18750 kgs, of Wellmune Dispersible Powder - 174.991 kgs & of Acerola - 228.733 Kgs) 1 Number 2 Wellmune Dispersible Powder 45.00 mg. 3 Isomalt 2092.50 mg. Soothing Throat lozenges or Soothing Throat Drops or Lozenges or Drops (Each Lozenges Contains 3072 Mg of Isomalt & 27 mg of Wellmune Dispersible Powder) (Net Content of Isomalt - 109250 kgs & Wellmune Dispersible Powder - 960.205 Kgs) 1 Number 4 Wellmune Dispersible Powder 25.00 mg. Cough Drops or Cough Lozenges or Lozenges or Drops (Each Lozenges Contains 3072 1 Number 5 Isomalt 1334.13 mg UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

14 Mg of Isomalt) (Net Content of Isomalt - 22000 kgs)) 6 Elderberry Dry Extract Cough Relief Lozenges or Lozenges (Each Lozenges Contains 81.43 mg of Elderberry Extract & 10 Mg of Ivy Leaf Extract) (Net Content of Elderberry Extract - 1000 kgs & Ivy Leaf Extract - 122.085 kgs) 1 Number 7 Ivy Leaf Extract Not recommended, No Master Batch Formula given.

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

Case No. 18 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name PIRAMAL PHARMA LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00006320AM25 RA File Number 03AX04005442 AM24 Licence No and Date 0311031542/27/02/2024 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Vibegron (Gemtesa) Vibegron 1 Number 1 77.187 mg./Tablet UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

15 Tablets 75 mg (Average Potency 99.11%)

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

Case No. 19 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name SALVI CHEMICAL INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00009169AM24 RA File Number 03AX04005784 AM24 Licence No and Date 0311032244/16/03/2024 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Sodium Iron EDTA 1 kg. 1 EDTA Acid 0.73 kg.

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

Case No. 20 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name SALVI CHEMICAL INDUSTRIES LIMITED UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

16 Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00009206AM24 RA File Number 03AX04005785 AM24 Licence No and Date 0311032328/19/03/2024 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. N-IODO SUCCINIMIDE 1 kg. 1 IODINE 0.74 kg.

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

Case No. 21 / NC/3/MEET/Jun/202627/4 Case Status Case Rejected Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002626AM25 RA File Number 05AX04001408 AM25 Licence No and Date 0511027294/21/08/2024 Norms Committee Decision: The Committee considered the application of the firm. It was observed that the firm had not furnished the specific information sought by the Committee during its meetings held on 27/03/2025 and 18/12/2025. In view of the non-submission of the requisite information, the Committee decided to reject the firm's application.

Case No. 22 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name BHAGWATI ORGANICS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00003824AM25 RA File Number 08AX04001178 AM25 Licence No and Date 0811012998/23/10/2024 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 Tri Ethyl Ortho Formate 1.21 kg. 2 Cyanoacetamide 0.74 kg. 3 Morpholine 0.767 kg. 3-Amino-Pyrazole Carboxamidehemisulfate / (5- AminoPyrazole-4-Carboxamide Hemisulph 1 kg. 4 Hydrazine Hydrate 80% 0.480 kg.

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

Case No. 23 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00004214AM25 RA File Number 05AX04002700 AM25 Licence No and 0511029003/19/11/2024 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

18 Date Norms Committee Decision: The Representative of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of the Representative of the firm, and after due deliberation, the Committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm or as applied, whichever is less:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 Nepafenac (Micronized) 5.1 mg. Nepafenac Ophthalmic Suspension, 0.1% w/v Sterile Eye Drops, 5ml ( (Each ml contains Nepafenac 1.0 mg (Equivalent to 625.000 Gram of Bulk Drug) 1 Number 2 1 Litre Polyelite El Powder Transfer Sterile Full Flat Ferrule Bag 4s 01elir Drawing No. Sffb1ir Hosokawa (Expo) (Packaging) Deleted

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

Case No. 24 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name BVC SPECIALITIES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00004279AM25 RA File Number 34AX04000704 AM25 Licence No and Date 3411005693/21/11/2024 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Copy of Purchase Order. 1. Copy of Shipping Bills. 2.

Case No. 25 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name DECCAN NUTRACEUTICALS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00006138AM26 RA File Number 02AX04000733 AM25 Licence No and Date 0211008274/05/03/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Nalbuphine Hydrochloride 1 kg. 1 Noroxymorphone Base 1.067 kg.

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

Case No. 26 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name VIJAYASRI ORGANICS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00000053AM26 RA File Number 09AX04001141 AM25 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

20 Licence No and Date 0911009349/02/04/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Apr/202627/2 dated 28/04/2026 against advance authorization No.0911008760 dated 06/01/2025, it was decided to fix ad-hoc 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. allowed. 1 Methyl Iso Butyryl Acetate (MIBA)(Liquid) 7150.0 kg. 2 (4R,CIS)-1,1-Dimethylethyl- 6-Cyano Methyl-2,2- Dimethyl-1,3-Dioxane-4- Acetate(Solid) 5830.0 kg. 3 Tri Ethyl Amine (TEA)(Liquid) 2420.0 kg. 4 Aniline Oil(Liquid) 4400.0 kg. 5 Methylene Chloride (MDC)(Liquid) 14080.0 kg. 6 Fluorobenzene (Liquid) 4950.0 kg. 7 Acetone (Liquid) 4730.0 kg. Tert-Butyl 2-((4R,6R)-6- (2-(2-(4-fluorophenyl)-5- isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H- pyrrol-1-yl)ethyl)-2,2- dimethyl-1,3- dioxane-4-yl)acetate (ATV-1) CAS No.125971-95-1) 11000 Kg. 8 Iso Propyl Alcohol (IPA) (Liquid) 27500.0 kg.

RA concerned may take further necessary action as per above decision of NC-III. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Case No. 27 / NC/3/MEET/Jun/202627/4 Case Status Case Rejected Party Name MANKIND PHARMA LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00006715AM26 RA File Number 05AX04004491 AM25 Licence No and Date 0511031702/02/04/2025 Norms Committee Decision: The Committee considered the firm’s request for review of the ad hoc norms. However, it was observed that the norms given are based on the approved composition in the Drug Manufacturing Licence and wastage as per SION. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

Case No. 28 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name DECCAN NUTRACEUTICALS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00006139AM26 RA File Number 02AX04000021 AM26 Licence No and Date 0211008522/15/04/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Naltrexone Hydrochloride 1 kg. 1 Noroxymorphone Base 1.136 kg. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

22 USP/PH.EUR

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

Case No. 29 / NC/3/MEET/Jun/202627/4 Case Status Case Rejected Party Name JUBILANT GENERICS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00006347AM26 RA File Number 05AX04000079 AM26 Licence No and Date 0511031904/15/04/2025 Norms Committee Decision: The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that the firm had not furnished any additional technical justification or supporting information for the proposed enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

Case No. 30 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name NATURAL AND ESSENTIAL OILS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00000320AM26 RA File Number 07AX04000087 AM26 Licence No and Date 0711014206/17/04/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Copy of Shipping Bills 1. Copy of Bill of Entry 2. Certificate of Analysis (CoA) of import items. 3.

Case No. 31 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00000379AM26 RA File Number 07AX04000114 AM26 Licence No and Date 0711014238/22/04/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Ascorbic Acid BP/Ascorbic Acid Ph.Eur/Ascorbic Acid USP / Ascorbic Acid 50 MT 1 Sodium Ascorbate 35.0 MT

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

Case No. 32 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name VEKO CARE PRIVATE LIMITED UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

24 Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00000562AM26 RA File Number 03AX04000465 AM26 Licence No and Date 0311043463/01/05/2025 Norms Committee Decision: The Committee considered the case as per agenda and it is observed that details given by the firm are confusing. Hence, it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case along with relevant information / documents from the firm.

Case No. 33 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name MATRIX LIFE SCIENCE PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00000609AM26 RA File Number 03AX04000503 AM26 Licence No and Date 0311043518/05/05/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 Fatty Acid Distillate / Deodorised Distillate 6.13 kg. Tocopheryl Acetate 405 IU Powder 1 kg. 2 Heptane - S 2.50 kg.

RA concerned may take further necessary action as per above decision of NC. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Case No. 34 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name HETERO LABS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001326AM26 RA File Number 09AX04000229 AM26 Licence No and Date 0911009779/06/06/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 Methyl((S)-1-(2s,5s)-2-(9-(2-((2s,4s)-4- (Methoxymethyl) Pyrrolidin-2-Yl) 1himidazol-5-Yl)1,11- Dihydroisochromeno (4,3:6,7) Naphtho (1,2-D) Imidazol-2-Yl)5- Methylpyrrolidin-1-Yl)-3- Methyl-1-Oxobutan-2-Yl) Carbamate) 0.51 kg. Velpatasvir Copovidone Premix (Containing NLT 50% Velpatasvir) 1 kg. 2 Acetic Acid Ethenyl Ester Polymer with 1-Ethenyl-2-Pyrrolidine, 1- Vinyl-2-Pyrrolidone Polymer with Vinyl Acetate (Copovidone)) 0.51 kg.

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

Case No. 35 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name APITORIA PHARMA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001359AM26 RA File Number 09AX04000237 AM26 Licence No and Date 0911009784/06/06/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 N-Boc Tp Butanoic Acid (or) (R)-3- (tertbutoxycarbonylamino)-4-(2,4,5- trifluorophenyl) butanoic acid 0.81 kg. Sitagliptin Phosphate Anhydrous 1 kg. 2 Methanol (Methyl Alcohol) 5.25 kg.

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

Case No. 36 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name AETHER INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001424AM26 RA File Number 52AX04000071 AM26 Licence No and Date 5211014068/10/06/2025 Norms Committee Decision: UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

27 The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
Complete and balanced chemical reactions with molecular weight and percentage yield on molar basis. 1. Material balance for each step. 2. Requirement and recovery of solvent at each step. 3.

Case No. 37 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name BRAWN LABORATORIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001508AM26 RA File Number 05AX04000958 AM26 Licence No and Date 0511033337/16/06/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Ciprofloxacin Tablets 250 mg (Off White, Elongated, Biconvex, Film Coated Tablet,Scored On One Side) 1 Number 1 Ciprofloxacin Hydrochloride USP (Faintly Yellowish To Light Yellow Crystals) 283.06 mg. Ciprofloxacin Tablets 500 mg (Off White, Elongated, Biconvex, Film Coated Tablet, Ciprofloxacin Hydrochloride USP (Faintly Yellowish To 1 Number 2 566.12 mg. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

28 Scored On One Side) Light Yellow Crystals)

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

Case No. 38 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name AETHER INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001515AM26 RA File Number 52AX04000087 AM26 Licence No and Date 5211014419/16/06/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Complete and balanced chemical reactions w v ith molecular weight and percentage yield on molar basis. I. Material balance for each step. II. Requirement and recovery of solvent at each step. III.

Case No. 39 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name APITORIA PHARMA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001520AM26 RA File Number 09AX04000282 AM26 Licence No and Date 0911009831/16/06/2025 Norms Committee Decision: UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

29 The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 N-BOC TP Butanoic Acid (or) (R)-3- (tertbutoxycarbonylamino) -4- (2,4,5-trifluorophenyl) butanoic acid) 0.81 kg. Sitagliptin Phosphate Anhydrous 1 kg. 2 Methanol (Methyl Alcohol) 5.25 kg.

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

Case No. 40 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001605AM26 RA File Number 07AX04000327 AM26 Licence No and Date 0711014809/20/06/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

30 Calcium Gluconate (EP For Injection EP/Ph.Eur/JP/USP/BP/Powder) 1 kg. 1 Calcium Gluconate 1.09 kg. Calcium Borogluconate 1 kg. 2 Calcium Gluconate 0.913 kg. Calcium Glubionate (For Injection) / Calcium Glubionate 1 kg. 3 Calcium Gluconate 0.43 kg.

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

Case No. 41 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001647AM26 RA File Number 07AX04000518 AM26 Licence No and Date 0711014819/24/06/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
Complete and balanced chemical reaction showing molecular weight, percentage yield on molar basis. 1. By-product recovery and its commercial value. 2. Past Production/consumption data certified by Chartered Accountant. 3.

Case No. 42 / NC/3/MEET/Jun/202627/4 Case Status Case Rejected Party Name SARNA CHEMICALS PRIVATE LIMITED UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

31 Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM REVIW00006460AM26 RA File Number 52AX04000098 AM26 Licence No and Date 5211014633/25/06/2025 Norms Committee Decision: The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that the firm had not furnished any additional technical justification or supporting information for the proposed enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

Case No. 43 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name SYNERGIA SCIENCES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00001757AM26 RA File Number 03AX04001477 AM26 Licence No and Date 0311045174/27/06/2025 Norms Committee Decision: The Representative of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of the Representative of the firm, and after due deliberation it was directed to firm to furnish the following information/documents for further consideration:- Quantity of export made from import item No. 1 and 3 with documentary evidence along with Copy of Shipping Bills and Bill of Entry. 1. Quanty of export made from import item no. 2 and 3 for this particular licence with statement. 2.

Case No. 44 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name FRESENIUS KABI INDIA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

32 HQ File Number HQRNORM APPLY 00002450AM26 RA File Number 31AX04000204 AM26 Licence No and Date 3111005148/01/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 L-ALANINE EP 1.89 gm. Aminowel 5% Infusion 250 ml 1 Number 2 GLYCINE EP IP 0.919 gm

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

Case No. 45 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name ROOPA INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002459AM26 RA File Number 09AX04000324 AM26 Licence No and Date 0911010165/01/08/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
Complete chemistry, chemical reaction, stichometric balance on molar basis with mol weight 1. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

33 and percentage yield for each step of reaction Recovery of solvent if any 2. How to arrive at the quanty of import asked on the basis of above details? 3.

Case No. 46 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002478AM26 RA File Number 09AX04000480 AM26 Licence No and Date 0911010173/04/08/2025 Norms Committee Decision: : The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 Liraglutide (API- (Water content 6.4% and NA 1.80%) = 8.2% %) 19.8 mg. 2 3.0 ml. Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ-Fill Nexa VB 3mL) Relevant, as per Packing Policy and General Notes with accountability BD Vystr Disposable Pen Body Subassembly with Blue Colour Dose Button (VYSTRA BSA FR PL 284C BTN 284C Pinsubet 6 mg. /ml. PEN 1X2'S (ORBI-CIP-GB)- Liraglutide Injection 18 mg/3 mL (6 mg/mL)((Each 3 mL contains Liraglutide 18 Mg) 1 Number 3 Relevant, as per Packing Policy and General Notes. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

34 30IU) 4 BD Vystra Disposable Pen Printed Cartridge Holder (Vystra Cartridge Holder Printed 0.6-15) Relevant, as per Packing Policy and General Notes with accountability 5 BD Vystra Disposable Pen Cap (Vystra Cap Pl Modern 284C Relevant, as per Packing Policy and General Notes with accountability. 6 Liraglutide (API- (Water content 6.4% and NA 1.80% ) = 8.2 % %) 19.8 mg. 7 3.0 mL Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ-Fill Nexa VB 3mL) Relevant, as per Packing Policy and General Notes with accountability. 8 BD Vystr Disposable Pen Body Subassembly with Blue Colour Dose Button(VYSTRA BSA FR PL 284C BTN 284C 30IU) Relevant, as per Packing Policy and General Notes with accountability. 9 BD Vystra Disposable Pen Printed Cartridge Holder (Vystra Cartridge Holder Printed 0.6-15) Relevant, as per Packing Policy and General Notes with accountability. BD Vystra Disposable Pen Relevant, as per Pinsubet 6 mg / ml. PEN 1X3'S ORBI-CIP-GB)- Liraglutide Injection 18 mg/3 mL (6 mg/mL)((Each 3 mL contains Liraglutide 18 Mg) 1 Number 10 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

35 Cap (Vystra Cap Pl Modern 284C Packing Policy and General Notes with accountability.

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

Case No. 47 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002479AM26 RA File Number 09AX04000481 AM26 Licence No and Date 0911010174/04/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 Liraglutide (API- (Water content 6.4% and NA 1.80% ) = 8.2%%) 19.8 mg. 2 3.0 ml Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ- Fill Nexa VB 3ml) Relevant, as per Packing Policy and General Notes with accountability. PLAOBES 6 mg / ml Pen Liraglutide Injection 18 mg /3 ml. (6 mg/ml) ((Each 3 ml contains Liraglutide 18 Mg) Fill Volume- 3.3 ml. 1 Number UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

36 3 BD Vystra Disposable Pen Body Subassembly with Dose Button (VYSTRA BSA FR PL 284C BTN 2685C 50 IU) Relevant, as per Packing Policy and General Notes with accountability. 4 BD Vystra Disposable Pen Printed Cartridge Holder (Vystra Cartridge Holderprinted 0.6-15) Relevant, as per Packing Policy and General Notes with accountability. 5 BD Vystra Disposable Pen Cap (Vystra CAP PL Modern 284C) Relevant, as per Packing Policy and General Notes with accountability.

Note: NC also recommended to make a new SION for the export product.

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

Case No. 48 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002480AM26 RA File Number 09AX04000482 AM26 Licence No and Date 0911010175/04/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

37 Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 Liraglutide (API- (Water content 6.4% and NA 1.80%) = 8.2%%) 19.8 mg. 2 3.0 ml Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ- Fill Nexa VB 3ml) Relevant, as per Packing Policy and General Notes with accountability. 3 BD Vystra Disposable Pen Body Subassembly with Dose Button (VYSTRA BSA FR PL 284C BTN 2685C 50 IU) Relevant, as per Packing Policy and General Notes with accountability. 4 BD Vystra Disposable Pen Printed Cartridge Holder (Vystra Cartridge Holderprinted 0.6-15) Relevant, as per Packing Policy and General Notes with accountability PLAOBES 6 mg / ml Pen Liraglutide Injection 18 mg /3 ml. (6 mg/ml) ((Each 3 ml contains Liraglutide 18 Mg) Fill Volume- 3.3 ml. 1 Number 5 BD Vystra Disposable Pen Cap (Vystra CAP PL Modern 284C) Relevant, as per Packing Policy and General Notes with accountability.

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

Case No. 49 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name TOPNOTCH CHEMICALS PVT LTD Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002482AM26 RA File Number 03AX04002282 AM26 Licence No and Date 0311046218/04/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202627/3 dated 26/05/2026
against advance authorization No.0311045608 dated 11/07/2025 , it was decided to fix ad-hoc 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. allowed. Artemether 1 kg. 1 Artemisinin 1.04 kg.

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

Case No. 50 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name TOPNOTCH CHEMICALS PVT LTD Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002483AM26 RA File Number 03AX04002260 AM26 Licence No and Date 0311046219/04/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

39 same export product/import item in meeting No.NC/3/MEET/May/202627/3 dated 26/05/2026
against advance authorization No.0311046034 dated 29/07/2025 , it was decided to fix ad-hoc 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. allowed. 1 9H FLUORENE 0.814 kg. 2 Di N Butylamine 0.390 kg. 3 Sodium Borohydride 0.040 kg. 4 Para Chloro Benzaldehyde 0.336 kg. Lumefantrine 1 kg. 5 Di Methyl Formamide 0.555 kg.

Note: NC also recommended to make a new SION for the export product.

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

Case No. 51 / NC/3/MEET/Jun/202627/4 Case Status Case Rejected Party Name ETERNIS FINE CHEMICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002493AM26 RA File Number 03AX04001543 AM26 Licence No and Date 0311046232/04/08/2025 Norms Committee Decision: UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

40 The firm was initially granted an Advance Authorisation for the export product “Etambernis” under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023, products falling under the category of perfume or perfumery compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to be processed under Para 4.06 of the HBP. It was observed that the firm obtained the authorisation by misdeclaring that its application was covered under the provisions of Para 4.07, and has not furnished any technical justification/information for the export product. Accordingly, the Committee found no merit in fixing the norms and decided to reject the application. The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs duty along with interest. Further, the RA should also submit a report on how this authorisation was issued under Para 4.07 of HBP, to the Chairperson of the Norms Committee and to PC-4 Section, DGFT Headquarters. The RA concerned may take further necessary action in line with the above decision of the Committee.

Case No. 52 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name BELCHEM INDUSTRIES (INDIA) PVT LTD Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002495AM26 RA File Number 03AX04002280 AM26 Licence No and Date 0311046235/04/08/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
Complete chemistry, chemical reaction, stochiametric balance on molar basis with molecular weight and percentage yield for each step of reaction. 1.

41 Case No. 53 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name ASENCE PHARMA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002497AM26 RA File Number 34AX04000416 AM26 Licence No and Date 3411006808/04/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case along with following information / documents from the firm: Whether export item is sterile. 1. What is the difference between import and export item when both are showing as EP grade. 2. Step-wise process and technical justification for each step of manufacturing process. 3.

Case No. 54 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002503AM26 RA File Number 03AX04002077 AM26 Licence No and Date 0311046266/05/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Sl. No. Export Product Quantity Medical cream Gel & Ointment (Nitroglycerin Ointment USP 2% 1 gm (Box of 48 SACHET) Wt: 960.00 Kgs (Net Cont: Nitroglycerin on Lactose 1 1 Number UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

42 192 Kgs, Pharmalan USP 336 Kgs)) 2 Medical cream Gel & Ointment (Nitroglycerin Ointment USP 2% 30 gm Tube Wt: 780.00 Kgs (Net Cont: Nitroglycerin on Lactose 156 Kgs, Pharmalan USP 273 Kgs) 1 Number

Sl. No. Import Product Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 2% wastage. 2 Relevant Excipients Net content in the export product plus 2% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy & General Notes. Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption. i.

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

Case No. 55 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002506AM26 RA File Number 03AX04002255 AM26 Licence No and Date 0311046271/05/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202526/3 dated 04/06/2025
UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

43 against advance authorization No.0311038037 dated 17/10/2024 , it was decided to fix ad-hoc 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 Item Qty. allowed. Diclofenac Gel 3% 25g (DOFIDAZ) (Net Wt. of Sodium Hyaluronate is 12.10 Kgs.) 1 Number 1 Sodium Hyaluronate 1.61 gm.

Soliker 30 mg/g gel 90 gm ES / Diclofenac Gel 3% 90g (Net Wt. of Sodium Hyaluronate is 3.27 Kgs.) 1 Number 2 Sodium Hyaluronate 1.62 gm. Diclofenac Gel 3% 50g DE (Net Wt. of Sodium Hyaluronate is 1.82 Kgs.) 1 Number 3 Sodium Hyaluronate 1.62 gm. Soliker 30 mg/g gel 60 gms ES 60g / Diclofenac Gel 3% 60g (Net Wt. of Sodium Hyaluronate is 2.18 Kgs.) 1 Number 4 Sodium Hyaluronate 8.41 gm.

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

Case No. 56 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ASHISH LIFE SCIENCE PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002516AM26 RA File Number 03AX04002241 AM26 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

44 Licence No and Date 0311046286/05/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Feb/202425/17 dated 25/02/2026 against advance authorization No. 0311024513 dated 13/06/2023, it was decided to fix ad-hoc 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. allowed. Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50 mg) 50 ml vial ((Net content of exempted material is 1346.072 Kgs 30100 nos)) 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50 mg) 100 ml vial ((Net content of exempted material is 3765.424 Kgs 42100 nos)) 1 Number 2 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50 mg) 250 ml vial ((Net content of exempted material is 1878.24 Kgs 8400 nos)) 1 Number 3 PROPYLENE GLYCOL 197.60 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50 mg) 500 ml vial ((Net content of exempted material is 2683.2 Kgs 6000 nos)) 1 Number 4 PROPYLENE GLYCOL 395.20 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 50ml vial ((Net content of exempted material is 1283.464 Kgs 30100 Nos)) 1 Number 5 PROPYLENE GLYCOL 35.256 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 100ml vial ((Net content of exempted material is 5125.328 Kgs 60100 Nos)) 1 Number 6 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 250 ml vial ((Net content of exempted material is 3198 Kgs 15000 1 Number 7 PROPYLENE GLYCOL 176.28 gm/Vial UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

45 Nos)) PAN Ashoxy 3% (Oxytetracycline Injection 30 mg) 100 ml vial ((Net content of exempted material is 2566.928 Kgs 30100 Nos)) 1 Number 8 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200 mg) 50 ml vial ((Net content of exempted material IS 281.74 KGS & 30100 NOS)) 1 Number 9 PROPYLENE GLYCOL 9.00 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200 mg) 100 ml vial ((Net content of exempted materials is 563.72 kgs 30100 nos)) 1 Number 10 PROPYLENE GLYCOL 18.00 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200 mg) 250 ml vial ((Net content of exempted material is 1408.68 kgs 30100 nos)) 1 Number 11 PROPYLENE GLYCOL 45.00 gm/Vial Ashiver 1% (Ivermectin 10 Mg Injection) 10 ml vial ((Net content of exempted material is 306.7792 Kgs 30100 Nos)) 1 Number 12 PROPYLENE GLYCOL 10.40 gm/Vial Ashiver 1% (Ivermectin 10 Mg Injection) 50 ml vial ((Net content of exempted material is 1905.904 Kgs 37400 Nos)) 1 Number 13 PROPYLENE GLYCOL 52.00 gm/Vial Ashiver 1% (Ivermectin 10 Mg Injection) 100ml vial ((Net content of exempted material is 6431.152 Kgs 63100 Nos)) 1 Number 14 PROPYLENE GLYCOL 104.00 gm/Vial Ashiver 1% (Ivermectin 10 Mg Injection) 250 ml vial ((Net content of exempted material is 3822 Kgs 15000 Nos)) 1 Number 15 PROPYLENE GLYCOL 260.00 gm/Vial Ashiver 1% (Ivermectin 10 Mg Injection) 500 ml vial ((Net content of exempted material is 3051.36 Kgs 6000 Nos)) 1 Number 16 PROPYLENE GLYCOL 520.00 gm/Vial UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

46 Ashiver Forte (Ivermectin 10 mg and Clorsulon 100 mg Injection) 50 ml vial ((Net content of exempted material is 1543.287 Kgs 30100 nos)) 1 Number 17 PROPYLENE GLYCOL 50.96 gm/Vial Ashiver Forte (Ivermectin 10 mg and Clorsulon 100 mg Injection) 100 ml vial ((Net content of exempted material is 3099.096 Kgs 30100 nos)) 1 Number 18 PROPYLENE GLYCOL 101.92 gm/Vial Ashienro 10% (Enrofloxacin Injection 100 mg) 50 ml vial ((Net content of exempted material is 156.52 Kgs 30100 Nos)) 1 Number 19 PROPYLENE GLYCOL 5.20 gm/Vial Ashienro 10% (Enrofloxacin Injection 100mg) 100 ml vial ((Net content of exempted material is 313.04 Kgs 30100 Nos)) 1 Number 20 PROPYLENE GLYCOL 10.40 gm/Vial Ashienro 10% (Enrofloxacin Injection 100 mg) 250 ml vial ((Net content of exempted material is 782.6 Kgs 30100 Nos)) 1 Number 21 PROPYLENE GLYCOL 26.00 gm/Vial Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200 mg) 50 ml vial ((Net content of exempted material is 313.04 Kgs 30100 nos)) 1 Number 22 PROPYLENE GLYCOL 10.40 gm/Vial Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200 mg) 100 ml vial ((Net content of exempted material is 938.08 Kgs 40100 nos) 1 Number 23 PROPYLENE GLYCOL 20.80 gm/Vial Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200 mg) 250 ml vial ((Net content of exempted material is 785.2 Kgs 15100 nos)) 1 Number 24 PROPYLENE GLYCOL 52.00 gm/Vial Ashityl 5% (Tylosin Tartrate injection eq to Tylosin 50 mg) 50 ml vial ((Net 1 Number 25 PROPYLENE GLYCOL 10.40 gm/Vial UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

47 content of exempted material is 313.04 Kgs 30100 nos)) Ashital 10% (Closantel 10% Inj) 100 ml vial ((Net content of exempted material is 1659.112 Kgs 30100 Nos)) 1 Number 26 PROPYLENE GLYCOL 55.12 gm/Vial

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

Case No. 57 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name MICRO LABS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002522AM26 RA File Number 07AX04000835 AM26 Licence No and Date 0711015275/05/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Apr/202425/2 dated 30/04/2024
against advance authorization No.0711008352 dated 22/06/2023, it was decided to fix ad-hoc 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. allowed. Bromocriptin Tablets 2.5 mg.

1 Number 1 Bromocriptin Mesylate BP/EP/IP/USP 2.924 mg. RA concerned may take further necessary action as per above decision of NC.

Case No. 58 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002535AM26 RA File Number 03AX04002299 AM26 Licence No and Date 0311046328/06/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance authorization No. 0311037113 dated 12/09/2024, it was decided to fix ad-hoc 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. allowed. Ciclopirox Gel 0.77percent (Pack 30 gms) (Net wt. of Ciclopirox USP is 20.790 Kgs.) 1 Number 1 Ciclopirox USP 235.62 mg / pack Ciclopirox Gel 0.77percent (Pack 45 Gms) (Net wt. of Ciclopirox USP is 17.325 Kgs.) 1 Number 2 Ciclopirox USP 352.967 mg / pack Ciclopirox Gel 0.77percent (Pack 100 gms) (Net wt. of Ciclopirox USP is 50.05 Kgs.) 1 Number 3 Ciclopirox USP 785.00 mg / pack

RA concerned may take further necessary action as per above decision of NC. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Case No. 59 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002536AM26 RA File Number 03AX04002192 AM26 Licence No and Date 0311046329/06/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Dec/202425/13 dated 07/01/2025 against advance authorization No. 0311035257 dated 07/07/2024, it was decided to fix ad-hoc 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. allowed. Colesevelam HCL OS 3.75 gm 30/ Colesevelam Hydrochloride for oral suspension 3.75 gm (Per Pack 30 Pouchs) 21000 Numbers Packs. (630000 Numbers Pouch) 1 Colesevelam Hydrochloride 2480.62 kg.

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

Case No. 60 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002559AM26 RA File Number 05AX04001596 AM26 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

50 Licence No and Date 0511034353/07/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case along with relevant information / documents from the firm:

Case No. 61 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name APITORIA PHARMA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002577AM26 RA File Number 09AX04000469 AM26 Licence No and Date 0911010216/08/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 7-Amino Des-Acetoxy Cephalosporanic Acid (7-ADCA) 0.643 kg. 2 Penicillin G Amidase 0.004 kg. 3 Methyl D-(-)-4-Hydroxyphenylglycinate (OR) D-(-)-4-Hydroxyphenylglycine Methyl ester 0.634 kg. Cefadroxil /Cefadroxil Monohydrate 1 kg. 4 Acetone 0.323 kg. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

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

Case No. 62 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002585AM26 RA File Number 03AX04002331 AM26 Licence No and Date 0311046381/08/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 Clindamycin Phosphate USP 3.57 kg. Clindamycin & Benzoyl Peroxide Gel 1 Percent/5 Percent (Pack Size 25 gm ) ((Net Wt. of Import Item Sr. No. 1 is 3.50 Kgs. & Sr. No. 2 is 17.50 Kgs.)) 14000 Numbers 2 Hydrous Benzoyl Peroxide USP 17.85 kg. 3 Clindamycin Phosphate USP 46.41 kg. Clindamycin & Benzoyl Peroxide Gel 1 Percent/ 5 Percent (Pack Size 35 gm ) ((Net Wt. of Import Item Sr. No. 1 is 45.50 Kgs. & Sr. No. 2 is 227.50 Kgs.)) 130000 Numbers 4 Hydrous Benzoyl Peroxide USP 232.05 kg. 5 Clindamycin Phosphate USP 66.30 kg. Clindamycin & Benzoyl Peroxide Gel 1 Percent/ 5 Percent (Pack Size 50 gm 130000 Numbers UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

52 ) ((Net Wt. of Import Item Sr. No. 1 is 65.00 Kgs. & Sr. No. 2 is 325.00 Kgs.)) 20000 Numbers 6 Hydrous Benzoyl Peroxide USP 331.50 kg. Clindamycin Phosphate Gel 1 Percent (Pack Size 30 gm ) ((Net Wt. of Import Item Sr. No. 1 is 6.00 Kgs.)) 20000 Numbers 7 Clindamycin Phosphate USP 6.12 kg. Clindamycin Phosphate Gel 1 Percent (Pack Size 60 gm) ((Net Wt. of Import Item Sr. No. 1 is 12.00 Kgs.)) 8 Clindamycin Phosphate USP 12.24 kg. Adapalene & Benzoyl Peroxide Gel 0.1 Percent/ 2.5 Percent (Pack Size 45 gm ) ((Net Wt. of Import Item Sr. No. 2 is 22.50) 20000 Numbers 9 Hydrous Benzoyl Peroxide USP 22.95 kg. Clindamycin Phosphate Foam 1 Percent (Pack Size 50 gm) ((Net Wt. of Import Item Sr. No. 1 is 10.00 Kgs.)) 20000 Numbers 10 Clindamycin Phosphate USP 10.20 kg. Clindamycin Phosphate Foam 1 Percent (Pack Size 100 gm) ((Net Wt. of Import Item Sr. No. 1 is 20.00 Kgs.)) 20000 Numbers 11 Clindamycin Phosphate USP 20.40 kg.

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

Case No. 63 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name AURORE LIFE SCIENCES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

53 HQ File Number HQRNORM APPLY 00002589AM26 RA File Number 09AX04000484 AM26 Licence No and Date 0911010235/08/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Dec/202526/11 dated 18/12/2025 against advance authorization No. 0911009404 dated 09/04/2025, it was decided to fix ad-hoc 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. allowed. 1 4-Fluoro Benzaldehyde 3.18 kg. 2 Propionic Anhydride 3.15 kg. 3 Sodium Propionate 2.32 kg. 4 Methanol 3.14 kg. 5 Acetic acid 5.71 kg. Sulindac 1 kg. 6 Cyano Acetic acid 1.16 kg.

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

Case No. 64 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002590AM26 RA File Number 31AX04000207 AM26 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

54 Licence No and Date 3111005163/08/08/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
Justfication of low yield of 85 % in the reaction involved Methyl Ethyl Ketone (MEK). 1. Whether MEK can be recycled. 2.

Case No. 65 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ASHISH LIFE SCIENCE PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002604AM26 RA File Number 03AX04002424 AM26 Licence No and Date 0311046416/11/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance authorization No. 0311029686 dated 27/12/2023, it was decided to fix ad-hoc 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. allowed. ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack size 50 ML vial((EACH VIAL CONTAINS 19 ML 2-pyrrolidone) (Nett Wt. of EXEMPTED 1086 kg. 1 2-Pyrrolidone 1141.13 kg. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

55 MATERIAL IS 1086.8 Kgs) (55000 Nos)) ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack size 100 ML vial ((EACH VIAL CONTAINS 38ML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 2687.36 Kgs) (68000 Nos)) 2687 kg. 2 2-Pyrrolidone 2821.73 kg. ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack size 250 ML vial ((EACH VIAL CONTAINS 95 ML 2-pyrrolidone) (Nett wt. of EXEMPTED MATERIAL IS 988 Kgs) (10000 Nos)) 988 kg. 3 2-Pyrrolidone 1037.4 kg

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

Case No. 66 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002607AM26 RA File Number 05AX04001565 AM26 Licence No and Date 0511034405/11/08/2025 Norms Committee Decision: UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

56 The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Nov/202425/10 dated 22/11/2024
against advance authorization No.0511025488 dated 14/05/2024, it was decided to fix ad-hoc 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. allowed. 1 Moxifloxacin Hydrochloride 6580.875 gram. Moxifloxacin HCL and Dexamethasone Sodium Phosphate Eye Drops 0.5%w/v, 0.1% w/v, 5ml ((Each ml contain Moxifloxacin Base 5 mg. Equivalent to Moxifloxacin HCL 5.45mg & Dexamethasone Phosphate 1mg equi. to Dexamethasone Sodium Phosphate 1.1mg (Equi. to 6267.50 gm of Moxifloxacin HCL and 1265.00 gm of Dexamethasone Sodium Phosphate )) 230000 Numbers 2 Dexamethasone Sodium Phosphate 1328.25 gram.

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

Case No. 67 / NC/3/MEET/Jun/202627/4 Case Status Case Rejected Party Name ETERNIS FINE CHEMICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002615AM26 RA File Number 03AX04002296 AM26 Licence No and Date 0311046434/11/08/2025 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

57 Norms Committee Decision: The Committee examined the application of the firm and noted that the export product is a well- established perfumery compound with widespread use as a synthetic aroma chemical. Considering the nature and established usage of the product, the Committee decided to uphold its earlier decision and advised the firm to seek fixation of norms under Para 4.06 of the HBP. Accordingly, the application was rejected.

Case No. 68 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name VENUS REMEDIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002623AM26 RA File Number 30AX04000326 AM26 Licence No and Date 3011007506/12/08/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
Certificate of Analysis of import item showing percentage content of L-Arginine in the import item. 1. Master-Batch Formula for each export. 2.

Case No. 69 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name APITORIA PHARMA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002625AM26 RA File Number 09AX04000504 AM26 Licence No and Date 0911010246/12/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

58 deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 (1R,2R)-1,2- Cyclohexanedimethanol 0.652 kg. 2 Methanesulfonyl Chloride 1.56 kg. 3 Piperazine derivative(or) 3-(1- Piperazinyl)-1,2-benzisothiazole hydrochloride 0.87 kg. 4 Methanol 1.47 kg. 5 Acetone 3.35 kg. 6 Acetonitrile 5.25 kg. 7 Carbon Enoanticromos (Activated carbon) 0.055 kg. Lurasidone Hydrochloride 1 kg. 8 Dicarboxymide 0.42 kg.

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

Case No. 70 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name EAST AFRICAN INDIA OVERSEAS Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

59 HQ File Number HQRNORM APPLY 00002636AM26 RA File Number 05AX04001373 AM26 Licence No and Date 0511034022/12/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ampicillin Trihydrate 294.032 mg. RO-Amiclox Ampicillin & Cloxacillin Capsules (10 X 10'S) (100 x 350000 = 35000000 Capsules) (250 mg + 250 mg) 1 Number 2 Cloxacillin Sodium 277.95 mg.

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

Case No. 71 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name NEOGEN CHEMICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002663AM26 RA File Number 03AX04002376 AM26 Licence No and Date 0311046505/13/08/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

60 Percentage Hexane content in export. 1. Percentage yield of reaction. 2.

Case No. 72 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002695AM26 RA File Number 08AX04000782 AM26 Licence No and Date 0811015860/14/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Tranexamic Acid in 0.7% Sodium Chloride Injection 1,000 mg per 100 mL (10 mg/mL) 1 Number 1 Tranexamic acid (Injectable grade, US FDA approved) 1050 mg.

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

Case No. 73 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

61 HQ File Number HQRNORM APPLY 00002696AM26 RA File Number 08AX04000772 AM26 Licence No and Date 0811015864/14/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jul/202526/6 dated 31/07/2025
against advance authorization No.0811013728 dated 07/01/2025, it was decided to fix ad-hoc 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. allowed. Magnesium Sulfate In Water for Injection (0.325 m Eq mg++/ml) 40 mg/ml 2g Total 1 Number 1 Magnesium Sulfate Heptahydrate 2.00 gm. Magnesium Sulfate In Water for Injection (0.325 m Eq mg++/ml) 40 mg/ml 4g Total) 1 Number 2 Magnesium Sulfate Heptahydrate 4.00 gm.

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

Case No. 74 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name PIRAMAL PHARMA LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002702AM26 RA File Number 03AX04002514 AM26 Licence No and Date 0311046562/14/08/2025 Norms Committee Decision: UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

62 The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202627/3 dated 26/05/2026
against advance authorization No.0311045822 dated 21/07/2025, it was decided to fix ad-hoc 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. allowed. Vibegron (Obgemsa / Gemtesa) Tablets 75 mg 1 Number 1 Vibegron 76.50 mg.

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

Case No. 75 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name PIRAMAL PHARMA LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002703AM26 RA File Number 03AX04002515 AM26 Licence No and Date 0311046563/14/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202627/3 dated 26/05/2026
against advance authorization No.0311045822 dated 21/07/2025, it was decided to fix ad-hoc 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. allowed. Vibegron (Obgemsa / Gemtesa) 1 Number 1 Vibegron 76.50 mg. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

63 Tablets 75 mg

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

Case No. 76 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name VENUS REMEDIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002704AM26 RA File Number 30AX04000321 AM26 Licence No and Date 3011007533/14/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. MEROPENEM 500 mg Powder for Solution for Injection or Infusion(Each Vial Contains: Active Pharmaceutical Ingredients Meropenem Trihydrate equivalent to Meropenem Anhydrous...500 mg , Excipients : Anhydrous Sodium carbonate ph.Eur ....104 mg equivalent to 45.1mg of Sodium) 1 Number 1 Meropenem and Sodium Carbonate (Sterile Bulk) 672.6 mg/Vial MEROPENEM 1000 mg Powder for Solution for Injection or Infusion(Each Vial 1 Number 2 Meropenem and Sodium Carbonate (Sterile Bulk) 1345 mg/Vial UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

64 Contains: Active Pharmaceutical Ingredients Meropenem Trihydrate equivalent to Meropenem Anhydrous...1000 mg , Excipients : Anhydrous Sodium carbonate ph.Eur ...208 mg equivalent to 90.2mg of Sodium) MEROPENEM 2 gm Powder for Solution for Injection or Infusion(Each Vial Contains: Active Pharmaceutical Ingredients Meropenem Trihydrate equivalent to 2000 mg Meropenem Anhydrous Excipients : Anhydrous Sodium carbonate ph.eur 416 mg equivalent to 180.4mg of Sodium) 1 Number 3 Meropenem and Sodium Carbonate (Sterile Bulk) 2690 mg/Vial

Note: NC also recommended to make a new SION for the export product.

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

Case No. 77 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name CIRON DRUGS AND PHARMACEUTICALS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002718AM26 RA File Number 03AX04002498 AM26 Licence No and Date 0311046581/18/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

65 same export product/import item in meeting No.NC/3/MEET/Apr/202627/2 dated 28/04/2026
against advance authorization No.0311040388 dated 13/01/2025, it was decided to fix ad-hoc 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. allowed. Bimatoprost Opthalmic Solution 0.3 mg/ml - 3 ml (Each ml contains Bimatoprost 0.3 mg) (2,70,000 Nos) (Net Content :Bimatoprost - 0.243KGS) 1 Number 1 Bimatoprost 0.918 mg/3 ml. Vial

Note: NC also recommended to make a new SION for the export product.

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

Case No. 78 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002722AM26 RA File Number 03AX04002497 AM26 Licence No and Date 0311046588/18/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:- UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

Sl. No. Export Product Quantity 1 Medical cream ointment & gel (Fluorouracil Cream 5% 15 Gm Tot Wt 3750 Kgs, Net Cont: 5-Fluorouracil 187.5 Kgs, STEARYL ALCO 562.5 Kgs, Propylene 431.25 Kgs, Methyl para 0.938, Propyl para 0.563, Tween 60 187.50, white petrolatum 806.25)) 1 Number

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

Case No. 79 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name AURORE LIFE SCIENCES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002733AM26 RA File Number 09AX04000532 AM26 Licence No and Date 0911010282/18/08/2025 Norms Committee Decision: UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

67 The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Cyclopropyl methyl ketone 1.02 kg. 2 Potassium Tert butoxide 2.04 kg. 3-Bromomethyl-2- Cyclopropyl-4-(4- Fluorophenyl) Quinoline 1 kg. 3 2-amino-4-Fluorobenzophenone 0.98 kg.

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

Case No. 80 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name AURORE LIFE SCIENCES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002738AM26 RA File Number 09AX04000531 AM26 Licence No and Date 0911010283/18/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

68 Tert-Butyl [(4r. 6s)-6- Formyl-2,2-Dimethyl-1,3- Dioxan-4-Yl]Acetate (Aldehyde Side Chain) (Drug Intermidiate) 1 kg. 1 tert.butyl - 2 [(4R, cis) - 6 - acetyloxy methyl - 2, 2 - dimethyl - 1, 3 - dioxane - 4 yl] acetate 1.575 kg.

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

Case No. 81 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name SENTISS PHARMA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002760AM26 RA File Number 05AX04001674 AM26 Licence No and Date 0511034545/19/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Oct/202526/9 dated 14/10/2025
against advance authorization No.0511031579 dated 25/03/2025, it was decided to fix ad-hoc 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. allowed. Picloxydine Opthalmic Solution 10 ml Vial (Piclosept) - (Each ml contains 0.5 mg of Picloxydine Dihydrochloride) 1 Number 1 Picloxydine dihydrochloride 0.5 mg equivalent to Picloxydine base 0.434 mg 5.10 mg. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

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

Case No. 82 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name SENTISS PHARMA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002761AM26 RA File Number 05AX04001675 AM26 Licence No and Date 0511034546/19/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Inokain Eye Drops 0.4 Percent 5 ml (Each ml contains 4 mg of Benoxinate Hydrochloride) 1 Number Vial 1 Benoxinate HCL 20.4 mg/5 ml. Vial

Note: NC also recommended to make a new SION for the opthalimic solution.

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

Case No. 83 / NC/3/MEET/Jun/202627/4 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

70 Case Status Case Deferred Party Name REACH GLOBAL INDIA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002784AM26 RA File Number 31AX04000216 AM26 Licence No and Date 3111005186/20/08/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
Please indicate the other material used with quantity export product. 1.

Case No. 84 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name M CHEMICALS Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002788AM26 RA File Number 52AX04000162 AM26 Licence No and Date 5211016140/20/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Schaeffers Acid (Highly Purified) 1 kg. 1 Beta Naphthol 0.80 kg.

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

Case No. 85 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name DEEPAK NOVOCHEM SPECIALITIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002798AM26 RA File Number 31AX04000228 AM26 Licence No and Date 3111005188/21/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026
against advance authorization No. 3111004980 dated 17/06/2025, it was decided to fix ad-hoc 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 Item Qty. allowed. 1 Phenol 0.963 kg. 2 Methanol 0.750 kg. 2,6 Xylenol 1 kg. 3 Catalyst (Katalco) 0.004 kg.

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

Case No. 86 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name DEEPAK NOVOCHEM SPECIALITIES LIMITED UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

72 Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002802AM26 RA File Number 31AX04000231 AM26 Licence No and Date 3111005189/21/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026
against advance authorization No. 3111004980 dated 17/06/2025, it was decided to fix ad-hoc 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 Item Qty. allowed. 1 Phenol 0.963 kg. 2 Methanol 0.750 kg. 2,6 Xylenol 1 kg. 3 Catalyst (Katalco) 0.004 kg.

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

Case No. 87 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name CHEMPLAST SANMAR LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002811AM26 RA File Number 04AX04000535 AM26 Licence No and Date 0411010246/21/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

73 deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Hydrogen Cyanamide 50% 0.565 kg. Phenyl Guanidine Carbonate Monohydrate 1 kg. 2 Aniline 0.626 kg.

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

Case No. 88 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002821AM26 RA File Number 07AX04000928 AM26 Licence No and Date 0711015437/22/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Feb/202526/13 dated 20/02/2026
against advance authorization No. 0711011739 dated 05/07/2024, it was decided to fix ad-hoc 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. allowed. Magnesium Orotate 1 MT 1 Orotic Acid (Monohydrate) 0.990 MT UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

74 Calcium Orotate 1 MT 2 Orotic Acid (Monohydrate) 0.948 MT Potassium Orotate 1 MT 3 Orotic Acid (Monohydrate) 0.944 MT Zinc Orotate 1 MT 4 Orotic Acid (Monohydrate) 0.890 MT Ferrous Orotate 1 MT 5 Orotic Acid (Monohydrate) 0.872 MT

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

Case No. 89 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name MICRO LABS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002822AM26 RA File Number 07AX04000953 AM26 Licence No and Date 0711015442/22/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Caffeine Citrate Injection 60mg/3ml (Equivalent to 30 mg of Caffeine Base) (46.875 KGS) 1 Number 1 Caffeine Anhydrous EP/BP/USP 33.0 mg UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

75 Caffeine Citrate Oral Solution 60 mg / 3 ml (Equivalent To 30 mg of Caffeine Base) (3.750KGS) 1 Number 2 Caffeine Anhydrous EP/BP/USP 30.6 mg.

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

Case No. 90 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name KAIRAV CHEMOFARBE INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002866AM26 RA File Number 03AX04002549 AM26 Licence No and Date 0311046843/25/08/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
Material balance in each step of purification with specification of import and intermediate stage. 1. Justification of 30% wastage (stage wise). 2. Certificate of Analysis of Import item from foreign supplier. 3. Item of imort seems to be from waste chemical plant as such complete specification. 4.

Case No. 91 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name MICRO LABS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002890AM26 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

76 RA File Number 07AX04000983 AM26 Licence No and Date 0711015463/26/08/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Sep/202526/8 dated 17/09/2025
against advance authorization No. 0711013540 dated 04/02/2025, it was decided to fix ad-hoc 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. allowed. 1 Lisinopril Dihydrate Ph. Eur 5.10 mg. Lisinopril 5 mg + Amlodipine 5 mg Tablets (21.00kgs)) 1 Number Tablet 2 Amlodipine Besilate BP 5.10 mg. 3 Lisinopril Dihydrate Ph. Eur 10.2 mg. Lisinopril 10 mg + Amlodipine 5 mg Tablets (40.50kgs)) 1 Number Tablet 4 Amlodipine Besilate BP 5.10 mg.

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

Case No. 92 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name VENUS REMEDIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002899AM26 RA File Number 30AX04000358 AM26 Licence No and Date 3011007589/26/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

77 the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Leucovorin Calcium Injection USP 50 mg/5 ml (Each ml contains: Leucovorin Calcium USP (INN. Calcium Folinate) Equivalent to Leucovorin ...... 10 mg Water for Injection USP .... .... q.s) 1 Number 1 Leucovorin Calcium 59.42 mg. Leucovorin Calcium Injection USP 100 mg/10 ml (Each ml contains: Leucovorin Calcium USP (INN. Calcium Folinate) Equivalent to Leucovorin ...... 10 mg Water for Injection USP ............ q.s) 1 Number 2 Leucovorin Calcium 118.84 mg. Leucovorin Calcium Injection USP 300 mg/30 ml (Each ml Contains: : Leucovorin Calcium USP (Inn. Calcium Folinate) Equivalent To Leucovorin ........10 mg Water For Injection USP ..... Q.S) 1 Number 3 Leucovorin Calcium 340.323 mg.

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

Case No. 93 / NC/3/MEET/Jun/202627/4 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

78 Case Status Case Approved Party Name AARTI INDUSTRIES LTD Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002920AM26 RA File Number 03AX04002553 AM26 Licence No and Date 0311046898/28/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Para Nitro Aniline 1 kg. 1 Para Nitro Chloro Benzene 1.176 kg.

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

Case No. 94 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name DECCAN NUTRACEUTICALS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002923AM26 RA File Number 02AX04000416 AM26 Licence No and Date 0211009403/28/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

79 Export Product Qty. Sl. No. Import Item Qty. allowed. Nalbuphine Hydrochloride 1 kg. 1 Noroxymorphone Base 1.067 kg.

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

Case No. 95 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name JUBILANT GENERICS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002932AM26 RA File Number 05AX04001859 AM26 Licence No and Date 0511034778/29/08/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Zopiclone Tablet 7.5mg 1 Number 1 Zopiclone Ph.Eur 7.53 mg/Tablet

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

Case No. 96 / NC/3/MEET/Jun/202627/4 Case Status Case Approved UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

80 Party Name HONOUR LAB LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002947AM26 RA File Number 09AX04000566 AM26 Licence No and Date 0911010368/01/09/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Nov/202526/10 dated 14/11/2025
against advance authorization No. 0911008057 dated 27/09/2024, it was decided to fix ad-hoc 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. allowed. Ethyl-(2R,4S)-5-([1,1-biphenyl]- 4-yl)-4-amino-2- methylpentanoate hydrochloride 1 kg. 1 (2R,4S)-5-([1,1-biphenyl]-4- yl)-4-((tert-butoxycarbonyl) amino)-2-methylpentanoic 1.21 kg.

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

Case No. 97 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name FDC LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002963AM26 RA File Number 03AX04002773 AM26 Licence No and Date 0311046962/01/09/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

81 Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Latanoprost Eye Drops 2.5 ml (Latanoprost 0.005% Eye Drops 2.5 ml) ((Each Vial Contains Latanoprost 0.125 mg Net Wt of Bulk Drug is 80.750 Grams)) 646000 Vials 1 Latanoprost 82.365 gm. Latanoprost 0.005% + Timolol 0.5% Eye Drops. 2.5 ml ((Each Vial Contains Latanoprost 0.125 mg Net Wt of Bulk Drug is 50.375 Grams)) 403000 vials 2 Latanoprost 51.383 gm.

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

Case No. 98 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002967AM26 RA File Number 07AX04000996 AM26 Licence No and Date 0711015496/01/09/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
For export item No. 7 (Calcium Magnesium Lactate Gluconate). As per manufacture process 1. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

82 given import item Glucono Delta Lactone is not shown in the process. Please clarify and give the revised manufacturing process and details. Certificate of Analysis (CoA) of import item from foreign supplier indicating percentage purity and copies of Bill of Entry (since for some export item purity of imported item shown as 90 per cent) 2.

Case No. 99 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name SRI KRISHNA PHARMACEUTICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002976AM26 RA File Number 09AX04000534 AM26 Licence No and Date 0911010379/02/09/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Ascorbic Acid 50 mg Tablets (Pack Size 28 No of Packs 32143) 1 Number 1 Ascorbic Acid PH EUR CEP 51.00 mg/Tablet Ascorbic Acid 100 mg Tablets (Pack Size 28 No of Packs 32143) 1 Number 2 Ascorbic Acid PH EUR CEP 102 mg/Tablet Ascorbic Acid 200 mg Tablets (Pack Size 28 No of Packs 32143) 1 Number 3 Ascorbic Acid PH EUR CEP 204 mg/Tablet Ascorbic Acid 500 mg Tablets Ascorbic Acid 1 Number 4 510 mg/Tablet UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

83 (Pack Size 28 No of Packs 64286) PH EUR CEP

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

Case No. 100 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name PROCTER & GAMBLE HEALTH LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002978AM26 RA File Number 03AX04002788 AM26 Licence No and Date 0311046999/02/09/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Thiamine Disulfide 1 kg. 1 Thiamine HCL 1.4199 kg.

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

Case No. 101 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name STERMONE CHEMICALS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

84 HQ File Number HQRNORM APPLY 00002981AM26 RA File Number 34AX04000468 AM26 Licence No and Date 3411006905/02/09/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202627/3 dated 26/05/2026
against advance authorization No. 3411006764 dated 23/07/2025, it was decided to fix ad-hoc 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. allowed. Clobetasol Propionate BP/EP/USP 1 kg. 1 Betamethasone 17-Propionate 1.08 kg.

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

Case No. 102 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name LA CHANDRA PHARMALAB PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002983AM26 RA File Number 08AX04000917 AM26 Licence No and Date 0811016028/02/09/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
Stepwise complete and balanced chemical reactions showing molecular weight and I. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

85 percentage of yield on molar basis. Copy of Technical Literature/Justification for low yield of 21% in last stage of flow-charts. II.

Case No. 103 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name SHREE CHEMOPHARMA ANKLESHWAR PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002986AM26 RA File Number 34AX04000447 AM26 Licence No and Date 3411006912/02/09/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 5 Nitro Salicylic Acid 1 kg. 1 Ortho Chloro Benzoic Acid (99% Minimum) 1.221 kg.

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

Case No. 104 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name SHILPA PHARMA LIFESCIENCES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002991AM26 RA File Number 07AX04000948 AM26 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

86 Licence No and Date 0711015519/02/09/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Percentage yield on molar basis for each step based on present data on conversion. 1. Production/Consumption data for the last three years certified by Chartered Accountant. 2.

Case No. 105 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name SUPERFORM CHEMISTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002993AM26 RA File Number 03AX04002468 AM26 Licence No and Date 0311047022/03/09/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. Phenyl Isocyanate 1 kg. 1 Aniline 0.823 kg.

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

Case No. 106 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name LEBEN LABORATORIES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00002995AM26 RA File Number 03AX04002807 AM26 Licence No and Date 0311047017/03/09/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jul/202526/6 dated 31/07/2025
against advance authorization No. 0311040145 dated 06/01/2025, it was decided to fix ad-hoc 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. allowed. Lampy-250 Capsule. Ampicillin Capsule BP 250 Mg. (Each Capsule Containing Ampicillin Trihydrate Equivalent to 250 mg. Ampicillin Base. Net content of Import/Exempt Material used in Export Product 1) Ampicillin Trihydrate BP (Compacted)-2018.539 Kg (Excl. 2 % Wastage)) 1 Number 1 Ampicillin Trihydrate BP Compacted 294.5 mg. Lampy-500 Capsule. Ampicillin Capsule BP 500 mg. (Each Capsule Containing Ampicillin Trihydrate Equivalent to 500 mg. Ampicillin Base. Net content of Import/Exempt Material Used In Export Product 1) Ampicillin Trihydrate BP (Compacted) -1155.411 Kg (Excl. 2% Wastage)) 1 Number 2 Ampicillin Trihydrate BP Compacted 589.0 mg. Lampyklox Capsule. Ampicillin 1 Number Ampicillin Trihydrate 3 294.5 mg. UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

88 Trihydrate and Cloxacillin Sodium Capsules (250 mg + 250 mg) (Each Capsule Contains Ampicillin Trihydrate Equialent to 250 mg of Ampicillin and Cloxacillin Sodium Equivalent To 250 mg Cloxacillin. Consumes Qty 1) Ampicillin Trihydrate BP (Compacted) - 1606.736 kg (Excl. 2% Wastage))

BP Compacted Lampyklox Dry Syrup. Ampicillin Trihydrate and Cloxacillin Sodium Suspension ((Each 5 ml Reconstituted Suspension Contains Ampicillin Trihydrate BP Equivalent to Ampicillin BP 125 mg ). Net Content of Import / Exempt Material Used in Export Product

Ampicillin Trihydrate BP (Compacted)- 121.275 kgs (Excl 2% Wastage)) 100 ml Bottle. 1 Number Bottle 4 Ampicillin Trihydrate BP Compacted 2945.0 mg.

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

Case No. 107 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00003018AM26 RA File Number 52AX04000164 AM26 Licence No and Date 5211016505/03/09/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202627/3 dated 26/05/2026
against advance authorization No. 5211007280 dated 06/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

89 Export Product Qty. Sl. No. Import Items Qty. allowed. 1 1(1-(2-Tetrahydropyranyl)-1H Pyrazole-5-Boronic Acid Pinacol Ester ( 1-(Tetrahydro 2H Pyran 2yl )-5-(4,4,5,5 Tetramethyl 1,3,2 Dioxaborolane-2-Yl)-1h- Pyrazole)) 1.50 kg. 2 4-Bromo-2-Chloro Benzonitrile 1.165 kg. 3 2-Amino-1-Propanol (S- (+)-2-Amino-1-Propanol) ((S)- 2-aminopropan-1-ol (L- Alininol) 0.46 kg. 4 Di Tert Butyl Dicarbonate 1.34 kg. 5 Di-isopropyl azodicarboxylate 1.034 kg. Heterocyclic Compounds With Nitrogen atom with an unfused pyrazole ring with hydrogenated in the structure: 4-{1- [(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile) 1 kg. 6 Triphenylphosphine 1.89 kg.

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

Case No. 108 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name STERICON PHARMA PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00003027AM26 RA File Number 07AX04000793 AM26 Licence No and Date 0711015524/03/09/2025 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

90 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:
Copy of Drug Manufacturing Licence (DML) for each export item showing approved composition of each export item. 1. Copy of Master-Batch Formula for each export item. 2. Certificate of Analysis (CoA) of import item from Foreign Supplier. 3. Net content of import item in each export and wastage claimed thereon. 4.

Case No. 109 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name NASENSE LABS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00003034AM26 RA File Number 09AX04000517 AM26 Licence No and Date 0911010403/04/09/2025 Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Complete chemistry, chemical reaction, stochiomatric balance on molar basis with molecular weight and percentage yield for each step of reaction.

Case No. 110 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00003039AM26 RA File Number 52AX04000165 AM26 UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

91 Licence No and Date 5211016542/04/09/2025 Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026
against advance authorization No. 5211008490 dated 13/06/2024, it was decided to fix ad-hoc 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. allowed. 1 Hydrazine Hydrate 64% (RM for mfg of Semicarbazide HCL for further mfg of TPO) 2.14 kg. 2 2-Chloro Pyridine 1.33 kg. 1,2,4 - Triazolo (4,3-a) Pyridin - 3 (2H) - one - 98% MIN. 1 kg. 3 Ethylene Glycol Monoethyl Ether/2- Ethoxy Ethanol 1.35 kg.

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

Case No. 111 / NC/3/MEET/Jun/202627/4 Case Status Case Deferred Party Name PANVO ORGANICS PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00003044AM26 RA File Number 04AX04000591 AM26 Licence No and Date 0411010313/04/09/2025 Norms Committee Decision: UDIN00233072AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 23-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 23-Jul-2026 09:52:13 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

92 The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

Complete chemistry, chemical reaction, stochiomatric balance on molar basis with molecular weight and percentage yield for each step of reaction.

Case No. 112 / NC/3/MEET/Jun/202627/4 Case Status Case Approved Party Name ZYDUS LIFESCIENCES LIMITED Meeting Number and Date NC/ 3/ MEET/ Jun/ 202627/ 4 and 22/06/2026 HQ File Number HQRNORM APPLY 00003056AM26 RA File Number 08AX04000947 AM26 Licence No and Date 0811016047/04/09/2025 Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-

Export Product Qty. Sl. No. Import Item Qty. allowed. 1 Sucralfate USP 1020 mg. 2 Corn Starch NF (Maize Starch B) 76.5 mg. Sucralfate Tablets USP 1 gm (Active Ingredient: Sucralfate USP - Net Wt. 37490.800 Kgs)) 1 Number 3 Magnesium Stearate PH.E/NF/JP 12.0 mg.

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

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