IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2026-05-26

DGFT Committee Minutes

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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/May/202627/3 DATED: 26/05/2026

Minutes of the Norms Committee–3 Meeting NC/3/MEET/May/202526/3 dated 26/05/2026 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 Nand Lal Consultant (Chemical) 4 Shri Raman Kumar, Joint DGFT DGFT (HQ) 5 Smt. Skina Rani, FTDO DGFT (HQ) 3. The Norms Committee has taken decisions only with respect to the technical aspect/ wastage norms. While redeeming the application, RAs should check that the applicant has fulfilled all UDIN00197896AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 03-Jul-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 03-Jul-2026 17:17:44 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

2 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. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

3 Case Details and Decision(s): Case No. 1 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name AUROBINDO PHARMA LTD Meeting Number and Date NC/ 3/ MEET/ May/ 202627/ 3 and 26/05/2026 HQ File Number HQRNORM APPLY 00000125AM26 RA File Number NA Licence No and Date NA

Norms Committee Decision:

Decision:The representative of the firm appeared for the personal hearing and requested the fixation of norms in respect of Advance Authorisation No. 0910039411 dated 25.09.2009. 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. 0910039411 dated 25.09.2009. 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/May/202627/3 Case Status Case Deferred Party Name BIOLOGICAL E. LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000304AM27 RA File Number NA Licence No and Date NA The Committee considered the case as per agenda and it was decided to refer the case to Deptt. of Bio-Technology for obtaining their comments.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

4 Case No. 3 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name SIGACHI INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000787AM27 RA File Number NA Licence No and Date NA 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. 1. Batch Manufacturing formula. 2.

Case No. 4 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name HEMA DYECHEM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002356AM26 RA File Number NA Licence No and Date NA The Committee considered the case in accordance with the agenda and, upon examination, observed that the subject matter pertains to the fixation of SION. The ad-hoc norms (under the "No Norms" category) have already been fixed. The Committee further noted that the production/consumption data submitted by one of the manufacturers, M/s Vapi Spectrochem, pertains to a different raw material, namely Para Dimethoxy Aniline, instead of the subject raw material, Para Dimethoxy Benzene. Accordingly, the Committee decided to seek the following information/documents from the firm: Production and consumption data relating to the export product and the correct raw material, 1. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

5 i.e., Para Dimethoxy Benzene, for the last three years, duly certified by a Chartered Accountant and obtained from 2–3 manufacturers.

Case No. 5 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name INTAS PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00004088AM26 RA File Number NA Licence No and Date NA 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 firm was advised that the quantity of the import item can be worked out by RA in line with SION A-412 (based on 100% potency of active ingredient). For any variation in potency envisaged, the firm may be advised to apply the application under

para 4.07 with all necessary documentary evidence, Certificate of Analysis of actual import

from foreign supplier, etc.

Case No. 6 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name CYKLO PHARMA CHEM PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00004006AM26 RA File Number 032404000318 AM04 Licence No and Date 0310204913/29/05/2003 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. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 7 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name WEXFORD LABORATORIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003783AM25 RA File Number 072404000382 AM14 Licence No and Date 0710101548/23/01/2014 The Committee considered the application of the firm and observed that the import item and export product are identical. The Committee further noted that, despite being provided with multiple opportunities, the firm failed to appear for the personal hearing. In view of the above, the Committee decided to reject the application.

Case No. 8 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name BELOORBAYIR BIOTECH LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00007896AM24 RA File Number 072404000347 AM16 Licence No and Date 0710109255/12/01/2016 The Committee examined the application of the firm and noted that several opportunities were provided to the firm to appear for a personal hearing and present its case. However, the firm did not avail itself of these opportunities. In view of the above, the Committee decided to reject the application.

Case No. 9 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name SHREE BANKEY BEHARI LAL FLAVORS UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

7 Meeting Number and Date HQ File Number HQRNORM REVIW00006890AM24 RA File Number 052404000067 AM19 Licence No and Date 0510406412/10/05/2018 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 Meta - Cresol Above 98.5% Pure 0.992 kg. 2 Iso Propyl Alcohol 0.750 kg. L-Menthol /Menthol (Laveo) / Menthol (L) / Liquid Menthol 1 kg. 3 Arrowzyme / Lipase Amano IME 0.01 kg.

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

Case No. 10 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name GLOBE TROTTERS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000620AM27 RA File Number 039404000713 AM19 Licence No and Date 0310825212/26/11/2018 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

8 The Committee examined the request of the firm for fixation of ad-hoc norms . After due indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ampicillin Trihydrate IP/BP/USP 9390 kg. 2 Acetonitrile (ACN) 3 Methylene Chloride 4 Triethylamine Ampicillin Sodium Sterile BP 10000 kg. 5 Ethyl Acetate Not required.

Note: The above norms are for regularization and closure purpose only.

Case No. 11 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name KEVA FRAGRANCES PRIVATE LIMITED Meeting Number and Date HQ File Number 018205000499AM20 RA File Number 039404000373 AM20 Licence No and Date 0310830887/07/08/2019 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

9 The firm was initially granted an Advance Authorisation for the export product “Valencene 80 & Dodecane Rec Ex Valencene” 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. 12 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name ALPHAMED FORMULATIONS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000267AM27 RA File Number 092404000313 AM20 Licence No and Date 0910067997/13/09/2019 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 firm may be advised to get the Advance Authorisation amended with a reasonable import quantity against above export product.

Case No. 13 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name STERLING AUXILIARIES PVT LTD UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

10 Meeting Number and Date HQ File Number HQRNORM REVIW00000410AM27 RA File Number 039504000340 AM20 Licence No and Date 0310831915/30/09/2019 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 meeting held on 30.06.2025. In view of the non-submission of the requisite information, the Committee decided to reject the firm's application.

Case No. 14 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name STERLING AUXILIARIES PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00000417AM27 RA File Number 039504000135 AM20 Licence No and Date 0310831916/30/09/2019 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 meeting held on 30.06.2025. In view of the non-submission of the requisite information, the Committee decided to reject the firm's application.

Case No. 15 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name CIPLA LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003807AM25 RA File Number 039404000166 AM21 Licence No and Date 0310836755/19/06/2020 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

11 The committee considered the application of the firm and it has been observed that various opportunities were given to firm but the firm has not appeared for personal hearing before committee to explain their case, therefore, the committee decided to reject the application of the firm.

Case No. 16 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name STERLING AUXILIARIES PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00000460AM27 RA File Number 039504000492 AM21 Licence No and Date 0310839386/06/11/2020 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 meeting held on 30.06.2025. In view of the non-submission of the requisite information, the Committee decided to reject the firm's application.

Case No. 17 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name STERLING AUXILIARIES PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00000458AM27 RA File Number 03AA04074026 AM22 Licence No and Date 0311006960/15/09/2021 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 meeting held on 25.02.2025 and 03.12.2025. In view of the non-submission of the requisite information, the Committee decided to reject the firm's application. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 18 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name STERLING AUXILIARIES PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00000433AM27 RA File Number 03AA04082803 AM22 Licence No and Date 0311007171/23/09/2021 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 meeting held on 25.02.2025 and 03.12.2025. In view of the non-submission of the requisite information, the Committee decided to reject the firm's application.

Case No. 19 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000539AM27 RA File Number 52AX04000039 AM23 Licence No and Date 5211002485/13/05/2022 observed that the firm had not furnished any 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. 20 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name SALVI CHEMICAL INDUSTRIES LIMITED UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

13 Meeting Number and Date HQ File Number HQRNORM REVIW00006380AM25 RA File Number 03AX04001943 AM23 Licence No and Date 0311016208/08/07/2022 The Committee considered the case and noted that the firm has proposed the import of Soda Ash, which falls under the restricted category of imports. In view of the policy restriction, the Committee decided to reject the application. The Committee also directed the concerned RA to undertake a visit to the firm's factory premises and verify the records pertaining to the utilisation of Soda Ash and other raw materials claimed for the manufacture of the export product. The findings of the verification, along with supporting details, may be furnished to the Norms Committee and Policy-4 Section for appropriate action.

Case No. 21 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name KOPRAN RESEARCH LABORATORIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004127AM25 RA File Number 03AX04002151 AM23 Licence No and Date 0311016241/11/07/2022 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 firm was advised to get the Advance Authorisation amended for actual import.

Case No. 22 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000140AM27 RA File Number 03AX04004371 AM23 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

14 Licence No and Date 0311019903/12/12/2022 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. 23 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name SARAL CHEMTECH LLP Meeting Number and Date HQ File Number HQRNORM APPLY 00000865AM24 RA File Number 33AX04000105 AM23 Licence No and Date 3311001206/16/05/2023 The Representative of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the firm was advised to get Advance Authorisation amended for actual import.

Case No. 24 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name ASTEC LIFESCIENCES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005177AM26 RA File Number 03AX04001433 AM24 Licence No and Date 0311024964/28/06/2023 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. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 25 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name BEST VALUE CHEM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00006203AM26 RA File Number 34AX04000209 AM24 Licence No and Date 3411003978/02/08/2023 The firm was initially granted an Advance Authorisation for the export product “Cyclo Hexyl Salicylate” 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. 26 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name HIKAL LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005541AM26 RA File Number 03AX04002023 AM24 Licence No and Date 0311026196/10/08/2023 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

16 that the firm has not furnished the requisite technical details as prescribed in Annexure to

Copy of Advance Authorisation in support of 4th import item.

Case No. 27 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name STANEX DRUGS AND CHEMICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005456AM24 RA File Number 09AX04000507 AM24 Licence No and Date 0911005765/05/09/2023 indicated below.:- Export Product Qty. Sl. No. Import Items Qty. allowed. Heparin Sodium Injection 25000IU 75000 Vials 1 Low grade Glycosamino Glycans or Glycosamino glycans (25000 Mega) 15.4 kg. Heparin Sodium Injection 5000IU 75000 Vials 2 Low grade Glycosamino Glycans or Glycosamino glycans (25000 Mega) 3.08 kg.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 28 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name USV PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00008930AM24 RA File Number 03AX04003005 AM24 Licence No and Date 0311027533/03/10/2023 The Committee considered the request of firm for the fixation of ad-hoc norms, and it has been observed that the firm vide e-mail dated 22/05/2026 has informed that they have closed the licence and requested to withdraw the application from the portal. Therefore, it was decided to close the application of the firm.

Case No. 29 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name MANKIND PHARMA LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00006697AM26 RA File Number 05AX04002118 AM24 Licence No and Date 0511021548/16/10/2023 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/May/202627/3 Case Status Case Rejected Party Name PRIVI SPECIALITY CHEMICALS LIMITED UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

18 Meeting Number and Date HQ File Number HQRNORM REVIW00000628AM27 RA File Number 03AX04003186 AM24 Licence No and Date 0311027939/17/10/2023 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. 31 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name ASTEC LIFESCIENCES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005179AM26 RA File Number 03AX04003793 AM24 Licence No and Date 0311028844/22/11/2023 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. 32 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name BEST VALUE CHEM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005283AM26 RA File Number 34AX04000494 AM24 Licence No and Date 3411004386/29/11/2023 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

19 The firm was initially granted an Advance Authorisation for the export product “Anethole (para- Methoxy phenlpropene)” 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. 33 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00007173AM24 RA File Number 05AX04002730 AM24 Licence No and Date 0511022438/04/12/2023 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 it was observed that no technical expert was present during the hearing to explain the deficiency raised by the Committee; therefore, it was decided to reject the application of the firm.

Case No. 34 / NC/3/MEET/May/202627/3 Case Status Case Approved UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

20 Party Name METROCHEM API PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00007728AM24 RA File Number 09AX04000875 AM24 Licence No and Date 0911006481/03/01/2024 indicated below.:-

Export Product Qty. Qty. allowed. 1 3R,5R)-5-(2,4-difluorophenyl)-5- (iodomethyl) tetrahydrofuran-3-yl) methanol 0.855 kg. 2 2-[(1S,2S)-1-ethyl-2-bezyloxypropyl]- 2,4-dihydro-4-[4-[4-(4- hydroxyphenyl)-1- piperazinyl]phenyl]- 3H-1,2,4- Triazol-3-one 1.23 kg. 3 (S)-Methyl Lactate Not required 4 Dichloromethane / Metrhylene dichloride 2.00 kg. 5 Methanol 1.50 kg. Posaconazole 1 kg. 6 Palladium metal Not shown in reaction

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 35 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name NEOGEN CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005504AM26 RA File Number 03AX04004498 AM24 Licence No and Date 0311029998/08/01/2024 indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 Propionyl Bromide 0.7515 kg. 2-Bromopropionyl Bromide (BPBr) 1 kg. 2 Liquid Bromine 0.8705 kg.

Case No. 36 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00008367AM24 RA File Number 52AX04000336 AM24 Licence No and Date 5211007280/06/02/2024 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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

    Export Product

Qty. Qty. allowed. 1 1-(2-Tetrahydropyranyl) -1H Pyrazole-5-Boronic Acid Pinacol Ester(1-(2- Tetrahydropyranyl)-1H Pyrazole-5-Boronic Acid Pinacol Ester ( 1-(Tetrahydro 2 H 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. 4-{1-[(2S)-2-Aminopropyl]-1- H-Pyrazole-3-yl}-2- Chlorobenzonitrile) 1 kg. 6 Triphenylphosphine 1.89 kg.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 37 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00006714AM26 RA File Number 05AX04003618 AM24 Licence No and Date 0511023881/09/02/2024 observed that the norms given are based on 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. 38 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name PRIVI SPECIALITY CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000631AM27 RA File Number 03AX04005326 AM24 Licence No and Date 0311031507/27/02/2024

Case No. 39 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name ASTEC LIFESCIENCES LIMITED UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

24 Meeting Number and Date HQ File Number HQRNORM REVIW00005181AM26 RA File Number 03AX04005541 AM24 Licence No and Date 0311031703/05/03/2024 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. 40 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00006698AM26 RA File Number 05AX04003839 AM24 Licence No and Date 0511024393/07/03/2024 observed that the norms given are based on approved composition in 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. 41 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name GALAXY SURFACTANTS LTD Meeting Number and Date HQ File Number HQRNORM REVIW00004387AM25 RA File Number 03AX04006008 AM24 Licence No and Date 0311032549/27/03/2024 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

25 indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 Lauric Acid 0.8268 kg. Lauric monoethanolamide (Galaxy 200) 1 kg. 2 Mono Ethanol Amine 0.2552 kg.

Case No. 42 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name SYNERGIA SCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000333AM25 RA File Number 03AX04000023 AM25 Licence No and Date 0311033222/19/04/2024 The committee considered the application of the firm, and it has been observed that various opportunities were given to the firm, but the firm has not appeared for a personal hearing before the committee to explain their case; therefore, the committee decided to reject the application of the firm.

Case No. 43 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name APTRA SYNTHESIS PRIVATE LIMITED UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

26 Meeting Number and Date HQ File Number HQRNORM APPLY 00000952AM25 RA File Number 26AX04000006 AM25 Licence No and Date 2611001464/28/05/2024 The committee considered the application of the firm, and it has been observed that various opportunities were given to the firm, but the firm has not appeared for a personal hearing before the committee to explain their case; therefore, the committee decided to reject the application of the firm.

Case No. 44 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name CIPLA LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000511AM27 RA File Number 03AX04000876 AM25 Licence No and Date 0311034159/28/05/2024 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. 45 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name ETERNIS FINE CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000259AM27 RA File Number 03AX04001186 AM25 Licence No and Date 0311034574/13/06/2024 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 46 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name ETERNIS FINE CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000260AM27 RA File Number 03AX04001135 AM25 Licence No and Date 0311034573/13/06/2024

Case No. 47 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name SUPRIYA LIFESCIENCE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005576AM26 RA File Number 03AX04001271 AM25 Licence No and Date 0311034600/13/06/2024 The Committee considered the request of the firm for review of ad-hoc norms and it was decided to extend the ad-hoc norms given earlier in Advance Authorisation No. 0311031241 dated 15.02.2024 for another periof of one year, as per the details indicated below:- UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 VITAMIN B2 OR RIBOFLAVIN 1.30 kg. 2 PYRIDINE 2.00 kg. 3 ACETONITRILE 1.73 kg. RIBOFLAVIN SODIUM PHOSPHATE HYDRATE EP 11.2 1 kg. 4 PHOSPHORUS OXYCHLORIDE 2.00 kg.

Note:

The firm will produce improvement in the consumption norms after a period of one year. I. Further cases after one year will be decided based on improved consumption norms. II.

Case No. 48 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001820AM25 RA File Number 52AX04000089 AM25 Licence No and Date 5211008812/08/07/2024 The Committee examined the request of the firm for fixation of ad-hoc norms . After due UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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

    Export Product

Qty. Qty. allowed. 1 1-(2-Tetrahydropyranyl) -1H Pyrazole-5-Boronic Acid Pinacol Ester(1-(2- Tetrahydropyranyl)-1H Pyrazole-5-Boronic Acid Pinacol Ester ( 1-(Tetrahydro 2 H 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. 4-{1-[(2S)-2-Aminopropyl]-1- H-Pyrazole-3-yl}-2- Chlorobenzonitrile) 1 kg. 5 Di-isopropyl azodicarboxylate 1.034 kg.

Case No. 49 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name FRESENIUS KABI INDIA PRIVATE LIMITED UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

30 Meeting Number and Date HQ File Number HQRNORM APPLY 00001994AM25 RA File Number 03AX04001885 AM25 Licence No and Date 0311035597/18/07/2024 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.0311026174 dated 09/08/2023, 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. 1 Sodium Chloride (SANAL) (EP) 0.4725 gm. 6 BOP Infusion (Art.No 0434171) Net content in export + 1% wastage 11 BOP Injection (Art. 0434481) Net content in export + 1% wastage 16 SSC Infusion (0434181) Net content in export + 1% wastage 21 SSC Injection (Art. 0434371) Net content in export + 1% wastage 26 SF9-11 195/95 Prim. Film (0369581) Net content in export + 1% wastage OFR2-11 150/524 for 50 and 100ml Net content in export + 1% Sodium Chloride 0.9% 50 ml 1 Number 33 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

31 (0369701) wastage 36 UFR2-11 150/524-50 ml to 1000 (0369661) Net content in export + 1% wastage 41 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage 2 Sodium Chloride (SANAL) (EP) 0.945 gm. 7 BOP Infusion (Art.No 0434171) Net content in export + 1% wastage 12 BOP Injection (Art. 0434481) Net content in export + 1% wastage 17 SSC Infusion (0434181) Net content in export + 1% wastage 22 SSC Injection (Art. 0434371) Net content in export + 1% wastage 27 SF9-11 195/95 Prim .film (0369581) Net content in export + 1% wastage 34 OFR2-11 150/524 for 50 and 100 ml (0369701) Net content in export + 1% wastage 37 UFR2-11 150/524-50 ml to 1000 (0369661) Net content in export + 1% wastage Sodium Chloride 0.9% 100 ml 1 Number UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

32 42 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage 3 Sodium Chloride (SANAL) (EP) 2.3625 gm. 8 BOP Infusion (Art.No 0434171) Net content in export + 1% wastage 13 BOP Injection (Art. 0434481) Net content in export + 1% wastage 18 SSC Infusion (0434181) Net content in export + 1% wastage 23 SSC Injection (Art. 0434371) Net content in export + 1% wastage 28 SF9-11 195/100 Prim. Film (Art.0369591) Net content in export + 1% wastage 35 OFR2-11 150/524 for 50 and 100 ml (0369701) Net content in export + 1% wastage 38 UFR2-11 150/524-50 ml to 1000 (0369661) Net content in export + 1% wastage Sodium Chloride 0.9 % 250 ml 1 Number 43 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage Sodium Chloride Sodium Chloride 0.9% 500 ml 1 Number 4 4.725 gm. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

33 (SANAL) (EP) 9 BOP Infusion (Art.No 0434171) Net content in export + 1% wastage 14 BOP Injection (Art. 0434481) Net content in export + 1% wastage 19 SSC Infusion (0434181) Net content in export + 1% wastage 24 SSC Injection (Art. 0434371) Net content in export + 1% wastage 29 SF9-11 195/135 Prim film Art.0369621) Net content in export + 1% wastage 31 OFR2-11 120/524-500 ml and 1000 ml (0369681) Net content in export + 1% wastage 39 UFR2-11 150/524-50 ml to 1000 (0369661) Net content in export + 1% wastage 44 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage 5 Sodium Chloride (SANAL) (EP) 9.45 gm. 10 BOP Infusion (Art.No 0434171) Net content in export + 1% wastage Sodium Chloride 0.9% 1000 ml 1 Number UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

34 15 BOP Injection (Art. 0434481) Net content in export + 1% wastage 20 SSC Infusion (0434181) Net content in export + 1% wastage 25 SSC Injection (Art. 0434371) Net content in export + 1% wastage 30 SF9-11 195/140 Prim. film (Art.0369631) Net content in export + 1% wastage 32 OFR2-11 120/524-500 ml and 1000 ml (0369681) Net content in export + 1% wastage 40 UFR2-11 150/524-50 ml to 1000 (0369661) Net content in export + 1% wastage 45 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage

Case No. 50 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name DINAKARA LIFE SCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000178AM27 RA File Number 09AX04000270 AM25 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

35 Licence No and Date 0911007602/18/07/2024 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. 51 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name ALEMBIC PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002051AM25 RA File Number 34AX04000849 AM24 Licence No and Date 3411005190/22/07/2024 The Representative of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the firm was advised to submit the following documents:- Copy of Shipping Bill and Bill of Entry 1. Justification for description on of import and export item which are not matching with Drug Manufacturing Licence (DML). 2.

Case No. 52 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name PRIVI SPECIALITY CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000632AM27 RA File Number 03AX04002117 AM25 Licence No and Date 0311036002/01/08/2024 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 53 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name JUBILANT INGREVIA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002279AM25 RA File Number 05AX04001164 AM25 Licence No and Date 0511026980/02/08/2024 indicated below.:-

Export Product Qty. Qty. allowed. 1 Alumino Silicate Catalyst 0.019 kg. 2 Denatured Ethyl Alcohol 1.13 kg. 3 Methanol 0.70 kg. 4 Thionyl Chloride 1.44 kg. 5 Dimethyl Formamide 0.886 kg. 4-(Dimethyl Amino)-Pyridine 1 kg. 6 Toluene 0.203 kg. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 54 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name CHROMO LABORATORIES INDIA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00006640AM26 RA File Number 09AX04000325 AM25 Licence No and Date 0911007740/14/08/2024 Appendix-4E. After detailed deliberations and in view of the recommendations of the Technical

The commercial value of by-product Acetone obtained during process, supported by invoice/s.

Case No. 55 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name USV PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000518AM26 RA File Number 03AX04002550 AM25 Licence No and Date 0311036761/29/08/2024 observed that the norms given are based on approved composition in 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. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 56 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name PRIVI FINE SCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000633AM27 RA File Number 03AX04002673 AM25 Licence No and Date 0311036880/04/09/2024

Case No. 57 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name PRIVI FINE SCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000635AM27 RA File Number 03AX04002672 AM25 Licence No and Date 0311036881/04/09/2024

Case No. 58 / NC/3/MEET/May/202627/3 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

39 Case Status Case Deferred Party Name MEDIPRAT INTERNATIONAL (INDIA) Meeting Number and Date HQ File Number HQRNORM APPLY 00002899AM25 RA File Number 05AX04001556 AM25 Licence No and Date 0511027587/06/09/2024 the imported inputs bulk Deproteinzed Calf Serum Extract Solution 200 mg/ml to make Protoseril (Deproteinized Calf Blood Extract each 1 ml. contains 40 mg/1 ml. Injections of various strength. It is also not clear, how the import item is used in manufacturering of export item. After detailed deliberations and in view of the recommendations of the Technical

Give all the steps in the form of flow chart with a mention of wastage incurred at each step. 1. Provide the information on marker and Certificate of Analysis (CoA) to confirm that an import item has 200 mg/ml of Deproteinzed Calf Serum Extract Solution. 2.

Case No. 59 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name METROCHEM API PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00003039AM25 RA File Number 09AX04000248 AM25 Licence No and Date 0911007949/13/09/2024 indicated below.:-

Export Product Qty. Qty. allowed. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

40 1 3R,5R)-5-(2,4-difluorophenyl)-5- (iodomethyl) tetrahydrofuran-3-yl) methanol 0.855 kg. 2 2-[(1S,2S)-1-ethyl-2-bezyloxypropyl]- 2,4-dihydro-4-[4-[4-(4- hydroxyphenyl)-1- piperazinyl]phenyl]- 3H-1,2,4- Triazol-3-one 1.23 kg. 3 (S)-Methyl Lactate Not required 4 Dichloromethane / Metrhylene dichloride 2.00 kg. 5 Methanol 1.50 kg. 6 Palladium metal Not shown in reaction Posaconazole 1 kg. 7 Iso propyl alcohol 2.00 kg.

Case No. 60 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00006694AM26 RA File Number 05AX04001968 AM25 Licence No and Date 0511027793/18/09/2024 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

41 observed that the norms given are based on approved composition in 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. 61 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00003178AM25 RA File Number 05AX04001863 AM25 Licence No and Date 0511027857/20/09/2024 The representative of the firm attended the personal hearing and presented the firm's case. Upon examination, the Committee observed that several inputs sought under the authorisation do not appear to be used in the manufacture of the export product. Accordingly, the firm was advised to get the authorisation suitably amended to align the approved inputs with the actual manufacturing requirements of the export product

Case No. 62 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00003321AM25 RA File Number 05AX04002052 AM25 Licence No and Date 0511028003/27/09/2024 The representative of the firm attended the personal hearing and presented the firm's case. Upon examination, the firm was advised to get the authorisation suitably amended to align the approved inputs with the actual manufacturing requirements of the export product. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 63 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name BVC SPECIALITIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000280AM27 RA File Number 34AX04000497 AM25 Licence No and Date 3411005487/03/10/2024

Case No. 64 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name BVC SPECIALITIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000281AM27 RA File Number 34AX04000550 AM25 Licence No and Date 3411005489/03/10/2024

Case No. 65 / NC/3/MEET/May/202627/3 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

43 Case Status Case Approved Party Name ENALTEC LABS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00003514AM25 RA File Number 03AX04003311 AM25 Licence No and Date 0311037686/07/10/2024 same export product/import item in meeting No.NC/3/MEET/Apr/202627/2 dated 28/04/2026 against advance authorization No.0311041804 dated 04/03/2025, it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Qty. allowed. Midodrine Hydrochloride USP 1 kg. 1 2-Amino-1- (2,5dimethoxyphenyl) ethanone hydrochloride 1.76 kg.

Case No. 66 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name ENCEE AROMATICS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005418AM26 RA File Number 32AX04000460 AM25 Licence No and Date 3211007682/08/10/2024 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 67 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name BVC SPECIALITIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000282AM27 RA File Number 34AX04000564 AM25 Licence No and Date 3411005540/15/10/2024

Case No. 68 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name BVC SPECIALITIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000283AM27 RA File Number 34AX04000597 AM25 Licence No and Date 3411005544/16/10/2024 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 69 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name ETERNIS FINE CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000254AM27 RA File Number 03AX04003565 AM25 Licence No and Date 0311038045/18/10/2024

Case No. 70 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00000537AM27 RA File Number 52AX04000217 AM25 Licence No and Date 5211010354/18/10/2024 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. 71 / NC/3/MEET/May/202627/3 Case Status Case Rejected UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

46 Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004476AM26 RA File Number 05AX04002457 AM25 Licence No and Date 0511028610/28/10/2024 observed that the norms given are based on approved composition in 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. 72 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ASTA BIOCHEMICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00004300AM25 RA File Number 07AX04001295 AM25 Licence No and Date 0711012868/22/11/2024 same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026 against advance authorization No.0711014690 dated 11/06/2025, it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Calcium Thioglycolate 1 kg. 1 Thioglycolic Acid 0.927 kg.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 73 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name ADCOCK INGRAM LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00004318AM25 RA File Number 07AX04001351 AM25 Licence No and Date 0711012875/22/11/2024 The committee considered the application of the firm and it has been observed that various opportunities were given to firm but the firm has not appeared for personal hearing before committee to explain their case, therefore, the committee decided to reject the application of the firm.

Case No. 74 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00006699AM26 RA File Number 05AX04002820 AM25 Licence No and Date 0511029128/22/11/2024 observed that the norms given are based on 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. 75 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ZYDUS LIFESCIENCES LIMITED UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

48 Meeting Number and Date HQ File Number HQRNORM APPLY 00005503AM26 RA File Number NA Licence No and Date 0811013677/02/01/2025 same export product/import item in meeting No.NC/3/MEET/Nov/202425/10 dated 22/11/2024 against DGFT (HQ) File No.HQRNORMAPPLY00003140AM25, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 AZITHROMYCIN DIHYDRATE USP 330.12 mg. AZITHROMYCIN ORAL SUSPENSION USP 100MG/5ML (300MG/15ML BOTTLE) ((ACTIVE INGREDIENT: AZITHROMYCIN DIHYDRATE USP EQUIVALENT TO AZITHROMYCIN USP - NET WT. 132.597 KGS)) 1 Number 2 SUCROSE NF FINE GRADE (COMPRESSUC PS) 11616.00 mg. 3 AZITHROMYCIN DIHYDRATE USP 660.24 mg. AZITHROMYCIN ORAL SUSPENSION USP 200MG/5ML (600MG/15ML BOTTLE) ((ACTIVE INGREDIENT: AZITHROMYCIN DIHYDRATE USP EQUIVALENT TO AZITHROMYCIN USP - NET WT. 530.382 KGS)) 1 Number 4 SUCROSE NF FINE GRADE (COMPRESSUC PS) 11616.00 mg. 5 AZITHROMYCIN DIHYDRATE USP 990.36 mg. AZITHROMYCIN ORAL SUSPENSION USP 200MG/5ML (900MG/22.5ML BOTTLE) ((ACTIVE INGREDIENT: AZITHROMYCIN DIHYDRATE USP EQUIVALENT TO AZITHROMYCIN USP - NET WT. 278.973 KGS)) 1 Number 6 SUCROSE NF FINE GRADE (COMPRESSUC PS) 17424.00 mg. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

49 7 AZITHROMYCIN DIHYDRATE USP 1320.48 mg. AZITHROMYCIN ORAL SUSPENSION USP 200MG/5ML (1200MG/30ML BOTTLE) ((ACTIVE INGREDIENT: AZITHROMYCIN DIHYDRATE USP EQUIVALENT TO AZITHROMYCIN USP - NET WT. 2174.778 KGS)) 1 Number 8 SUCROSE NF FINE GRADE (COMPRESSUC PS) 23232.00 mg.

Case No. 76 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name VIVA CORPORATION PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001034AM26 RA File Number 03AX04000827 AM26 Licence No and Date 0311044162/23/05/2025 indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Calcium Laurate 1 kg. 1 Lauric Acid 0.947

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 77 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ZENITH DYEINTERMEDIATES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00003610AM26 RA File Number NA Licence No and Date 0311044458/04/06/2025 same export product/import item in meeting No.NC/3/MEET/Aug/202425/8 dated 28/08/2024 against Advance Authorisation No.0311033314 dated 24/04/2024, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. NAS-5((2-DIAZO-1- NAPTHOL-5-SULFONIC ACID, SODIUM SALT)) 1 kg. 1 Tobias Acid (Purity 97%) 0.70 kg.

Note: NC also decided to make new SION for the above export product.

Case No. 78 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name AARTI PHARMALABS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001799AM26 RA File Number 03AX04001592 AM26 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

51 Licence No and Date 0311045241/01/07/2025 same export product/import item in meeting No.NC/3/MEET/Jan/202526/5 dated 30/06/2025 against Advance Authorisation No.0311038930 dated 22/11/2024, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Theophylline (Anhydrous) 1 kg. 1 Cyano Acetic Acid 70% 0.89 kg.

Note: NC also decided to make new SION for the above export product.

Case No. 79 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name RISHABH METALS & CHEMICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001800AM26 RA File Number 03AX04001508 AM26 Licence No and Date 0311045242/01/07/2025 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:
Specific nitrile function compound to be exported with its structural formula and molecular weight.
1. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

52 2. Specific items to be imported since other items are shown indiginous

Case No. 80 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name SIDDHARTH CARBOCHEM PRODUCTS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001801AM26 RA File Number 03AX04001472 AM26 Licence No and Date 0311045243/01/07/2025 indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 SALICYLIC ACID 0.661 kg. 2 N HEXANOL 0.636 kg. HEXYL SALICYLATE 1 kg. 3 HDPE RESIN PACKING Relevant, as per Packing Policy & General Notes.

Case No. 81 / NC/3/MEET/May/202627/3 Case Status Case Approved UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

53 Party Name LEBEN LABORATORIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001805AM26 RA File Number 03AX04001600 AM26 Licence No and Date 0311045250/01/07/2025 indicated below.:-

Export Product Qty. Qty. allowed. Doxyleb Capsule (Doxycycline Capsules Bp) 100 mg. (In Packing of 10 X 10's , 10 x 100's & 1000's. Qty Consumed Of Exempt Material Doxycycline Hyclate BP- 115.400 mg / Capsule.) 1 Number Tablet 1 Doxycycline Hyclate BP 117.72 mg

Note: NC also decided to make new SION for the above export product.

Case No. 82 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001807AM26 RA File Number 09AX04000309 AM26 Licence No and 0911009941/01/07/2025 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

54 Date same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026 against Advance Authorisation No.0911009916 dated 26/06/2025, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Qty. allowed. 1 Liraglutide (API- (Water Content - upto 6.4%, Sodium Ion- 1.8%)=8.20%) 19.8 mg/ Vial 2 3.0 mL Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ- Fill Nexa VB 3mL) Relevant, as per Packing Policy & General Notes. 3 BD Vystra Disposable Pen Body Subassembly with Purple Colour Dose Button (VYSTRA BSA FR PL 284C BTN 2685C 50IU) Relevant, as per Packing Policy & General Notes. 4 Pen Printed Cartridge Holder (VYSTRA CARTRIDGE HOLDER PRINTED 0.6-15) Relevant, as per Packing Policy & General Notes. Liraglutide Injection 18 mg/3 ml (6 mg/mL) 1x3's ((Each 3 ml contains Liraglutide 18 mg) Fill Volume- 3.3 ml) 1 Number 5 Pen Cap (VYSTRA CAP PL MODERN 284C) Relevant, as per Packing Policy & General Notes. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 83 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001808AM26 RA File Number 09AX04000308 AM26 Licence No and Date 0911009942/01/07/2025 same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026 against Advance Authorisation No.0911009916 dated 26/06/2025, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Qty. allowed. 1 Liraglutide (API- (Water Content - upto 6.4%, Sodium Ion- 1.8%)=8.20%) 19.8 mg/ Vial 2 3.0 mL Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ- Fill Nexa VB 3mL) Relevant, as per Packing Policy & General Notes. Pen Body Subassembly Relevant, as per Packing Liraglutide Injection 18 mg/3 ml (6 mg/mL) 1x3's ((Each 3 ml contains Liraglutide 18 mg) Fill Volume- 3.3 ml) 1 Number 3 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

56 with Purple Colour Dose Button (VYSTRA BSA FR PL 284C BTN 2685C 50IU) Policy & General Notes. 4 Pen Printed Cartridge Holder (VYSTRA CARTRIDGE HOLDER PRINTED 0.6-15) Relevant, as per Packing Policy & General Notes. 5 Pen Cap (VYSTRA CAP PL MODERN 284C) Relevant, as per Packing Policy & General Notes.

Case No. 84 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name CAPTAVIS BIOCARE PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001824AM26 RA File Number 08AX04000527 AM26 Licence No and Date 0811015452/02/07/2025 Copy of Drug Manufacturing Licence (DML). 1. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

57 Copy of Master Batch Formula. 2.

Case No. 85 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001877AM26 RA File Number 52AX04000088 AM26 Licence No and Date 5211014866/04/07/2025 same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026 against Advance Authorisation No.5211005508 dated 21/08/2023, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Tert-Butyl((1S)-2-hydroxy-1- methylethyl) carbamate 1.70 kg. 2 Diisopropyl azodicarboxylate 1.96 kg. 4-{1- [(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile) 1 kg. 3 Triphenylphosphine 2.54 kg.

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

Case No. 86 / NC/3/MEET/May/202627/3 Case Status Case Approved UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

58 Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001880AM26 RA File Number 03AX04001691 AM26 Licence No and Date 0311045385/05/07/2025 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 1 Medical Cream, Ointment, Gel (Fluorouracil Cream 5% 15 Gm Tot Wt 6378.11 Kgs, Net Cont: 5-Fluorouracil 318.90 Kgs,Stearyl Alco 956.71 Kgs, Propylene 765.37 Kgs, Methyl para 1.91 Kgs, Propyl para 1.27 Kgs, Tween 60 318.90 Kgs, white petrolatum 1403.18 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.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 87 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name LEBEN LABORATORIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001898AM26 RA File Number 03AX04001714 AM26 Licence No and Date 0311045358/07/07/2025 same export product/import item in meeting No.NC/3/MEET/May/202526/3 dated 04/06/2025 against Advance Authorisation No.0311038087 dated 21/10/2024, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Qty. allowed. Moxileb-250 dt.Amoxicillin Tablet 250 mg ((Each Tablet Containing Amoxicillin Trihydrate Equivalent To 250 mg of Amoxicillin ). Net Content of Import/Exempt Material Used In Export Product 1)Amoxicillin Trihydrate BP (Compacted) -157.853 kgs (Excl 2% Wastage)) 1 Number 1 Amoxicillin Trihydrate BP Compacted 292.639 mg. Moxileb-250 Capsule. (Amoxicillin Capsule 250 mg) ((Each Capsule Containing Amoxicillin Trihydrate Equovalent To 250 mg of Amoxicillin). Net Content of Import/Exempt Material Used In Export Product 1) Amoxicillin Trihydrate BP (Compacted) -1205.402 kgs (Excl 2% Wastage)) 1 Number 2 Amoxicillin Trihydrate BP Compacted 292.639 mg. Moxileb-500 Capsule. (Amoxicillin Amoxicillin 1 Number 3 585.28 mg. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

60 Capsule 500 mg). ((Each Capsule Containing Amoxicillin Trihydrate Equivalent To 500 mg of Amoxicillin). Net Content of Import/Exempt Materialused In Export Product 1) Amoxicillin Trihydrate BP (Compacted) -5737.13 kgs (Excl 2% Wastage)) Trihydrate BP Compacted Moxileb Oral Suspension Amoxicillin Oral Suspension (Amoxicillin Syrup) 125 mg/100 ml Bottle. ((Each 5 ml Contains Amoxicillin Trihydrate Euqivalent To 125 mg of Amoxicillin). Net Content of Import/Exempt Material Used In Export Product 1) Amoxicillin Trihydrate BP - (Compacted) - 60.264 kgs (Excl 2% Wastage)) 1 Number 4 Amoxicillin Trihydrate BP Compacted 2625.00 mg. Moxileb Oral Suspension. Amoxicillin Oral Suspension (Amoxicillin Syrup) 250 Mg /100 ml Bottle. ((Each 5ml Contains Amoxicillin Trihydrate Equivalent To 250 mg of Amoxicillin). Net Content of Import/Exempt Material Used In Export Product 1) Amoxicillin Trihydrate BP (Compacted) - 120.54 Kgs (Excl 2% Wastage).) 1 Number 5 Amoxicillin Trihydrate BP Compacted 5250.00 mg.

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

Case No. 88 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM APPLY 00001901AM26 RA File Number 05AX04001216 AM26 Licence No and Date 0511033709/07/07/2025 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

61 indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Naloxone Hydrochloride Injection USP, 0.4 mg /ml 1 Number 1 Naloxone Hydrochloride USP 0.44 mg/Vial

Case No. 89 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM APPLY 00001904AM26 RA File Number 05AX04001205 AM26 Licence No and Date 0511033713/07/07/2025 same export product/import item in meeting No.NC/3/MEET/Jun/202526/5 dated 30/06/2025 against Advance Authorisation No.0511029128 dated 22/11/2024, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

62 Tobramycin Inhalation Solution, 300 mg/ 4ml 1 Number Pack 1 Tobramycin USP 315 mg./Vial Tobramycin Inhalation Solution, 300 mg/ 5ml 1 Number Pack 2 Tobramycin USP 315 mg./Vial

Case No. 90 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM APPLY 00001905AM26 RA File Number 05AX04001215 AM26 Licence No and Date 0511033716/07/07/2025 same export product/import item in meeting No.NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance authorization No. 0511027509 dated 03/09/2024 , it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Atropine Sulphate Ophthalmic Solution USP, 1% 5 ml. 1 Number 1 Atropine Sulphate 51.00 mg.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 91 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name FDC LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001907AM26 RA File Number 03AX04001485 AM26 Licence No and Date 0311045423/07/07/2025 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:-

Export description is not matching with the composition given in Drug Manufacturing Licence (DML). I. Import quantity not matching with Drug Manufacturing Licence approved composition. II.

Case No. 92 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001915AM26 RA File Number 03AX04001681 AM26 Licence No and Date 0311045442/07/07/2025 indicated below.:-

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

64 Export Product Qty. Qty. allowed. Secnol (Secnidazole Sachet 2 gm) (Net content of Secnidazole IH 2 mg) 1 Number 1 Secnidazole IH 2.00 gm/Sachet

Case No. 93 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name BEST VALUE CHEM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001917AM26 RA File Number 34AX04000306 AM26 Licence No and Date 3411006695/07/07/2025 The firm was initially granted an Advance Authorisation for the export product “CIS-3-Hexenyl Salicylate” 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. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 94 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name BEST VALUE CHEM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001918AM26 RA File Number 34AX04000297 AM26 Licence No and Date 3411006696/07/07/2025 The firm was initially granted an Advance Authorisation for the export product “CIS-3-Hexenyl Acetate” 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. 95 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001920AM26 RA File Number 07AX04000553 AM26 Licence No and Date 0711014962/07/07/2025 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Complete chemical reaction, indicating molecular weight of reactant/s and product/s with overall yield of the reaction for the export item. 1. To indicate indigenous item/s in Annexure to Appendix-4E table. 2.

Case No. 96 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name VENUS REMEDIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001929AM26 RA File Number 30AX04000224 AM26 Licence No and Date 3011007307/08/07/2025 indicated below.:-

Export Product Qty. Qty. allowed. MEROPENEM 500 mg Powder for Solution for Injection or Infusion (Each Vial Contains: Active Pharmaceutical Ingredients Meropenem Trihydrate equivalent to Meropenem Anhydrous 1 Number 1 Meropenem and Sodium Carbonate (Sterile Bulk) 0.6726 gm. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

67 ...500 mg , Excipients : Anhydrous Sodium carbonate ph.Eur ....104 mg equivalent to 45.1mg of Sodium) MEROPENEM 1000 mg Powder for Solution for Injection or Infusion (Each Vial Contains: Active Pharmaceutical Ingredients Meropenem Trihydrate equivalent to Meropenem Anhydrous ...1000 mg , Excipients : Anhydrous Sodium carbonate ph.Eur ...208 mg equivalent to 90.2 mg of Sodium ) 1 Number 2 Meropenem and Sodium Carbonate (Sterile Bulk) 1.345 gm. 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 180.4 mg of Sodium ) 1 Number 3 Meropenem and Sodium Carbonate (Sterile Bulk) 2.690 gm.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

68 Case No. 97 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name RAJASTHAN ANTIBIOTICS LTD Meeting Number and Date HQ File Number HQRNORM APPLY 00001934AM26 RA File Number 05AX04001195 AM26 Licence No and Date 0511033746/08/07/2025 indicated below.:-

Export Product Qty. Qty. allowed. Vancomycin Hydrochloride IP/ BP/ USP (Sterile Powder) 1 kg. 1 Vancomycin HCL Non-Sterile 1.01 kg.

Case No. 98 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001935AM26 RA File Number 03AX04001747 AM26 Licence No and Date 0311045467/08/07/2025 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 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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

Sl. No. Export Product Quantity 1 Medical Ointment & Cream("Fluorouracil Topical Solution USP 5%, 10 ml Total Nt Wt. 250 Kgs ( fluo 12.50 Kgs, ede 0.13 kgs, met 0.25, gly 119.76,

para 0.08 Kgs, tro 21 kgs, hyd 6.25 kg, bot 25000, drop 25000, cap

25000)") 1 Number 2 Medical Ointment & Cream (Fluorouracil Cream USP 5% 40 Gm Total Nt Wt.14000 Kgs (fluo700 Kgs,wh petro2940 kgs, pro gly 1680 Kgs, stearyl alco 2100, poly 560 Kgs, pro para 2.1 kgs, methyl 3.5 Kgs)) 1 Number

The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption. i.

Case No. 99 / NC/3/MEET/May/202627/3 Case Status Case Approved UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

70 Party Name HELLO AROMATICS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001946AM26 RA File Number 05AX04001143 AM26 Licence No and Date 0511033752/08/07/2025 The Committee examined the request of the firm for fixation of ad-hoc norms . After due indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Thymol (Thymol Above 99%) 1 kg. 1 M CRESOL (Meta Cresol Above 99%) 0.818 kg.

Case No. 100 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name REYAANSH HEALTHCARE Meeting Number and Date HQ File Number HQRNORM APPLY 00001948AM26 RA File Number 03AX04001780 AM26 Licence No and Date 0311045487/08/07/2025 indicated below.:- UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

    Export Product

Qty. Qty. allowed. Fluralaner & Moxidectin Spot On 0.40 ml Tube (Each ml Contains Fluralaner 280 mg + Moxidectin 14 mg. Net Quantity of Moxidectin Consumed Including Wastages & Overages : 0.300 Kgs ( Net Content of Moxidectin 0.2727 KGS )) 1 Number 1 Moxidectin 5.712 mg. Fluralaner & Moxidectin Spot On 0.90 ml Tube. (Each ml Contains Fluralaner 280 mg + Moxidectin 14 mg. Net Quantity of Moxidectin Consumed Including Wastages & Overages : 0.700 Kgs (Net Content of Moxidectin 0.6364 KGS )) 1 Number 2 Moxidectin 12.852 mg. Fluralaner & Moxidectin Spot On 1.80 ml Tube (Each ml Contains Fluralaner 280 mg + Moxidectin 14 mg. Net Quantity of Moxidectin Consumed Including Wastages & Overages : 1.300 Kgs (Net Content of Moxidectin 1.1818 KGS )) 1 Number 3 Moxidectin 25.704 mg.

Case No. 101 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name SAGA LIFESCIENCES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001952AM26 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

72 RA File Number 08AX04000582 AM26 Licence No and Date 0811015528/08/07/2025 indicated below.:-

    Export Product

Qty. Qty. allowed. 1 Diosmin 459.00 mg. Diosmin and Hesperidin Tablets 500 mg. 1 Number 2 Hesperidin 51.00 mg.

Case No. 102 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name MICRO LABS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001953AM26 RA File Number 07AX04000609 AM26 Licence No and Date 0711014972/08/07/2025 indicated below.:-

    Export Product

Qty. Qty. allowed. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

73 Dicloxacillin Capsules 250 mg 1 Number 1 Dicloxacillin Sodium BP/EP/USP 267.5 mg/250 mg capsule Dicloxacillin Capsules 500 mg 1 Number 2 Dicloxacillin Sodium BP/EP/USP 535.0 mg/500 mg Capsule

Case No. 103 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name MICRO LABS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001954AM26 RA File Number 07AX04000616 AM26 Licence No and Date 0711014973/08/07/2025 same export product/import item in meeting No.NC/3/MEET/Sep/202526/8 dated 17/09/2025 against advance authorization No. 0711013517 dated 30/01/2025, it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Ramelteon 8 mg Tablets 1 Number Tablet 1 Ramelteon 8.16 mg/Tablet

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 104 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name MICRO LABS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001955AM26 RA File Number 07AX04000613 AM26 Licence No and Date 0711014976/08/07/2025 same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026 against advance authorization No. 0711014615 dated 03/06/2025, it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Phloroglucinol 160 mg OD Tablets 1 Number 1 Phloroglucinol Dihydrate BP/EP/IP/USP 163.2 mg.

Case No. 105 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name SENTISS PHARMA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001978AM26 RA File Number 05AX04001234 AM26 Licence No and Date 0511033779/09/07/2025 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

75 same export product/import item in meeting No.NC/3/MEET/Feb/202526/13 dated 20/02/2026 against advance authorization No. 0511032964 dated 28/05/2025, it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Qty. allowed. Visallergol Eye Drops 0.2%, 2.5ml (Each vials of Visallergol Contains 5 mg of Olopatadine 1 Number 1 Olopatadine HCL 5.61 mg Oftahist Eye Drops 0.1% 5 ml (OFTHAHIST (Olopatadine Eye Solution 0.1% in 5ml Vial) (Each Vials of Oftahist contains 5mg of Olopatadine)) 1 Number 2 Olopatadine HCL 5.61 mg

Case No. 106 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name MERIDIAN ENTERPRISES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001998AM26 RA File Number 03AX04001810 AM26 Licence No and Date 0311045558/10/07/2025 same export product/import item in meeting No.NC/3/MEET/Feb/202526/13 dated 20/02/2026 against advance authorization No. 0511032964 dated 28/05/2025, it was decided to fix ad-hoc UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

76 whichever is less:-

    Export Product

Qty. Qty. allowed. Dequalinium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent (net content of Input per ml=5mg,Net content per 25ml bottle = 125 mg Total net content = 3.00Kgs)) 1 Number 1 Dequalinium Chloride 127.50 mg.

Case No. 107 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name LEE PHARMA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002005AM26 RA File Number 09AX04000022 AM26 Licence No and Date 0911010000/10/07/2025 same export product/import item in meeting No.NC/3/MEET/Jun/202526/5 dated 30/06/2025 against advance authorization No. 0911008677 dated 20/12/2024, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

77 1 4-Chloro-6-Ethyl-5-Fluoropyrimidine 3.30 kg. 2 Tetrahydrofura 20.50 kg. Voriconazole 1 kg. 3 L Camphor Sulfonic Acid((R)(-)- Camphorsulphonic Acid) 1.01 kg.

Case No. 108 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name LA CHANDRA PHARMALAB PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002006AM26 RA File Number 08AX04000617 AM26 Licence No and Date 0811015546/10/07/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to Stepwise complete and balanced chemical reactions showing molecular weight and percentage of yield on molar basis. I. Copy of Technical Literature/Justification for low yield of 21% in last stage of flow-charts. II.

Case No. 109 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name CALYX CHEMICALS AND PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002020AM26 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

78 RA File Number 03AX04001789 AM26 Licence No and Date 0311045608/11/07/2025 same export product/import item in meeting No.NC/3/MEET/Jun/202526/5 dated 30/06/2025 against advance authorization No. 0911008677 dated 20/12/2024, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Artemether 1 kg. 1 Artemisinin 1.04 kg.

Case No. 110 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name OPTIMUS DRUGS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002045AM26 RA File Number 09AX04000384 AM26 Licence No and Date 0911010015/14/07/2025 indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

79 1 1-Tert-Butyl 3-Methyl 4-Oxo Piperidine-1,3- Dicarboxylate 0.979 kg. 2 Benzyl Bromide 0.68 kg. 3 Tetra Hydro Furan (THF) 3.06 kg. 4 N-Heptane 7.83 kg. 5 Potassium Carbonate [K2CO3] 1.27 kg. 6 Acetic Acid 0.225 kg. 7 2-Methyl THF 5.60 kg. 8 MMH 80% Solution 0.215 kg. Tert-Butyl 2-Methyl-3-Oxo- 3a-Benzyl-2H-4, 5, 6, 7, 3a- Pentahydro-5-Azaindazole-5- Carboxylate 1 kg. 9 Sodium Bicarbonate [NAHCO3] 0.39 kg.

Case No. 111 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002059AM26 RA File Number 08AX04000625 AM26 Licence No and Date 0811015572/14/07/2025 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

80 Authority, the Committee decided to ask the firm to furnish the following documents:- Drug Manufacturing Licence (DML) for export item No.3 and 4 are not given. 1. Import quantity applied for export item No. 3 and 4 are not matching with composition shown in export description. 2. Firm may be advised to get their Advance Authorisation amended with all corrections.
3.

Case No. 112 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name USV PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002062AM26 RA File Number 03AX04001851 AM26 Licence No and Date 0311045646/14/07/2025 same export product/import item in meeting No.NC/3/MEET/feb/202526/13 dated 20/02/2026 against advance authorization No. 031144099 dated 22/05/2025, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Idezar 150 mg Tablets 28 S (Irbesartan Tablets 150 Mg 28 S )((45,525 Boxes X 28 Tablets per Boxes = 12,74,700 Tablets) (Total Weight of Export Product = 191.205 Kgs) (Exempts imported input / material weight inclusive of wastage = 200.440 Kgs)) 1 Number 1 Irbesartan Ph. Eur 153.0 mg. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 113 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name USV PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002063AM26 RA File Number 03AX04001854 AM26 Licence No and Date 0311045647/14/07/2025 same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026 against advance authorization No. 0311045097 dated 25/06/2025, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Doxycycline Hyclate DR Tablets USP 100 mg , 100 S US((8,250 Bottles X 100 Per Bottles = 8,25,000 Tablets) (Total Weight of Export Product = 82.500 Kgs) (Exempts imported input / material weight inclusive of wastage = 105.262 Kgs)) 1 Number Tablet 1 Doxycycline Hyclate USP 117.72 mg.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 114 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name USV PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002064AM26 RA File Number 03AX04001853 AM26 Licence No and Date 0311045649/15/07/2025 indicated below.:-

Export Product Qty. Qty. allowed. Doxycycline Tablets, USP 100 MG 50 S ((1,40.000 Bottles X 50 Per Bottles = 70,00,000 Tablets) (Total Weight of Export Product = 700.000 Kgs) (Exempts imported input / material weight inclusive of wastage = 757.120 Kgs)) 1 Number 1 Doxycycline USP (Monohydrate) 109.68 mg/100 mg Tablet Doxycycline Tablets, USP 100 MG 500 S ((16,800 Bottles X 500 Per Bottles = 84,00,000 Tablets) (Total Weight of Export Product = 840.000 Kgs) (Exempts imported input /material weight inclusive of wastage = 908.544 Kgs)) 1 Number 2 Doxycycline USP (Monohydrate) 109.68 mg/100 mg Tablet

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 115 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name DEEPAK NITRITE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002104AM26 RA File Number 34AX04000324 AM26 Licence No and Date 3411006740/16/07/2025 The Committee examined the request of the firm for fixation of ad-hoc norms . After due indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 Ethyl Hexanol 0.748 kg. 2 Ethyl Hexyl Nitrate 1 kg. 2 Nitric Acid 98 Percent 0.386 kg.

Case No. 116 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name SAPTAGIR LABORATORIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002111AM26 RA File Number 09AX04000337 AM26 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

84 Licence No and Date 0911010039/16/07/2025 The firm was initially granted an Advance Authorisation for the export product “Ambrogir” 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. 117 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name MACLEODS PHARMACEUTICALS LTD Meeting Number and Date NC/ 3/ MEET/ May/ 202627/ 3 and 26/05/2026 HQ File Number HQRNORM APPLY 00002128AM26 RA File Number 03AX04001857 AM26 Licence No and Date 0311045715/17/07/2025 The Committee examined the request of the firm for fixation of ad-hoc norms . After due indicated below.:-

    Export Product

Qty. Qty. allowed. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

85 1 9,10-Difluoro-2,3- Dihydro-3-Methyl-7- Oxo-(3s)-7h- Pyrido(1,2,3-De)1,4- Benzoxazine-6- Carboxylic Acid (Levofloxacin Q Acid) (KSM of Levofloxacin Hemihydrate) 0.447 gm. LEVOFLOXACIN 500 MG TABLET (each tablet contain Levofloxacin Hemihydrate equivalent to Levofloxacin 500mg) ((1 tablet contain consumed raw material 522.75 mg Levo Hemihydrate made from 547.7 mg 9,10-Difluoro- 2,3-Dihydro-3-Methyl-7-Oxo- (3s)-7h- Pyrido (1,2,3-De)1,4- Benzoxazine-6-Carboxylic Acid (Levo Q Acid) and 438.215 mg 1- Methylpiperazine (N-Methylpiperazine)) 1 Number 2 1-Methylpiperazine (N- Methylpiperazine) (Intermediate of Levofloxacin Hemihydrate) 0.226 gm.

Case No. 118 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name APITORIA PHARMA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002132AM26 RA File Number 09AX04000394 AM26 Licence No and Date 0911010042/17/07/2025 indicated below.:-

Export Product Qty. Sl. No. Import Items Qty. allowed. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

86 1 Diethyl chlorophosphate (or) Diethyl phosphorochloridate 0.620 kg. 2 Methanol (Methyl Alcohol) 5.50 kg. Rivaroxaban 1 kg. 3 Activated Carbon (Carbon Enoanticromos) 0.0322 kg.

Case No. 119 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name DEVI PHARMATECH PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002135AM26 RA File Number 09AX04000330 AM26 Licence No and Date 0911010048/17/07/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to

A balanced chemical reaction, indicating molecular weight of reactant/s and product/s with overall yield of the reaction for the export item.

Case No. 120 / NC/3/MEET/May/202627/3 Case Status Case Rejected Party Name TOJO VIKAS INTERNATIONAL PRIVATE LIMITED UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

87 Meeting Number and Date HQ File Number HQRNORM APPLY 00002152AM26 RA File Number 05AX04001341 AM26 Licence No and Date 0511033928/17/07/2025 The firm was initially granted an Advance Authorisation for the export product “Linalyl Acetate Refined”” 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. 121 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ATUL LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002156AM26 RA File Number 08AX04000663 AM26 Licence No and Date 0811015606/17/07/2025 same export product/import item in meeting No.NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance authorization No. 0811010749 dated 13/02/2024, it was decided to fix ad-hoc UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

88 whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Para Tertiary Butyl Phenol 0.54 kg. Lapox ARD-12 (Reactive Diluent) (4-ter-Butylphenol glycidyl ether) 1 kg. 2 pichlorohydrin 0.48 kg.

Case No. 122 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name NAPROD LIFE SCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002166AM26 RA File Number 03AX04001946 AM26 Licence No and Date 0311045745/18/07/2025 same export product/import item in meeting No.NC/3/MEET/Nov/202324/16 dated 17/11/2023 against advance authorization No. 0311004323 dated 04/06/2021, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Bleomycin Sulfate for Injection 15000 IU (Lyophilised) 1 Number 1 Bleomycin Sulfate PH EUR 10.00 mg. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 123 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name VENUS REMEDIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002169AM26 RA File Number 30AX04000269 AM26 Licence No and Date 3011007397/18/07/2025 same export product/import item in meeting No.NC/3/MEET/Feb/202526/13 dated 20/02/2026
against Advance Authorization No.3011007033 dated 27/05/2025 , it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Qty. allowed. Ceftriaxone powder for solution for injection 500 mg (Each vial contains: Ceftriaxone Sodium equivalent to ceftriaxone...500 mg) 1 Number 1 Ceftriaxone Sodium Sterile 580 mg. Ceftriaxone powder for solution for injection1000 mg (Each vial contains: Ceftriaxone sodium Equivalent to ceftriaxone..1000 mg) 1 Number 2 Ceftriaxone Sodium Sterile 1.16 gm. Ceftriaxone powder for solution for injection 2000 mg (Each vial contains: Ceftriaxone sodium equivalent to ceftriaxone..2000 mg) 1 Number 3 Ceftriaxone Sodium Sterile 2.32 gm. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 124 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name VENUS REMEDIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002170AM26 RA File Number 30AX04000270 AM26 Licence No and Date 3011007398/18/07/2025 same export product/import item in meeting No.NC/3/MEET/Oct/202526/9 dated 14/10/2025
against Advance Authorization No. 3011006632 dated 05/03/2025, it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Qty. allowed. Topotecan Hydrochloride for Injection 4.0 mg (Each vial contains: Topotecan Hydrochloride Equivalent to Topotecan ....4 mg) 1 Number 1 Topotecan Hydrochloride 4.78 mg/Vial

Case No. 125 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name KLJ PLASTICIZERS LIMITED. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

91 Meeting Number and Date HQ File Number HQRNORM APPLY 00002173AM26 RA File Number 05AX04001340 AM26 Licence No and Date 0511033947/18/07/2025 same export product/import item in meeting No.NC/3/MEET/Feb/202526/13 dated 20/02/2026
against Advance Authorization No. 0511032197 dated 29/04/2025, it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 Maleic Anhydride 0.67 kg. Di-Ethyl Maleate (DEM) 1 kg. 2 Denatured Ethyl Alcohol 0.65 kg.

Case No. 126 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name KOPRAN RESEARCH LABORATORIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002191AM26 RA File Number 03AX04001883 AM26 Licence No and Date 0311045792/21/07/2025 same export product/import item in meeting No.NC/3/MEET/Jul/202526/6 dated 31/07/2025
against Advance Authorization No. 0311039942 dated 29/12/2024, it was decided to fix ad-hoc UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

92 whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Azithromycin Dihydrate 1 kg. 1 Azithromycin Amine 0.9434 kg.

Case No. 127 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002198AM26 RA File Number 08AX04000640 AM26 Licence No and Date 0811015631/21/07/2025 same export product/import item in meeting No.NC/3/MEET/Jul/202526/6 dated 31/07/2025
against Advance Authorization No. 0811013766 dated 09/01/2025, it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Esmolol Hydrochloride in Sodium Chloride Injection 2,500 mg/250 ml (10 mg/ml) 1 Number 1 Esmolol 2625 mg. Esmolol Hydrochloride in Sodium 1 Number 2 Esmolol 2100 mg. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

93 Chloride Injection [Double Strength] 2,000 mg/100 ml (20 mg/ml)

Case No. 128 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name FDC LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002206AM26 RA File Number 03AX04001970 AM26 Licence No and Date 0311045808/21/07/2025 indicated below.:-

    Export Product

Qty. Qty. allowed. Chloramphenicol Eye Drops 10 Ml ((Each Vial Contains Chloramphenicol Micronized 0.050 gm Net Wt of Bulk Drug is 16 Kgs)) 1 Number 1 Chloramphenicol Micronized (API) 51.00 mg.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

94 Case No. 129 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name CALYX CHEMICALS AND PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002216AM26 RA File Number 03AX04001932 AM26 Licence No and Date 0311045821/21/07/2025 same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026
against Advance Authorization No. 0311045089 dated 25/06/2025, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Artemether 1 kg. 1 Artemisinin 1.04 kg.

Case No. 130 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name PIRAMAL PHARMA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002217AM26 RA File Number 03AX04001986 AM26 Licence No and Date 0311045822/21/07/2025 same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026
against Advance Authorization No. 9311944919 dated 19/06/2025, it was decided to fix ad-hoc UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

95 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.

Case No. 131 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name STERMONE CHEMICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002254AM26 RA File Number 34AX04000381 AM26 Licence No and Date 3411006762/23/07/2025 indicated below.:-

    Export Product

Qty. Qty. allowed. Betamethasone Dipropionate BP/EP/USP 1 kg. 1 Betamethasone 17-Propionate 0.94 kg.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 132 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name STERMONE CHEMICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002256AM26 RA File Number 34AX04000382 AM26 Licence No and Date 3411006764/23/07/2025 indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Clobetasol Propionate BP/EP/USP 1 kg. 1 Betamethasone 17-Propionate 1.08 kg.

Case No. 133 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name DR.ACHARYA LABORATORIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002260AM26 RA File Number 03AX04002004 AM26 Licence No and 0311045883/23/07/2025 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

97 Date

To give yield of the reaction with justification. 1. A balanced chemical reaction indicating molecular weight of tetrahydrofuran (THF). 2. Stoichiometric material balance of the reaction on molar basis. 3.

Case No. 134 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name SHREE BANKEY BEHARI LAL AROMATICS Meeting Number and Date HQ File Number HQRNORM APPLY 00002290AM26 RA File Number 05AX04001415 AM26 Licence No and Date 0511034080/24/07/2025

Certificate of Analysis (CoA) of import item from foreign supplier indicating percentage content of Eucalyptol in import.

Case No. 135 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM APPLY 00002291AM26 RA File Number 05AX04001451 AM26 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

98 Licence No and Date 0511034082/24/07/2025 indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Proparacaine Hydrochloride Ophthalmic Solution USP 0.5%, 15 ml. 1 Number 1 Proparacaine Hydrochloride USP 76.5 mg/Vial

Case No. 136 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name APITORIA PHARMA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002301AM26 RA File Number 09AX04000422 AM26 Licence No and Date 0911010084/25/07/2025 The Committee examined the request of the firm for fixation of ad-hoc norms . After due indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

99 1 7-Amino Des-Acetoxy Cephalosporanic Acid (7-ADCA) 0.6528 kg. 2 Carbon Enoanticromos (Activated Carbon) 0.019 kg. 3 D-phenyl glycine methyl ester Hydrochloride 0.696 kg. 4 Penicillin G Amidase 0.0045 kg. 5 Methylene Chloride 0.1501 kg. Cefalexin Monohydrate 1 kg. 6 Acetone 0.1046 kg.

Note: Revision of SION A-114 as per above proposed norms. i. Suspension of SION A-116 for revision from Penicillin G which is raw material for 6- ADCA. ii.

Case No. 137 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002346AM26 RA File Number 07AX04000756 AM26 Licence No and Date 0711015186/28/07/2025 UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

100 Authority, the Committee decided to ask the firm to furnish the following documents:- A balanced chemical reaction, indicating molecular weight of reactant/s and product/s with yield of the reaction for the manufacture of export item. 1. To indicate indigenous item/s in Annexure to Appendix-4E. 2.

Case No. 138 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name GANPATI PHARMA Meeting Number and Date HQ File Number HQRNORM APPLY 00002350AM26 RA File Number 13AX04000137 AM26 Licence No and Date 1311004092/28/07/2025 indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Tablet Perphenazine 2 mg 1 Number 1 Perphenazine CAS: 58-39-9) 2.04 mg/Tablet Tablet Perphenazine 4 mg 1 Number 2 Perphenazine CAS: 58-39-9) 4.08 mg/Tablet Tablet Perphenazine 8 mg 1 Number 3 Perphenazine CAS: 58-39-9) 8.16 mg/Tablet UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

101

Case No. 139 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ZENITH DYEINTERMEDIATES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00003608AM26 RA File Number NA Licence No and Date 0311045978/28/07/2025 same export product/import item in meeting No.NC/3/MEET/Aur/202425/8 dated 28/08/2024
against Advance Authorization No. 0311033314 dated 24/04/2024, it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. NAS-5((2-DIAZO-1-NAPTHOL-5- SULFONIC ACID, SODIUM SALT)) 1 kg. 1 Tobias Acid (Purity 97%) 0.70 kg.

Note: NC also decided to make new SION for the above export product.

Case No. 140 / NC/3/MEET/May/202627/3 Case Status Case Approved UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

102 Party Name SRI KRISHNA PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002367AM26 RA File Number 09AX04000413 AM26 Licence No and Date 0911010093/29/07/2025 indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Paracetamol & Caffeine 500/65 mg Tablets 1 Number 1 Caffeine Anhydrous Ph.Eur CEP 66.3 mg.

Case No. 141 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002383AM26 RA File Number 09AX04000400 AM26 Licence No and Date 0911010105/29/07/2025 same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026
against Advance Authorization No. 0911009916 dated 26/06/2025, it was decided to fix ad-hoc whichever is less:-

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

103 Export Product Qty. Qty. allowed. 1 Liraglutide(API- (Water content 6.4% and NA 1.80% ) = 8.2 %) 19.8 mg/Vial 2 3.0 mL Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ-Fill Nexa VB 3mL Relevant, as per Packing Policy and General Notes. 3 Pen Body Subassembly with Purple Colour Dose Button (VYSTRA BSA FR PL 284C BTN 2685C 50IU) Relevant, as per Packing Policy and General Notes. 4 Pen Printed Cartridge Holder (VYSTRA CARTRIDGE HOLDER PRINTED 0.6-15) Relevant, as per Packing Policy and General Notes. ARX-LIRAGLUTIDE INJECTION 18 mg/3 ml (6 mg/ml) ((Each 3 ml contains LIRAGLUTIDE 18 Mg) Fill Volume- 3.3 ml. 1 Number 5 Pen Cap (VYSTRA CAP PL MODERN 284C Relevant, as per Packing Policy and General Notes.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

104

Case No. 142 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name CALYX CHEMICALS AND PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002384AM26 RA File Number 03AX04002160 AM26 Licence No and Date 0311046034/29/07/2025 same export product/import item in meeting No.NC/3/MEET/Oct/202526/9 dated 14/10/2025
against Advance Authorization No. 0311042441dated 24/03/2025, it was decided to fix ad-hoc 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.

Case No. 143 / NC/3/MEET/May/202627/3 Case Status Case Approved UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

105 Party Name VEKO CARE PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002392AM26 RA File Number 03AX04002128 AM26 Licence No and Date 0311046045/30/07/2025 indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 Doxycycline Hyclate BP/EP/USP 101.00 gm. NEODOX GOLD WSP (pack Size 1 Kgs Jar) Each gram contains: Doxycycline Hyclate BP/EP/USP 100 mg, (Neomycin Sulfate BP/EP/USP 100 mg Net wt. Doxycycline Hyclate BP/EP/USP 500.00 Kgs Net wt. Neomycin Sulfate BP/EP/USP 500.00 Kgs) 1 Number 3 Neomycin Sulfate BP/EP/USP 101.00 gm. 2 Doxycycline Hyclate BP/EP/USP 10.10 gm. NEODOX -GOLD WSP (pack Size 100 Gms Sachet) Each gram contains: Doxycycline Hyclate BP/EP/USP 100 mg, (Neomycin Sulfate BP/EP/USP 100 mg Net wt. Doxycycline Hyclate BP/EP/USP 250.00 Kgs Net wt. Neomycin Sulfate BP/EP/USP 1 Number 4 Neomycin Sulfate BP/EP/USP 10.10 gm. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

106 250.00 Kgs)

Case No. 144 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name TORRENT PHARMACEUTICALS LTD Meeting Number and Date HQ File Number HQRNORM APPLY 00002395AM26 RA File Number 08AX04000747 AM26 Licence No and Date 0811015732/30/07/2025 same export product/import item in meeting No.NC/3/MEET/Sep/202526/8 dated 17/09/2025
against Advance Authorization No. 0811013820 dated 16/01/2025, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. SEVELAMER CARBONATE FOR ORAL SUSPENSION 2.4 G (SEVELAMER CARBONATE 2.4 GRAM POWDER FOR ORAL SUSPENSION SACHETS) (EACH PACKETS/SACHETS CONTAINS : SEVELAMER CARBONATE FOR ORAL SUSPENSION 2.4 Gram NET CONTENT OF SEVELAMER CARBONATE SHOULD NOT BE LESS THAN 792.00 KG IN EXPORT ITEM) 330000 Numbers 1 Sevelamer Carbonate

831.60 kg. UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

107

Case No. 145 / NC/3/MEET/May/202627/3 Case Status Case Deferred Party Name ADCOCK INGRAM LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002411AM26 RA File Number 07AX04000792 AM26 Licence No and Date 0711015226/30/07/2025 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. 146 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name PIRAMAL PHARMA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002417AM26 RA File Number 03AX04002124 AM26 Licence No and Date 0311046087/31/07/2025 same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026
against Advance Authorization No. 0311044919 dated 19/06/2025, it was decided to fix ad-hoc whichever is less:-

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

108 Export Product Qty. Sl. No. Import Items Qty. allowed. Vibegron (Gemtesa/ Obgemsa) Tablets 75 mg 1 Number 1 Vibegron 76.50 mg.

Case No. 147 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ALCHEMIE FINECHEM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002421AM26 RA File Number 03AX04001481 AM26 Licence No and Date 0311046100/31/07/2025 indicated below.:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 Para Toluidine 0.956 kg. AF131-1(NMPT) (AF131-1 (N,Methyl Para Toluidine)) 1 kg. 2 Methanol 0.286 kg.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

109

Case No. 148 / NC/3/MEET/May/202627/3 Case Status Case Approved Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002426AM26 RA File Number 09AX04000399 AM26 Licence No and Date 0911010140/31/07/2025 same export product/import item in meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026 against Advance Authorisation No.0911009916 dated 26/06/2025, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Qty. allowed. 1 Liraglutide (API- (Water Content - upto 6.4%, Sodium Ion- 1.8%)=8.20%) 19.8 mg/ Vial 2 3.0 mL Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ- Fill Nexa VB 3mL) Relevant, as per Packing Policy & General Notes. 3 Pen Body Subassembly with Purple Colour Dose Button (VYSTRA BSA FR PL 284C BTN 2685C 50IU) Relevant, as per Packing Policy & General Notes. Liraglutide Injection 18 mg/3 ml (6 mg/mL) 1x3's ((Each 3 ml contains Liraglutide 18 mg) Fill Volume- 3.3 ml) 1 Number UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

110 4 Pen Printed Cartridge Holder (VYSTRA CARTRIDGE HOLDER PRINTED 0.6-15) Relevant, as per Packing Policy & General Notes. 5 Pen Cap (VYSTRA CAP PL MODERN 284C) Relevant, as per Packing Policy & General Notes.

UDIN00197896AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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