IN FORCE Advance Authorisation

DGFT 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 Email Office : egtf-dgft@gov.in , Phone Office : 011-23062777

(DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

Meeting No-NC/3/MEET/Apr/202627/2 Meeting Date-28/04/2026 Minutes of the Norms Committee–3 Meeting NC/3/MEET/Apr/202627/2 dated 28/04/2026 (actually held on 07/05/2026) 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) UDIN00148384AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 09-Jun-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 09-Jun-2026 15:43:00 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

by Raman Kumar, Joint DGFT,DGFT(HQ) on 09-Jun-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 09-Jun-2026 15:43:00 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified

2 4 Shri Raman Kumar, Joint DGFT DGFT (HQ) 5 Smt. Skina Rani, FTDO DGFT (HQ)

    The Norms Committee has taken decisions only with respect to technical

aspect/ wastage norms. While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure, including those in notifications, public notices and policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularisation of the case. 4. RAs shall ensure compliance with SION, General Notes and Chapter Notes wherever applicable. 5. RAs shall also ensure that authorization is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard, full compliance with the provisions of

Para 4.12 of FTP, Para 4.16, Para 4.21, and Para 4.51 of HBP shall be made.

Case No. 1 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name BIOLOGICAL E. LIMITED Meeting Number and Date NC/ 3/ MEET/ Apr/ 202627/ 2 and 28/04/2026 HQ File Number HQRNORM APPLY 00000215AM27 RA File Number NA Licence No and Date NA

Norms Committee Decision:

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.

Case No. 2 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ABBOTT HEALTHCARE PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006000AM26 RA File Number NA Licence No and NA UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

3 Date 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/Mar/202425/18 dated 17/03/2025
against advance authorization No.0311035818 dated 25/07/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 Fenofibrate Micronized IH/Ph.Eur 0.3155 kg. Fenofibrate Bulk Granulate 1 kg. 2 Sucrose Ph.Eur 0.3124 kg.

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

Case No. 3 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ABBOTT HEALTHCARE PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006496AM26 RA File Number NA Licence No and Date NA same export product/import item in meeting No.NC/3/MEET/Mar/202425/18 dated 17/03/2025
against advance authorization No.0311035818 dated 25/07/2024, it was decided to fix ad-hoc whichever is less:-

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

/18 dated 17/03/2025
against advance authorization No.0311035818 dated 25/07/2024, it was decided to fix ad-hoc whichever is less:-

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

4 Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Fenofibrate Micronized IH/Ph.Eur 0.3155 kg. Fenofibrate Bulk Granulate 1 kg. 2 Sucrose Ph.Eur 0.3124 kg.

Case No. 4 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name FARMSON BASIC DRUGS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00006380AM26 RA File Number NA Licence No and Date NA 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 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.

Case No. 5 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name FINE ORGANIC INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00006387AM26 RA File Number NA Licence No and Date NA UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

NE ORGANIC INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00006387AM26 RA File Number NA Licence No and Date NA UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

5 decided to reject the case, thereby maintaining the status quo.

Case No. 6 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name MANKIND PHARMA LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004474AM26 RA File Number 05AX04003041 AM23 Licence No and Date 0511016882/17/01/2023 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. 7 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name TOJO VIKAS INTERNATIONAL PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004084AM26 RA File Number 05AX04002999 AM23 Licence No and Date 0511016918/18/01/2023 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:

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents:

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Complete manufacturing process in detail indicating wastage at each stage of manufacture.

Case No. 8 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ABBOTT HEALTHCARE PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004612AM26 RA File Number 03AX04005248 AM23 Licence No and Date 0311020993/27/01/2023 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 Fenofibrate Micronized IH/Ph Eur 147.90 mg. Fenofibrate 145mg tablets)(6,78,60,000 Nos)(Net Content:1) 9955.062KGS 2) 9878.380KGS 3) (Indi):2004.584KGS 4) (Indi):196.115KGS 5) (Indi):681.993KGS 6) (Indi):8864.552KGS 7) (Indi):5778.279KGS 8) (Indi):5067.785KGS 9)(Indi):61.074KGS 10)(Indi): 2015.442KGS ) 1 kg. 2 Sucrose PH.Eur (exepient) 146.45 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

(Indi):5778.279KGS 8) (Indi):5067.785KGS 9)(Indi):61.074KGS 10)(Indi): 2015.442KGS ) 1 kg. 2 Sucrose PH.Eur (exepient) 146.45 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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

Case No. 9 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name COPMED PHARMACEUTICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004587AM26 RA File Number 05AX04003260 AM23 Licence No and Date 0511017390/17/02/2023 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Moxikind-CV 375 Tablets (Amoxicillin and Potassium Clavulanate Tablets BP) 1 Number 1 Amoxicillin Trihydrate (BP / IP (Compacted)) 292.639 mg. Moxikind-CV 625 Tablets (Amoxicillin and Potassium Clavulanate Tablets BP) 1 Number 2 Amoxicillin Trihydrate (BP / IP (Compacted)) 585.278 mg. Moxikind-CV 1000 Tablets (Amoxicillin and Potassium Clavulanate Tablets BP) 1 Number 3 Amoxicillin Trihydrate (BP / IP (Compacted)) 1024.238 mg. Moxikind-CV 457 (Amoxicillin and Potassium Clavulanate Oral suspension BP) 100 ML 1 Number Bottle 4 Amoxicillin Trihydrate (BP / IP (Micronised)) 8400.00 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

lin and Potassium Clavulanate Oral suspension BP) 100 ML 1 Number Bottle 4 Amoxicillin Trihydrate (BP / IP (Micronised)) 8400.00 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

8 Moxikind-CV 228.5 (Amoxicillin and Potassium Clavulanate Oral suspension BP) 100 ML 1 Number Bottle 5 Amoxicillin Trihydrate (BP / IP (Micronised)) 4200.00 mg.

Case No. 10 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name NAVIN FLUORINE ADVANCED SCIENCES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003028AM26 RA File Number 03AX04005808 AM23 Licence No and Date 0311021816/01/03/2023 that the firm has not furnished the requisite technical details as prescribed in Annexure to Justification of low Yield of 44 %. 1.

Case No. 11 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name SHARP MINT LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002034AM26 RA File Number 05AX04003344 AM23 Licence No and Date 0511017592/02/03/2023 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ing Number and Date HQ File Number HQRNORM REVIW00002034AM26 RA File Number 05AX04003344 AM23 Licence No and Date 0511017592/02/03/2023 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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

Copy of shipping bills indicating menthol content in export.

Case No. 12 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name ATUL LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003730AM26 RA File Number 08AX04001977 AM23 Licence No and Date 0811007532/10/03/2023

Case No. 13 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name S KANT CHEMICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004614AM26 RA File Number 03AX04000033 AM24 Licence No and Date 0311022832/17/04/2023 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 14 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004848AM26 RA File Number 05AX04000214 AM24 Licence No and Date 0511018497/25/04/2023 observed that the norms earlier ratified done as per Drug Manufacturing Licence with 2% wastage.

HQRNORM REVIW00004848AM26 RA File Number 05AX04000214 AM24 Licence No and Date 0511018497/25/04/2023 observed that the norms earlier ratified done as per Drug Manufacturing Licence with 2% wastage. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

Case No. 15 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name AZAKEM LABS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004151AM26 RA File Number 09AX04000127 AM24 Licence No and Date 0911005042/17/05/2023 observed that the norms earlier ratified were done as per actual past consumption data. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

Case No. 16 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name ZYDUS LIFESCIENCES LIMITED UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

reby maintaining the status quo.

Case No. 16 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name ZYDUS LIFESCIENCES LIMITED UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

11 Meeting Number and Date HQ File Number HQRNORM REVIW00003199AM26 RA File Number 08AX04000333 AM24 Licence No and Date 0811008323/06/06/2023 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.

Case No. 17 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name BROOKS STERISCIENCE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002351AM26 RA File Number 34AX04000101 AM24 Licence No and Date 3411003857/30/06/2023 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Meropenem for Injection USP 1000 mg 1 Number 1

Sterile Meropenem with Sodium Carbonate USP (Meropenem For Injection (Bulk Sterile Mixture) IP & USP) 1.345 mg. Sterile Meropenem with 1 Number 2 0.6726 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Sodium Carbonate USP (Meropenem For Injection (Bulk Sterile Mixture) IP & USP) 1.345 mg. Sterile Meropenem with 1 Number 2 0.6726 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

12 USP 500 mg Sodium Carbonate USP (Meropenem For Injection (Bulk Sterile Mixture) IP & USP)

Case No. 18 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name BROOKS STERISCIENCE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002352AM26 RA File Number 34AX04000271 AM24 Licence No and Date 3411003892/14/07/2023 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. USP 1000 mg 1 Number 1

Meropenem with Sodium Carbonate USP (Sterile Meropenem trihydrate with sodium carbonate 1.345 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 19 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name ELPPE CHEMICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002786AM26 RA File Number 03AX04001792 AM24 Licence No and Date 0311025670/24/07/2023

Case No. 20 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name KELVIN NATURAL MINT PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004689AM26 RA File Number 05AX04001031 AM24 Licence No and Date 0511019800/31/07/2023 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.

se 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. 21 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002080AM26 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

14 RA File Number 03AX04002029 AM24 Licence No and Date 0311026195/10/08/2023 documents from the firm.

Case No. 22 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name BROOKS STERISCIENCE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002353AM26 RA File Number 34AX04000179 AM24 Licence No and Date 3411004010/10/08/2023 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. USP 1000 mg 1 Number 1

Meropenem with Sodium Carbonate USP (Sterile Meropenem trihydrate with sodium carbonate 1.345 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

owed. USP 1000 mg 1 Number 1

Meropenem with Sodium Carbonate USP (Sterile Meropenem trihydrate with sodium carbonate 1.345 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

15 Case No. 23 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name ATUL LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003736AM26 RA File Number 08AX04000894 AM24 Licence No and Date 0811009108/16/08/2023

Case No. 24 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004843AM26 RA File Number 05AX04001448 AM24 Licence No and Date 0511020507/21/08/2023 same export product/import item in meeting No. NC/3/MEET/Jan/202324/20 dated 18/01/2024
against advance authorization No. 0511018497 dated 25/04/2023, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Ofloxacin Otic Solution, 5 ml (Having net content of 7.01 kg of Bulk Drug) 1 Number 1 Ofloxacin USP 15.30 mg. Ofloxacin Otic Solution, 10 ml 1 Number 2 Ofloxacin USP 30.60 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

content of 7.01 kg of Bulk Drug) 1 Number 1 Ofloxacin USP 15.30 mg. Ofloxacin Otic Solution, 10 ml 1 Number 2 Ofloxacin USP 30.60 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

16 (Having net content of 10.76 kg of Bulk Drug) Ofloxacin Ophthalmic Solution, USP, 5 ml (Having net content of 7.01 kg of Bulk Drug) 1 Number 3 Ofloxacin USP 15.30 mg

Case No. 25 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name PARAGON FINE AND SPECIALITY CHEMICAL LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004546AM26 RA File Number 08AX04000985 AM24 Licence No and Date 0811009232/29/08/2023 that the firm has not furnished the requisite technical details as prescribed in Annexure to

Complete chemical reactions with molecular and structural formula and molecular weight alongwith stage wise percentage yield on molar basis.

Case No. 26 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name CHEMPLAST SANMAR LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005052AM26 RA File Number 04AX04000283 AM24 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ed Party Name CHEMPLAST SANMAR LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005052AM26 RA File Number 04AX04000283 AM24 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

17 Licence No and Date 0411005945/31/08/2023

Case No. 27 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name AMI LIFESCIENCES PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00004969AM26 RA File Number 34AX04000495 AM24 Licence No and Date 3411004147/21/09/2023 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Betahistine Dihydrochloride 1 kg. 1 Pyridine 2 Ethanol 0.931 kg.

Case No. 28 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

18 Meeting Number and Date HQ File Number HQRNORM REVIW00003632AM26 RA File Number 05AX04001798 AM24 Licence No and Date 0511021104/22/09/2023

Case No. 29 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name TIDE INDUSTRIES Meeting Number and Date HQ File Number HQRNORM REVIW00002886AM26 RA File Number 34AX04000582 AM24 Licence No and Date 3411004327/08/11/2023 The committee considered the case as per agenda and it was decided to fix ad-hoc norms as per SION A-3688.

VIW00002886AM26 RA File Number 34AX04000582 AM24 Licence No and Date 3411004327/08/11/2023 The committee considered the case as per agenda and it was decided to fix ad-hoc norms as per SION A-3688.

Case No. 30 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name MEONE HEALTHCARE PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002182AM26 RA File Number 04AX04000678 AM24 Licence No and Date 0411006454/22/11/2023 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

19 that the firm has not furnished the requisite technical details as prescribed in Annexure to Certificate of Analysis (CoA) of export item. 1. Certificate of Analysis (CoA) of import item from foreign supplier. 2. Bill of entry for import item. 3.

Case No. 31 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name BROOKS STERISCIENCE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002354AM26 RA File Number 34AX04000689 AM24 Licence No and Date 3411004418/07/12/2023 indicated below:- Export Product Qty. Sl. No. Import Items Qty. allowed. USP 500 mg 1 Number 1

Meropenem with Sodium Carbonate USP (Sterile Meropenem Trihydrate with sodium Carbonate) 0.6726 mg. USP 1000 mg 1 Number 2 Meropenem with Sodium Carbonate USP (Sterile Meropenem Trihydrate with sodium Carbonate) 1.345 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

26 mg. USP 1000 mg 1 Number 2 Meropenem with Sodium Carbonate USP (Sterile Meropenem Trihydrate with sodium Carbonate) 1.345 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 32 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name AMI LIFESCIENCES PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00004972AM26 RA File Number 34AX04000693 AM24 Licence No and Date 3411004416/07/12/2023

Case No. 33 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name CHEMPLAST SANMAR LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005054AM26 RA File Number 04AX04000830 AM24 Licence No and Date 0411006605/21/12/2023

Case No. 34 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

21 Meeting Number and Date HQ File Number HQRNORM REVIW00003631AM26 RA File Number 05AX04003290 AM24 Licence No and Date 0511023265/15/01/2024

Case No. 35 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004067AM26 RA File Number 52AX04000323 AM24 Licence No and Date 5211007312/08/02/2024 same export product/import item in meeting No. NC/3/MEET/Apr/202627/1 dated 07/04/2026
against advance authorization No. 5211005508 dated 21/08/2023, it was decided to fix ad-hoc whichever is less:-

Export Product Qty. Sl. No. Import Items Qty.

MEET/Apr/202627/1 dated 07/04/2026
against advance authorization 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. Heterocyclic Compounds with Nitrogen atom with an unfused pyrazole ring with hydrogenated in the structure: 4-{1-[(2S)-2- Aminopropyl]-1-H-Pyrazole-3- yl}-2- Chlorobenzonitrile) 1 kg. 3 Triphenylphosphine 2.54 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 36 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004846AM26 RA File Number 05AX04003657 AM24 Licence No and Date 0511023947/13/02/2024 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 that the firm may be advised to explain details given in Appendix-4E and Appendix-4K with copy of Drug Manufacturing Licence.

Case No. 37 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00001844AM26 RA File Number 07AX04001818 AM24 Licence No and Date 0711010595/21/02/2024

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

g Number and Date HQ File Number HQRNORM REVIW00001844AM26 RA File Number 07AX04001818 AM24 Licence No and Date 0711010595/21/02/2024

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 38 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name S KANT CHEMICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004615AM26 RA File Number 03AX04005393 AM24 Licence No and Date 0311031505/27/02/2024

Case No. 39 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002093AM26 RA File Number 03AX04005399 AM24 Licence No and Date 0311031475/28/02/2024 documents from the firm.

Case No. 40 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004844AM26 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

24 RA File Number 05AX04003903 AM24 Licence No and Date 0511024411/08/03/2024 indicated below:- Export Product Qty. Sl. No. Import Items Qty.

0148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

24 RA File Number 05AX04003903 AM24 Licence No and Date 0511024411/08/03/2024 indicated below:- Export Product Qty. Sl. No. Import Items Qty. allowed. Naloxone Hydrochloride Injection USP, 0.4 mg/ml (Having net content of 456.00 gm of Bulk drug (filling volume 1.2ml in each number)) 1 Number 1 Naloxone Hydrochloride USP 0.44 mg.

Case No. 41 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name GALAXY SURFACTANTS LTD Meeting Number and Date HQ File Number HQRNORM REVIW00001919AM26 RA File Number 03AX04005978 AM24 Licence No and Date 0311032511/26/03/2024

Case No. 42 / NC/3/MEET/Apr/202627/2 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

25 Case Status Case Deferred Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002091AM26 RA File Number 03AX04006163 AM24 Licence No and Date 0311032812/04/04/2024 documents from the firm.

Case No. 43 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002085AM26 RA File Number 03AX04006141 AM24 Licence No and Date 0311032832/05/04/2024 documents from the firm.

Case No. 44 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002090AM26 RA File Number 03AX04006162 AM24 Licence No and Date 0311032839/05/04/2024 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ing Number and Date HQ File Number HQRNORM REVIW00002090AM26 RA File Number 03AX04006162 AM24 Licence No and Date 0311032839/05/04/2024 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

26 documents from the firm.

Case No. 45 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name UMEDICA LABORATORIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003341AM26 RA File Number 03AX04000009 AM25 Licence No and Date 0311032889/08/04/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Rosuvastatin Tablet BP / USP 10 mg. ((Each Tablet contains Rosuvastatin Calcium 10.400 mg) Eq. to Rosuvastatin 10 mg. (Net wt of import material is 490.474 kg.)) 1 Number 1 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4- fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin- 5-yl)vinyl)-2,2-dimethyl-1,3- dioxan-4-yl)acetate) 13.79 mg/ Tablet

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

uorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin- 5-yl)vinyl)-2,2-dimethyl-1,3- dioxan-4-yl)acetate) 13.79 mg/ Tablet

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 46 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002092AM26 RA File Number 03AX04000156 AM25 Licence No and Date 0311033116/16/04/2024 documents from the firm.

Case No. 47 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004475AM26 RA File Number 05AX04000176 AM25 Licence No and Date 0511025034/18/04/2024

Case No. 48 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00002838AM26 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

28 RA File Number 52AX04000014 AM25 Licence No and Date 5211007960/24/04/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty.

ation: DGFT(HQ)

28 RA File Number 52AX04000014 AM25 Licence No and Date 5211007960/24/04/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2-chloro-4-(1H-pyrazol-3-yl) benzonitrile 0.963 kg. 2 Tert-Butyl((1S)-2-hydroxy-1- methylethyl) carbamate 1.70 kg. 3 Diisopropyl azodicarboxylate 1.96 kg. Heterocyclic Compounds with Nitrogen atom with an unfused pyrazole ring with hydrogenated in the structure: 4-{1-[(2S)-2- Aminopropyl]-1-H-Pyrazole-3-yl}- 2- Chlorobenzonitrile 1 kg. 4 Triphenylphosphine 2.54 kg.

Case No. 49 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name JALAQUA INTERNATIONAL LLP Meeting Number and Date HQ File Number HQRNORM REVIW00004862AM26 RA File Number 52AX04000032 AM25 Licence No and Date 5211008159/15/05/2024 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

29 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Corrosive Solid, Basic, Organic, N.O.S (Chloramine T) 1 kg. 1 Trichloroisocyanuric Acid 0.636 kg.

Case No. 50 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004741AM26 RA File Number 05AX04000713 AM25 Licence No and Date 0511025847/03/06/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty.

M26 RA File Number 05AX04000713 AM25 Licence No and Date 0511025847/03/06/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Tobramycin Inhalation Solution, 300 1 Number 1 Tobramycin USP 306.0 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

30 mg / 4 ml (Having net content of 49.26 kg of Bulk drug (filling volume 4.35ml in each number)

Case No. 51 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name MOREPEN LABORATORIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003775AM26 RA File Number 05AX04000722 AM25 Licence No and Date 0511025892/05/06/2024

Case No. 52 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name CHEMPLAST SANMAR LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005053AM26 RA File Number 04AX04000189 AM25 Licence No and Date 0411007575/13/06/2024 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ing Number and Date HQ File Number HQRNORM REVIW00005053AM26 RA File Number 04AX04000189 AM25 Licence No and Date 0411007575/13/06/2024 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 53 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004472AM26 RA File Number 05AX04001007 AM25 Licence No and Date 0511026356/27/06/2024

Case No. 54 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004071AM26 RA File Number 52AX04000062 AM25 Licence No and Date 5211008717/02/07/2024 same export product/import item in meeting No. NC/3/MEET/Apr/202627/1 dated 07/04/2026
against advance authorization No. 5211005508 dated 21/08/2023, it was decided to fix ad-hoc whichever is less:-

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

32 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. Heterocyclic Compounds with Nitrogen atom with an unfused pyrazole ring with hydrogenated in the structure: 4-{1-[(2S)-2- Aminopropyl]-1-H-Pyrazole-3-yl}- 2- Chlorobenzonitrile

1 kg. 3 Triphenylphosphine 2.54 kg.

Case No. 55 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00003347AM26 RA File Number 52AX04000090 AM25 Licence No and Date 5211008811/08/07/2024 same export product/import item in meeting No.

Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00003347AM26 RA File Number 52AX04000090 AM25 Licence No and Date 5211008811/08/07/2024 same export product/import item in meeting No. NC/3/MEET/Apr/202627/1 dated 07/04/2026
against advance authorization 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. Heterocyclic Compounds with Nitrogen atom with an unfused 1 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

33 2 Diisopropyl azodicarboxylate 1.96 kg. pyrazole ring with hydrogenated in the structure: 4-{1-[(2S)-2- Aminopropyl]-1-H-Pyrazole-3-yl}- 2- Chlorobenzonitrile 3 Triphenylphosphine 2.54 kg.

Case No. 56 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name BROOKS STERISCIENCE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002355AM26 RA File Number 34AX04000341 AM25 Licence No and Date 3411005213/25/07/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. USP 500 mg 1 Number 2 Meropenem with Sodium Carbonate USP Sterile Meropenem Trihydrate with sodium Carbonate) 0.6726 mg. USP 1000 mg 1 Number 1

Meropenem with Sodium Carbonate USP (Sterile Meropenem Trihydrate with sodium Carbonate) 1.345 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

26 mg. USP 1000 mg 1 Number 1

Meropenem with Sodium Carbonate USP (Sterile Meropenem Trihydrate with sodium Carbonate) 1.345 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 57 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name CHEMPLAST SANMAR LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005055AM26 RA File Number 04AX04000360 AM25 Licence No and Date 0411007898/26/07/2024

Case No. 58 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name AMI LIFESCIENCES PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00004973AM26 RA File Number 34AX04000349 AM25 Licence No and Date 3411005224/29/07/2024

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

35 Case No. 59 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name AMI LIFESCIENCES PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00004974AM26 RA File Number 34AX04000347 AM25 Licence No and Date 3411005226/29/07/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Bisbentiamine 1 kg. 1 Thiamine Hydrochloride 1.094 kg.

Case No. 60 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00003346AM26 RA File Number 52AX04000126 AM25 Licence No and Date 5211009387/14/08/2024 same export product/import item in meeting No. NC/3/MEET/Apr/202627/1 dated 07/04/2026
against advance authorization No.

RA File Number 52AX04000126 AM25 Licence No and Date 5211009387/14/08/2024 same export product/import item in meeting No. NC/3/MEET/Apr/202627/1 dated 07/04/2026
against advance authorization No. 5211005508 dated 21/08/2023, it was decided to fix ad-hoc whichever is less:- UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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. Heterocyclic Compounds with Nitrogen atom with an unfused pyrazole ring with hydrogenated in the structure: 4-{1- [(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile) 1 kg. 3 Triphenylphosphine 2.54 kg.

Case No. 61 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name DEEPAK NOVOCHEM TECHNOLOGIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004317AM26 RA File Number 31AX04000169 AM25 Licence No and Date 3111003807/21/08/2024 The Committee considered the firm’s request for review of the ad-hoc norms but observed that no technicaljustification or supporting data was provided for the proposed enhancement. Accordingly, the Committee decided to request the firm to furnish a detailed justification for the enhancement of norms.

Case No. 62 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ish a detailed justification for the enhancement of norms.

Case No. 62 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

37 Meeting Number and Date HQ File Number HQRNORM REVIW00004473AM26 RA File Number 05AX04001720 AM25 Licence No and Date 0511027509/03/09/2024

Case No. 63 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004068AM26 RA File Number 52AX04000167 AM25 Licence No and Date 5211009740/10/09/2024 same export product/import item in meeting No. NC/3/MEET/Apr/202627/1 dated 07/04/2026
against advance authorization 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. Heterocyclic Compounds with Nitrogen atom with an unfused pyrazole ring with hydrogenated in the structure: 4-{1-[(2S)-2- Aminopropyl]-1-H-Pyrazole-3-yl}- 2- Chlorobenzonitrile 1 kg. 3 Triphenylphosphine 2.54 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ydrogenated in the structure: 4-{1-[(2S)-2- Aminopropyl]-1-H-Pyrazole-3-yl}- 2- Chlorobenzonitrile 1 kg. 3 Triphenylphosphine 2.54 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 64 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004736AM26 RA File Number 05AX04001842 AM25 Licence No and Date 0511027714/13/09/2024

Case No. 65 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00001845AM26 RA File Number 07AX04001050 AM25 Licence No and Date 0711012421/26/09/2024

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 66 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002079AM26 RA File Number 03AX04003196 AM25 Licence No and Date 0311037481/27/09/2024 documents from the firm:

Case No. 67 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name KOPRAN RESEARCH LABORATORIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002378AM26 RA File Number 03AX04002821 AM25 Licence No and Date 0311037863/11/10/2024

Case No. 68 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004735AM26 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

se No. 68 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004735AM26 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

40 RA File Number 05AX04002293 AM25 Licence No and Date 0511028402/18/10/2024

Case No. 69 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name UMEDICA LABORATORIES PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Apr/ 202627/ 2 and 28/04/2026 HQ File Number HQRNORM REVIW00003339AM26 RA File Number 03AX04003491 AM25 Licence No and Date 0311038102/21/10/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Rosuvastatin Tablet BP /USP10 mg.((Each Tablet contains Rosuvastatin Calcium 10.400 mg) Eq. to Rosuvastatin 10 mg. (Net wt of import material is 988.000 kg)) 1 Number 1 Tert-butyl 2-((4R,6S)-6-((E)- 2-(4-(4-fluorophenyl)-6- isopropyl-2- (N- methylmethylsulfonamido) pyrimidin-5-yl)vinyl)-2,2- dimethyl-1,3- dioxan-4-yl)acetate) 13.79 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

-(4-fluorophenyl)-6- isopropyl-2- (N- methylmethylsulfonamido) pyrimidin-5-yl)vinyl)-2,2- dimethyl-1,3- dioxan-4-yl)acetate) 13.79 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 70 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name MALIK LIFESCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003509AM26 RA File Number 05AX04002054 AM25 Licence No and Date 0511028020/22/10/2024 indicated below:-

Case No. 71 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name MALIK LIFESCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003718AM26 RA File Number 05AX04002960 AM25 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ame MALIK LIFESCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003718AM26 RA File Number 05AX04002960 AM25 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

42 Licence No and Date 0511029432/10/12/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Cefixime Tablets 200 mg(Cefixime Tablets 200 mg (each tablet contains Cefixime USP (as Trihydrate) equivalent to Cefixime 200 mg on anhydrous basis), Pack size:1, Strip = 10 Tablets)) 1 Number 1 Cefixime USP (Cefixime USP (As Trihydrate)) (Cefixime Trihydrate) 228.293 mg. Cefixime Tablets 100mg(Each tablet contains Cefixime USP (as Trihydrate equivalent to Cefixime 100mg on anhydrous basis)) 1 Number 2 Cefixime USP(Cefixime USP (As Trihydrate)) (Cefixime Trihydrate) 114.150 mg.

Case No. 72 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name DCM NOUVELLE SPECIALTY CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003531AM26 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

tatus Case Approved Party Name DCM NOUVELLE SPECIALTY CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003531AM26 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

43 RA File Number 05AX04003062 AM25 Licence No and Date 0511029764/20/12/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Dibenzylamine 1 kg. 1 Benzonitrile 1.229 kg.

Case No. 73 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name DCM NOUVELLE SPECIALTY CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003532AM26 RA File Number 05AX04003061 AM25 Licence No and Date 0511029765/20/12/2024 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Benzylamine 1 kg. 1 Benzonitrile 1.07 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 74 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name Meeting Number and Date HQ File Number HQRNORM REVIW00004737AM26 RA File Number 05AX04003326 AM25 Licence No and Date 0511029939/30/12/2024

Case No. 75 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name VIJAYASRI ORGANICS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005468AM25 RA File Number 09AX04000871 AM25 Licence No and Date 0911008760/06/01/2025 indicated below:-

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

RA File Number 09AX04000871 AM25 Licence No and Date 0911008760/06/01/2025 indicated below:-

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

45 Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Methyl Iso Butyryl Acetate (MIBA)(Liquid) 7150.0 kg. 2 (4R,CIS)-1,1-Dimethylethyl- 6-Cyano Methyl-2,2- Dimethyl-1,3-Dioxane-4- Acetate(Solid) 5830.0 kg. 3 Tri Ethyl Amine (TEA)(Liquid) 2420.0 kg. 4 Aniline Oil(Liquid) 4400.0 kg. 5 Methylene Chloride (MDC)(Liquid) 14080.0 kg. 6 Fluorobenzene (Liquid) 4950.0 kg. 7 Acetone (Liquid) 4730.0 kg. Tert-Butyl 2-((4R,6R)-6- (2-(2-(4-fluorophenyl)-5- isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H- pyrrol-1-yl)ethyl)-2,2- dimethyl-1,3- dioxane-4-yl)acetate (ATV-1) CAS No.125971-95-1) 11000 Kg. 8 Iso Propyl Alcohol (IPA) (Liquid) 27500.0 kg.

Case No. 76 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name WEST BENGAL CHEMICAL INDUSTRIES LTD. Meeting Number and Date HQ File Number HQRNORM APPLY 00005473AM25 RA File Number 02AX04000630 AM25 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

WEST BENGAL CHEMICAL INDUSTRIES LTD. Meeting Number and Date HQ File Number HQRNORM APPLY 00005473AM25 RA File Number 02AX04000630 AM25 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

46 Licence No and Date 0211007901/06/01/2025 The Committee noted that the justification/reply submitted by the firm is not satisfactory. Further, comments from the RA on the matter are still awaited. Accordingly, the Committee decided to issue a reminder to the RA for furnishing its comments and also to direct the firm to submit proper justification establishing that the export product is used in the pharmaceutical industry.

Case No. 77 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005596AM25 RA File Number 05AX04003551 AM25 Licence No and Date 0511030251/10/01/2025 The Committee considered the case as per agenda and it has been observed that the firm has not furnished the complete reply of Deficiency letter, therefore, 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:- Step wise complete and balanced chemical reactions with molecular weight and percentage yield on molar basis. I. Detailed working for import item no. 3, 6 and 7. II. Consumption Certifiate (CC) for API used. III.

te and balanced chemical reactions with molecular weight and percentage yield on molar basis. I. Detailed working for import item no. 3, 6 and 7. II. Consumption Certifiate (CC) for API used. III.

Case No. 78 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name VINDHYA ORGANICS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005621AM25 RA File Number 09AX04000885 AM25 Licence No and Date 0911008835/13/01/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

47 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2-Azabicyclo[2.2.1] Hept-5-En-3-One
(Vince Lactam) 1.18 kg. 2 Sodium Borohydride 0.214 kg. 3 D (-) Tartaric Acid 0.742 kg. Amino Carbinol Tartrate 1 kg. 4 L + Tartaric Acid 0.90 kg.

Case No. 79 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name CIRON DRUGS AND PHARMACEUTICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002985AM26 RA File Number 03AX04005211 AM25 Licence No and Date 0311040388/13/01/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ing Number and Date HQ File Number HQRNORM REVIW00002985AM26 RA File Number 03AX04005211 AM25 Licence No and Date 0311040388/13/01/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

48 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Bimatoprost Opthalmic Solution 0.3 mg/ml - 3 ml (Each ml contains Bimatoprost 0.3 mg) (2,50,000 Nos) (Net Content: Bimatoprost - 0.225 KGS) 1 Number 1 Bimatoprost 0.918 mg./3ml. Vial

Case No. 80 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name VARUN MEDIMPEX INC. Meeting Number and Date HQ File Number HQRNORM REVIW00004337AM26 RA File Number 05AX04003468 AM25 Licence No and Date 0511030419/20/01/2025 indicated below:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 PVC Sheet Rolls 28550 Square Meter Acrylic Presure Dettol Plaster Antiseptik (SIZE 19 mm X 73mm) 18990000 Numbers 2 3898 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

allowed. 1 PVC Sheet Rolls 28550 Square Meter Acrylic Presure Dettol Plaster Antiseptik (SIZE 19 mm X 73mm) 18990000 Numbers 2 3898 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

49 Sensitive Adhesive 3 Non Woven Rolls 5981.85 Square Meter

Case No. 81 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name KALPSUTRA GUJARAT Meeting Number and Date HQ File Number HQRNORM APPLY 00005770AM25 RA File Number 34AX04000913 AM25 Licence No and Date 3411005984/21/01/2025 same export product/import item in meeting No.NC/3/MEET/Nov/202526
dated
14/11/2025against advance authorization No.3411005382 dated 09/09/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. Undecylenic Aldehyde 1 kg. 1 Undecylenic Acid 1.30 kg.

Case No. 82 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Qty. allowed. Undecylenic Aldehyde 1 kg. 1 Undecylenic Acid 1.30 kg.

Case No. 82 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

50 Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005789AM25 RA File Number 09AX04000881 AM25 Licence No and Date 0911008880/22/01/2025 The Committee considered the case as per agenda and it was again 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. 83 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005808AM25 RA File Number 09AX04000882 AM25 Licence No and Date 0911008886/22/01/2025 The Committee considered the case as per agenda and it was again 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. 84 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name FRESENIUS KABI INDIA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005926AM25 RA File Number 31AX04000396 AM25 Licence No and Date 3111004377/29/01/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ng Number and Date HQ File Number HQRNORM APPLY 00005926AM25 RA File Number 31AX04000396 AM25 Licence No and Date 3111004377/29/01/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

51 indicated below:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 Sodium Chloride (SANAL) (EP) 0.4725 gm. 5 SHIP-SHAPE-BREAK-OFF-PART (INFUSION BLUE -0434171) Net content in export + 1% wastage. 9 SHIP-SHAPE-BREAK-OFF-PART INJECTION (WHITE - 0434481) Net content in export + 1% wastage. 13 SHIP-SHAPE-CORPUS- (INFUSION - 0434181?) Net content in export + 1% wastage. 17 SHIP-SHAPE-CORPUS INJECTION (WITH PP- MEMBRANE 0.8 - 0434371?) Net content in export + 1% wastage. 21 SF9-11 195/95 Primary film (0369581) 50 & 100ml) Net content in export + 1% wastage. 26 OFR2-11 150/524 Secondary Film ( 0369701 ) for 50 & 100ml) Net content in export + 1% wastage. 29 UFR2-11 150/524- Secondary Film (0369661 ) for 50ml to 1000ml) Net content in export + 1% wastage. Hot Stamping Foil Net content in Sodium Chloride 0.9% 50 ml 1 Number 33 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

61 ) for 50ml to 1000ml) Net content in export + 1% wastage. Hot Stamping Foil Net content in Sodium Chloride 0.9% 50 ml 1 Number 33 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

52 ( 0368991 ) export + 1% wastage. 2 Sodium Chloride (SANAL) (EP) 0.945 gm. 6 SHIP-SHAPE-BREAK-OFF- PART(INFUSION BLUE -0434171) Net content in export + 1% wastage. 10 SHIP-SHAPE-BREAK-OFF-PART INJECTION (WHITE - 0434481) Net content in export + 1% wastage. 14 SHIP-SHAPE-CORPUS- (INFUSION - 0434181) Net content in export + 1% wastage. 18 SHIP-SHAPE-CORPUS INJECTION (WITH PP- MEMBRANE 0.8 - 0434371) Net content in export + 1% wastage. 22 SF9-11 195/95 Primary film (0369581 ) 50 & 100ml) Net content in export + 1% wastage. 27 OFR2-11 150/524 Secondary Film (0369701 ) for 50 & 100ml) Net content in export + 1% wastage. 30 UFR2-11 150/524- Secondary Film (0369661 ) for 50ml to 1000ml) Net content in export + 1% wastage. Sodium Chloride 0.9% 100 ml 1 Number 34 Hot Stamping Foil ( 0368991 ) Net content in export + 1% wastage. 3 Sodium Chloride (SANAL) (EP) 2.3625 gm. SHIP-SHAPE-BREAK-OFF- Sodium Chloride 0.9 % 250 ml 1 Number UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

content in export + 1% wastage. 3 Sodium Chloride (SANAL) (EP) 2.3625 gm. SHIP-SHAPE-BREAK-OFF- Sodium Chloride 0.9 % 250 ml 1 Number UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

53 7 PART(INFUSION BLUE -0434171) Net content in export + 1% wastage. 11 SHIP-SHAPE-BREAK-OFF-PART INJECTION (WHITE - 0434481) Net content in export + 1% wastage. 15 SHIP-SHAPE-CORPUS- (INFUSION - 0434181) Net content in export + 1% wastage. 19 SHIP-SHAPE-CORPUS INJECTION(WITH PP- MEMBRANE 0.8 - 0434371) Net content in export + 1% wastage. 23 SF9-11 195/100 Primary film (0369591 ) for 250ml) Net content in export + 1% wastage. 28 OFR2-11 150/524 Secondary Film (0369701 ) for 50 & 100ml) Net content in export + 1% wastage. 31 UFR2-11 150/524- Secondary Film (0369661 ) for 50ml to 1000ml) Net content in export + 1% wastage. 35 Hot Stamping Foil ( 0368991 ) Net content in export + 1% wastage. 4 Sodium Chloride (SANAL) (EP) 4.725 gm. 8 SHIP-SHAPE-BREAK-OFF- PART(INFUSION BLUE -0434171) Net content in export + 1% wastage. Net content in export + 1% Sodium Chloride 0.9% 500 ml 1 Number 12 SHIP-SHAPE-BREAK-OFF-PART INJECTION(WHITE - 0434481) UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

1% wastage. Net content in export + 1% Sodium Chloride 0.9% 500 ml 1 Number 12 SHIP-SHAPE-BREAK-OFF-PART INJECTION(WHITE - 0434481) UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

54 wastage. 16 SHIP-SHAPE-CORPUS- (INFUSION - 0434181) Net content in export + 1% wastage. 20 SHIP-SHAPE-CORPUS INJECTION(WITH PP- MEMBRANE 0.8 - 0434371) Net content in export + 1% wastage. 24 SF9-11 195/135 Primary film((0369621) for 500ml) Net content in export + 1% wastage. 25 OFR2-11 120/524- Secondary Film (0369681 ) (for 500ml & 1000 ml) Net content in export + 1% wastage. 32 UFR2-11 150/524- Secondary Film (0369661 ) for 50ml to 1000ml) Net content in export + 1% wastage. 36 Hot Stamping Foil (0368991) Net content in export + 1% wastage.

Case No. 85 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ASHISH LIFE SCIENCE PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005984AM25 RA File Number 03AX04005605 AM25 Licence No and Date 0311040984/01/02/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ng Number and Date HQ File Number HQRNORM APPLY 00005984AM25 RA File Number 03AX04005605 AM25 Licence No and Date 0311040984/01/02/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

55 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. TYLOSIN TARTRATE INJECTION 20% - PACK 50 ML VIAL (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200 MG) ((nett content of exempt material is 1000 Kgs) (100000 Nos)) 1 Number 1 Tylosin Tartrate (API) 12.222 gm. TYLOSIN TARTRATE INJECTION 20% - PACK 100 ML VIAL (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200 MG) ((nett content of exempt material is 1620 Kgs) (81000 Nos)) 1 Number 2 24.444 gm. TYLOSIN TARTRATE POWDER 100% - PACK 1000 GM (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) ((nett content of exempt material is 500 Kgs) (500 Nos)) 1 Number 3 1010 gm. TYLOSIN TARTRATE POWDER 20% - PACK 5 GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) ((nett content of exempt material is 30 Kgs) (30000 Nos)) 1 Number 4 1.1756 gm. TYLOSIN TARTRATE POWDER 20% - PACK 25 GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) ((nett content of exempt material is 150 Kgs) (30000 Nos)) 1 Number 5 5.05 gm. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) ((nett content of exempt material is 150 Kgs) (30000 Nos)) 1 Number 5 5.05 gm. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

56 TYLOSIN TARTRATE POWDER 20% - PACK 100 GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) ((nett content of exempt material is 600 Kgs) (30000 Nos)) 1 Number 6 23.513 gm. TYLOSIN TARTRATE POWDER 20%- PACK 500 GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) ((nett content of exempt material is 50Kgs) (500 Nos)) 1 Number 7 117.564 gm. TYLOSIN TARTRATE POWDER 20%-PACK 1000 GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) ((nett content of exempt material is 100Kgs) (500 Nos)) 1 Number 8 235.128 gm. TYLOSIN TARTRATE 200 MG AND DOXYCYCLINE HYCLATE 400 MG POWDER-PACK 1000 GM ((EACH GRAM CONTAIN TYLOSIN TARTRATE 200 MG AND DOXYCYCLINE HYCLATE 400 MG) (nett content of exempt material is 100 Kgs) (500 Nos)) 1 Number 9 202 gm.

Case No. 86 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name DEEPAK NOVOCHEM TECHNOLOGIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004318AM26 RA File Number 31AX04000415 AM25 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

e DEEPAK NOVOCHEM TECHNOLOGIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004318AM26 RA File Number 31AX04000415 AM25 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

57 Licence No and Date 3111004396/03/02/2025 The Committee considered the firm’s request for review of the ad-hoc norms but observed that no technical justification or supporting data was provided for the proposed enhancement. Accordingly, the Committee decided to request the firm to furnish a detailed justification for the enhancement of norms.

Case No. 87 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name PUNJAB CHEMICALS AND CROP PROTECTION LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006042AM25 RA File Number 03AX04005681 AM25 Licence No and Date 0311041097/06/02/2025 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Oxalic Acid 0.89 kg. 2 Ethyl Alcohol Denatured 0.76 kg. 3 Benzene Not allowed as shown indiginious. Diethyl Oxalate 1 kg. 4 Soda Ash Not allowed as shown indiginious.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

hol Denatured 0.76 kg. 3 Benzene Not allowed as shown indiginious. Diethyl Oxalate 1 kg. 4 Soda Ash Not allowed as shown indiginious.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 88 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name KLJ PLASTICIZERS LIMITED. Meeting Number and Date HQ File Number HQRNORM APPLY 00006194AM25 RA File Number 05AX04003930 AM25 Licence No and Date 0511030876/13/02/2025 indicated below:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 BENZOIC ACID 0.761 kg. 2 DIETHYLENE GLYCOL (DEG) 0.26 kg. KANATOL-DPGB 25 1 kg. 3 DIPROPYLENE GLYCOL (DPG) 0.109 kg.

Case No. 89 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name ANANTA MEDICARE LIMITED Meeting Number and Date UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

59 HQ File Number HQRNORM APPLY 00006210AM25 RA File Number 05AX04003649 AM25 Licence No and Date 0511030885/13/02/2025 The Committee considered the case as per the agenda and it was decided to call the firm to attend a Personal Hearing before the Norms Committee to explain its case along with relevant information/documents from the firm.

Case No. 90 / NC/3/MEET/Apr/202627/2 Case Status Case Rejected Party Name ENCEE AROMATICS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006239AM25 RA File Number 32AX04000749 AM25 Licence No and Date 3211008445/14/02/2025 The Committee considered the request of the firm for fixation of ad-hoc norms on the basis of

r HQRNORM APPLY 00006239AM25 RA File Number 32AX04000749 AM25 Licence No and Date 3211008445/14/02/2025 The Committee considered the request of the firm for fixation of ad-hoc norms on the basis of information provided by the firm, and it has again been observed that the item of export is primarily utilized as synthetic aroma molecule in the fragrance industry, therefore, it is a perfumery compound. Hence, the committee decided to reject the application of the firm.

Case No. 91 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name DEEPAK NOVOCHEM SPECIALITIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004940AM26 RA File Number 31AX04000440 AM25 Licence No and Date 3111004443/17/02/2025 The Committee considered the firm’s request for review of the ad-hoc norms but observed that no technical justification or supporting data was provided for the proposed enhancement. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

r review of the ad-hoc norms but observed that no technical justification or supporting data was provided for the proposed enhancement. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

60 Accordingly, the Committee decided to request the firm to furnish a detailed justification for the enhancement of norms.

Case No. 92 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name DEEPAK NOVOCHEM SPECIALITIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004941AM26 RA File Number 31AX04000438 AM25 Licence No and Date 3111004444/17/02/2025 The Committee considered the firm’s request for review of the ad-hoc norms but observed that no technical justification or supporting data was provided for the proposed enhancement. Accordingly, the Committee decided to request the firm to furnish a detailed justification for the enhancement of norms.

Case No. 93 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name MICRO LABS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006409AM25 RA File Number 07AX04001966 AM25 Licence No and Date 0711013758/25/02/2025 same export product/import item in meeting No.NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance authorization No.0711011510 dated 08/06/2024 , it was decided to fix ad-hoc whichever is less:-

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

2 dated 10/12/2024 against advance authorization No.0711011510 dated 08/06/2024 , it was decided to fix ad-hoc whichever is less:-

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

61 Export Product Qty. Sl. No. Import Items Qty. allowed. Azelastine Hydrochloride Eye Drops Solution 0.05% weight by volume. 1 Number 1 Azelastine Hydrochloride BP/EP/USP/IP 5.10 mg/10 ml. Vial

Case No. 94 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ATUL LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006517AM25 RA File Number 08AX04002033 AM25 Licence No and Date 0811014276/03/03/2025 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Aromatic Amines 1 kg. 1 Aniline (Aniline Oil) 1.0 kg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

62 Case No. 95 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ENALTEC LABS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006530AM25 RA File Number 03AX04006114 AM25 Licence No and Date 0311041804/04/03/2025 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Midodrine Hydrochloride USP 1 kg. 1 2-Amino-1-(2,5 dimethoxyphenyl) ethanone hydrochloride 1.76 kg.

Case No. 96 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name LECIPURE BIOTECH LLP Meeting Number and Date HQ File Number HQRNORM APPLY 00006544AM25 RA File Number 08AX04002069 AM25 Licence No and Date 0811014307/04/03/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ng Number and Date HQ File Number HQRNORM APPLY 00006544AM25 RA File Number 08AX04002069 AM25 Licence No and Date 0811014307/04/03/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

63 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Sunflower Lecithin Liquid (Edible Grade) 1 kg. 1 Crude Sunflower Lecithin Liquid 1.0 kg.

Case No. 97 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name SV PLASTOCHEM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006571AM25 RA File Number 31AX04000435 AM25 Licence No and Date 3111004491/05/03/2025 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 TIN INGOTS 0.497 kg. CATALYST (SV CAT 2000) (Mono Butyl Tin Oxide Powder 98%) 1 kg. 2 TETRA BUTYL TIN 0.441 kg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 98 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name MISTAIR HEALTH AND HYGIENE PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006607AM25 RA File Number 03AX04006115 AM25 Licence No and Date 0311041942/07/03/2025 The Committee considered the case as per the agenda and it was decided to call the firm to attend a Personal Hearing before Norms Committee to explain its case along with relevant information/documents from the firm.

Case No. 99 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name APITORIA PHARMA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006613AM25 RA File Number

e firm.

Case No. 99 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name APITORIA PHARMA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006613AM25 RA File Number 09AX04001129 AM25 Licence No and Date 0911009156/07/03/2025 The Committee considered the case as per agenda and it has been observed that the firm has not furnished the complete reply of Deficiency letter, therefore, 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:

Molecular weight of export product. 1. Composition of export item as used in export. 2. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 100 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name NOVA INTERCHEM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006700AM25 RA File Number 08AX04002133 AM25 Licence No and Date 0811014430/17/03/2025 indicated below:- Export Product Qty. Sl. No. Import Items Qty. allowed. Meta Amino Acetanilide Hydrochloride 1 kg. 1 Meta Phenylene Diamine 0.630 kg.

Case No. 101 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name CHEMPLAST SANMAR LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006756AM25 RA File Number 04AX04001210 AM25 Licence No and Date 0411009312/19/03/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

ng Number and Date HQ File Number HQRNORM APPLY 00006756AM25 RA File Number 04AX04001210 AM25 Licence No and Date 0411009312/19/03/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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

The commercial value of by-product Methanol obtained during the process. 1. The justification of 80% overall yield of the reaction and to indicate wastage of raw materials in process. 2.

Case No. 102 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name Meeting Number and Date NC/ 3/ MEET/ Apr/ 202627/ 2 and 28/04/2026 HQ File Number HQRNORM APPLY 00006841AM25 RA File Number 52AX04000400 AM25 Licence No and Date 5211012552/24/03/2025 same export product/import item in meeting No. NC/3/MEET/Jan/202526/12 dated 15/01/2026
against advance authorization No. 5211010354 dated 18/10/2024 , it was decided to fix ad-hoc whichever is less:-

    Export Product

Qty. Sl. No. Import Items Qty. allowed. 1 1-(2-Tetrahydropyranyl)-1H Pyrazole-5-Boronic Acid Pinacol Ester ( 1-(Tetrahydro 2H Pyran 2yl )-5-(4,4,5,5 Tetramethyl 1,3,2 Dioxaborolane-2-yl)-1H- Pyrazole) ) 1.50 kg. 2 4-Bromo-2-Chloro Benzonitrile 1.165 kg. 4-{1-[(2S)-2-Aminopropyl]- 1-H-Pyrazole-3-yl}-2- Chlorobenzonitrile ) 1 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

azole) ) 1.50 kg. 2 4-Bromo-2-Chloro Benzonitrile 1.165 kg. 4-{1-[(2S)-2-Aminopropyl]- 1-H-Pyrazole-3-yl}-2- Chlorobenzonitrile ) 1 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

67 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.

Case No. 103 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name KLJ PLASTICIZERS LIMITED. Meeting Number and Date HQ File Number HQRNORM APPLY 00006891AM25 RA File Number 05AX04004375 AM25 Licence No and Date 0511031584/26/03/2025 same export product/import item in meeting No.NC/3/MEET/Feb/202526/1 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 1 kg. 2 Denatured Ethyl Alcohol 0.65 kg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 104 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name Meeting Number and Date HQ File Number HQRNORM APPLY 00006906AM25 RA File Number 52AX04000392 AM25 Licence No and Date 5211012634/26/03/2025 same export product/import item in meeting No. NC/3/MEET/Apr/202627/1 dated 07/04/2026
against advance authorization 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.

Case No. 105 / NC/3/MEET/Apr/202627/2 Case Status Case Approved UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

e-3-yl}-2- Chlorobenzonitrile) 1 kg. 3 Triphenylphosphine 2.54 kg.

Case No. 105 / NC/3/MEET/Apr/202627/2 Case Status Case Approved UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

69 Party Name DCM NOUVELLE SPECIALTY CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006926AM25 RA File Number 05AX04004410 AM25 Licence No and Date 0511031632/27/03/2025 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Dibenzylamine 1 kg. 1 Benzonitrile 1.229 kg.

Case No. 106 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name LAXAI LIFE SCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00006945AM25 RA File Number 09AX04001195 AM25 Licence No and Date 0911009324/28/03/2025 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

70 1,5-Dihydroxyanthraquinone 1 kg. 1 1,5-Dinitroanthraquinone (Powder) 1.379 kg.

Case No. 107 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name AZAKEM LABS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000017AM26 RA File Number 09AX04001123 AM25 Licence No and Date 0911009334/01/04/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to

End-use (name of API) of the export item. 1. Complete and balanced chemical reaction with molecular weight and percentage yield on molar basis. 2.

technical details as prescribed in Annexure to

End-use (name of API) of the export item. 1. Complete and balanced chemical reaction with molecular weight and percentage yield on molar basis. 2.

Case No. 108 / NC/3/MEET/Apr/202627/2 Case Status Case Deferred Party Name ADCOCK INGRAM LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000127AM26 RA File Number 07AX04000018 AM26 Licence No and Date 0711014131/08/04/2025 UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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

Please give detailed calculation for working out import item in line with Drug Manufacturing Licence and Certificate of Analysis of import item, relevant to present Advance Authorisation. 1. Import details given are relevant to November, 2024 where as Advance Authorisation is April, 2025. Please clarifiy. 2.

Case No. 109 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name AURORE LIFE SCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000133AM26 RA File Number 09AX04001145 AM25 Licence No and Date 0911009401/08/04/2025 indicated below:-

Export Product Qty. Sl. No. Import Items Qty.

APPLY 00000133AM26 RA File Number 09AX04001145 AM25 Licence No and Date 0911009401/08/04/2025 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Dimethyl acetylene dicarboxylate 2.50 kg. 1 Methyl 2 [2 (5 methyl 1,3,4 oxadiazole 2 carboxamido) propan 2yl] 6oxo 4 {[(4fluorophenyl) methyl] carbamoyl} 1,6 dihydropyrimidine-5ol (Drug 1 kg. 2 Trimethyl oxosulfonium bromide 0.545 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

72 intermediate)

Case No. 110 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ATUL LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000244AM26 RA File Number 08AX04000041 AM26 Licence No and Date 0811014718/15/04/2025 same export product/import item in meeting No.NC/3/MEET/Aug/202526/7 dated 22/08/2025 against advance authorization No. 0811007532 dated 10/03/2023, it was decided to fix ad-hoc whichever is less:-

    Export Product

DETDA 0.167 kg. Formulated Aromatic Amine 1 1 kg. 3 Iso Phoron Diamine | (Vestamine IPD | Baxxodur EC 201 | Wanamine IPDA) 0.101 kg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 111 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ALEMBIC PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000280AM26 RA File Number 34AX04001073 AM25 Licence No and Date 3411006226/16/04/2025 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP 2% & 0.5% - 10 ML (Net content of active ingredients - 20.490 kgs.) 1 Number 1 Timolol Maleate USP 69.666 mg. Brimonidine Tartrate / Timolol Maleate Ophthalmic solution 0.2%/0.5% - 5 ML (Net content of active ingredients - 15.30 kgs.) 1 Number 2 Timolol Maleate USP 34.68 mg. Brimonidine Tartrate / Timolol Maleate Ophthalmic solution 0.2%/0.5% - 10 ML (Net content of 1 Number 3 Timolol Maleate USP 69.56 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Brimonidine Tartrate / Timolol Maleate Ophthalmic solution 0.2%/0.5% - 10 ML (Net content of 1 Number 3 Timolol Maleate USP 69.56 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

74 active ingredients - 20.40 kgs.)) Brimonidine Tartrate / Timolol Maleate Ophthalmic solution 0.2%/0.5% - 15 ML (Net content of active ingredients - 30.60 kgs.) 1 Number 4 Timolol Maleate USP 104.4 mg. Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% - 5 ML (Net content of active ingredients - 10.20 kgs.) 1 Number 5 Timolol Maleate USP 34.68 mg. Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% - 5 ML (Net content of active ingredients - 5.10 kgs.) 1 Number 6 Timolol Maleate USP 17.34 mg.

Case No. 112 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ADCOCK INGRAM LIMITED Meeting Number and Date NC/ 3/ MEET/ Apr/ 202627/ 2 and 28/04/2026 HQ File Number HQRNORM APPLY 00000460AM26 RA File Number 07AX04000137 AM26 Licence No and Date 0711014284/25/04/2025 indicated below:-

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

M26 RA File Number 07AX04000137 AM26 Licence No and Date 0711014284/25/04/2025 indicated below:-

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

75 Export Product Qty. Sl. No. Import Items Qty. allowed. 1 THEOPHYLLINE BP / EP / USP / PH.EUR ANHYDROUS POWDER 127.50 mg. NUELIN 125 MG TABLETS (THEOPHYLLINE 125mg +GUAR GUM 4.375 mg (NUELIN SR 125MG TABLETS) (Theop-2000.000 + GUAR GUM 70.000 KGS) Total KGS-2070.000 (No. of Tablets - 16000000) BP/EP/USP/PH.EUR) 1 Number 2 GUAR GUM IH (BP/EP/USP/PH.EUR) 4.375 mg. 3 THEOPHYLLINE BP/EP/USP/PH.EUR ANHYDROUS POWDER 204.00 mg. NUELIN 200 MG TABLETS (THEOPHYLLINE 200 mg + GUAR GUM 7.00mg (NUELIN SR 200MG TABLETS) (Theop-2000.000 + GUAR GUM 70.000 KGS) Total KGS-2070.000 (No. of Tablets -10000000) BP/EP/USP/PH.EUR) 1 Number 4 GUAR GUM IH (BP/EP/USP/PH.EUR) 7.00 mg. 5 THEOPHYLLINE BP/EP/USP/PH.EUR ANHYDROUS POWDER 255.00 mg. NUELIN 250 MG TABLETS (THEOPHYLLINE 250mg + GUAR GUM 8.750 mg (NUELIN SR 250 MG TABLETS) (Theop-4000.000 + GUAR GUM 140.000 KGS) Total KGS-4140.000 (No. of Tablets - 16000000) BP/EP/USP/PH.EUR) 1 Number 6 GUAR GUM IH (BP/EP/USP/PH.EUR) 8.75 mg. 7 THEOPHYLLINE BP/EP/USP/PH.EUR ANHYDROUS POWDER 306.00 mg. NUELIN 300 MG TABLETS (THEOPHYLLINE 300mg + GUAR GUM 10.5 mg (NUELIN SR 300MG TABLETS) (Theop-2100.000 +GUAR GUM 73.500 KGS) Total KGS-2173.500 (No. of Tablets - 7000000) BP/EP/USP/PH.EUR) 1 Number 8 GUAR GUM IH (BP/EP/USP/PH.EUR) 10.50 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

M 73.500 KGS) Total KGS-2173.500 (No. of Tablets - 7000000) BP/EP/USP/PH.EUR) 1 Number 8 GUAR GUM IH (BP/EP/USP/PH.EUR) 10.50 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

Case No. 113 / NC/3/MEET/Apr/202627/2 Case Status Case Approved Party Name ADCOCK INGRAM LIMITED Meeting Number and Date NC/ 3/ MEET/ Apr/ 202627/ 2 and 28/04/2026 HQ File Number HQRNORM APPLY 00000461AM26 RA File Number 07AX04000136 AM26 Licence No and Date 0711014285/25/04/2025 indicated below:-

Export Product Qty. Sl. No. Import Items Qty. allowed. 1 THEOPHYLLINE BP / EP / USP / PH.EUR ANHYDROUS POWDER 127.50 mg. NUELIN 125 MG TABLETS (THEOPHYLLINE 125mg +GUAR GUM 4.375 mg (NUELIN SR 125MG TABLETS) (Theop-2000.000 + GUAR GUM 70.000 KGS) Total KGS-2070.000 (No. of Tablets - 16000000) BP/EP/USP/PH.EUR) 1 Number 2 GUAR GUM IH (BP/EP/USP/PH.EUR) 4.375 mg. 3 THEOPHYLLINE BP/EP/USP/PH.EUR ANHYDROUS POWDER 204.00 mg. NUELIN 200 MG TABLETS (THEOPHYLLINE 200 mg + GUAR GUM 7.00mg (NUELIN SR 200MG TABLETS) (Theop-2000.000 + GUAR GUM 70.000 KGS) Total KGS-2070.000 (No. of Tablets -10000000) BP/EP/USP/PH.EUR) 1 Number 4 GUAR GUM IH (BP/EP/USP/PH.EUR) 7.00 mg. NUELIN 250 MG TABLETS (THEOPHYLLINE 250mg + GUAR GUM 8.750 mg (NUELIN SR 250 MG THEOPHYLLINE BP/EP/USP/PH.EUR ANHYDROUS 1 Number 5 255.00 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

MG TABLETS (THEOPHYLLINE 250mg + GUAR GUM 8.750 mg (NUELIN SR 250 MG THEOPHYLLINE BP/EP/USP/PH.EUR ANHYDROUS 1 Number 5 255.00 mg. UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

77 POWDER TABLETS) (Theop-4000.000 + GUAR GUM 140.000 KGS) Total KGS-4140.000 (No. of Tablets - 16000000) BP/EP/USP/PH.EUR) 6 GUAR GUM IH (BP/EP/USP/PH.EUR) 8.75 mg. 7 THEOPHYLLINE BP/EP/USP/PH.EUR ANHYDROUS POWDER 306.00 mg. NUELIN 300 MG TABLETS (THEOPHYLLINE 300mg + GUAR GUM 10.5 mg (NUELIN SR 300MG TABLETS) (Theop-2100.000 +GUAR GUM 73.500 KGS) Total KGS-2173.500 (No. of Tablets - 7000000) BP/EP/USP/PH.EUR) 1 Number 8 GUAR GUM IH (BP/EP/USP/PH.EUR) 10.50 mg.

UDIN00148384AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)

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