DGFT Minutes
In force — no superseding record on file.
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
Minutes of the Norms Committee–3 Meeting No.NC/3/MEET/Apr/202627/1 dated 07/04/2026 (actualy held on 08/04/2026) 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) Shri Nand Consultant 3 UDIN00106096AM27 This document has been digitally signed by Raman Kumar, Joint DGFT,DGFT(HQ) on 20-May-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 20-May-2026 10:08:02 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified
by Raman Kumar, Joint DGFT,DGFT(HQ) on 20-May-2026. Digitally Signed. Name: RAMAN KUMAR( Joint DGFT ) Date: 20-May-2026 10:08:02 Reason: ramankumar@nic.in Location: DGFT(HQ) Signature Not Verified
2 Lal (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 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/202627/1 Case Status Case Approved Party Name B G P HEALTHCARE PRIVATE LIMITED Meeting Number and Date NC/ 3/ MEET/ Apr/ 202627/ 1 and 07/04/2026 HQ File Number HQRNORM APPLY 00004745AM26 RA File Number NA Licence No and Date NA
Norms Committee Decision:
The Committee examined the request of the firm for fixation of ad-hoc norms. 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. Nicotine Polacrilex (Contains 20% Nicotine) 1 kg. 1 ION EXCHANGE RESIN 0.852 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
3 RA concerned may take further necessary action as per above decision of NC.
Case No. 2 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name BIOLOGICAL E. LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005879AM25 RA File Number NA Licence No and Date NA The Committee considered the cases as per the agenda. The representatives of the firm attended the Personal Hearing through Video Conference (VC) wherein Technical Expert of the Department of Bio- Technology was also present through VC. The representative of the firm explained the reason for fixation of ad-hoc norms filed under para 4.06 of HBP. The Committee heard the explanation of the firm and after due deliberation with the Technical Expert of Deptt. of Bio-Technology decided to submit the following documents as sought by DBT during hearing from the firm:- Batch Production Record. 1. Calculation Sheet of Bulk Antigen. 2. Certificate of Analysis (CoA). 3. General Control Record. 4.
following documents as sought by DBT during hearing from the firm:- Batch Production Record. 1. Calculation Sheet of Bulk Antigen. 2. Certificate of Analysis (CoA). 3. General Control Record. 4.
Case No. 3 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name JAGSON PAL PHARMACEUTICALS LIMITED. Meeting Number and Date HQ File Number HQRNORM REVIW00005861AM26 RA File Number 052304000165 AM16 Licence No and Date 0510395004/20/07/2015 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
4 indicated below.:- Export Product Qty. Sl. No. Import Items Qty. allowed. Mifepristone Tablets 200 mg. 1 Number 1 Mifepristone (USDMF Grade ) (API) 204.0 mg. Misoprostol Tablets 200 mcg. 1 Number 2 Misoprostol Dispersion(API) 204.0 mcg.
Case No. 4 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name SIRMAXO CHEMICALS PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00004150AM26 RA File Number 039504000492 AM17 Licence No and Date 0310809770/13/12/2016 The Committee considered the firm’s request for review of the ad-hoc norms. However, it was 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. 5 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name CIPLA LIMITED Meeting Number and Date UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
ining the status quo.
Case No. 5 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name CIPLA LIMITED Meeting Number and Date UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
5 HQ File Number HQRNORM REVIW00005522AM26 RA File Number 039404000726 AM18 Licence No and Date 0310817755/13/12/2017 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 Master Batch Formula for each export item.
Case No. 6 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name HALEOS LABS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002911AM26 RA File Number 092404000654 AM18 Licence No and Date 0910066137/12/04/2018 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.
dered 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, thereby maintaining the status quo.
Case No. 7 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name SIRMAXO CHEMICALS PVT LTD Meeting Number and Date HQ File Number HQRNORM REVIW00004149AM26 RA File Number 039504000221 AM19 Licence No and Date 0310821782/20/06/2018 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
6 The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that the norms had earlier been ratified on the basis of the Drug Manufacturing Licence with permissible wastage of 2%. Accordingly, the Committee did not find any justification for revising the existing norms and decided to reject the request, thereby maintaining the status quo.
Case No. 8 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003165AM26 RA File Number 039404000312 AM19 Licence No and Date 0310822337/17/07/2018 that the firm had not furnished any technical justification or supporting information for the proposed
Case No. 9 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name HALEOS LABS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002912AM26 RA File Number 092404000205 AM19
ed
Case No. 9 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name HALEOS LABS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002912AM26 RA File Number 092404000205 AM19 Licence No and Date 0910066505/24/07/2018 the firm had not furnished any technical justification or supporting information for the proposed
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
7
Case No. 10 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name HONOUR LAB LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003500AM26 RA File Number 092404000369 AM19 Licence No and Date 0910066835/13/11/2018 The case is under consideration and TE was requested to expedite his comments.
Case No. 11 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003166AM26 RA File Number 039404000744 AM19 Licence No and Date 0310825255/28/11/2018 the firm had not furnished any technical justification or supporting information for the proposed
Case No. 12 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name VENOR PHARMA LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002542AM26 RA File Number 612404000020 AM19 Licence No and Date 6110001570/13/12/2018 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
ting Number and Date HQ File Number HQRNORM REVIW00002542AM26 RA File Number 612404000020 AM19 Licence No and Date 6110001570/13/12/2018 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
8 indicated below:- Export Product Qty. Sl. No. Import Items Qty. allowed. Injection Levobupivacaine HCL 5 mg/ml, 10 ml Ampoule 1 Number 1 Levobupivacaine HCL 55.00 mg.
Case No. 13 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name HONOUR LAB LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003501AM26 RA File Number 092404000534 AM19 Licence No and Date 0910067129/04/02/2019
Case No. 14 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name INDO AMINES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002408AM26 RA File Number 039404000984 AM19 Licence No and Date 0310827206/21/02/2019 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
9 indicated below:- Export Product Qty. Sl. No. Import Items Qty. allowed. C12-C14 AMINE PURE 1 kg. 1 CRUDE COCO AMINE (C12-C14 AMINE CRUDE) 1.055 kg.
Case No. 15 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name AVIK PHARMACEUTICAL LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004917AM26 RA File Number 039404000496 AM20 Licence No and Date 0310831890/27/09/2019 indicated below:-
Export Product
Qty. Sl. No. Import Items Qty. allowed. Triamicinolone IP/EP/BP/USP 1 kg. 1 3,20-Dioxopregna-1,4,9(11),16 - Tetraen - 21- Ylacetate (3 TR) 1.15 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
Import Items Qty. allowed. Triamicinolone IP/EP/BP/USP 1 kg. 1 3,20-Dioxopregna-1,4,9(11),16 - Tetraen - 21- Ylacetate (3 TR) 1.15 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
10 Triamicinolone Acetonide IP/EP/BP/USP 1 kg. 2 3,20-Dioxopregna-1,4,9(11),16 - Tetraen - 21- Ylacetate (3 TR) 1.05 kg.
Case No. 16 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name TOJO VIKAS INTERNATIONAL PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005976AM26 RA File Number 052404000616 AM20 Licence No and Date 0510413195/03/01/2020 that the firm had not furnished any technical justification or supporting information for the proposed
Case No.
17 / NC/3/MEET/Apr/202627/1
Case Status
Case Deferred
Party Name
BALAJI AMINES LIMITED
Meeting Number
and Date
HQ File Number
HQRNORM REVIW00005021AM26
RA File Number
318304000150 AM20
Licence No and
Date
3110067697/25/02/2020
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:
UDIN00106096AM27
Digitally Signed.
DGFT )
Location: DGFT(HQ)
d in view of the recommendations of the Technical Authority,
the Committee decided to ask the firm to furnish the following documents:
UDIN00106096AM27
Digitally Signed.
DGFT )
Location: DGFT(HQ)
11 To give complete chemistry giving molecular weight of both reactants and products indicating yield of the reaction. 1. Based on yield of the reaction, to give calculation of requirement of raw material. 2.
Case No. 18 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ALPHAMED FORMULATIONS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00006119AM26 RA File Number 092404000036 AM21 Licence No and Date 0910068668/24/04/2020 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 NACOL 18-98 P (Stearl Alcohol) 2160.0 kg. PLENISH-K 600 SR TABLETS 36,000,000 Numbers 2 Ethanol Absolute (Ethanol Anhydrous) 2502.0 kg.
RA concerned may take further necessary action as per above decision of NC-III.
Case No. 19 / NC/3/MEET/Apr/202627/1 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
g.
RA concerned may take further necessary action as per above decision of NC-III.
Case No. 19 / NC/3/MEET/Apr/202627/1 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
12
Case Status
Case Approved
Party Name
ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Apr/ 202627/ 1 and 07/04/2026
HQ File Number
HQRNORM REVIW00006021AM26
RA File Number
092404000632 AM20
Licence No and Date
0910068801/26/05/2020
The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meeting No. NC/3/MEET/Jan/2022/4 dated 12/02/2021
against advance authorization No. 0910068698 dated 29/04/2020, 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 Glucuronolactone 51.00 mg 2 Ascorbic Acid (Crystalline) 306.0 mg 3 Caffeine Anhydrous 51.00 mg. 4 Sodium Polyphosphate 50.0 mg. 5 Sodium Hydrogen Carbonate 950. mg. 6 Gin Fizz Micron Flavour 30.0 mg. 7 Macrogol 6000 135.00 mg. Bolt Energy Effervescent Tablets; (Each Tablet Contains- Glucuronolactone 50 mg, Ascorbic Acid 300 mg, Caffeine 50 mg. 1 Number Tablet 8 Monosodium Fumarate 2000.00 mg.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
ch Tablet Contains- Glucuronolactone 50 mg, Ascorbic Acid 300 mg, Caffeine 50 mg. 1 Number Tablet 8 Monosodium Fumarate 2000.00 mg.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
13
Case No. 20 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name ALPHAMED FORMULATIONS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00006048AM26 RA File Number 092404000605 AM20 Licence No and Date 0910068804/27/05/2020
Case No. 21 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002715AM26 RA File Number 039404000210 AM21 Licence No and Date 0310836960/30/06/2020 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Secnidazole Taste Masked Pellets 1 kg. 1 Secnidazole IH 478.235 gm.
RA concerned may take further necessary action as per above decision of NC-III. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
Taste Masked Pellets 1 kg. 1 Secnidazole IH 478.235 gm.
RA concerned may take further necessary action as per above decision of NC-III. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
14
Case No. 22 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002716AM26 RA File Number 039404000210 AM21 Licence No and Date 0310836960/30/06/2020 The Committee examined the request of the firm for the fixation of ad-hoc norms. After due indicated below:- Export Product Qty. Sl. No. Import Items Qty. allowed. Secnidazole Taste Masked Pellets 1 kg. 1 Secnidazole IH 478.235 gm.
Case No. 23 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name SAVLA CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004374AM26 RA File Number 039504000192 AM21 Licence No and Date 0310837078/08/07/2020 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 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
ailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
15
following documents:-
Copy of Bill of Entries
1.
Case No. 24 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name KOSHA CHEMTECH PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005966AM26 RA File Number 039404000306 AM21 Licence No and Date 0310837580/10/08/2020 that the firm had not furnished any technical justification or supporting information for the proposed
Case No. 25 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005625AM26 RA File Number 03AA04014068 AM21 Licence No and Date 0311000348/22/12/2020 indicated below:-
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
16 Export Product Qty. Sl. No. Import Items Qty. allowed. Secnidazole Taste Masked Pellets 1 kg. 1 Secnidazole IH 478.235 gm. Secnidazole 2 gm. Sachets (Secnizol) 1 Number 2 Secnidazole IH 2.02 gm. Secnidazole 2 gm. Sachets (Tribactin 2 gm. Sachets) 1 Number 3 Secnidazole IH 2.02 gm.
Case No. 26 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name BHAGWATI INDUSTRIES Meeting Number and Date HQ File Number HQRNORM REVIW00006055AM26 RA File Number 08AA04001833 AM22 Licence No and Date 0811001364/29/04/2021 indicated below:-
Export Product Qty. Sl. No. Import Items Qty.
Number and Date HQ File Number HQRNORM REVIW00006055AM26 RA File Number 08AA04001833 AM22 Licence No and Date 0811001364/29/04/2021 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ethyl Alcohol 0.65 kg. Chloral Anhydrous 1 kg. 2 Caustic Soda 0.40 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
17
Case No. 27 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name KOPRAN RESEARCH LABORATORIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002372AM26 RA File Number 03AA04019330 AM22 Licence No and Date 0311004745/19/06/2021 same export product/import item in meeting No. NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance Authorization No. 0511024949 dated 10/04/2024 it was decided to fix ad-hoc whichever is less:-
Export Product Qty. Qty. allowed. Meropenem Sodium Sterile (Meropenem for Injection) 1 kg. 1 Meropenem Trihydrate (Non Sterile) 0.8968 kg.
2 Packing Material Relevant as per Packing Policy & General Notes.
Case No. 28 / NC/3/MEET/Apr/202627/1 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
n Sterile) 0.8968 kg.
2 Packing Material Relevant as per Packing Policy & General Notes.
Case No. 28 / NC/3/MEET/Apr/202627/1 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
18 Case Status Case Rejected Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003189AM26 RA File Number 03AA04033537 AM22 Licence No and Date 0311005080/02/07/2021 the firm has requested to add additional item of export and import, however, the firm has not submitted the amended license for additional items. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.
Case No. 29 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name METROPOLITAN EXIMCHEM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005332AM26 RA File Number 03AA040108347 AM22 Licence No and Date 0311007901/25/10/2021 that the firm had not furnished any technical justification or supporting information for the proposed
Case No. 30 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ARKRAY HEALTHCARE PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003329AM26 RA File Number 52AA04018127 AM22 Licence No and Date 5211001587/18/11/2021 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
ing Number and Date HQ File Number HQRNORM REVIW00003329AM26 RA File Number 52AA04018127 AM22 Licence No and Date 5211001587/18/11/2021 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
19 indicated below:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Anti Mouse Ig G [Goat]) 10.863 gram 2 Mab to P. Falciparum For NCM/Malaria K 3.647 gram 3 Mab to P. Falciparum Colloidal Gold Reagent 1.711 gram 4 Mouse Ig G Purified 0.856 gram 5 Conjugate Releasing Pad Gr 6615-21 MM X 500 FT- Parah) 167811 Feet 6 Conjugated Releasing Pad 10 mm Grade 6615) 167811 Feet 7 Sample Pad Grade 238 Size 12 mm X 100 m 55567 Meter 8 Absorbent Pad for Rapid Test 22 Mm X 50 mtr-CF5 55567 Meter PARAHIT-F DEVICE TEST KIT([1 KIT = 50 TESTS OR 25 TESTS OR 10 TESTS] [RAPID DIAGNOSTICS TEST KIT]) 12502500 Numbers 9 Dis Seafty Seal Lancets [Pack of 25] & [Pack of 10]) 1,25,02,500 Numbers
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
ESTS] [RAPID DIAGNOSTICS TEST KIT]) 12502500 Numbers 9 Dis Seafty Seal Lancets [Pack of 25] & [Pack of 10]) 1,25,02,500 Numbers
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
20 Case No. 31 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name LAZERHEAD LIFESCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004743AM26 RA File Number 09AA04012424 AM22 Licence No and Date 0911001950/26/11/2021
Case No. 32 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name PMC RUBBER CHEMICALS INDIA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00006034AM26 RA File Number 02AA04035173 AM22 Licence No and Date 0211001583/02/12/2021 that the firm had not furnished any technical justification or supporting information for the proposed
Case No. 33 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name MANKIND PHARMA LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004845AM26 RA File Number 05AX04000761 AM23 Licence No and Date 0511013170/13/06/2022 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
ing Number and Date HQ File Number HQRNORM REVIW00004845AM26 RA File Number 05AX04000761 AM23 Licence No and Date 0511013170/13/06/2022 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
21 the firm had not furnished any technical justification or supporting information for the proposed
Case No. 34 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name MANKIND PHARMA LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00006693AM26 RA File Number 05AX04000760 AM23 Licence No and Date 0511013171/13/06/2022 the norms had earlier been ratified on the basis of the Drug Manufacturing Licence with permissible wastage of 2%. Accordingly, the Committee did not find any justification for revising the existing norms and decided to reject the request, thereby maintaining the status quo.
Case No. 35 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005941AM26 RA File Number 03AX04001157 AM23 Licence No and Date 0311015490/14/06/2022 the norms had earlier been ratified on the basis of the Drug Manufacturing Licence with permissible wastage of 2%. Accordingly, the Committee did not find any justification for revising the existing norms and decided to reject the request, thereby maintaining the status quo.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
did not find any justification for revising the existing norms and decided to reject the request, thereby maintaining the status quo.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
22
Case No.
36 / NC/3/MEET/Apr/202627/1
Case Status
Case Deferred
Party Name
ALTA LABORATORIES LIMITED
Meeting Number
and Date
HQ File Number
HQRNORM REVIW00005722AM25
RA File Number
03AX04002261 AM23
Licence No and
Date
0311016368/15/07/2022
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:
Chemical reaction indicating molecular weight of both reactant and the products with yield
of the reaction.
1.
Stoichiometric material balance on a molar basis and to give value of by-product Methanol
obtained during the reaction.
2.
Concentration of the ammonia in aqueous solution and accordingly, calculation of
requirement of both the chemical
3.
Case No. 37 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name KOPRAN RESEARCH LABORATORIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002375AM26 RA File Number 03AX04002208 AM23 Licence No and Date 0311016558/25/07/2022 that the firm had not furnished any technical justification or supporting information for the proposed
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
and Date 0311016558/25/07/2022 that the firm had not furnished any technical justification or supporting information for the proposed
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
23
Case No. 38 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name PRACHEM LABORATORIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002184AM26 RA File Number 08AX04000754 AM23 Licence No and Date 0811005702/08/08/2022 indicated below:- Export Product Qty. Sl. No. Import Items Qty. allowed. Triamcinolone Acetonide BP/EP/USP(( 9?-Fluoro- 11?,21-dihydroxy-16?,17- isopropylidenedioxy-1,4- pregnadiene-3,20-dione)) 1 kg. 1 3TR (Tetraene Acetate) (21- (Acetyloxy)-Pregna-1,4,9(11),16 Tetraene-3,20-Dione) 1.05 kg.
Case No. 39 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002872AM26 RA File Number 03AX04002399 AM23 Licence No and Date 0311017082/10/08/2022 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
ing Number and Date HQ File Number HQRNORM REVIW00002872AM26 RA File Number 03AX04002399 AM23 Licence No and Date 0311017082/10/08/2022 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
24
Case No. 40 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00003195AM26 RA File Number 03AX04002728 AM23 Licence No and Date 0311017256/16/08/2022 that the firm has requested to add additional items of export and import; however, the firm has not submitted the amended license for additional items. 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/Apr/202627/1 Case Status Case Rejected Party Name KOPRAN RESEARCH LABORATORIES LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00002377AM26 RA File Number 03AX04003060 AM23 Licence No and Date 0311018071/22/09/2022 the firm had not furnished any technical justification or supporting information for the proposed
Case No. 42 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name MANKIND PHARMA LIMITED Meeting Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
on for the proposed
Case No. 42 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name MANKIND PHARMA LIMITED Meeting Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
25 and Date HQ File Number HQRNORM REVIW00004847AM26 RA File Number 05AX04002651 AM23 Licence No and Date 0511016260/08/12/2022 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 the details given in Appendix-4E and Appendix-4K with a copy of the Drug Manufacturing Licence.
Case No. 43 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name JUBILANT INGREVIA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005825AM23 RA File Number 05AX04003069 AM23 Licence No and Date 0511016941/19/01/2023 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 submit the following information/documents:-
To give proper Chemical reaction starting clearly from import items asked for, in the license, giving molecular weight and name of the chemicals and also yield of the reaction. I.
tion/documents:-
To give proper Chemical reaction starting clearly from import items asked for, in the license, giving molecular weight and name of the chemicals and also yield of the reaction. I. Function/application of each raw material asked for in the process indicating raw material, catalyst solvent/diluents, etc., as the case may be, giving Stoichiometric material balance on a molar basis. II. Value of by-product, if any and with End use of export item. III.
Case No. 44 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name AGRO SOLVENT PRODUCTS PVT LTD UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
26 Meeting Number and Date HQ File Number HQRNORM APPLY 00001107AM24 RA File Number 56AX04000449 AM23 Licence No and Date 5611001909/25/05/2023 The firm was called for a Personal Hearing on 08.04.2026 through Video Conference, but the firm could not appear before the Norms Committee because of a medical condition. It was decided to grant one more opportunity to the firm for a Personal Hearing with relevant documents/information.
Case No. 45 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name FRESENIUS KABI INDIA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00004957AM24 RA File Number 03AX04002106 AM24 Licence No and Date 0311026174/09/08/2023 The Committee examined the request of the firm for fixation of ad-hoc norms . After due indicated below.:- Export Product Qty. Qty.
umber 03AX04002106 AM24 Licence No and Date 0311026174/09/08/2023 The Committee examined the request of the firm for fixation of ad-hoc norms . After due indicated below.:- Export Product Qty. 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. Sodium Chloride 0.9% 50 ml (AUS) 1 Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
27 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) 50 and 100 ml Net content in export + 1% wastage. 31 OFR2-11 150/524 for 50 and 100 ml (0369701) Net content in export + 1% wastage. 36 UFR2-11 150/524-50ml 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 Net content in export + 1% wastage. 22 SSC Injection (Art. 0434371) Net content in export + 1% wastage. Sodium Chloride 0.9 % 100 ml (AUS) 1 Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
export + 1% wastage. 22 SSC Injection (Art. 0434371) Net content in export + 1% wastage. Sodium Chloride 0.9 % 100 ml (AUS) 1 Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
28 27 SF9-11 195/95 Prim.film (0369581) 50 and 100 ml Net content in export + 1% wastage. 32 Net content in export + 1% wastage. 37 UFR2-11 150/524-50 ml to 1000 (0369661) Net content in export + 1% wastage. 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 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. 33 Net content in export + 1% wastage. Sodium Chloride 0.9% 250 ml (AUS) 1 Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
m (Art.0369591) Net content in export + 1% wastage. 33 Net content in export + 1% wastage. Sodium Chloride 0.9% 250 ml (AUS) 1 Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
29 38 to 1000 (0369661) Net content in export + 1% wastage. 43 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage. 4 Sodium Chloride (SANAL) (EP) 4.725 gm. 9 BOP Infusion (Art.No 0434171) Net content in export + 1% wastage. 14 BOP Injection (Art. 0434481) Net content in export + 1% wastage. 19 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) 500 ml Net content in export + 1% wastage. 34 OFR2-11 120/524-500ml and 1000 ml (0369681) Net content in export + 1% wastage. 39 to 1000 (0369661) Net content in export + 1% wastage. Sodium Chloride 0.9% 500 ml (AUS) 1 Number 44 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
xport + 1% wastage. Sodium Chloride 0.9% 500 ml (AUS) 1 Number 44 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
30 5 Sodium Chloride (SANAL) (EP) 9.45 gm 10 BOP Infusion (Art.No 0434171) Net content in export + 1% wastage. 15 BOP Injection (Art. 0434481) Net content in export + 1% wastage. 20 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)1 ltr Net content in export + 1% wastage. 35 OFR2-11 120/524-500 ml and 1000 ml (0369681) Net content in export + 1% wastage. 40 to 1000 (0369661) Net content in export + 1% wastage. Sodium Chloride 0.9% 1000 ml AUS 1 Number 45 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage.
Case No. 46 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
1% wastage.
Case No. 46 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
31 Date HQ File Number HQRNORM REVIW00003348AM26 RA File Number 52AX04000128 AM24 Licence No and Date 5211005508/21/08/2023 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Tert-Butyl((1S)-2-hydroxy-1- methylethyl) carbamate 1.70 kg. 1 kg. 2 Diisopropyl azodicarboxylate 1.96 kg. 4-{1- [(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile)
3 Triphenylphosphine 2.54 kg.
Case No. 47 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name FRESENIUS KABI INDIA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00005822AM24 RA File Number 03AX04002768 AM24 Licence No and Date 0311027333/22/09/2023 The Committee examined the request of the firm for fixation of ad-hoc norms . After due UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
AM24 Licence No and Date 0311027333/22/09/2023 The Committee examined the request of the firm for fixation of ad-hoc norms . After due UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
32 indicated below.:- Export Product Qty. 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 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) 50 and 100 ml Net content in export + 1% wastage. 31 Net content in export + 1% wastage. 36 UFR2-11 150/524-50ml to 1000 (0369661) Net content in export + 1% wastage. Sodium Chloride 0.9% 50 ml (AUS) 1 Number 41 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
33 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 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) 50 and 100 ml Net content in export + 1% wastage. 32 Net content in export + 1% wastage. 37 to 1000 (0369661) Net content in export + 1% wastage. Sodium Chloride 0.9 % 100 ml (AUS) 1 Number 42 Hot Stamping foil (Art.
nt in export + 1% wastage. 32 Net content in export + 1% wastage. 37 to 1000 (0369661) Net content in export + 1% wastage. Sodium Chloride 0.9 % 100 ml (AUS) 1 Number 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. Sodium Chloride 0.9% 250 ml (AUS) 1 Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
34 13 BOP Injection (Art. 0434481) Net content in export + 1% wastage. 18 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. 33 Net content in export + 1% wastage. 38 to 1000 (0369661) Net content in export + 1% wastage. 43 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage. 4 Sodium Chloride (SANAL) (EP) 4.725 gm. 9 BOP Infusion (Art.No 0434171) Net content in export + 1% wastage. 14 BOP Injection (Art. 0434481) Net content in export + 1% wastage. Net content in Sodium Chloride 0.9% 500 ml (AUS) 1 Number 19 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
age. 14 BOP Injection (Art. 0434481) Net content in export + 1% wastage. Net content in Sodium Chloride 0.9% 500 ml (AUS) 1 Number 19 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
35 export + 1% wastage. 24 SSC Injection(Art. 0434371) Net content in export + 1% wastage. 29 SF9-11 195/135 Prim film Art. 0369621) 500 ml Net content in export + 1% wastage. 34 OFR2-11 120/524-500ml and 1000 ml (0369681) Net content in export + 1% wastage. 39 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. 15 BOP Injection (Art. 0434481) Net content in export + 1% wastage. 20 Net content in export + 1% wastage. Net content in export + 1% Sodium Chloride 0.9% 1000 ml AUS 1 Number 25 SSC Injection (Art. 0434371) UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
content in export + 1% wastage. Net content in export + 1% Sodium Chloride 0.9% 1000 ml AUS 1 Number 25 SSC Injection (Art. 0434371) UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
36 wastage. 30 SF9-11 195/140 Prim. film (Art.0369631)1 ltr Net content in export + 1% wastage. 35 OFR2-11 120/524-500 ml and 1000 ml (0369681) Net content in export + 1% wastage. 40 Net content in export + 1% wastage.
to 1000 (0369661)
45 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage.
Case No. 48 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00004069AM26 RA File Number 52AX04000234 AM24 Licence No and Date 5211006397/10/11/2023 indicated below:- Qty. Export Product Qty. Sl. No. Import Items UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
37 allowed. 1 Tert-Butyl((1S)-2-hydroxy-1- methylethyl) carbamate 1.70 kg. 2 Diisopropyl azodicarboxylate 1.96 kg. 3 Triphenylphosphine 2.54 kg. 4-{1- [(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile) 1 kg. 4 2-chloro-4-(1H-pyrazol-3-yl) benzonitrile 0.963 kg.
Case No. 49 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name JUBILANT INGREVIA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00008210AM24 RA File Number 05AX04003445 AM24 Licence No and Date 0511023507/30/01/2024 The Representative of the firm had attended the Personal Hearing and explained the case.
Number HQRNORM APPLY 00008210AM24 RA File Number 05AX04003445 AM24 Licence No and Date 0511023507/30/01/2024 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/information:- To give balance chemical reaction indicating molecular weight of all the reactants and product with stage wise yield of the reaction. I. To indicate where Alumino Silicate catalyst, Denatured Ethyl alcohol and methanol are used in the chemical reaction, giving their application/use. II. Calculation of the requirement of all the chemicals with justification of low yield, if any. III. In chemical reaction Ethyl acetate has been shown as one of the reactants whereas the same IV. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
38 has neither been shown in import nor in indigenous inputs.
Case No. 50 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name YELLOWSTONE FINE CHEMICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00008613AM24 RA File Number 03AX04005249 AM24 Licence No and Date 0311031269/16/02/2024 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 1.
2/2024 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
- Molecular weight of export product.
Case No. 51 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name FRESENIUS KABI INDIA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00009103AM24 RA File Number 03AX04005671 AM24 Licence No and Date 0311032149/14/03/2024 The Committee examined the request of the firm for fixation of ad-hoc norms . After due indicated below.:-
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
39 Export Product Qty. 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 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) 50 and 100 ml Net content in export + 1% wastage. 31 Net content in export + 1% wastage. 36 UFR2-11 150/524-50ml to 1000 (0369661) Net content in export + 1% wastage. Sodium Chloride 0.9% 50 ml (AUS) 1 Number 41 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage. 2 Sodium Chloride (SANAL) (EP) 0.945 gm. Sodium Chloride 0.9 % 100 ml (AUS) 1 Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
Art. 0368991) Net content in export + 1% wastage. 2 Sodium Chloride (SANAL) (EP) 0.945 gm. Sodium Chloride 0.9 % 100 ml (AUS) 1 Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
40 7 BOP Infusion (Art.No 0434171) Net content in export + 1% wastage. 12 BOP Injection (Art. 0434481) Net content in export + 1% wastage. 17 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) 50 and 100 ml Net content in export + 1% wastage. 32 Net content in export + 1% wastage. 37 to 1000 (0369661) Net content in export + 1% wastage. 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. BOP Injection Net content in Sodium Chloride 0.9% 250 ml (AUS) 1 Number 13 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
fusion (Art.No 0434171) Net content in export + 1% wastage. BOP Injection Net content in Sodium Chloride 0.9% 250 ml (AUS) 1 Number 13 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
41 (Art. 0434481) export + 1% wastage. 18 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. 33 Net content in export + 1% wastage. 38 to 1000 (0369661) Net content in export + 1% wastage. 43 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage. 4 Sodium Chloride (SANAL) (EP) 4.725 gm. 9 BOP Infusion (Art.No 0434171) Net content in export + 1% wastage. 14 BOP Injection (Art. 0434481) Net content in export + 1% wastage. Net content in export + 1% Sodium Chloride 0.9% 500 ml (AUS) 1 Number 19 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
42 wastage. 24 SSC Injection(Art. 0434371) Net content in export + 1% wastage. 29 SF9-11 195/135 Prim film Art. 0369621) 500 ml Net content in export + 1% wastage. 34 OFR2-11 120/524-500ml and 1000 ml (0369681) Net content in export + 1% wastage. 39 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. 15 BOP Injection (Art. 0434481) Net content in export + 1% wastage. 20 Net content in export + 1% wastage. 25 SSC Injection (Art.
Infusion (Art.No 0434171) Net content in export + 1% wastage. 15 BOP Injection (Art. 0434481) Net content in export + 1% wastage. 20 Net content in export + 1% wastage. 25 SSC Injection (Art. 0434371) Net content in export + 1% wastage. Sodium Chloride 0.9% 1000 ml AUS 1 Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
43 30 SF9-11 195/140 Prim. film (Art.0369631)1 ltr Net content in export + 1% wastage. 35 OFR2-11 120/524-500 ml and 1000 ml (0369681) Net content in export + 1% wastage. 40 to 1000 (0369661) Net content in export + 1% wastage.
45 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage.
Case No. 52 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM REVIW00005461AM26 RA File Number 52AX04000061 AM25 Licence No and Date 5211008490/13/06/2024 indicated below:-
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
HQ File Number HQRNORM REVIW00005461AM26 RA File Number 52AX04000061 AM25 Licence No and Date 5211008490/13/06/2024 indicated below:-
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
44 Export Product Qty. Qty. allowed. 1 Hydrazine Hydrate 64% (RM for mfg of Semicarbazide HCL for further mfg of TPO) 2.14 kg. 2 2-Chloro Pyridine 1.33 kg. 1,2,4 - Triazolo (4,3-a) Pyridin - 3 (2H) - one - 98% MIN. 1 kg. 3 Ethylene Glycol Monoethyl Ether/2- Ethoxy Ethanol 1.35 kg.
Case No. 53 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name PI INDUSTRIES LIMITED Meeting Number and Date NC/ 3/ MEET/ Apr/ 202627/ 1 and 07/04/2026 HQ File Number HQRNORM APPLY 00003572AM25 RA File Number 13AX04000225 AM25 Licence No and Date 1311003391/09/10/2024 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2-Chloro-5- Chloromethylthiazole 0.57 kg. Dicloromezotiaz Technical (ZI2901)(Chemical Name : 1- 1 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
No. Import Items Qty. allowed. 1 2-Chloro-5- Chloromethylthiazole 0.57 kg. Dicloromezotiaz Technical (ZI2901)(Chemical Name : 1- 1 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
45 2 Potassium Carbonate 1.42 kg. 3 3,5-Dichlorobenzoyl Chloride 1.02 kg. 4 Dimethyl Carbonate 0.89 kg. [(2-chlorothiazol-5-yl)methyl]-3- (3,5-dichlorophenyl)-9-methyl- 2,4-dioxo-3,4-dihydro-2H-1?5- pyrido[1,2-a]pyrimidin-1-ylium- 3-ide) 5 Acetonitrile 1.03 kg.
Case No. 54 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name NAVIN FLUORINE ADVANCED SCIENCES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00003633AM25 RA File Number 03AX04003448 AM25 Licence No and Date 0311037925/15/10/2024 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Trifluoroacetyl 0.9 kg. 2 Ethyl Vinyl Ether (EVE) 0.50 kg. 5-[1-Methyl (sulfanyl) ethyl]-2- (trifluoromethyl) pyridine (PSI) 1 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
wed. 1 Trifluoroacetyl 0.9 kg. 2 Ethyl Vinyl Ether (EVE) 0.50 kg. 5-[1-Methyl (sulfanyl) ethyl]-2- (trifluoromethyl) pyridine (PSI) 1 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
46 3 21% Sodium Thiomethoxide 2.30 kg. 4 Pyrrolidine 0.45 kg.
Case No. 55 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name PARADISE HEALTHCARE Meeting Number and Date HQ File Number HQRNORM APPLY 00003965AM25 RA File Number 34AX04000658 AM25 Licence No and Date 3411005628/30/10/2024 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 6-chloro-4-hydroxy-2-methyl- 2H-thieno[2,3-e][1,2]thiazine- 3-carboxylate 1,1-dioxide 1 kg. 1 Methyl 3-Amino-2 thiophenecarboxylate 97% Min 3.15 kg.
Case No. 56 / NC/3/MEET/Apr/202627/1 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
47 Case Status Case Approved Party Name SALVI CHEMICAL INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00004814AM25 RA File Number 03AX04004624 AM25 Licence No and Date 0311039663/16/12/2024 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Iodine 0.120 kg. Povidone Iodine USP 1 kg. 2 Polyvinylpyrrolidone 0.800 kg.
Case No. 57 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name JUBILANT INGREVIA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00004895AM25 RA File Number 05AX04003211 AM25 Licence No and Date 0511029723/19/12/2024 The Representative of the firm had attended the Personal Hearing and explained the case.
Number HQRNORM APPLY 00004895AM25 RA File Number 05AX04003211 AM25 Licence No and Date 0511029723/19/12/2024 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 submit the following information/documents:- UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
48 To give balance chemical reaction indicating molecular weight of all the reactants and product with stage wise yield of their action/ I. Process flow charts indicating where Alumino Silicate Catalyst, Denatured Ethyl Alcohol and Methanol are used in the chemical reaction giving their application/use. II. Calculation of the requirement of all the chemicals with justification of low yield. III.
Case No. 58 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name PARADISE HEALTHCARE Meeting Number and Date NC/ 3/ MEET/ Apr/ 202627/ 1 and 07/04/2026 HQ File Number HQRNORM APPLY 00005333AM25 RA File Number 34AX04000854 AM25 Licence No and Date 3411005897/01/01/2025 indicated below:- Export Product Qty. Sl. No. Import Items Qty. allowed. 6-chloro-4hydroxy-2-methyl-3- Methoxycarbonyl-2h-thieno[2,3-e] [1,2] thiazine-11Dioxide 1 kg. 1 Methyl 3-Amino-2 thiophenecarboxylate 97% Min 3.15 kg.
Case No. 59 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name PARAGON FINE AND SPECIALITY CHEMICAL LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000004AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
Case Deferred Party Name PARAGON FINE AND SPECIALITY CHEMICAL LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000004AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
49 RA File Number 08AX04002207 AM25 Licence No and Date 0811014582/01/04/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to Percentage Yield of reaction. 1. Commercial value of by-product obtained. 2. Justification for import of water. 3.
Case No. 60 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name PARAGON FINE AND SPECIALITY CHEMICAL LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000005AM26 RA File Number 08AX04002208 AM25 Licence No and Date 0811014583/01/04/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to Justification of low yield of 72%. 1. Commercial value of by-product acetic acid obtained. 2. Justification of import of water 3.
Case No. 61 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name PARAGON FINE AND SPECIALITY CHEMICAL LIMITED Meeting Number and Date UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
o. 61 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name PARAGON FINE AND SPECIALITY CHEMICAL LIMITED Meeting Number and Date UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
50 HQ File Number HQRNORM APPLY 00000076AM26 RA File Number 08AX04002246 AM25 Licence No and Date 0811014626/03/04/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to
Bill of entry to indicate the purity of K-Acid as 70% (as indicated in the process). 1. Justification for import of Ice. 2.
Case No. 62 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name BENZO CHEM INDUSTRIES PVT LTD Meeting Number and Date HQ File Number HQRNORM APPLY 00000087AM26 RA File Number 03AX04000001 AM26 Licence No and Date 0311042847/04/04/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ortho Methyl Phenyl Acetic Acid 1.40 kg. 2 Mono Chloro Benzene 0.30 kg. 3 Iso Chromanone (3 I C) 1 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
No. Import Items Qty. allowed. 1 Ortho Methyl Phenyl Acetic Acid 1.40 kg. 2 Mono Chloro Benzene 0.30 kg. 3 Iso Chromanone (3 I C) 1 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
51 3 Liquid Chlorine 0.65 kg. 4 2,2-Azobis iso butyro nitrile (AIBN / Cat-X) 0.02 kg. 5 Sodium Hydroxide (Caustic Soda Lye) 0.50 kg. 6 Sodium Bi Carbonate 0.20 kg. 7 Hydro Chloric Acid (HCL 30%) 0.50 kg. 8 Methanol 0.30 kg.
Case No. 63 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name LA CHANDRA PHARMALAB PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00000242AM26 RA File Number 08AX04000065 AM26 Licence No and Date 0811014717/15/04/2025 indicated below:-
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
52 Export Product Qty. Sl. No. Import Items Qty. allowed. Mifepristone (N.A.) 1 kg. 1 N 1 Mifepristone (NA) 1.15 kg.
Case No. 64 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name SRS FORMULATIONS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001216AM26 RA File Number 03AX04000936 AM26 Licence No and Date 0311044395/02/06/2025 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
Please furnish export quantity in Numbers or Sachets in line with Drug Manufacturing Licence. 1. Weight of each Sachet. 2. Copy of Master-Batch Formula for export item. 3.
ions of the Technical
Please furnish export quantity in Numbers or Sachets in line with Drug Manufacturing Licence. 1. Weight of each Sachet. 2. Copy of Master-Batch Formula for export item. 3.
Case No. 65 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name RUBICON RESEARCH LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001233AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
53 RA File Number 03AX04000913 AM26 Licence No and Date 0311044428/02/06/2025 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:
Copy of Master-Batch Formula for each export item.
Case No. 66 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001256AM26 RA File Number 08AX04000384 AM26 Licence No and Date 0811015193/03/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Zinc Sulfate Injection USP, 1 mg / ml (10 ml) 1 Number 1 Zinc sulphate heptahydrate 48.378 mg. Zinc Sulfate Injection USP, 5 mg / ml (5 ml) 1 Number 2 Zinc sulphate heptahydrate 120.944 mg.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
1 Zinc sulphate heptahydrate 48.378 mg. Zinc Sulfate Injection USP, 5 mg / ml (5 ml) 1 Number 2 Zinc sulphate heptahydrate 120.944 mg.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
54
Case No. 67 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name MICRO LABS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001261AM26 RA File Number 07AX04000383 AM26 Licence No and Date 0711014615/03/06/2025 indicated below:-
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. 68 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name LEBEN LABORATORIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001273AM26 RA File Number 03AX04001066 AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
55 Licence No and Date 0311044429/04/06/2025 indicated below:-
Export Product Qty. Qty. allowed. MOXILEB -CV -375 TABLET USP. ( AMOXICILLIN & CLAVULANATE POTASSIUM TABLETS USP 375 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 USP (COMPACTED) EXTRADRY - 49.709 KG (EXCL 2% WASTAGE) 1 Number 1 Amoxicillin Trihydrate USP Compacted 292.639 mg. MOXILEB -CV -625 TABLET USP. (AMOXICILLIN & CLAVULANATE POTASSIUM TABLETS USP 625 MG). (EACH TABLET CONTAINING AMOXICILLIN TRIHYDRATE EQUIAVLENT TO 500 MG OF AMOXICILLIN).
Compacted 292.639 mg. MOXILEB -CV -625 TABLET USP. (AMOXICILLIN & CLAVULANATE POTASSIUM TABLETS USP 625 MG). (EACH TABLET CONTAINING AMOXICILLIN TRIHYDRATE EQUIAVLENT TO 500 MG OF AMOXICILLIN). NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE USP COMPACTED) EXTRA DRY - 128.117KG (EXCL 2% WASTAGE) 1 Number 2 Amoxicillin Trihydrate USP Compacted 585.28 mg. MOXILEB -CV -1000TABLET USP. Amoxicillin Trihydrate 1 Number 3 892.511 mg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
56 (AMOXICILLIN & CLAVULANATE POTASSIUM TABLETS USP 1000 MG) (EACH TABLET CONTAINING AMOXICILLIN TRIHYDRATE EQUIVALENT TO 875 MG OF AMOXICILLIN ). NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE USP (COMPACTED ) EXTRA DRY - 238.359 KG (EXCL 2% WASTAGE) USP Compacted MOXILEB -CV -156.25 DRY SYRUP USP. (AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP 156.25MG/5ML) ((EACH 5ML CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO 125MG OF AMOXICILLIN). NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1 AMOXICILLIN TRIHYDRATE USP (COMPACTED) EXTRA DRY -44.083KG (EXCL 2% WASTAGE)) 100 ml Bottle. 1 Number 4 Amoxicillin Trihydrate USP Compacted 2625 mg. MOXILEB -CV -228.5 DRY SYRUP USP. (AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP 228.5 MG/5ML) (( EACH 5ML CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO 200 MG OF AMOXICILLIN) .
OXILEB -CV -228.5 DRY SYRUP USP. (AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP 228.5 MG/5ML) (( EACH 5ML CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO 200 MG OF AMOXICILLIN) . NET CONTENT OF IMPORT /EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE USP (COMPACTED) EXTRA DRY - 87.202KG (EACL 2% WASTAGE) 100 ml. Bottle. 1 Number 5 Amoxicillin Trihydrate USP Compacted 4200.0 mg. MOXILEB -CV -457 DRY SYRUP USP. (AMOXICILLIN AND 1 Number 6 Amoxicillin Trihydrate USP Compacted 6384.0 mg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
57 CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP 457MG/5ML)((EACH 5ML CONTIANS AMOXICILLIN TRIHYDRATE EQUIVALENT TO 400MG OF AMOXICILLIN). NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE USP (COMPACTED) EXTRA DRY - 187.825 KG (EXCL 2% WASTAGE) 70 ml. Bottle.
Case No. 69 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name SAGAR LIFE SCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001284AM26 RA File Number 34AX04000209 AM26 Licence No and Date 3411006552/04/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Trifluromethane Sulfonate Acid 5000 kg. TriMethyl silyl TriFluoromethane sulfonate 7404 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
t Qty. Sl. No. Import Items Qty. allowed. 1 Trifluromethane Sulfonate Acid 5000 kg. TriMethyl silyl TriFluoromethane sulfonate 7404 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
58 2 Trimethylsilyl chloride 3619.528 kg.
Case No. 70 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name STERILE INDIA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001294AM26 RA File Number 05AX04000712 AM26 Licence No and Date 0511033130/05/06/2025 same export product/import item in meeting No. NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance Authorization No. 0511024949 dated 10/04/2024 it was decided to fix ad-hoc whichever is less:-
Export Product Qty. Qty. allowed. Meropenem Sodium Sterile (Meropenem for Injection) 1 kg. 1 Meropenem Trihydrate (Non Sterile) 0.8968 kg.
Case No. 71 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name INTIGREAT CONSULTING SERVICES LLP UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
59 Meeting Number and Date HQ File Number HQRNORM APPLY 00001313AM26 RA File Number 03AX04001090 AM26 Licence No and Date 0311044509/05/06/2025 In this application, it is observed that the import item and export product are essentially the same/similar in description, character and use, with no substantial manufacturing process resulting in transformation into a distinct product having a different name, character or use.
Para 4.03 of FTP provides for duty-free import of inputs that are physically incorporated in the
export product after undergoing a process of manufacture. The scheme contemplates admissibility of inputs required for manufacture of resultant export products and not for mere trading, repacking, relabeling, or negligible processing where the imported and exported goods remain essentially identical. Since the proposed export product does not emerge as a distinct manufactured product from the imported material, the request for fixation of norms is not found admissible under Para 4.03 of FTP. Accordingly, the application for the fixation of ad hoc/input-output norms is rejected. RA is requested to initiate recovery of duty and interest for imported items as per applicable provisions of FTP and HBP read with the FTDR Act.
Case No. 72 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name HETERO LABS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001326AM26 RA File Number 09AX04000229 AM26 Licence No and Date 0911009779/06/06/2025
Case No. 73 / NC/3/MEET/Apr/202627/1 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
M APPLY 00001326AM26 RA File Number 09AX04000229 AM26 Licence No and Date 0911009779/06/06/2025
Case No. 73 / NC/3/MEET/Apr/202627/1 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
60 Case Status Case Approved Party Name INDO AMINES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001349AM26 RA File Number 03AX04001084 AM26 Licence No and Date 0311044547/06/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Dicyandiamide 0.499 kg. 2 Enzonitrile 0.612 kg. Benzoguanamine or IAL BGA 1 kg. 3 N-Butanol 0.750 kg.
Case No. 74 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name APITORIA PHARMA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001359AM26 RA File Number 09AX04000237 AM26 Licence No and Date 0911009784/06/06/2025 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
61
Case No. 75 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name STERLING AUXILIARIES PVT LTD Meeting Number and Date HQ File Number HQRNORM APPLY 00001398AM26 RA File Number 03AX04001199 AM26 Licence No and Date 0311044637/10/06/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to
Percentage purity of export product.
Case No. 76 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name SANOFI CONSUMER HEALTHCARE INDIA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001399AM26 RA File Number 03AX04001131 AM26 Licence No and Date 0311044640/10/06/2025
oved Party Name SANOFI CONSUMER HEALTHCARE INDIA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001399AM26 RA File Number 03AX04001131 AM26 Licence No and Date 0311044640/10/06/2025 The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Dec/202526/6 dated 18/12/2025 against advance authorization No. 0311042739 dated 01/04/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. Qty. allowed. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
62 Festal (Tablets) Enterosolube 10 x 10s ((Total Net Weight of Pancreatin 18691.60 kgs Strength of Pancreatin 192 mg/Tablet)) 1 Number Tablet 1 Pancreatin 195.84 mg
RA concerned may take further necessary action as per above decision of NC
Case No. 77 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name SANOFI CONSUMER HEALTHCARE INDIA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001400AM26 RA File Number 03AX04001116 AM26 Licence No and Date 0311044641/10/06/2025 The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Dec/202526/6 dated 18/12/2025 against advance authorization No. 0311042739 dated 01/04/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.
ct/import item in meeting No. NC/3/MEET/Dec/202526/6 dated 18/12/2025 against advance authorization No. 0311042739 dated 01/04/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. Qty. allowed. Festal (Tablets) Enterosolube 10 x 10s ((Total Net Weight of Pancreatin 18691.60 kgs Strength of Pancreatin 192 mg/Tablet)) 1 Number Tablet 1 Pancreatin 195.84 mg
Case No. 78 / NC/3/MEET/Apr/202627/1 Case Status Case Approved UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
63 Party Name SYDLER REMEDIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001401AM26 RA File Number 03AX04001215 AM26 Licence No and Date 0311044648/10/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Ursodeoxycholic Acid Granules namely UDCA 200 mg. DC Granules (Net content 0.6765 of export qty.) 1 kg. 1 Ursodeoxycholic Acid Powder 0.69 kg.
Case No. 79 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name STERILE INDIA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001423AM26 RA File Number 05AX04000851 AM26 Licence No and Date 0511033239/10/06/2025 same export product/import item in meeting No. NC/3/MEET/Feb/202526/13 dated 20/02/2026 against advance authorization No. 0511032819 dated 23/05/2025, it was decided to fix ad-hoc UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
o. NC/3/MEET/Feb/202526/13 dated 20/02/2026 against advance authorization No. 0511032819 dated 23/05/2025, it was decided to fix ad-hoc UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
64 whichever is less:- Export Product Qty. Qty. allowed. Ceftriaxone Sodium Sterile 1 kg. 1 Ceftriaxone Sodium (Non Sterile) 1.04 kg.
Case No. 80 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name AETHER INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001424AM26 RA File Number 52AX04000071 AM26 Licence No and Date 5211014068/10/06/2025
Case No. 81 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name MANKIND PHARMA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001448AM26 RA File Number 05AX04000950 AM26 Licence No and Date 0511033264/11/06/2025 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
65 same export product/import item in meeting No. NC/3/MEET/Oct/202526/9 dated 14/10/2025 against advance authorization No. 3011006688 dated 19/03/2025, it was decided to fix ad-hoc whichever is less:- Export Product Qty. Qty. allowed. Sugammadex Injection, 100 mg/ml, 2 ml. 1 Number 1 Sugammadex Sodium 239.326 mg.
Case No. 82 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name BENZO CHEM INDUSTRIES PVT LTD Meeting Number and Date HQ File Number HQRNORM APPLY 00001449AM26 RA File Number 03AX04001143 AM26 Licence No and Date 0311044707/11/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty.
umber and Date HQ File Number HQRNORM APPLY 00001449AM26 RA File Number 03AX04001143 AM26 Licence No and Date 0311044707/11/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 2,4-Dichloro Benzaldehyde (2,4-DCB) 1 kg. 1 2, 4 - Dichloro toluene (2.4-DCT) 1.083 kg.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
66
Case No. 83 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ASTA BIOCHEMICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001458AM26 RA File Number 07AX04000427 AM26 Licence No and Date 0711014690/11/06/2025 same export product/import item in meeting No. NC/3/MEET/Feb/202526/13 dated 20/02/2026 against advance authorization No. 0711014435 dated 15/05/2025, it was decided to fix ad-hoc whichever is less:- Export Product Qty. Qty. Allowed. Calcium Thioglycolate (Imported Item Output is 99,500 kg. and Domestic Content is 17,219 kg. and Total Export Item Weight 116,719 kg.) 1 Kg. 1 Thioglycolic Acid 0.927 Kg.
Case No. 84 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number and Date UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
Case No. 84 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number and Date UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
67 HQ File Number HQRNORM APPLY 00001477AM26 RA File Number 03AX04001076 AM26 Licence No and Date 0311044748/12/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Mometasone Furoate BP 3825 gm. Mometasone Furoate & Azelastine HCL Nasal Spray (50 mcg + 140 mcg) 150 MD ((Glenspray Active/Modexa AZ/ Momat A Nasal Spray/Momat Rino Advance/Momate - AZ/Nasalsona Plus) (Net Wt. of Import Sr. No. 1 is 7585.09 Grams and Import Sr. No. 2 is 21238.25 Grams)) 1011345 Numbers 2 Azelastine Hydrochloride BP 21663.3 gm. 3 Mometasone Furoate BP 1917.13 gm. Mometasone Furoate & Azelastine HCL Nasal Spray (50 mcg + 140 mcg) 75 MD ((Glenspray Active/Modexa AZ/ Momat A Nasal Spray/Momat Rino Advance/Momate – AZ / Nasalsona Plus) (Net Wt. of Import Sr. No. 1 is 1879.54 Grams and Import Sr. No.2 is 5262.71 Grams)) 501210 Numbers 4 Azelastine Hydrochloride BP 5367.96 gm.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
Import Sr. No. 1 is 1879.54 Grams and Import Sr. No.2 is 5262.71 Grams)) 501210 Numbers 4 Azelastine Hydrochloride BP 5367.96 gm.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
68
Case No. 85 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name SVR DRUGS AND INTERMEDIATES Meeting Number and Date HQ File Number HQRNORM APPLY 00001480AM26 RA File Number 07AX04000404 AM26 Licence No and Date 0711014713/12/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Para Toluene sulphonyl chloride 0.395 kg. 2 Imidazole 0.141 kg. 3 Benzoyal Chloride 0.582 kg. 4 2,4 Dichloro Acetophenone 0.783 kg. Cis Tosylate 1 kg. 5 Glycerine 0.381 kg.
Case No. 86 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name DR.REDDY'S LABORATORIES LTD UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
69 Meeting Number and Date HQ File Number HQRNORM APPLY 00001483AM26 RA File Number 09AX04000210 AM26 Licence No and Date 0911009815/12/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty.
umber and Date HQ File Number HQRNORM APPLY 00001483AM26 RA File Number 09AX04000210 AM26 Licence No and Date 0911009815/12/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Sacubitril Valsartan Sodium Tablets 50 mg (Consists of 42 Kgs of Sacubitril Valsartan Sodium) Pack Size : 28s) 1 Number Tablet 1 Sacubitril Valsartan Sodium 51.0 mg. Sacubitril Valsartan Sodium Tablets 100 mg (Consists of 84 Kgs of Sacubitril Valsartan Sodium) Pack Size : 28s 1 Number Tablet 2 Sacubitril Valsartan Sodium 102.0 mg
Case No. 87 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name AVIK PHARMACEUTICAL LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001490AM26 RA File Number 52AX04000074 AM26 Licence No and Date 5211014358/13/06/2025 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
70 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Triamicinolone Acetonide IP/EP/BP/USP 1 kg. 1 3,20-Dioxopregna-1,4,9 (11),16 - Tetraen - 21- Ylacetate (3 TR) 1.05 kg.
Case No. 88 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name BRAWN LABORATORIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001508AM26 RA File Number 05AX04000958 AM26 Licence No and Date 0511033337/16/06/2025
Case No. 89 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name AETHER INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001515AM26 RA File Number 52AX04000087 AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
Party Name AETHER INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001515AM26 RA File Number 52AX04000087 AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
71 Licence No and Date 5211014419/16/06/2025
Case No. 90 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name MACSON PRODUCTS Meeting Number and Date HQ File Number HQRNORM APPLY 00001516AM26 RA File Number 52AX04000079 AM26 Licence No and Date 5211014420/16/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Schaffers Acid (Highly Purified) 1 kg. 1 Beta Naphthol 0.80 kg.
Case No. 91 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name MEDREICH LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001517AM26 RA File Number 07AX04000443 AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
72 Licence No and Date 0711014735/16/06/2025 same export product/import product in meeting No. NC/3/MEET/Sep/202526/8 dated 17/09/2025 against advance authorization No. 0711013518 dated 30/01/2025, it was decided to fix ad-hoc whichever is less:-
Export Product Qty. Qty.
uct in meeting No. NC/3/MEET/Sep/202526/8 dated 17/09/2025 against advance authorization No. 0711013518 dated 30/01/2025, it was decided to fix ad-hoc whichever is less:-
Export Product Qty. Qty. allowed. Clindamycin Hydrochloride 300 mg Capsules [1628.900 kg.] [Each Capsule contains Clindamycin Hydrochloride 325.78 mg equivalent to Clindamycin 300 mg]) 1 Number 1 Clindamycin Hydrochloride Ph.Eur 332.29 mg.
Case No. 92 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ENVEE DRUGS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001518AM26 RA File Number 34AX04000156 AM26 Licence No and Date 3411006600/16/06/2025 same export product/import product in meeting No. NC/3/MEET/Sep/202526/8 dated 17/09/2025 against advance authorization No. 0711013518 dated 30/01/2025, it was decided to fix ad-hoc whichever is less:- UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
73
Export Product Qty. Sl. No. Import Items Qty.
ion No. 0711013518 dated 30/01/2025, it was decided to fix ad-hoc whichever is less:- UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
73
Export Product Qty. Sl. No. Import Items Qty. allowed. Prednisolone Sodium Metasulfobenzoate 1 kg. 1 Prednisolone (EP/BP/USP) 1.00 kg.
Case No. 93 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name APITORIA PHARMA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001520AM26 RA File Number 09AX04000282 AM26 Licence No and Date 0911009831/16/06/2025
Case No. 94 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name SHREAS INDUSTRIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001534AM26 RA File Number 09AX04000256 AM26 Licence No and Date 0911009849/17/06/2025 same export product/import product in meeting No. NC/3/MEET/Jan/202526/12 dated UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
74 15/01/2026 against advance authorization No. 0911009590 dated 08/05/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. Qty. allowed. Methylene Chloride (Methylene Di- Chloride/ Di- Chloromethane) 1 kg. 1 Methanol 0.418 kg.
Case No. 95 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name STYRAX PHARMA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001535AM26 RA File Number 09AX04000246 AM26 Licence No and Date 0911009850/17/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty.
umber and Date HQ File Number HQRNORM APPLY 00001535AM26 RA File Number 09AX04000246 AM26 Licence No and Date 0911009850/17/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 L-Menthyl Glyoxylate Hydrate (L-MGH) 0.81 kg 5-(4-Amino-2-Oxo-Pyrimidinyl)- Oxathiolane-2-Carboxylic Acid- 1 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
75 2 2,5-Dihydroxy-1,4-Diathine 0.312 kg 3 Di Methyl Formamide (DMF) 0.26 kg 4 Cytosine 0.395 kg 5 Hexa Methyl Disilazane (HMDS) 0.286 kg 6 Methylene Di Chloride (MDC) 2.63 kg 7 Tri Ethyl Amine (TEA) 0.034 kg Isopropylmethyl- Cyclohexyl Ester or CHE) 8 Triphosgine 0.40 kg
Case No. 96 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name SPAR PHARMA LLP Meeting Number and Date HQ File Number HQRNORM APPLY 00001536AM26 RA File Number 09AX04000248 AM26 Licence No and Date 0911009851/17/06/2025 The Committee considered the case as per the agenda and taking cue from the earlier decision for the same export product/import item in the meeting No. NC/3/MEET/Oct/202526/5 dated 14/01/2025 against Advance Authorisation No. 0911009149 dated 06/03/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
s 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:-
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
76 Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Aniline Oil (Liquid) 0.47 kg. 2 Fluorobenzene (Liquid) 0.52 kg. 3 Acetone (Liquid) 0.50 kg. 4 Methyl Aceto Acetate (Liquid) 1.06 kg. 4-Fluoro-alpha-[2-methyl-1- oxopropyl]-gamma-oxo-N-beta- diphenyl benzene butanamide. (Solid) 1 kg. 5 Iso Butyryl Chloride (Liquid) 0.97 kg.
Case No. 97 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name DEEPAK NOVOCHEM SPECIALITIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001537AM26 RA File Number 31AX04000107 AM26 Licence No and Date 3111004980/17/06/2025 The Committee considered the case as per the agenda and taking cue from the earlier decision for the same export product/import item in the meeting No. NC/3/MEET/Oct/202526/9 dated 14/01/2025 against Advance Authorisation No. 3111004443 dated 17/12/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. Sl. No. Import Items Qty. allowed. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
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. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
77 1 Phenol 0.963 kg. 2 Methanol 0.750 kg. 2,6 Xylenol 1 kg. 3 Catalyst (Katalco) 0.004 kg.
Case No. 98 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name DEEPAK NOVOCHEM SPECIALITIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001538AM26 RA File Number 31AX04000106 AM26 Licence No and Date 3111004981/17/06/2025 The Committee considered the case as per the agenda and taking cue from the earlier decision for the same export product/import item in the meeting No. NC/3/MEET/Oct/202526/9 dated 14/01/2025 against Advance Authorisation No. 3111004443 dated 17/12/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Phenol 0.963 kg. 2 Methanol 0.750 kg. 2,6 Xylenol 1 kg. 3 Catalyst (Katalco) 0.004 kg.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
roduct Qty. Sl. No. Import Items Qty. allowed. 1 Phenol 0.963 kg. 2 Methanol 0.750 kg. 2,6 Xylenol 1 kg. 3 Catalyst (Katalco) 0.004 kg.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
78
Case No. 99 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ALEMBIC PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001542AM26 RA File Number 34AX04000188 AM26 Licence No and Date 3411006619/17/06/2025 same export product/import product in meeting No.NC/3/MEET/Apr/202526/2 dated 08/05/2025 against advance authorization No. 3411005503 dated 08/10/2024, it was decided to fix ad-hoc whichever is less:-
Export Product Qty. Sl. No.Import Items Qty. allowed. 1 Duloxetine Hydrochloride Ph,Eur. 22.88 mg. 2 Sugar Spheres (30-35 PHARM- A-SPHERES) 20.33 mg. Duloxetine Caps. 20 mg (Net content of active ingredients 180.000 kgs ) 1 Number Capsule 3 Sucrose (CompressucPS) 50.67 mg. 4 Duloxetine Hydrochloride Ph,Eur. 34.36 mg. 5 Sugar Spheres (30-35 PHARM- A-SPHERES) 30.50 mg. Duloxetine Caps. 30 mg (Net content of active ingredients 750.00 kgs ) 1 Number Capsule 6 Sucrose (CompressucPS) 23.50 mg UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
ES) 30.50 mg. Duloxetine Caps. 30 mg (Net content of active ingredients 750.00 kgs ) 1 Number Capsule 6 Sucrose (CompressucPS) 23.50 mg UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
79 7 Duloxetine Hydrochloride Ph,Eur. 45.76 mg 8 Sugar Spheres (30-35 PHARM- A-SPHERES) 40.67 mg. Duloxetine Caps. 40 mg (Net content of active ingredients 360.000 kgs ) 1 Number Capsule 9 Sucrose (CompressucPS) 31.34 mg. 10 Duloxetine Hydrochloride Ph,Eur. 68.71 mg. 11 Sugar Spheres (30-35 PHARM- A-SPHERES) 61.00 mg. Duloxetine Caps. 60 mg (Net content of active ingredients 1500.00 kgs ) 1 Number Capsule 12 Sucrose (CompressucPS) 47.00 mg.
Case No. 100 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name DEEPAK NOVOCHEM TECHNOLOGIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001552AM26 RA File Number 31AX04000108 AM26 Licence No and Date 3111004982/18/06/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to
The chemical name of the export item DNOVO BP 838. 1. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
has not furnished the requisite technical details as prescribed in Annexure to
The chemical name of the export item DNOVO BP 838. 1. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
80 Difference in DNOVO BP 838 and DNOVO BP 388. 2.
Case No. 101 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ACUTAAS CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001569AM26 RA File Number 52AX04000085 AM26 Licence No and Date 5211014477/19/06/2025 indicated below:-
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. 102 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name PIRAMAL PHARMA LIMITED UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
81 Meeting Number and Date HQ File Number HQRNORM APPLY 00001570AM26 RA File Number 03AX04001413 AM26 Licence No and Date 0311044919/19/06/2025 The Committee considered the case as per the agenda and taking cue from the earlier decision for the same export product/import item in the meeting No. NC/3/MEET/Dec/202526/11 dated 18/12/2025 against Advance Authorisation No. 0311042932 dated 08/04/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. Sl. No. Import Items Qty.
8/04/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Vibegron (Obgemsa) Tablets 75 mg. 1 Number 1 Vibegron 76.50 mg.
Case No. 103 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name LEE PHARMA LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001573AM26 RA File Number 09AX04000287 AM26 Licence No and Date 0911009874/19/06/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
82 Stepwise complete and balanced chemical reactions from starting stage with molecular weight. and percentage yield on molar basis. 1. Material balance for each step. 2. Requirement and recovery of solvent of each step. 3.
Case No. 104 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name DEEPAK NOVOCHEM SPECIALITIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001580AM26 RA File Number 31AX04000110 AM26 Licence No and Date 3111004985/19/06/2025 The Committee considered the case as per the agenda and taking cue from the earlier decision for the same export product/import item in the meeting No. NC/3/MEET/Oct/202526/9 dated 14/01/2025 against Advance Authorisation No. 3111004443 dated 17/12/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. Sl.
No. 3111004443 dated 17/12/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Phenol 0.963 kg. 2 Methanol 0.750 kg. 2,6 Xylenol 1 kg. 3 Catalyst (Katalco) 0.004 kg.
Case No. 105 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
83 Party Name ROSSARI BIOTECH LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001589AM26 RA File Number 03AX04001422 AM26 Licence No and Date 0311044962/20/06/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to
Complete chemical name of both import items with Certificate of Analysis (CoA). 1. Molecular weight of import and export. 2.
Case No. 106 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ENCUBE ETHICALS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001593AM26 RA File Number 03AX04001373 AM26 Licence No and Date 0311044978/20/06/2025 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.
mmittee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less, as per the details indicated below.:-
Sl. No. Export Product Quantity Medical Cream,Ointment & Gel (ESTRADIOL GEL 0.06% 50 Gm Pump Wt: 2750 Kgs (Net Cont: ESTRADIOL 1.65 Kgs, ETHANOL 1147.58 Kgs, CARBOPOL 28.6 Kgs, TROLAMINE 27.50 Kgs, WHITE CAP, WHITE 1 1 Number UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
84 BOTTLE, WHITE PUMP 55000 Nos EACH)) 2 Medical Cream,Ointment & Gel (ESTRADIOL GEL 0.1% , 1.25 Gm Sachet Wt: 750 Kgs (Net Cont: ESTRADIOL 0.75 Kgs, ETHANOL 412.50 Kgs, CARBOPOL 9.75 Kgs, TROLAMINE 2.10 Kgs, PROPYLENE 90 Kgs)) 1 Number 3 Medical Cream, Ointment & Gel (ESTRADIOL GEL 0.1% , 0.25 Gm Sachet Wt: 150 Kgs (Net Cont: ESTRADIOL 0.15 Kgs, ETHANOL 82.50 Kgs, CARBOPOL 1.95 Kgs, TROLAMINE 0.42 Kgs, PROPYLENE 18 Kgs)) 1 Number 4 Medical Cream, Ointment & Gel (ESTRADIOL GEL 0.1% , 1 Gm Sachet Wt: 600 Kgs (Net Cont: ESTRADIOL 0.6 Kgs, ETHANOL 330.00 Kgs, CARBOPOL 7.8 Kgs, TROLAMINE 1.68 Kgs, PROPYLENE 72 Kgs)) 1 Number 5 Medical Cream, Ointment & Ge l(ESTRADIOL GEL 0.1% , 0.75 Gm Sachet Wt: 450 Kgs (Net Cont: ESTRADIOL 0.45 Kgs, ETHANOL 247.50 Kgs, CARBOPOL 5.85 Kgs, TROLAMINE 1.26 Kgs, PROPYLENE 54 Kgs)) 1 Number 6 Medical Cream,Ointment & Gel (ESTRADIOL GEL 0.1% , 0.50 Gm Sachet Wt: 300 Kgs (Net Cont: ESTRADIOL 0.30 Kgs, ETHANOL 165 Kgs, CARBOPOL 3.90 Kgs, TROLAMINE 0.84 Kgs, PROPYLENE 36 Kgs)) 1 Number
Sl. No.
al Cream,Ointment & Gel (ESTRADIOL GEL 0.1% , 0.50 Gm Sachet Wt: 300 Kgs (Net Cont: ESTRADIOL 0.30 Kgs, ETHANOL 165 Kgs, CARBOPOL 3.90 Kgs, TROLAMINE 0.84 Kgs, PROPYLENE 36 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.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
85
Case No. 107 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001605AM26 RA File Number 07AX04000327 AM26 Licence No and Date 0711014809/20/06/2025
Case No. 108 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name RUBICON RESEARCH LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001621AM26 RA File Number 03AX04001361 AM26 Licence No and Date 0311045012/23/06/2025 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:
Past production / consumption data certified by Chartered Accountant alongwith Drug Manufacturing Licence (DML). 1.
to explain its case along with following information / documents from the firm:
Past production / consumption data certified by Chartered Accountant alongwith Drug Manufacturing Licence (DML). 1.
Case No. 109 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name CIRON DRUGS AND PHARMACEUTICALS PRIVATE LIMITED UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
86 Meeting Number and Date HQ File Number HQRNORM APPLY 00001630AM26 RA File Number 03AX04001469 AM26 Licence No and Date 0311045023/23/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Tobramycin & Dexamethasone Opthalmic Solution 3mg/ml - 5 ml (Each ml contains Tobramycin USP 3 mg) (65,000 Nos) (Protaba Drops (Tobramycin and Dexamethasone Opthalmic Suspension USP) - 5 ml. Each ml contains : Tobramycin USP(3 mg) Dexamethasone USP (1 mg) Benzalkonium Chloride NF (0.2 mg) (65,000 Nos) Net Content: 1) Tobramycin USP:0.975 KGS) 65000 Numbers 1 Tobramycin USP 1.024 kg.
Case No. 110 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001647AM26 RA File Number 07AX04000518 AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
y Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001647AM26 RA File Number 07AX04000518 AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
87 Licence No and Date 0711014819/24/06/2025
Case No. 111 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001648AM26 RA File Number 07AX04000517 AM26 Licence No and Date 0711014820/24/06/2025 same export product/import item in meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against advance authorization No. 0211007647 dated 22/11/2024, it was decided to fix ad-hoc whichever is less:-
Export Product Qty. Sl. No. Import Items Qty. allowed Ferric Maltol 1 kg. 1 Maltol 0.962 kg.
Case No. 112 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name TIDE INDUSTRIES Meeting Number and Date HQ File Number HQRNORM APPLY 00001659AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
MEET/Apr/202627/1 Case Status Case Approved Party Name TIDE INDUSTRIES Meeting Number and Date HQ File Number HQRNORM APPLY 00001659AM26 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
88 RA File Number 34AX04000259 AM26 Licence No and Date 3411006647/24/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Acrylic Acid 0.56 kg. Gamma Undecalactone (Aldehyde C14) 1 kg. 2 Alcohol C 8 (N-Octanol) 1.0 kg.
Case No. 113 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ALEMBIC PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001668AM26 RA File Number 34AX04000264 AM26 Licence No and Date 3411006650/24/06/2025 The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Apr/202526/2 dated 08/05/2025 against advance authorization No. 3411005503 dated 08/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
as 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:-
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
89 Export Product Qty. Sl. No.Import Items Qty. allowed. 1 Duloxetine Hydrochloride Ph,Eur. 22.88 mg. 2 Sugar Spheres (30-35 PHARM-A- SPHERES) 20.33 mg. Duloxetine Caps. 20 mg (Net content of active ingredients 180.000 kgs ) 1 Number Capsule 3 Sucrose (Compressuc PS) 50.67 mg. 4 Duloxetine Hydrochloride Ph,Eur. 34.36 mg. 5 Sugar Spheres (30-35 PHARM-A- SPHERES) 30.50 mg. Duloxetine Caps. 30 mg (Net content of active ingredients 750.00 kgs ) 1 Number Capsule 6 Sucrose (Compressuc PS) 23.50 mg 7 Duloxetine Hydrochloride Ph,Eur. 45.76 mg 8 Sugar Spheres (30-35 PHARM-A- SPHERES) 40.67 mg. Duloxetine Caps. 40 mg (Net content of active ingredients 360.000 kgs ) 1 Number Capsule 9 Sucrose (Compressuc PS) 31.34 mg. 10 Duloxetine Hydrochloride Ph,Eur. 68.71 mg. 11 Sugar Spheres (30-35 PHARM-A- SPHERES) 61.00 mg. Duloxetine Caps. 60 mg (Net content of active ingredients 1500.00 kgs ) 1 Number Capsule 12 Sucrose (Compressuc PS) 47.00 mg.
Case No. 114 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
500.00 kgs ) 1 Number Capsule 12 Sucrose (Compressuc PS) 47.00 mg.
Case No. 114 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
90 Party Name HELLO AROMATICS PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001685AM26 RA File Number 05AX04000971 AM26 Licence No and Date 0511033486/25/06/2025 that the firm has not furnished the requisite technical details as prescribed in Annexure to
To give chemical reaction indicating molecular weight of reactant and products and also yield of the reaction. 1. Manufacturing process and to give indigenous items to use in Annexure to Appendix-4E table with justification of wastage of raw materials. 2. To indicate the value of by-product/s formed during the process. 3.
Case No. 115 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name VITAL LABORATORIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001686AM26 RA File Number 03AX04000194 AM26 Licence No and Date 0311045089/25/06/2025 same export product/import product in meeting No. NC/3/MEET/Jul/202526/6 dated 31/07/2025 against advance authorization No. 0311040055 dated 31/12/2024, it was decided to fix ad-hoc whichever is less:-
Export Product
Qty. Sl. No. Import Items Qty. allowed. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
0055 dated 31/12/2024, it was decided to fix ad-hoc whichever is less:-
Export Product
Qty. Sl. No. Import Items Qty. allowed. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
91 1 Artemisinin 1.04 kg. Artemether PH.I/ USP 1 kg. 2 Trimethyl Ortho Acetate 0.50 kg. Artesunate PH.I 1 kg. 3 Artemisinin 0.80 kg. Dihydro Artemisinin 1 kg. 4 Artemisinin 0.92 kg.
Note: NC also decided to make new SION for the above export product.
Case No. 116 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name VITAL LABORATORIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001687AM26 RA File Number 03AX04000195 AM26 Licence No and Date 0311045090/25/06/2025 same export product/import product in meeting No. NC/3/MEET/Jul/202526/6 dated 31/07/2025 against advance authorization No. 0311040055 dated 31/12/2024, it was decided to fix ad-hoc whichever is less:-
Export Product
Qty. Sl. No. Import Items Qty. allowed. 1 Artemisinin 1.04 kg. Artemether PH.I/ USP 1 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
c whichever is less:-
Export Product
Qty. Sl. No. Import Items Qty. allowed. 1 Artemisinin 1.04 kg. Artemether PH.I/ USP 1 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
92 2 Trimethyl Ortho Acetate 0.50 kg. Artesunate PH.I 1 kg. 3 Artemisinin 0.80 kg. Dihydro Artemisinin 1 kg. 4 Artemisinin 0.92 kg.
Note: NC also decided to make new SION for the above export product.
Case No. 117 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name USV PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001690AM26 RA File Number 03AX04001519 AM26 Licence No and Date 0311045097/25/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Doxycycline Hyclate DR Tablets USP 100 mg 100 S((3,300 Bottles X 100 Per Bottles = 3,30,000 Tablets) (Total Weight of Export Product = 33.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 42.105 Kgs)) 1 Number Tablet 1 Doxycycline Hyclate USP 117.72 mg UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
0 Kgs) (Exempts imported input/material weight inclusive of wastage = 42.105 Kgs)) 1 Number Tablet 1 Doxycycline Hyclate USP 117.72 mg UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
93 Doxycycline Hyclate DR Tablets USP 150 mg 100 S((1,750 Bottles X 100 Per Bottles = 1,75,000 Tablets) (Total Weight of Export Product = 26.250 Kgs) (Exempts imported input/material weight inclusive of wastage = 33.492 Kgs) 1 Number Tablet 2 Doxycycline Hyclate USP 176.58 mg Doxycycline Hyclate DR Tablets USP 200 mg 60 S((2,333 Bottles X 60 Per Bottles = 1,39,980 Tablets) (Total Weight of Export Product = 27.996 Kgs) (Exempts imported input/material weight inclusive of wastage = 35.720 Kgs)) 1 Number Tablet 3 Doxycycline Hyclate USP 235.44 mg.
Note: NC also recommended making a new SION for the above export product.
Case No. 118 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name VENUS REMEDIES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001692AM26 RA File Number 30AX04000179 AM26 Licence No and Date 0511033498/25/06/2025 The Committee considered the case as per the agenda and taking cue from the earlier decision for the same export product/import item in the meeting No. NC/3/MEET/Oct/202526/9 dated 14/10/2025 against Advance Authorisation No. 3011006688 dt. 19/03/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product
Qty. Sl. No. Import Items Qty.
5, 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. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
94 Sugammadex solution for Injection 100 mg / ml (200 mg / 2 ml) (Each vial of 2 ml contains: Sugammadex Sodium equivalent to sugammadex ....... ..... 200 mg Hydrochloric acid 3.7% (to adjust pH) and/or Sodium hydroxide (to adjust pH) Water for Injections ......... q.s) 1 Number 1 Sugammadex Sodium 239.326 mg
Case No. 119 / NC/3/MEET/Apr/202627/1 Case Status Case Rejected Party Name ETERNIS FINE CHEMICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001697AM26 RA File Number 03AX04001461 AM26 Licence No and Date 0311045117/25/06/2025 The firm was initially granted an Advance Authorisation for the export product “Alpha Hexyl Cinnamaldehyde and or Hexyl Cinnamic Aldehyde” 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.
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 regularized 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. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
95 The RA concerned may take further necessary action in line with the above decision of the Committee.
Case No. 120 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001714AM26 RA File Number 09AX04000238 AM26 Licence No and Date 0911009915/26/06/2025 The Committee considered the case as per the agenda and taking cue from the earlier decision for the same export product/import item in the meeting No. NC/3/MEET/Dec/202526/11 dated 18/12/2025 against Advance Authorisation No. 0911009506 dt. 24/04/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product
Qty. Qty.
009506 dt. 24/04/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product
Qty. Qty. allowed. Teriparatide Injection 560 mcg/2.24 ml (250 mcg/ml) Fill Volume 2.54 ml) 1 Number 1 Teriparatide (Parathyroid Hormone (1-34) Human, Acetate) 616.0 mcg/Vial
Case No. 121 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED Meeting Number and Date UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
96 HQ File Number HQRNORM APPLY 00001715AM26 RA File Number 09AX04000271 AM26 Licence No and Date 0911009916/26/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Liraglutide 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 BD Vystra? Disposable Pen Printed Cartridge Holder (VYSTRA CARTRIDGE HOLDER PRINTED 0.6-15) Relevant, as per Packing Policy & General Notes. BD Vystra? Disposable Relevant, as Liraglutide Injection 18 mg/3 ml (6 mg/ml) 1x5's ((Each 3 ml contains Liraglutide 18 mg) Fill Volume- 3.3 ml) 1 Number 5 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
Relevant, as Liraglutide Injection 18 mg/3 ml (6 mg/ml) 1x5's ((Each 3 ml contains Liraglutide 18 mg) Fill Volume- 3.3 ml) 1 Number 5 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
97 Pen Cap (VYSTRA CAP PL MODERN 284C) per Packing Policy & General Notes.
Case No. 122 / NC/3/MEET/Apr/202627/1 Case Status Case Deferred Party Name SYNERGIA SCIENCES PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001757AM26 RA File Number 03AX04001477 AM26 Licence No and Date 0311045174/27/06/2025 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. 123 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name HONOUR LAB LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001769AM26 RA File Number 09AX04000304 AM26 Licence No and Date 0911009933/30/06/2025 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
ng Number and Date HQ File Number HQRNORM APPLY 00001769AM26 RA File Number 09AX04000304 AM26 Licence No and Date 0911009933/30/06/2025 UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
98 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Ethyl-(2R,4S)-5-([1,1-biphenyl]-4- yl)-4-amino-2-methylpentanoate hydrochloride) 1 kg. 1 (2R,4S)-5-([1,1-biphenyl]-4-yl)- 4-(tert-butoxycarbonyl) amino)- 2-methylpentanoic acid 1.21 kg.
Case No. 124 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name HETERO LABS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001770AM26 RA File Number 09AX04000315 AM26 Licence No and Date 0911009934/30/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 L-Phenylalanine 0.68 kg 2 Tetra HydraFuran 1.30 kg (2S.3S.5s)-2-(2,6-Dimethyl phenoxy acetyl) amino-3- hydroxy-5-(tert-butoxy 1 kg UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
d. 1 L-Phenylalanine 0.68 kg 2 Tetra HydraFuran 1.30 kg (2S.3S.5s)-2-(2,6-Dimethyl phenoxy acetyl) amino-3- hydroxy-5-(tert-butoxy 1 kg UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
99 3 Methane sulfonic acid 3.58 kg 4 Sodium boro hydride 0.143 kg 5 Di Tert.Butyl Di Carbonate 0.233 kg carbonyl) amino-1,6- diphenylhexane 6 Di iso propyl ether 0.520 kg
Case No. 125 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name ANNORA PHARMA PRIVATE LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001774AM26 RA File Number 09AX04000184 AM26 Licence No and Date 0911009826/30/06/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. Etravirine Tablets USP 200 MG. Composition: Each tablet contains Etravirine Premix 700 mg, it is equaling to Etravirine 200 mg.) 1 Number 1 Etravirine Premix IH 714 mg/Tablet UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
100 Etravirine Tablets USP 100 MG. Composition: Each tablet contains Etravirine Premix 350 mg, it is equaling to Etravirine 100 mg.) 1 Number 2 Etravirine Premix IH 357 mg/Tablet
Case No. 126 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00001795AM26 RA File Number 03AX04001482 AM26 Licence No and Date 0311045230/30/06/2025 The Committee examined the request of the firm for fixation of ad-hoc norms.
Date HQ File Number HQRNORM APPLY 00001795AM26 RA File Number 03AX04001482 AM26 Licence No and Date 0311045230/30/06/2025 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. FLUCORT N SKIN CREAM 0.025% (Pack Size 5 gms) ( Net Wt. of FLUOCINOLONE ACETONIDE BP is 201.663 Gms.) 161330 Numbers 1 Fluocinolone Acetonide BP 205.70 gm. FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) ( Net Wt. of FLUOCINOLONE ACETONIDE BP is 604.988 161330 Numbers 2 617.09 gm. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
101 Gms.) FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) ( Net Wt. of FLUOCINOLONE ACETONIDE BP is 4537.500 Gms.) 1210000 Numbers 3 4628.3 gm. FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt. of BP is 605.000 Gms.) 484000 Numbers 4 617.10 gm. FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) ( Net Wt.of FLUOCINOLONE ACETONIDE BP is 121.000 Gms.) 48400 Numbers 5 123.42 gm. CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt. of BP is 121.000 Gms.) 96800 Numbers 6 123.42 gm, CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt. of BP is 120.998 Gms.) 32266 Numbers 7 123.42 gm. SUPRICORT CREAM 0.025% (Pack Size 5 gms) ( Net Wt. of BP is 363.000 Gms.) 290400 Numbers 8 370.26 gm. SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.
120.998 Gms.) 32266 Numbers 7 123.42 gm. SUPRICORT CREAM 0.025% (Pack Size 5 gms) ( Net Wt. of BP is 363.000 Gms.) 290400 Numbers 8 370.26 gm. SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt. of BP is 362.993 Gms.) 96798 Numbers 9 370.25 gm. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
102 SUPRICORT CREAM 0.025% (Pack Size 250 gms) ( Net Wt. of BP is 121.063 Gms.) 1937 Numbers 10 123.48 gm. SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt. of BP is 121.000 Gms.) 96800 Numbers 11 123.42 gm. SUPRICORT N CREAM 0.025% (Pack Size 15 gms) ( Net Wt. Of BP is 120.998 Gms.) 32266 Numbers 12 123.42 gm. Flucort C Cream 0.01% (Pack Size 15 gms) (Net Wt. of BP is 47.499 Gms) 31666 Numbers 13 48.45 gm. FLUCORT C OINTMENT 0.025% (Pack Size 15 gms) ( Net Wt. of BP is 302.494 Gms.) 80665 Numbers 14 308.54 gm. GLENCORT GEL 0.025 % (Pack Size 5 gms) (Net Wt. of BP is 226.000 Gms.) 180800 Numbers 15 230.52 gm. GLENCORT GEL 0.025 % (Pack Size 30 gms) (Net Wt. of BP is 242.010 Gms.) 32268 Numbers 16 246.85 gm. FLUCORT MZ SKIN OINTMENT 0.01% (Pack Size 15 gms) ( Net 48399 Numbers 17 74.05 gm. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
f BP is 242.010 Gms.) 32268 Numbers 16 246.85 gm. FLUCORT MZ SKIN OINTMENT 0.01% (Pack Size 15 gms) ( Net 48399 Numbers 17 74.05 gm. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
103 Wt. of FLUOCINOLONE ACETONIDE BP is 72.599 Gms.) FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) ( Net Wt. of BP is 12.100 Gms.) 4840 Numbers 18 12.34 gm.
Case No. 127 / NC/3/MEET/Apr/202627/1 Case Status Case Approved Party Name HPL ADDITIVES LIMITED Meeting Number and Date HQ File Number HQRNORM APPLY 00002735AM26 RA File Number 05AX04001422 AM26 Licence No and Date 0511034515/18/08/2025 indicated below:-
Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Hexamine 0.470 kg. 2 Sodium Nitrite 0.491 kg. 3 Hydrazine Hydrate (100%) 0.003 kg. Mikrofine ADST contains 55% N-N' Dinitroso pentamethylene tetramine (DNPT) and 5% Azodicarbonamide 1 kg. UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
104 4 TGU (Technical Grade Urea) 0.007 kg.
UDIN00106096AM27 Digitally Signed. DGFT ) Location: DGFT(HQ)
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