KDMF (Korea Drug Master File) Approved Products & Companies

Gerbe Korea Co., Ltd.

  • Product:

    Gadopicleol

  • Initial Registration:

    2026-01-12

  • Registration Number:

    Su405-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Gerbe Korea Co., Ltd.

  • Last Modified:

  • Country:

    france

  • Status:

    Active

  • Manufacturer:

    Guerbet

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    rue Denis PapinZI Kerpont, LANESTER, 56600, France

Gilead Sciences Korea Ltd.

  • Product:

    Tenofovir disoproxil fumarate

  • Initial Registration:

    2011-04-29

  • Registration Number:

    22-6-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Gilead Sciences Korea Ltd.

  • Last Modified:

    2022-12-05

  • Country:

    USA

  • Status:

    Active

  • Manufacturer:

    AMPAC Fine Chemicals LLC

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2017

  • Manufacturing Facility:

    US Hwy 50 and Hazel Ave. Roncho Cordova

Gilpung C&Pharm Co., Ltd.

  • Product:

    Ceftriaxone sodium

  • Initial Registration:

    2010-10-29

  • Registration Number:

    20101029-116-G-83-08

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Gilpung C&Pharm Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    HARBIN PHARMACEUTICAL GROUP CO., LTD GENERAL PHARM FACTORY

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    No.109 Xuefu Road Nangang Dist. Harbin PR China

GL Pharma Co., Ltd.

  • Product:

    pseudoephedrine hydrochloride

  • Initial Registration:

    2012-02-17

  • Registration Number:

    20050831-41-C-46-03(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    GL Pharma Co., Ltd.

  • Last Modified:

    2026-02-06

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    Malladi Drug & Pharmaceuticals Limited

  • Withdrawal Date:

    2026-02-06

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    7B&7C, SIPCOT Industrial Complex, Ranipet-632 403, Vellore District (52, Jawaharlal Nehru Salai, Ekkattuthangal, Chennai-600 097, Tamil Nadu, India)

GlaxoSmithKline Inc.

  • Product:

    Ranitidine hydrochloride

  • Initial Registration:

    2003-08-31

  • Registration Number:

    20050831-35-B-97-05

  • MFDS Classification:

    Appendix 1

  • Applicant:

    GlaxoSmithKline Inc.

  • Last Modified:

    2023-11-24

  • Country:

    Singapore

  • Status:

    Withdrawal

  • Manufacturer:

    Glaxo Wellcome Manufacturing Pte Ltd

  • Withdrawal Date:

    2023-11-24

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    1 Pioneer Sector 1, Singapore 628413

Good Pharma Co., Ltd.

  • Product:

    Meloxicam

  • Initial Registration:

    2012-01-06

  • Registration Number:

    20120106-148-I-39-16

  • MFDS Classification:

  • Applicant:

    Good Pharma Co., Ltd.

  • Last Modified:

    2012-07-03

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    AMSASpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Via G. di Vittorio, 6 22100 COMO

Goodwills Co., Ltd.

  • Product:

    Carvedilol

  • Initial Registration:

    2007-06-14

  • Registration Number:

    20070614-60-B-257-20

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Goodwills Co., Ltd.

  • Last Modified:

    2026-03-16

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    Cadila Healthcare Limited

  • Withdrawal Date:

    2026-03-16

  • Final Annual Reporting Year:

    2020

  • Manufacturing Facility:

    291 GIDC Industrial Estate, Ankleshwar-393 002, Gujarat

GP Therapeutics Korea Co., Ltd.

  • Product:

    Terbinafine

  • Initial Registration:

    2011-02-15

  • Registration Number:

    20110215-49-A-244-16

  • MFDS Classification:

    Appendix 1

  • Applicant:

    GP Therapeutics Korea Co., Ltd.

  • Last Modified:

    2024-03-26

  • Country:

    Ireland

  • Status:

    Active

  • Manufacturer:

    Novartis Ringaskiddy Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    Ringaskiddy, Co. Cork

Grace Farm

  • Product:

    Rivastigmine tartrate

  • Initial Registration:

    2017-07-14

  • Registration Number:

    20150605-184-I-460-12(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Grace Farm

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    MSN Organics Private Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    Sy. No. 224/A, Bibinagar (Village & Mandal), Nalgonda District - 508 126, India

Grand Biopharm Co., Ltd.

  • Product:

    Flurbiprofen

  • Initial Registration:

    2023-01-18

  • Registration Number:

    20190628-209-J-379(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Grand Biopharm Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Hy-Gro Chemicals Pharmtek Private Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Plot No. 174, Progressive Industrial Society, Bollaram Village, Jinnaram Mandal, Sanga Reddy District – 502 325, Telangana, India

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