KDMF (Korea Drug Master File) Approved Products & Companies

Green Cross Corporation

  • Product:

    Peramivir hydrate

  • Initial Registration:

    2010-08-13

  • Registration Number:

    Number 4597-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Green Cross Corporation

  • Last Modified:

    2021-03-16

  • Country:

    USA

  • Status:

    Active

  • Manufacturer:

    Siegfried USA, LLC

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    33 Industrial Park Road Pennsville, NJ 08070, USA

Green Cross Wellbeing Co., Ltd.

  • Product:

    Ziziphus jujuba hydrolysate

  • Initial Registration:

    2006-11-03

  • Registration Number:

    20061103-01-HP-2-01

  • MFDS Classification:

    human placenta origin

  • Applicant:

    Green Cross Wellbeing Co., Ltd.

  • Last Modified:

    2025-02-10

  • Country:

    korea

  • Status:

    Withdrawal

  • Manufacturer:

    GC Wellbeing Co., Ltd.

  • Withdrawal Date:

    2025-02-10

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    26, Mugeuk-ro 65beon-gil, Geumwang-eup, Eumseong-gun, Chungcheongbuk-do

Green Life Science Co., Ltd.

  • Product:

    Erdostein

  • Initial Registration:

    2025-10-29

  • Registration Number:

    20251029-138-H-454-23

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Green Life Science Co., Ltd.

  • Last Modified:

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Green Life Science Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    84, Yeosusandan 2-ro, Yeosu-si, Jeollanam-do

Guju Pharmaceutical Co., Ltd.

  • Product:

    Ofloxacin

  • Initial Registration:

    2011-08-05

  • Registration Number:

    20070723-89-E-2-02(9)

  • MFDS Classification:

    etc

  • Applicant:

    Guju Pharmaceutical Co., Ltd.

  • Last Modified:

    2025-03-26

  • Country:

    china

  • Status:

    Withdrawal

  • Manufacturer:

    Zhejiang East-Asia pharmaceutical co.,ltd

  • Withdrawal Date:

    2025-03-26

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    Economy Development Zone of Sanmen County, Zhejiang 317100

Gukjeon Co., Ltd.

  • Product:

    Acyclovir

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-33-A-76-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Gukjeon Co., Ltd.

  • Last Modified:

    2022-05-18

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    No. 35-1, Yixi Road, Daixi street, Luoyang town, Wujin District, Changzhou

Gunil Biopharm Co., Ltd.

  • Product:

    Undifferentiated desonide

  • Initial Registration:

    2025-08-05

  • Registration Number:

    20250626-209-J-1941(A)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Gunil Biopharm Co., Ltd.

  • Last Modified:

    2026-04-27

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Aarti Pharmalabs Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Plot No.: E-50, 50/1 & 59/1, Unit-IV, MIDC, Tarapur. Taluka & District - Palghar, 401506, Maharashtra State, India

Gunil Pharmaceutical Co., Ltd.

  • Product:

    Amoxicillin hydrate

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-30-A-59-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Gunil Pharmaceutical Co., Ltd.

  • Last Modified:

    2023-08-23

  • Country:

    Spain

  • Status:

    Active

  • Manufacturer:

    Sandoz Industrial Products SA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    Ctra.Granollers a Cardedeu Km4 E-08520 Les Franques del Barcelona, Spain

H-Linkers

  • Product:

    Omega-3 ethyl ester 90

  • Initial Registration:

    2020-01-23

  • Registration Number:

    Su69-7-ND

  • MFDS Classification:

    new substance

  • Applicant:

    H-Linkers

  • Last Modified:

    2026-03-18

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Huatai Biopharm Inc.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    No. 5, East Section, Industrial Avenue, Xiaohan Town, Guanghan, Deyang City, Sichuan, PR China

H.O. Pharm Co., Ltd.

  • Product:

    Melphalan hydrochloride

  • Initial Registration:

    2021-04-14

  • Registration Number:

    20210414-210-J-936

  • MFDS Classification:

    Appendix 1

  • Applicant:

    H.O. Pharm Co., Ltd.

  • Last Modified:

    2021-07-27

  • Country:

    India

  • Status:

    Business Closure

  • Manufacturer:

    Sionc Pharmaceuticals Pvt. Ltd

  • Withdrawal Date:

    2025-12-22

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Plot No.34A, Road No.1, Jawaharlal Nehru Pharma City, Thanam(V), Parawada Mandal, Visakhapatnam District-531 021, Andhra Pradesh, India

Hailyon Korea Co., Ltd.

  • Product:

    Phenylephrine hydrochloride

  • Initial Registration:

    2008-06-27

  • Registration Number:

    20080627-88-D-82-06

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hailyon Korea Co., Ltd.

  • Last Modified:

    2016-10-17

  • Country:

    germany

  • Status:

    Active

  • Manufacturer:

    Boehringer Ingelheim Pharma GmbH & Co. K.G.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    55216 Ingelheim Binger Str.173

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