KDMF (Korea Drug Master File) Approved Products & Companies

Vivobion Pharmaceutical Co., Ltd.

  • Product:

    Opiranzerin hydrochloride

  • Initial Registration:

    2024-12-12

  • Registration Number:

    Su1342-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Vivobion Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jilin Asymchem Laboratories Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.99, Hongda Road, Economic Development Zone, Dunhua, Jilin, 133700, China

Whanin Pharmaceutical Co., Ltd.

  • Product:

    sodium risedronate

  • Initial Registration:

    2011-06-30

  • Registration Number:

    20100129-121-G-8-05(5)

  • MFDS Classification:

    etc

  • Applicant:

    Whanin Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    Israel

  • Status:

    Active

  • Manufacturer:

    Assia Chemical Industries Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Neot-Hovav Eco-Industrial Park, Be'er Sheva 8412316, Israel

WiseMedi Co., Ltd.

  • Product:

    refined fish oil

  • Initial Registration:

    2014-10-15

  • Registration Number:

    Number 4786-1-ND(2)

  • MFDS Classification:

  • Applicant:

    WiseMedi Co., Ltd.

  • Last Modified:

    2016-09-06

  • Country:

    germany

  • Status:

    Active

  • Manufacturer:

    Lipoid GmbH

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    Frigenstrasse 4, D-67065 Ludwigshafen, Federal Republic of Germany

Withus Pharmaceutical Co., Ltd.

  • Product:

    Levodropizine

  • Initial Registration:

    2011-06-15

  • Registration Number:

    20101130-137-H-36-04(3)

  • MFDS Classification:

    etc

  • Applicant:

    Withus Pharmaceutical Co., Ltd.

  • Last Modified:

    2024-01-23

  • Country:

    china

  • Status:

    Withdrawal

  • Manufacturer:

    Hunan Jiudian Pharmaceutical Co.,Ltd.

  • Withdrawal Date:

    2024-01-23

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Hunan Liuyang Bio-Pharmaceutical Industrial Park

Wonpung Pharmaceutical Co., Ltd.

  • Product:

    Acyclovir

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-33-A-74-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Wonpung Pharmaceutical Co., Ltd.

  • Last Modified:

    2025-07-01

  • Country:

    taiwan

  • Status:

    Active

  • Manufacturer:

    Yung Zip Chemical Ind. Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    No.59, 61 You Shih Road, Youth Industrial District, Dajia, Taichung, Taiwan, 437, Republic of China

Woojin B&G Co., Ltd.

  • Product:

    Streptokinase and Streptodornase

  • Initial Registration:

    2009-09-24

  • Registration Number:

    20090924-123-G-21-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Woojin B&G Co., Ltd.

  • Last Modified:

    2023-01-27

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Woojin B&G Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    528-5, Songsan-ri, Yanggam-myeon, Hwaseong-si, Gyeonggi-do

Wooshin Labotach Co., Ltd.

  • Product:

    Carvedilol

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-60-B-161-11

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Wooshin Labotach Co., Ltd.

  • Last Modified:

    2025-11-25

  • Country:

    Poland

  • Status:

    Active

  • Manufacturer:

    Pharmaceutical Works Polpharma S.A.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    19. Pelplinska Str, 83-200 Starogard Gdanski, Poland

Yebong NCP Co., Ltd.

  • Product:

    Acetaminophen

  • Initial Registration:

    2013-05-02

  • Registration Number:

    20050831-32-C-118-01(22)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Yebong NCP Co., Ltd.

  • Last Modified:

    2024-01-05

  • Country:

    china

  • Status:

    Withdrawal

  • Manufacturer:

    Zhejiang Kangle Pharmaceutical Co.,Ltd.

  • Withdrawal Date:

    2024-01-05

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Qujiang Road, Economic Techinque Develop Zone, Wenzhou, Zhejiang, China

Young Poong Pharmaceutical Co., Ltd.

  • Product:

    Metformin hydrochloride

  • Initial Registration:

    2011-08-19

  • Registration Number:

    20050831-37-C-34-05(6)

  • MFDS Classification:

    etc

  • Applicant:

    Young Poong Pharmaceutical Co., Ltd.

  • Last Modified:

    2020-02-12

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Granules India Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2016

  • Manufacturing Facility:

    Plot No.: 15A/1, IDA, Phase-Ⅲ, IDA Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District - 500 055 Telangana State, India

Youngil Pharmaceutical Co., Ltd.

  • Product:

    Cimetidine

  • Initial Registration:

    2011-06-30

  • Registration Number:

    20050831-27-B-63-01(7)

  • MFDS Classification:

    etc

  • Applicant:

    Youngil Pharmaceutical Co., Ltd.

  • Last Modified:

    2023-06-19

  • Country:

    china

  • Status:

    Withdrawal

  • Manufacturer:

    Wuxi Kaili Pharmaceutical Co.,Ltd.

  • Withdrawal Date:

    2023-06-19

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    Zhoutie, Town, Yixing City, Jiangsu Province, PRChina

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