KDMF (Korea Drug Master File) Approved Products & Companies

CMS Pharmaceutical Co., Ltd.

  • Product:

    Iopamidol

  • Initial Registration:

    2024-09-26

  • Registration Number:

    20220620-164-I-639-08(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    CMS Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Starry Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.1 Starry Road, Xianju Modern Industrial Centralization Zone, Xianju County, Zhejiang, China

Coapharm Bio Co., Ltd.

  • Product:

    Clarithromycin

  • Initial Registration:

    2011-06-30

  • Registration Number:

    20110630-62-A-247-18

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Coapharm Bio Co., Ltd.

  • Last Modified:

    2026-04-28

  • Country:

  • Status:

    Active

  • Manufacturer:

    Zhejiang Better Pharmaceuticals Co., Ltd. @ [Manufacturer of Starting Material (Erythromycin thiocyanate)] HEC Pharm Co., Ltd. @ [Manufacturer of Starting Material (Erythromycin thiocyanate)] Yili Chuanning Biotechnology Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Sanjiang Road, Paojiang Industrial Zone, Yuecheng District, Shaoxing, Zhejiang, PR China@No.3 Industrial Park of HEC, Yidu City, Hubei Province, PRChina@No.1, Gongchen Road, Yining Park, Khorgos Economic Development Zone, Yili Kazak Autonomous Prefecture, Xinjiang, PR China

Cosmax Bio Co., Ltd.

  • Product:

    Naproxen

  • Initial Registration:

    2016-07-13

  • Registration Number:

    20130821-143-I-366-08(12)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Cosmax Bio Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Tianxin Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.215 Fengze Road, Tiantai, Zhejiang, China

Cosmax Pharma Co., Ltd.

  • Product:

    Levodropizine

  • Initial Registration:

    2010-11-30

  • Registration Number:

    20101130-137-H-36-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Cosmax Pharma Co., Ltd.

  • Last Modified:

    2021-07-07

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Hunan Jiudian Pharmaceutical Co.,Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    Hunan Liuyang Bio-Pharmaceutical Industrial Park

CSIM Co., Ltd.

  • Product:

    Erdostein

  • Initial Registration:

    2023-08-28

  • Registration Number:

    20200707-138-H-374-14(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    CSIM Co., Ltd.

  • Last Modified:

    2024-11-28

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    Aurore Pharmaceuticals Private Limited (Unit-1)

  • Withdrawal Date:

    2024-11-28

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Plot No. 35, 36, 38 to 40, 49 to 51, Phase IV, IDA, Jeedimetla, Hyderabad 500055 Telangana State India

CTC Bio Co., Ltd.

  • Product:

    Pseudoephedrine sulfate

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-75-B-198-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    CTC Bio Co., Ltd.

  • Last Modified:

    2016-06-09

  • Country:

    germany

  • Status:

    Active

  • Manufacturer:

    Siegfried PharmaChemikalien Minden GmbH

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Karlstrasße 15-39, 42-44 32423 Minden, Germany

Curacle Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2016-07-25

  • Registration Number:

    20160725-4-B-387-21

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Curacle Co., Ltd.

  • Last Modified:

    2026-01-23

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zenji Pharmaceuticals (Suzhou) Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.122, Xuqing Road, Xuguan Town, Suzhou, Jiangsu China

Cygen Korea Co., Ltd.

  • Product:

    Melphalan hydrochloride

  • Initial Registration:

    2024-04-16

  • Registration Number:

    20240416-210-J-1636

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Cygen Korea Co., Ltd.

  • Last Modified:

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    NerPharMa Srl

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Viale Pasteur, 10, 20014 NERVIANO (MILANO), Italy

Daebong LS Co., Ltd.

  • Product:

    Terbinafine hydrochloride

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-49-A-88-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Daebong LS Co., Ltd.

  • Last Modified:

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Daebong LS Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    (405-820) 123, Neungheodae-ro 649beon-gil, Namdong-gu, Incheon (Gojan-dong)

Daehan Newpharm Co., Ltd.

  • Product:

    Roxithromycin

  • Initial Registration:

    2011-10-14

  • Registration Number:

    20050831-9-A-2-02(9)

  • MFDS Classification:

    etc

  • Applicant:

    Daehan Newpharm Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Zhenyuan Pharmaceutical Co., Ltd. Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Paojiang Industrial Zone(YueDong road) Shaoxing 312000 Zhejiang province PR China (No.1015, West Shengli Road. Shaoxing, 312000 Zhejiang province PR China)

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