KDMF (Korea Drug Master File) Approved Products & Companies

Hanpoong Pharmaceutical Co., Ltd.

  • Product:

    Zhaoga, Achyranthes root, Saposhnikovia root, Eucommia bark, Citrus root, and dried black bean extract (20→1)

  • Initial Registration:

    2017-12-06

  • Registration Number:

    20171206-11-K-14-01

  • MFDS Classification:

    Appendix 1-2

  • Applicant:

    Hanpoong Pharmaceutical Co., Ltd.

  • Last Modified:

    2026-04-23

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Hanpoong Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2026

  • Manufacturing Facility:

    301, Wanjusandan 6-ro, Bongdong-eup, Wanju-gun, Jeonbuk Special Self-Governing Province, 705, Bongdong-ro

Hans Korea Co., Ltd.

  • Product:

    sodium chloride

  • Initial Registration:

    2023-04-07

  • Registration Number:

    20210527-211-J-824(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hans Korea Co., Ltd.

  • Last Modified:

  • Country:

    Denmark

  • Status:

    Active

  • Manufacturer:

    Dansk Salt A/S

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Hadsundvej 17, DK-9550 Mariager, Denmark

Hanseo Chem Co., Ltd.

  • Product:

    Terrazocin hydrochloride

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-48-B-127-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hanseo Chem Co., Ltd.

  • Last Modified:

    2008-02-22

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Hanseo Chem Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    41 Poseunggongdan-ro, Poseung-eup, Pyeongtaek-si, Gyeonggi-do

Hansol Pharma Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2012-08-24

  • Registration Number:

    20070504-4-B-240-14(18)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hansol Pharma Co., Ltd.

  • Last Modified:

    2024-01-29

  • Country:

    china

  • Status:

    Withdrawal

  • Manufacturer:

    Jiangxi Synergy Pharmaceutical Co., Ltd

  • Withdrawal Date:

    2024-01-29

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, China

Hansung Pharma Co., Ltd.

  • Product:

    Naproxen sodium

  • Initial Registration:

    2013-10-29

  • Registration Number:

    20130204-143-I-170-06(4)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hansung Pharma Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Tianxin Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    215 Fengze Road, Tiantai Zhejiang 317200, China

Hanwha Pharmaceutical Co., Ltd.

  • Product:

    Pelargonium sidoides

  • Initial Registration:

    2005-07-28

  • Registration Number:

    20-1-ND

  • MFDS Classification:

    Appendix 1-2

  • Applicant:

    Hanwha Pharmaceutical Co., Ltd.

  • Last Modified:

    2025-02-18

  • Country:

    germany

  • Status:

    Active

  • Manufacturer:

    Schwabe Extracta GmbH & Co. K.G.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    Willmar-Schwabe-Str. 4, 76227 Karlsruhe, Germany

Hanyoung Pharm Co., Ltd.

  • Product:

    Glyclazide

  • Initial Registration:

    2014-04-30

  • Registration Number:

    20050831-1-C-5-03(7)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hanyoung Pharm Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Shandong Keyuan Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    Keyuan Street, Shandong Shanghe Economic Development Zone, Jinan City, Shandong, China

Happycall Co., Ltd.

  • Product:

    Acetaminophen

  • Initial Registration:

    2013-05-27

  • Registration Number:

    20100115-32-C-256-17(4)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Happycall Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Hebei Jiheng (Group) Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No. 368 Jianshe Street, Hengshui City, Hebei Province

Hawon Precision Chemical Co., Ltd.

  • Product:

    Cefaclor hydrate

  • Initial Registration:

    2005-09-30

  • Registration Number:

    20050930-20-A-18-08

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hawon Precision Chemical Co., Ltd.

  • Last Modified:

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Hawon Precision Chemical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    404-18, Nojang-ri, Jeondong-myeon, Yeongi-gun, Chungnam

HiPharm Co., Ltd.

  • Product:

    Escitalopram oxalate

  • Initial Registration:

    2019-03-05

  • Registration Number:

    20180604-209-J-223(4)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    HiPharm Co., Ltd.

  • Last Modified:

    2025-08-04

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Hetero Labs Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Survey. No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, INDIA

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