KDMF (Korea Drug Master File) Approved Products & Companies

PharmaResearch Co., Ltd.

  • Product:

    Ziziphus jujuba extract

  • Initial Registration:

    2007-05-04

  • Registration Number:

    20070504-01-HP-12-10

  • MFDS Classification:

    human placenta origin

  • Applicant:

    PharmaResearch Co., Ltd.

  • Last Modified:

    2021-01-29

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Japan Biological Products Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    1493, NONAKAMACHI, KURUME-SHI, FUKUOKA

Pharmascience Korea Co., Ltd.

  • Product:

    Risperidon

  • Initial Registration:

    2014-07-25

  • Registration Number:

    20121107-10-C-300-17(A)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pharmascience Korea Co., Ltd.

  • Last Modified:

    2023-11-08

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Jubilant Pharmova Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    Plot. No. 18, 56, 57 & 58, KIADB Industrial area, Nanjangud-571 302, Mysore, Karnataka State, India

Pharmasol Co., Ltd.

  • Product:

    polycarbophil calcium

  • Initial Registration:

    2019-08-01

  • Registration Number:

    20180528-209-J-22(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pharmasol Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Shandong Xinhua Pharmaceutical Co. Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    East chemical zone of zibo high & new technology development zone, zibo, shandong, PR China

PharmGen Science Co., Ltd.

  • Product:

    Dexibuprofen

  • Initial Registration:

    2013-01-09

  • Registration Number:

    20120406-145-I-37-02(9)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    PharmGen Science Co., Ltd.

  • Last Modified:

    2025-07-15

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Hubei Biocause Heilen Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2016

  • Manufacturing Facility:

    122 Yangwan Road, Jingmen City, Hubei Province, 448000, PR China

Pharmsgen Co., Ltd.

  • Product:

    Valsartan

  • Initial Registration:

    2015-12-22

  • Registration Number:

    20121218-135-H-205-34(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pharmsgen Co., Ltd.

  • Last Modified:

    2023-10-20

  • Country:

    Spain

  • Status:

    Withdrawal

  • Manufacturer:

    Quimica Sintetica SA

  • Withdrawal Date:

    2023-10-20

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    C/U Dulcinea sn, 28805 Alcala de henares, Madrid (Spain)

Phil International Co., Ltd.

  • Product:

    Dutasteride

  • Initial Registration:

    2025-06-23

  • Registration Number:

    Su323-2-ND(B)

  • MFDS Classification:

    new substance

  • Applicant:

    Phil International Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Swati Spentose Private Limited (Unit-Ⅱ)

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Plot No. A-1/2110 - 2111, III Phase, GIDC VAPI, City: Vapi - 396 195, Dist. Valsad, Gujarat State, India

Polaris AI Pharma Co., Ltd.

  • Product:

    pitavastatin calcium

  • Initial Registration:

    2010-10-11

  • Registration Number:

    1962-2-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Polaris AI Pharma Co., Ltd.

  • Last Modified:

    2024-06-28

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Polaris AI Pharma Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Nos. 10 and 11, Block 34, Balan Industrial Complex, 25, Balan Gongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

Poonglim Pharmaceutical Co., Ltd.

  • Product:

    Artemisia annua isopropanol soft extract (20→1)

  • Initial Registration:

    2017-11-03

  • Registration Number:

    20171103-10-K-4-01

  • MFDS Classification:

    Appendix 1-2

  • Applicant:

    Poonglim Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Ningbo Green-Health Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Fenghua Xiwu Town Foreign Technological Garden, Ningbo, Zhejiang, China

Prochem Co., Ltd.

  • Product:

    gabapentin

  • Initial Registration:

    2019-09-24

  • Registration Number:

    20121214-142-I-193-08(8)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Prochem Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Chiral Medicine Chemicals Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Nanyang Economy Development Zone, Xiaoshan, hangzhou, China

Q-Sangsa Co., Ltd.

  • Product:

    Ketoconazole

  • Initial Registration:

    2017-08-09

  • Registration Number:

    20130522-167-I-135-04(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Q-Sangsa Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang East-Asia Pharmaceutical Co.,Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    Economic Development Zone of Sanmen County, Zhejiang. P.R.China

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