KDMF (Korea Drug Master File) Approved Products & Companies

J2H Biotech Co., Ltd.

  • Product:

    Donepezil hydrochloride hydrate

  • Initial Registration:

    2022-07-08

  • Registration Number:

    20220708-158-I-641-33

  • MFDS Classification:

    Appendix 1

  • Applicant:

    J2H Biotech Co., Ltd.

  • Last Modified:

    2025-08-26

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    J2H Biotech Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Buildings B and part of D, 349 Sandan-ro, Danwon-gu, Ansan-si, Gyeonggi-do

JAHT Co., Ltd.

  • Product:

    esomeprazole

  • Initial Registration:

    2011-03-31

  • Registration Number:

    20110331-127-H-42-06

  • MFDS Classification:

    Appendix 1

  • Applicant:

    JAHT Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Glenmark Pharmaceuticals Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2016

  • Manufacturing Facility:

    Plot N0.3109/C, GIDC Industrial Estate, Ankleshwar, Dist. Bharuch-393 002, Gujarat State (India)

Janssen Korea Co., Ltd.

  • Product:

    Risperidon

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-10-C-82-06

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Janssen Korea Co., Ltd.

  • Last Modified:

    2012-11-08

  • Country:

    Ireland

  • Status:

    Active

  • Manufacturer:

    Janssen Pharmaceutical Sciences Unlimited Company

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2017

  • Manufacturing Facility:

    Little Island Industrial EST., Little Island, Co. Cork, Ireland

JBP Korea Co., Ltd.

  • Product:

    Ziziphus jujuba extract

  • Initial Registration:

    2025-02-25

  • Registration Number:

    20250225-01-HP-24-19

  • MFDS Classification:

    human placenta origin

  • Applicant:

    JBP Korea Co., Ltd.

  • Last Modified:

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Japan Bio Products Co., Ltd. L'Atelier Fujimitsu

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    735-14 Aza Edamitsu, Fujimitsu Machi, Kurume Shi, Fukuoka-ken, Japan

JC Bio Co., Ltd.

  • Product:

    Rosuvastatin calcium

  • Initial Registration:

    2020-11-19

  • Registration Number:

    20201119-209-J-760

  • MFDS Classification:

    Appendix 1

  • Applicant:

    JC Bio Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Amoli Organics Private Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Block No. 422, ECP Canal Road, Village-Luna, Taluka-Padra, City : Luna – 391 440, District Vadodara, Gujarat State, India

Jeil Pharmaceutical Co., Ltd.

  • Product:

    Oteracil potassium

  • Initial Registration:

    2003-07-22

  • Registration Number:

    21-2-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Jeil Pharmaceutical Co., Ltd.

  • Last Modified:

    2021-05-14

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Sumitomo Chemicals Co., Ltd. Gifu Plant, Oita Works

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    3750, Aza Juhachicho, Maki, Anpachicho, Anpachigun, Gifu Prefecture, 503-0125, Japan (27-1, Shinkawa 2-chome, Chuo-ku, Tokyo 104-8260, Japan)

Jeil Pharmtech Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2011-10-14

  • Registration Number:

    20070504-4-B-240-14(6)

  • MFDS Classification:

    etc

  • Applicant:

    Jeil Pharmtech Co., Ltd.

  • Last Modified:

    2020-06-04

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jiangxi Synergy Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

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

Jeroncelbain Co., Ltd.

  • Product:

    Sodium polydeoxyribonucleotide

  • Initial Registration:

    2021-09-10

  • Registration Number:

    20210910-199-I-624-08

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Jeroncelbain Co., Ltd.

  • Last Modified:

    2025-02-18

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Jeroncelbain Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Building 2, 342 Yunboseon-ro, Dunpo-myeon, Asan-si, Chungcheongnam-do

Jin Biopharm Co., Ltd.

  • Product:

    Pelargonium sidoides 11% ethanol dry extract (5.5–6.6–1)

  • Initial Registration:

    2022-05-02

  • Registration Number:

    20220502-19-K-69-04

  • MFDS Classification:

    Appendix 1-2

  • Applicant:

    Jin Biopharm Co., Ltd.

  • Last Modified:

    2023-11-17

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Jin Biopharm Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    34, Dreamsandan 5-ro, Cheongbuk-eup, Pyeongtaek-si, Gyeonggi-do

Jinyang Pharmaceutical Co., Ltd.

  • Product:

    Meloxicam

  • Initial Registration:

    2013-02-14

  • Registration Number:

    20121010-148-I-54-04(8)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Jinyang Pharmaceutical Co., Ltd.

  • Last Modified:

    2025-02-20

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    Cipla Limited

  • Withdrawal Date:

    2025-02-20

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    D-7 MIDC Industrial Area, Kurkumbh, Taluka Daund, District : Pune, Maharashtra state, India

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