KDMF (Korea Drug Master File) Approved Products & Companies

Korea Pharmbio Co., Ltd.

  • Product:

    Deferasirox

  • Initial Registration:

    2017-05-04

  • Registration Number:

    Number 4838-18-ND(2)

  • MFDS Classification:

    new substance

  • Applicant:

    Korea Pharmbio Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Cipla Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    D-22, MIDC Industrial Area, Kurkumbh, Taluka Daund, District: Pune, Maharashtra State

Korea PMG Pharmaceutical Co., Ltd.

  • Product:

    Loxoprofen sodium hydrate

  • Initial Registration:

    2017-09-07

  • Registration Number:

    20170907-8-C-366-20

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Korea PMG Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

  • Status:

    Active

  • Manufacturer:

    Dongbang FTL @ Korea PMG Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do @ 59, Gyeongje-ro, Siheung-si, Gyeonggi-do

Korea Prime Pharmaceutical Co., Ltd.

  • Product:

    Omega-3 ethyl ester 90

  • Initial Registration:

    2019-11-29

  • Registration Number:

    Su1881-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Korea Prime Pharmaceutical Co., Ltd.

  • Last Modified:

    2026-04-09

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    KinOmegaBiopharm Inc.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    No.161, South Yinghuashan Road, Shifang, Deyang City, Sichuan, China

Korea UCB Pharmaceutical Co., Ltd.

  • Product:

    Cetirizine hydrochloride

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-40-C-141-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Korea UCB Pharmaceutical Co., Ltd.

  • Last Modified:

    2022-05-27

  • Country:

    Swiss

  • Status:

    Active

  • Manufacturer:

    UCB Farchim SA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    ZI Planchy d''Avau, Chemin de Croix Blanche 10 CH-1630 Bulle, Switzerland

Korea Union Pharmaceutical Co., Ltd.

  • Product:

    Loxoprofen sodium hydrate

  • Initial Registration:

    2023-05-10

  • Registration Number:

    20191210-8-C-376-21(13)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Korea Union Pharmaceutical Co., Ltd.

  • Last Modified:

    2024-02-08

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Dijia Pharmaceutical Group Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No. 268 Tianrun Road, Wendeng Economic Development Zone, Weihai, Shandong, 264400, China

Korea Unipharm Co., Ltd.

  • Product:

    Octenidine hydrochloride

  • Initial Registration:

    2016-02-01

  • Registration Number:

    Su4528-3-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Korea Unipharm Co., Ltd.

  • Last Modified:

    2026-01-12

  • Country:

    uk

  • Status:

    Active

  • Manufacturer:

    Sterling Pharma Solutions Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Cramlington Road Dudley Northumberland NE23 7QG

Korea United Pharmaceutical Co., Ltd.

  • Product:

    Amoxicillin hydrate

  • Initial Registration:

    2005-09-15

  • Registration Number:

    20050915-30-A-168-12

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Korea United Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    AUROBINDO PHARMA LTD.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    Unit-V plot No. 79-91, Chemical Zone, Pashamylaram, Medak District. India

Kosha Bio Co., Ltd.

  • Product:

    Amoxicillin hydrate

  • Initial Registration:

    2018-04-09

  • Registration Number:

    20050915-30-A-168-12(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Kosha Bio Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    AUROBINDO PHARMA LTD.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Unit-V plot NO. 79-91, Chemical Zone, Pasharmylarm, Medak District, India

KR Pharm Co., Ltd.

  • Product:

    Sepicsim hydrate

  • Initial Registration:

    2003-08-31

  • Registration Number:

    20050831-26-A-56-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    KR Pharm Co., Ltd.

  • Last Modified:

    2022-05-31

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Orchid Pharma Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Plot Nos. 121-128, 128A-133, 138-151 & 159-164, SIDCO Industrial Estate, Alathur, Chengalpattu District-603 110, India

Kwangdong Pharmaceutical Co., Ltd.

  • Product:

    Iron protein extract

  • Initial Registration:

    2009-11-12

  • Registration Number:

    20091112-130-G-69-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Kwangdong Pharmaceutical Co., Ltd.

  • Last Modified:

    2012-10-31

  • Country:

    New Zealand

  • Status:

    Active

  • Manufacturer:

    New Zealand Pharmaceuticals Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2011

  • Manufacturing Facility:

    68 Weld Street, Palmerston North, New Zealand

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