KDMF (Korea Drug Master File) Approved Products & Companies

Abbott Korea

  • Product:

    Terrazocin hydrochloride

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-48-B-132-05

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Abbott Korea

  • Last Modified:

    2024-02-02

  • Country:

    USA

  • Status:

    Withdrawal

  • Manufacturer:

    Abbott Laboratories

  • Withdrawal Date:

    2024-02-02

  • Final Annual Reporting Year:

    2013

  • Manufacturing Facility:

    North Chicago, IL 60064-4000

Abbott Korea Ltd.

  • Product:

    Estradiol hemihydrate

  • Initial Registration:

    2012-12-21

  • Registration Number:

    20121221-181-I-217-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Abbott Korea Ltd.

  • Last Modified:

    2023-06-14

  • Country:

    Netherlands

  • Status:

    Withdrawal

  • Manufacturer:

    Aspen Oss BV

  • Withdrawal Date:

    2023-06-14

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Veersemeer 4, 5347 JN Oss, The Netherlands

AbbVie Korea

  • Product:

    Bimatoprost

  • Initial Registration:

    2004-04-23

  • Registration Number:

    50-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    AbbVie Korea

  • Last Modified:

    2023-04-20

  • Country:

    Canada

  • Status:

    Active

  • Manufacturer:

    Piramal Healthcare (Canada) Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    110 Industrial Parkway North Aurora, Ontario L4G 3H4 Canada

Ace Biopharm Co., Ltd.

  • Product:

    Levocetirizine hydrochloride

  • Initial Registration:

    2011-04-29

  • Registration Number:

    20110429-40-C-279-18

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Ace Biopharm Co., Ltd.

  • Last Modified:

    2023-08-10

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Cohance Lifesciences Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    RS No.50/1, Mukteswarapuram Village, Jaggaiahpet Mandal, NTR District-521 457, Andhra Pradesh, India

Ace Pharma Co., Ltd.

  • Product:

    Melphalan hydrochloride

  • Initial Registration:

    2019-11-07

  • Registration Number:

    20191107-210-J-469

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Ace Pharma Co., Ltd.

  • Last Modified:

    2026-01-12

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Emcure Pharmaceuticals Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Plot No. D-24 & D-24/1, MIDC, Kurkumbh, Taluka- Daund, Pune, 413 802, Maharashtra, India.

Aekyung Biopharm Co., Ltd.

  • Product:

    Omega-3 ethyl ester 90

  • Initial Registration:

    2018-07-17

  • Registration Number:

    6148-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Aekyung Biopharm Co., Ltd.

  • Last Modified:

    2024-07-12

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Aekyung Biopharm Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    81 Sanggae-ro, Nam-gu, Ulsan (80, 80A)

Agerson Bio Co., Ltd.

  • Product:

    Terbinafine hydrochloride

  • Initial Registration:

    2021-07-26

  • Registration Number:

    20190322-49-A-349-21(11)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Agerson Bio Co., Ltd.

  • Last Modified:

    2025-04-30

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang East-asia Pharmaceutical Co., Ltd. Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Coastal Industrial City, Pubagang town, Sanmen county, Zhejiang, 317100, China

Aging Life Science Co., Ltd.

  • Product:

    Glyclazide

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-1-C-2-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Aging Life Science Co., Ltd.

  • Last Modified:

    2022-09-20

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    BAL PHARMA LTD.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    Plot No. 61B, Bommasandra Industrial area, Hosur Road, Bangalore - 560 099, India

Ajoo Pharmaceutical Co., Ltd.

  • Product:

    Cefaclor hydrate

  • Initial Registration:

    2012-07-18

  • Registration Number:

    20091125-20-A-229-14(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Ajoo Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Dongbang Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Pharm-Chem Zone, Duqiao, Linhai, Taizhou, Zhejiang

Alcon Korea Co., Ltd.

  • Product:

    sodium hyaluronate

  • Initial Registration:

    2008-02-28

  • Registration Number:

    20080228-96-E-51-12

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Alcon Korea Co., Ltd.

  • Last Modified:

    2015-02-23

  • Country:

    USA

  • Status:

    Active

  • Manufacturer:

    Lifecore Biomedical LLC

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2016

  • Manufacturing Facility:

    3515 Lyman Boulevard, chaska, MN55318

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