KDMF (Korea Drug Master File) Approved Products & Companies

Hiple Co., Ltd.

  • Product:

    Metformin hydrochloride

  • Initial Registration:

    2011-06-15

  • Registration Number:

    20050831-37-C-34-05(4)

  • MFDS Classification:

    etc

  • Applicant:

    Hiple Co., Ltd.

  • Last Modified:

    2025-03-26

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Granules India Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Plot No.: 15A/1, IDA, Phase-Ⅲ, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District - 500 055 Telangana State, India

Hiple Life Science Co., Ltd.

  • Product:

    human placenta

  • Initial Registration:

    2010-04-02

  • Registration Number:

    20100402-01-HP-22-17

  • MFDS Classification:

    human placenta origin

  • Applicant:

    Hiple Life Science Co., Ltd.

  • Last Modified:

  • Country:

    Ukraine

  • Status:

    Active

  • Manufacturer:

    Biopharma

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    9 M. Amosova Street, Kyiv, 03038

HiQ Pharm Co., Ltd.

  • Product:

    choline tartrate

  • Initial Registration:

    2023-11-15

  • Registration Number:

    20230313-211-J-1459(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    HiQ Pharm Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Bajaj Healthcare Limited (Unit-2)

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Block No. 588, Savli Karachia Road, At & Post - Gothada, Tal-Savli, Dist - Vadodara, Gujarat - 391 776, India

Hitech Pharm Co., Ltd.

  • Product:

    Ceftriaxone sodium

  • Initial Registration:

    2010-04-14

  • Registration Number:

    20100414-127-G-80-06

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hitech Pharm Co., Ltd.

  • Last Modified:

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Hitech Pharm Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    576-1, Seongbon-ri, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do

HK Innoen Co., Ltd.

  • Product:

    Spherical absorbent carbon

  • Initial Registration:

    2004-03-25

  • Registration Number:

    116-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    HK Innoen Co., Ltd.

  • Last Modified:

    2016-02-29

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    KUREHA CORPORATION

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Ochiai16, Nishiki-machi, Iwaki-shi, Fukushima 974-8686, Japan

HL Genomics Co., Ltd.

  • Product:

    Levocetirizine hydrochloride

  • Initial Registration:

    2008-08-29

  • Registration Number:

    20080829-40-C-248-11

  • MFDS Classification:

    Appendix 1

  • Applicant:

    HL Genomics Co., Ltd.

  • Last Modified:

    2021-09-01

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    HL Genomics Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    1552 Bogaewonsam-ro, Cheoin-gu, Yongin-si, Gyeonggi-do

HLB Pep Co., Ltd.

  • Product:

    Leuprorelin acetate

  • Initial Registration:

    2018-08-29

  • Registration Number:

    20180829-210-J-257

  • MFDS Classification:

    Appendix 1

  • Applicant:

    HLB Pep Co., Ltd.

  • Last Modified:

    2025-01-14

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Anigen Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Test Production Building 2 (3-story building) within the Jeollanam-do Nano-Bio Center, 123, Nanosandan-ro, Nam-myeon, Jangseong-gun, Jeollanam-do

HLB Pharmaceutical Co., Ltd.

  • Product:

    Terbinafine hydrochloride

  • Initial Registration:

    2020-03-19

  • Registration Number:

    20190322-49-A-349-21(8)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    HLB Pharmaceutical Co., Ltd.

  • Last Modified:

    2026-02-05

  • Country:

    china

  • Status:

    Withdrawal

  • Manufacturer:

    Zhejiang East-Asia Pharmaceutical Co., Ltd

  • Withdrawal Date:

    2026-02-05

  • Final Annual Reporting Year:

  • Manufacturing Facility:

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

Hokem Trading Co., Ltd.

  • Product:

    Ketoprofen

  • Initial Registration:

    2024-07-02

  • Registration Number:

    20210412-211-J-930(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hokem Trading Co., Ltd.

  • Last Modified:

    2025-08-13

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    BEC Chemicals PVT. Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Plot No. 24, MIDC, Dhatav, Roha Dist.: Raigad, 402116, Maharashtra, India.

HPNC Co., Ltd.

  • Product:

    Sodium hypochlorite (25%)

  • Initial Registration:

    2019-03-26

  • Registration Number:

    Su472-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    HPNC Co., Ltd.

  • Last Modified:

  • Country:

  • Status:

    Active

  • Manufacturer:

    Brenntag UK Ltd@Ercros SA

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Alpha House, Lawnswood Business Park, Redver Close Leeds, LS16 6QY, United Kingdom@Ercros centro de Sabinanigo.C/ Serrablo, 102 22600 Sabinanigo, Spain

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