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    3. /Hanmi Pharm. Co. Ltd
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    Hanmi Pharm. Co. Ltd

    CDMO
    South Korea
    https://www.hanmipharm.com/business/cmdo.hm

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    Drug Product
    Advanced Modalities
    Company Overview

    About

    Hanmi Pharm. Co. Ltd is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Formulation Development, Process Development, Scale-up

    Therapeutic Areas

    Neurology
    Quick Facts
    HQ:South Korea
    Founded:2002
    Employees:2,459
    Capabilities & Services

    Core Capabilities

    • Cytotoxic / ADC Handling
    • High-Potency API
    • Sterile Fill/Finish

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Topical / Transdermal

    Containment Capabilities

    OEB 4 (1-10 µg/m³)

    Production Scales

    R&D / Pre-clinical
    Lab Scale
    Pilot Scale

    Markets Served

    Global
    Manufacturing Facilities

    1 site worldwide

    Hanmi Pharm. Co., Ltd.

    114 Chupalsandan-ro, Paengseong-eup, Pyeongtaek, 17998
    View on Map

    Site Capabilities

    1 capability
    API MANUFACTURE
    International Regulatory
    EU GMP Certificates
    3
    Regulatory Bodies
    EMA/EudraGMDP
    Regulatory Approvals
    Drug Approval AFRVJK
    EMA · #APR-I8TUMWNL · 2022-10-01
    Drug Approval X9UX5P
    Health Canada · #APR-QT1XQWJX · 2019-08-01

    Case Studies

    0 published case studies showcasing past projects, challenges and outcomes.

    Certifications

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-6ERVG466
    Issued: 2020-11-05
    Expires: 2025-03-05

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-HAFDBZNY
    Issued: 2020-09-15
    Expires: 2025-01-06

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-43ZC2MIB
    Issued: 2020-05-22
    Expires: 2025-03-04
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    Key facts about Hanmi Pharm. Co. Ltd

    • Hanmi Pharm. Co. Ltd is headquartered in South Korea.
    • Hanmi Pharm. Co. Ltd was founded in 2002.
    • Hanmi Pharm. Co. Ltd has 2,459 employees.
    • Hanmi Pharm. Co. Ltd has one manufacturing site listed on CDMO Hub, in Pyeongtaek, South Korea.
    • Hanmi Pharm. Co. Ltd's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.

    Find CDMOs like Hanmi Pharm. Co. Ltd

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    CDMOs in South KoreaCDMOs in AsiaFill-Finish CDMOsTopical / Transdermal CDMOsOEB 4 (1-10 µg/m³) CDMOs
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