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    3. /Hodogaya Chemical Co., Ltd.

    Hodogaya Chemical Co., Ltd.

    CDMO
    Japan
    https://www.hodogaya.co.jp/english/

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    Drug Product
    Excipients & Specialty Ingredients
    Company Overview

    About

    Hodogaya Chemical Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Formulation Development, Process Development, Scale-up

    Therapeutic Areas

    Rare Disease
    Metabolic
    Quick Facts
    HQ:Japan
    Founded:2003
    Employees:1,512
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Drug Product
    • Biologics Manufacturing

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Prefilled Syringe
    Sterile Injectable

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Pilot Scale
    Clinical
    Commercial Scale

    Markets Served

    North America
    Regulatory Approvals
    Drug Approval 27TVS8
    PMDA · #APR-51T3WKE0 · 2018-10-01
    Drug Approval U3U0Y1
    EMA · #APR-KAZTYGZ4 · 2020-02-01

    Case Studies

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

    Certifications

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-R19S8K7H
    Issued: 2020-08-18
    Expires: 2025-01-14

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-ZWEUU8XE
    Issued: 2020-09-15
    Expires: 2025-03-01

    WHO GMP

    World Health Organization
    Cert #: CERT-QV3PE27B
    Issued: 2020-04-08
    Expires: 2025-11-17

    Health Canada GMP

    Health Canada
    Cert #: CERT-1AD2LFRB
    Issued: 2020-10-12
    Expires: 2025-01-28
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    Key facts about Hodogaya Chemical Co., Ltd.

    • Hodogaya Chemical Co., Ltd. is headquartered in Japan.
    • Hodogaya Chemical Co., Ltd. was founded in 2003.
    • Hodogaya Chemical Co., Ltd. has 1,512 employees.
    • Hodogaya Chemical Co., Ltd.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

    Find CDMOs like Hodogaya Chemical Co., Ltd.

    Directory pages this company appears in, each with the full list of matching manufacturers.

    CDMOs in JapanCDMOs in AsiaBiologics Drug Substance CDMOsBiologics Drug Product CDMOsPrefilled Syringe CDMOsSterile Injectable CDMOsCytotoxic / ADC Handling CDMOs
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