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    3. /Fuxin Custchem Fine Chemical Co., Ltd.
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    Fuxin Custchem Fine Chemical Co., Ltd.

    CDMO
    China
    https://www.custchemvip.com/

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    Drug Product
    Company Overview

    About

    Fuxin Custchem Fine Chemical Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Quality Control, Stability Testing, Method Development

    Therapeutic Areas

    Infectious Disease
    Quick Facts
    HQ:China
    Founded:2017
    Employees:2,813
    Capabilities & Services

    Core Capabilities

    • Small Molecule API
    • Small Molecule Drug Product
    • Oral Solid Dose

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Oral Solid Dose

    Containment Capabilities

    OEB 4 (1-10 µg/m³)

    Production Scales

    Pilot Scale
    Clinical
    Commercial Scale

    Markets Served

    Global
    Regulatory Approvals
    Drug Approval 82RH3N
    PMDA · #APR-QH1SBBLN · 2021-01-01
    Drug Approval RELO2D
    Health Canada · #APR-9RQ3848N · 2018-06-01
    Certifications

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-CZPDLDK5
    Issued: 2020-10-11
    Expires: 2025-11-02

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-UW9B5K2U
    Issued: 2020-05-24
    Expires: 2025-03-19

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-54E5PLDO
    Issued: 2020-12-20
    Expires: 2025-08-10
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    Key facts about Fuxin Custchem Fine Chemical Co., Ltd.

    • Fuxin Custchem Fine Chemical Co., Ltd. is headquartered in China.
    • Fuxin Custchem Fine Chemical Co., Ltd. was founded in 2017.
    • Fuxin Custchem Fine Chemical Co., Ltd. has 2,813 employees.
    • Fuxin Custchem Fine Chemical Co., Ltd.'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.

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    CDMOs in ChinaCDMOs in AsiaSmall Molecule API CDMOsSmall Molecule Drug Product CDMOsOral Solid Dose CDMOsOral Solid Dose CDMOsOEB 4 (1-10 µg/m³) CDMOs
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