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    Changsha Huir Biological-tech Co., Ltd logo

    Changsha Huir Biological-tech Co., Ltd

    CDMO
    China
    http://www.huirbio.com/

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    Excipients & Specialty Ingredients
    Company Overview

    About

    Changsha Huir Biological-tech Co., Ltd is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Formulation Development, Process Development, Scale-up

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:China
    Founded:2011
    Employees:436
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Sterile Injectable

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Markets Served

    North America
    Europe
    Regulatory Approvals
    Drug Approval 513PKY
    FDA · #APR-JR3X5YPL · 2019-02-01
    Drug Approval TWR1R2
    PMDA · #APR-DU8QPJLY · 2018-04-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-AM9WRAV0
    Issued: 2020-03-24
    Expires: 2025-08-10

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-ZEX5J2VJ
    Issued: 2020-08-12
    Expires: 2025-01-27

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-GDP9HMC7
    Issued: 2020-08-20
    Expires: 2025-01-19

    WHO GMP

    World Health Organization
    Cert #: CERT-PFOXCGXW
    Issued: 2020-05-09
    Expires: 2025-03-12
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    Key facts about Changsha Huir Biological-tech Co., Ltd

    • Changsha Huir Biological-tech Co., Ltd is headquartered in China.
    • Changsha Huir Biological-tech Co., Ltd was founded in 2011.
    • Changsha Huir Biological-tech Co., Ltd has 436 employees.
    • Changsha Huir Biological-tech Co., Ltd's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

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    CDMOs in ChinaCDMOs in AsiaBiologics Drug Substance CDMOsFormulation Development CDMOsSterile Injectable CDMOs
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