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    GenScript Biotech Corporation

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

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    Drug Product
    Excipients & Specialty Ingredients
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    GenScript Biotech Corporation is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Gene Therapy, Cell Therapy, mRNA

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:China
    Founded:1991
    Employees:895
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Sterile Injectable

    Containment Capabilities

    BSL-2 (Biosafety Level 2)

    Production Scales

    Phase II
    Clinical
    Pilot Scale

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval PDF0E4
    PMDA · #APR-JGCXG059 · 2018-09-01

    Case Studies

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

    Certifications

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-AVRTXVLJ
    Issued: 2020-07-05
    Expires: 2025-06-12

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-R25U9TK0
    Issued: 2020-05-22
    Expires: 2025-01-21

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-FZ0CSW8Z
    Issued: 2020-01-15
    Expires: 2025-12-12

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-GDCCHFUO
    Issued: 2020-12-19
    Expires: 2025-07-16
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    Key facts about GenScript Biotech Corporation

    • GenScript Biotech Corporation is headquartered in China.
    • GenScript Biotech Corporation was founded in 1991.
    • GenScript Biotech Corporation has 895 employees.
    • GenScript Biotech Corporation'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 CDMOsBSL-2 (Biosafety Level 2) CDMOs
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