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    STERIGENE

    CDMO
    France
    https://www.sterigene.com/

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    Manufacturing & Lab Equipment
    Qualification/Validation Services
    Company Overview

    About

    STERIGENE is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines

    Therapeutic Areas

    Oncology
    Hematology
    Quick Facts
    HQ:France
    Founded:1999
    Employees:444
    Capabilities & Services

    Core Capabilities

    • Oral Solid Dose
    • Solid Dose Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Lyophilized (Freeze-Dried)
    Sterile Injectable

    Containment Capabilities

    BSL-2 (Biosafety Level 2)

    Production Scales

    Phase II
    Clinical
    Pilot Scale

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval F7UHA6
    FDA · #APR-RBY4T24W · 2021-10-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-W012W3Q1
    Issued: 2020-04-03
    Expires: 2025-08-05

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-PRDGC4TK
    Issued: 2020-11-27
    Expires: 2025-12-15
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    Key facts about STERIGENE

    • STERIGENE is headquartered in France.
    • STERIGENE was founded in 1999.
    • STERIGENE has 444 employees.
    • STERIGENE's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.

    Find CDMOs like STERIGENE

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

    CDMOs in FranceCDMOs in EuropeOral Solid Dose CDMOsFormulation Development CDMOsLyophilized (Freeze-Dried) CDMOsSterile Injectable CDMOsBSL-2 (Biosafety Level 2) CDMOs
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