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    FUJIFILM Irvine Scientific

    CDMO
    Japan
    https://www.irvinesci.com/

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    Analytical & Bioanalytical Services
    Manufacturing & Lab Equipment
    Company Overview

    About

    FUJIFILM Irvine Scientific is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals

    Therapeutic Areas

    Rare Disease
    Metabolic
    Quick Facts
    HQ:Japan
    Founded:2008
    Employees:1,946
    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

    Production Scales

    Pilot Scale
    Clinical
    Commercial Scale

    Markets Served

    North America
    Europe
    Regulatory Approvals
    Drug Approval U2H283
    Health Canada · #APR-RPA13WMM · 2020-02-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-BY50SOZ7
    Issued: 2020-08-12
    Expires: 2025-01-25

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-44ZMDRD0
    Issued: 2020-04-06
    Expires: 2025-10-02
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    Key facts about FUJIFILM Irvine Scientific

    • FUJIFILM Irvine Scientific is headquartered in Japan.
    • FUJIFILM Irvine Scientific was founded in 2008.
    • FUJIFILM Irvine Scientific has 1,946 employees.
    • FUJIFILM Irvine Scientific's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

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    CDMOs in JapanCDMOs in AsiaBiologics Drug Substance CDMOsBiologics Drug Product CDMOsPrefilled Syringe CDMOsSterile Injectable CDMOs
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