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    ICON plc

    CDMO
    Australia
    https://www.iconplc.com/

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    Analytical & Bioanalytical Services
    Contract Research Organization
    Clinical Trial Supply & Logistics
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    ICON plc is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Formulation Development, Process Development, Scale-up

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:Australia
    Founded:2016
    Employees:133
    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 III Clinical Trials
    Commercial Scale
    Clinical

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval 0A4NC1
    PMDA · #APR-JSTIZHEM · 2020-08-01
    Drug Approval JDBS0L
    PMDA · #APR-78UXQVPM · 2021-06-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-TO7UYIQW
    Issued: 2020-11-16
    Expires: 2025-02-15

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-KJO6B3J2
    Issued: 2020-03-24
    Expires: 2025-12-12

    Health Canada GMP

    Health Canada
    Cert #: CERT-ENCAB1OK
    Issued: 2020-07-22
    Expires: 2025-04-02
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    Key facts about ICON plc

    • ICON plc is headquartered in Australia.
    • ICON plc was founded in 2016.
    • ICON plc has 133 employees.
    • ICON plc's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

    Find CDMOs like ICON plc

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    Biologics Drug Substance CDMOsFormulation Development CDMOsSterile Injectable CDMOsBSL-2 (Biosafety Level 2) CDMOs
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