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    KCAS Bio

    CDMO
    Australia
    https://kcasbio.com/

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    Analytical & Bioanalytical Services
    Contract Research Organization
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    KCAS Bio is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals

    Therapeutic Areas

    Neurology
    Quick Facts
    HQ:Australia
    Founded:2007
    Employees:1,303
    Capabilities & Services

    Core Capabilities

    • Cytotoxic / ADC Handling
    • High-Potency API
    • Sterile Fill/Finish

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Topical / Transdermal

    Production Scales

    Phase III Clinical Trials
    Commercial Scale
    Clinical

    Markets Served

    North America
    Europe
    Regulatory Approvals
    Drug Approval FTGR74
    PMDA · #APR-9VF52J1U · 2018-12-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-9PKA2UYC
    Issued: 2020-07-09
    Expires: 2025-01-18

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-VPGBUNPQ
    Issued: 2020-07-01
    Expires: 2025-07-18
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    Key facts about KCAS Bio

    • KCAS Bio is headquartered in Australia.
    • KCAS Bio was founded in 2007.
    • KCAS Bio has 1,303 employees.
    • KCAS Bio's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.

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    Fill-Finish CDMOsTopical / Transdermal CDMOs
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