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    Aphena Pharma Solutions

    CDMO
    United States
    https://aphenapharma.com/

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    Drug Product
    Clinical Trial Supply & Logistics
    Company Overview

    About

    Aphena Pharma Solutions is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines

    Therapeutic Areas

    Infectious Disease
    Quick Facts
    HQ:United States
    Founded:1992
    Employees:657
    Capabilities & Services

    Core Capabilities

    • Small Molecule API
    • Small Molecule Drug Product
    • Oral Solid Dose

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Oral Solid Dose

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Pilot Scale
    Clinical
    Commercial Scale

    Markets Served

    North America
    Manufacturing Facilities

    3 sites worldwide

    Aphena Pharma Solutions - Maryland, LLC

    7978 Industrial Park Road, Easton, Maryland, 21601
    View on Map

    Site Capabilities

    6 capabilities
    ANALYSIS
    LABEL
    MANUFACTURE
    PACK
    RELABEL
    REPACK

    Aphena Pharma Solutions LLC

    301A Robey St, Franklin, Kentucky, 42134
    View on Map

    Aphena Pharma Solutions LLC

    40 Aberdeen Dr, Glasgow, Kentucky, 42141
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    Regulatory Approvals
    Drug Approval MEKPSA
    EMA · #APR-A6NJHXM5 · 2022-12-01
    Drug Approval 7OJWJ7
    EMA · #APR-I263YID3 · 2022-08-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-9HZ17E55
    Issued: 2020-07-03
    Expires: 2025-09-05

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-TVSQ1DJU
    Issued: 2020-07-19
    Expires: 2025-05-19

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-19W5VFXZ
    Issued: 2020-04-17
    Expires: 2025-11-11

    Health Canada GMP

    Health Canada
    Cert #: CERT-BEPVFTOJ
    Issued: 2020-11-16
    Expires: 2025-04-16
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    Key facts about Aphena Pharma Solutions

    • Aphena Pharma Solutions is headquartered in the United States.
    • Aphena Pharma Solutions was founded in 1992.
    • Aphena Pharma Solutions has 657 employees.
    • Aphena Pharma Solutions has 3 manufacturing sites listed on CDMO Hub, in Easton, United States, Franklin, United States and Glasgow, United States.
    • Aphena Pharma Solutions's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.

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    CDMOs in United StatesCDMOs in North AmericaSmall Molecule API CDMOsSmall Molecule Drug Product CDMOsOral Solid Dose CDMOsOral Solid Dose CDMOsCytotoxic / ADC Handling CDMOs
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