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    CDMOHUB

    Connecting biotech and pharma teams with verified manufacturing partners worldwide.

    Platform

    • Find CDMOs
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    © 2026 CDMOHUB. All rights reserved.

    CDMO Hub, Inc. Registered in Delaware, USA

    CDMOHUBCDMOHUB
    Find ExpertsBriefingsPricing
    CDMOHUB

    Connecting biotech and pharma teams with verified manufacturing partners worldwide.

    Platform

    • Find CDMOs
    • Find Experts
    • CDMO Matchmaking
    • Expert Matchmaking
    • Modality Guides
    • Supplier Maps
    • Join as Partner

    Company

    • About Us
    • Contact

    Legal

    • Terms of Service
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    © 2026 CDMOHUB. All rights reserved.

    CDMO Hub, Inc. Registered in Delaware, USA

    CDMOHUBCDMOHUB
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    1. Home
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    3. /EMA-Certified CDMOs
    Certification

    EMA-Certified CDMOs

    Compare CDMOs with EMA GMP certification for EU-market pharmaceutical manufacturing. Filter by product type, member state, and manufacturing capabilities.

    About EMA GMP Certification

    EMA (European Medicines Agency) GMP certification confirms that a manufacturing facility complies with EU Good Manufacturing Practice standards. GMP inspections are conducted by national competent authorities (e.g., BfArM in Germany, ANSM in France, MHRA in the UK) and the resulting GMP certificates are recognized across the EU through mutual recognition.

    The EMA maintains Mutual Recognition Agreements with regulatory agencies in the US, Canada, Australia, Japan, Switzerland, and other countries. This means EU GMP inspections may be accepted by these agencies without re-inspection, reducing the regulatory burden on CDMOs serving multiple markets. The Qualified Person (QP) system -- unique to the EU -- provides an additional layer of batch release oversight.

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    Browse all CDMOs

    Frequently Asked Questions

    How does EU GMP certification work?+
    National competent authorities in EU member states conduct GMP inspections of manufacturing facilities. If compliant, the authority issues a GMP certificate valid for up to 3 years. The certificate covers specific activities (manufacturing, testing, batch release) and product types. The EudraGMDP database is the public registry of EU GMP certificates -- you can verify any CDMO's current certification status there.
    What is the Qualified Person (QP) role?+
    The Qualified Person is a unique EU regulatory requirement. Every batch of pharmaceutical product released in the EU must be certified by a QP -- a named individual with specific academic qualifications and experience. The QP takes personal legal responsibility for confirming that each batch was manufactured and tested according to GMP requirements and the marketing authorization. CDMOs serving the EU market must have access to QP services.

    Related Categories

    FDA-Registered CDMOsISO 9001 CDMOsCDMOs in EuropeBiologics CDMOsDrug Product CDMOs

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    CDMOHUB

    Connecting biotech and pharma teams with verified manufacturing partners worldwide.

    Platform

    • Find CDMOs
    • Find Experts
    • CDMO Matchmaking
    • Expert Matchmaking
    • Modality Guides
    • Supplier Maps
    • Join as Partner

    Company

    • About Us
    • Contact

    Legal

    • Terms of Service
    • Privacy Policy

    © 2026 CDMOHUB. All rights reserved.

    CDMO Hub, Inc. Registered in Delaware, USA