Certification
EMA-Certified CDMOs
Compare CDMOs with EMA GMP certification for EU-market pharmaceutical manufacturing. Filter by product type, member state, and manufacturing capabilities.
349 companies listed
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.
Companies (349)
Vetter Pharma
Germany
Vetter Pharma is a leading global Contract Development and Manufacturing Organization specializing in aseptic fill-and-finish services for injectable drug products. Headquartered in Ravensburg, Germany, Vetter operates as an independent, family-owned business with over 75 years of experience.
Biologics Drug ProductFill/Finish (Vials)Fill/Finish (Syringes)
Curapath
Spain
Curapath is a European CDMO specialized in polymer- and lipid-based non-viral drug delivery systems, supporting programs from preclinical through commercial manufacturing. The company has expertise in lipid nanoparticle (LNP) formulations, polymer excipients, and nanoparticle formulations for cell and gene therapy applications. Curapath operates manufacturing facilities in Valencia, Spain and has offices in Cambridge, Massachusetts.
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.
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