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)
C2 PHARMA
India
C2 PHARMA is a European pharmaceutical group established in 2014 that manufactures and distributes active pharmaceutical ingredients (APIs) and complex chemical compounds from natural and synthetic origins. The company specializes in ophthalmic and niche APIs with headquarters in Cork, Ireland.
Small Molecule APIAPI ManufacturingSupply Chain Management
celares GmbH
Germany
celares GmbH is a German CDMO focused on the development and manufacturing of polymer-based drug delivery excipients and bioconjugate drugs. The company specializes in PEGylation technology and conjugate vaccine development, with collaborations including EMD Millipore and NOF Corporation. celares has been acquired by Biosynth, which expanded its capabilities into conjugate vaccines and bioconjugation services.
Biologics Drug Substance
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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