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)
BioReliance (Merck KGaA, MilliporeSigma)
Scotland
BioReliance is the contract testing services division of Merck KGaA (MilliporeSigma), providing GMP-compliant biosafety testing, product characterization, and quality control testing for biologics, vaccines, and cell/gene therapies. With 25 FDA-registered FEI numbers and 102 FDA inspections across global sites, they are one of the largest contract testing organizations. They provide end-to-end testing solutions but do NOT manufacture drug substances or drug products -- they are a testing CRO.
Analytical ServicesMicrobiology TestingMethod Development & Validation
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Bushu Pharma
Japan
Bushu Pharma is Japan's premier CDMO with over 25 years of experience, specializing in contract manufacturing of solid dosage formulations, sterile injectables, lyophilized products, and prefilled syringes for both clinical trial supplies and commercial products. The company operates five factories in Japan with GMP certifications from 56 countries including FDA, EMA, and PMDA, serving over 90 pharmaceutical companies globally with nearly 50% of sales from foreign-affiliated clients.
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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