Contract Manufacturers in Germany
A contract manufacturer (Contract Manufacturing Organisation, CMO) produces medicines or medical products on behalf of other companies without holding the marketing authorisation. Contract manufacturers in Germany require a manufacturing authorisation under Section 13 AMG and must operate in compliance with Good Manufacturing Practice (GMP), subject to regular inspections by the responsible state authority. Services range from API production, formulation and filling to sterile manufacturing, packaging and quality control. All GMP-certified contract manufacturers in Germany can be found here with full contact details and locations.
Directory last updated: March 2026Contract Manufacturers
A contract manufacturer (Contract Manufacturing Organisation, CMO) produces medicines or medical products on behalf of other companies without holding the marketing authorisation. Contract manufacturers in Germany require a manufacturing authorisation under Section 13 AMG and must operate in compliance with Good Manufacturing Practice (GMP), subject to regular inspections by the responsible state authority. Services range from API production, formulation and filling to sterile manufacturing, packaging and quality control. All GMP-certified contract manufacturers in Germany can be found here with full contact details and locations.
Frequently asked questions about Contract Manufacturers
What is a pharmaceutical contract manufacturer?
A contract manufacturer (CMO) produces medicines or medical products on behalf of other companies. In Germany, CMOs require a manufacturing authorisation under Section 13 of the AMG (German Medicinal Products Act) and must comply with GMP (Good Manufacturing Practice) standards. They offer services across the entire production chain.
What requirements must contract manufacturers meet?
Contract manufacturers for medicines must hold a manufacturing authorisation under the AMG, produce in compliance with GMP standards and submit to regular inspections by the responsible state authorities. Qualification and validation of all manufacturing processes is mandatory.
How do I choose the right contract manufacturer?
When selecting a CMO, key criteria include GMP certification, expertise in the desired dosage form (e.g. tablets, injectable solutions, biologics, sterile products), production capacity and GDP-compliant storage. Sanoliste lists all contract manufacturers in Germany with manufacturing authorisation under Section 13 AMG and full contact details.