Custom Services
Cambrex’s custom development and manufacturing services are fully integrated from analytical and process validation to finished dosage 
formulation from both non-cGMP and cGMP products. Our streamlined processes and global resources focus on fast results whether you provide a technical package or require analytical development.
When entrusting the optimization and production of your product with Cambrex, you will not only be gaining our extensive experience and global clinical to commercial scale development and manufacturing facilities, we will also ensure that you save significant time and money in your manufacturing campaign and with regulatory agencies.
With our stringent good manufacturing practices and regulatory compliance, we have prepared numerous CMC sections for clients' IND, NDA and ANDA filings.
Capabilites
- Custom research, development and process optimization
- Process and analytical development, validation and qualification capabilities
- Streamlined process route selection
- Safety and toxicology assessments
- Stability studies and testing
- Dedicated project management
- Process safety assessment
- Customized stability program
- Detailed written proposal and sourcing evaluation
- cGMP kilo lab, pilot plant and commercial manufacturing
- Clinical drug substance supply
- Manufacturing and optimization of dosage forms
- Finished dosage form production
Our specialized API custom development services include
- Continuous-flow microwave-assisted organic synthesis using CaMWave™
- Enzymatic Biocatalysis
- High Potency and oncology API development
- High Energy API development