Generic and Branded APIs

Cambrex is a leading global supplier of generic and branded APIs and intermediates to the Pharma and Biotech industries. We work with generic drug companies well in advance of drug patent expiration, using high quality, non-patent infringing processes to manufacture desired APIs. To complement this service, Cambrex also provides access to our Drug Master Files for specified APIs.

We have expertise in the development, process optimization, scale-up and cGMP production of generic and branded APIs and intermediates, all of which are manufactured in our Italy, Sweden and US facilities.

Our capabilities include:

• Synthesis route selection with respect for patents
• Process validation
• Process optimization and verification for successful scale-up from small scale (1 kg) to commercial quantities (1500 kg)
• Pilot facilities to satisfy production of experimental quantities from one kilogram to hundreds of kilograms

Cambrex has an uncompromising commitment to cGMP standards, a proven track record of compliance with environmental, health and safety regulations and facilities that are approved to manufacture commercial APIs.