Generic APIs

We are a leading global supplier of generic APIs.

From our sites in Italy, Sweden and the USA, we work with generic drug companies well in advance of drug patent expiration, using high quality, non-patent infringing processes to manufacture APIs.

Our generic API manufacturing and development capabilities include:

  • Leading range of more than 100 generic APIs; 90 of which are commercially sold and free from patent
  • Around 30 APIs in different phases, from under development to fully validated
  • 90 Drug Master Files (DMFs) filed globally
  • Development and process optimization
  • Support for New Drug Applications (NDAs) and 505B2 NDAs for existing APIs
  • Commercial scale cGMP manufacturing
  • Strong regulatory performance with regulatory agencies around the world (FDA, PMDA, ANVISA, KFDA and AIFA to name a few)

Advanced intermediates

We’re recognized in the global pharmaceutical industry as a leading advanced intermediates manufacturer and supplier. Characterized by quality and reliability, you can trust us to deliver.

From our sites in Sweden, Italy and USA, we manufacture pharmaceutical intermediates, with an uncompromising commitment to cGMP standards.

As an advanced intermediates manufacturer, our facilities are approved to handle a wide range of pharmaceutical intermediates and we have a proven track record of compliance with environmental, health and safety regulations.

Our advanced intermediate capabilities include:

  • Process development
  • Analytical method development and validation
  • Pilot facilities to manufacture advanced intermediates from 1kg to 20kg
  • High energy reactions

Chiral compounds

Do you require chiral compound manufacturing services at pilot or commercial scale? At Cambrex, we have the technology and expertise to meet your chiral compound needs.

Using biotransformation technology, our expert team can produce chiral compounds that are:

  • Highly chemo-, regio- and stereo-selective
  • Cost-efficient
  • cGMP compliant
  • High enantio purity
  • Available in commercial volumes

Do you have a generic API requirement?

It’s easy to get in touch with a Cambrex expert that’s best suited to answer your questions. Just click below to contact a member of our team, they’ll be delighted to help.

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