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)

Do you have a generic API development or manufacturing requirement?

Contact us Our range of generic APIs