Speed to market: a case study on API large scale commercial manufacturing

A top 20 US-based pharmaceutical company was looking for a partner to supply large volumes of an API in clinical phase III within a short timeline to pre-approval inspection (PAI). They were looking for a CMO with commercial manufacturing capabilities, large scale assets, multinational sites and exemplary quality systems/US FDA track record. In the end, they chose Cambrex. Read our case study to learn why, including the highlights below.

  • Supplied commercial volumes of an API in clinical phase III.
  • Creation of new facility for commercial manufacturing complete with three trains, controlled substance security, ISO 8 qualified and maintained cleanrooms and ECB 3 containment capability.
  • Reduced timeline from 12 to 10 months in response to customer need.


Download our case study