Hovione has a track record for industrializing processes for molecules that few other companies can match. Our focus in developing and manufacturing difficult APIs has given us a deep understanding of the challenges and opportunities that exist in generic APIs.

Today, Hovione’s traditional expertise is complemented by advanced technologies in API Particle Design, inhalation formulation development as well as in the areas of parenteral grade and high potency APIs. Additionally, an unblemished track record at FDA assures our customers can take a totally compliant environment for granted.

Hovione has over 90 DMFs filed worldwide and have been granted 10 CEPs. We assist our customers throughout the development and registration stages by supplying impurities, technical documentation, analytical methods, validation, stability and regulatory support. During the last 6 years, Hovione has been involved in 3 FDA pre-approval inspections for 8 products. As a result of the service and quality we provide, every customer that has come to Hovione has become a repeat customer.


Generic products