Generics

Generic APIs have been a core part of Hovione's business for the past 49 years. Over that time we launched more than 45 generic APIs to the most demanding customers in the United States, Europe and Japan and has gained a reputation in the Industry for superior quality, reliability and customer service.

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.

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.

Main Generic Products:

• Tetracycline derived antibiotics;
• Macrolides;
• Mectins;
• Corticosteroids;
• Contrast Media.