Reconfirmation of FDA compliance

Thursday, September 19, 2019.

Building on strong track record of FDA approvals since 1998

Today, Skyepharma Production SAS announces that it has successfully passed an FDA (Food and Drug Authority) inspection which took place earlier in September 2019. The company did not receive an FDA Form 483, which underpins the quality of its manufacturing and scientific facilities and its alignment with the highest quality levels within the industry.

Commenting on this approval David Lescuyer, Managing Director said, “I am delighted that we have received yet again, positive feedback from the FDA after their recent inspection and recognition of the evolutionary journey we have been on. This underlines the importance we place on regulatory standards but also demonstrates that quality is in our DNA at Skyepharma.”

Today, the US market represents 40% of Skyepharma’s production. Recently, Skyepharma partnered two early stage development programmes with US clients.