Patheon has recently received FDA approval for its Bourgoin, France site to begin manufacturing and selling drugs to the US market.
The Bourgoin site specialises in development and commercial scale manufacture of solid oral forms and non-sterile liquids.
The US FDA conducted a pre-approval inspection at the site 20-28 March. As a result of the inspection and approval, the Bourgoin site can now manufacture and sell drugs to its US customers, in addition to the 110 countries already supplied by the site.
"We are very pleased that our facility is now able to supply drugs to our customers and their patients in the US," said David Lescuyer, executive director and general manager, Patheon Bourgoin. "This is a significant achievement for our site and we have several products in the development pipeline that we can now supply to the US market."
The Bourgoin site recently upgraded its facility with new manufacturing and packaging solutions, including high potent drug containment measures in granulation, compression and packaging, and a new bottling line to pack solid dose forms in bottles. These new capabilities allow the facility to better supply the US market.