FDA Approves the Patheon site in Bourgoin, France to Manufacture Drugs for U.S. Market
Patheon, the pharmaceutical services business owned by DPx Holdings, recently received FDA approval for its Bourgoin, France site to begin manufacturing and selling drugs to the U.S. market. The Bourgoin site specializes in development and commercial scale manufacture of solid oral forms and non-sterile liquids.
The U.S. FDA conducted a pre-approval inspection at the site March 20-28. As a result of the inspection and approval, the Bourgoin site can now manufacture and sell drugs to its U.S. 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 U.S.," said David Lescuyer, executive director & 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 U.S. 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 U.S. market.
Patheon is a leading provider of contract development and commercial manufacturing (CDMO) services to the global pharmaceutical industry for a full array of solid and sterile dosage forms. Patheon, a DPX business unit, encompasses the combined CMO capabilities and pharmaceutical product development services (PDS), as well as the Biosolutions and Biologics (BIO) business. For more information visit http://www.patheon.com.