FDA approves French plant’s manufacture of Horizon Pharma drug
DEERFIELD — The U.S. Food and Drug Administration has approved Horizon Pharma’s use of Sanofi’s manufacturing site in Compiègne, France to manufacture the rheumatoid arthritis drug Duexis.
“We have had a successful long-term partnership with Sanofi and are pleased with the FDA’s approval of the Compiègne site as an additional manufacturing facility for Duexis,” said Hans-Peter Zobel, Ph.D., senior vice president, manufacturing, Horizon Pharma. “This approval provides us a quality backup manufacturing site, enhancing our ability to ensure an adequate long-term supply of Duexis.”
Valiant Pharmaceuticals’ manufacturing site in Laval, Quebec, previously owned and operated by Sanofi, serves as the primary commercial manufacturing site for Duexis.