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Horizon Adds Sanofi Compiegne Site for DUEXIS

Gains FDA approval as an additional manufacturing facility

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Horizon Pharma, Inc. has received approval from the FDA to use Sanofi’s manufacturing site in Compiegne, France to manufacture DUEXIS (ibuprofen/famotidine), a single-tablet combination of ibuprofen (800 mg) and famotidine (26.6 mg). Valeant’s manufacturing site in Laval, Quebec, previously owned and operated by Sanofi, serves as the primary commercial manufacturing site for DUEXIS. 
 
“We have had a successful long-term partnership with Sanofi and are pleased with the FDA’s approval of the Compiegne 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.”

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