Patheon to Manufacture Ferric Citrate for Keryx

Patheon Manufacturing Services has partnered with Keryx Biopharmaceuticals to manufacture Auryxia (ferric citrate) in the U.S.

Keryx recently received approval from the U.S. Food and Drug Administration (FDA) for its application for a second drug product contract manufacturer for ferric citrate. Patheon Manufacturing Services of Greenville, NC, is now an FDA approved drug product manufacturer of Auryxia. With FDA approval of this manufacturer, the company said it has rebuilt supply and will make Auryxia available to wholesalers.

“We are pleased with today’s approval, as it expands our manufacturing capabilities and capacity,” said Greg Madison, president and chief executive officer, Keryx Biopharmaceuticals. “Getting a second drug product manufacturer approved was an important step to ensuring long-term supply of Auryxia is consistently available to patients.”