Boston : Keryx Biopharmaceuticals, Inc., a bio pharmaceutical company focused on bringing innovative medicines to people with renal disease, announced that the U.S. Food and Drug Administration (FDA) has approved its application for a second drug product contract manufacturer. Patheon Manufacturing Services LLC of Greenville, North Carolina, a leading global provider of pharmaceutical manufacturing services, is now an FDA approved drug product manufacturer of Auryxia®. With FDA approval of this manufacturer, the company has rebuilt supply and will promptly 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 of Keryx Bio pharmaceuticals. “Getting a second drug product manufacturer approved was an important step to ensuring long-term supply of Auryxia is consistently available to patients.”
Mr. Madison continued, “We are looking forward to attending American Society of Nephrology’s Kidney Week, the global, premier kidney conference. The timing of this conference next week gives us the opportunity to communicate with health care professionals in attendance that Auryxia supply is restored and is once again available for their patients.”