LEXINGTON, Mass.—The U.S. Food and Drug Administration (FDA) has approved two second source contract manufacturing organizations (CMO) to manufacture AMAG Pharmaceutical’s Feraheme (ferumoxytol) Injection for Intravenous (IV) use.
The two organizations provide drug substance (active pharmaceutical ingredient or API) and drug product for Feraheme. Currently, Feraheme is manufactured at the Company’s GMP facility in Cambridge, Mass. Over time, AMAG expects these CMOs will become the primary supply source of Feraheme.
“AMAG is committed to ensuring that the availability of Feraheme is never interrupted,” stated Scott T. McMillan, PhD, Vice President of Technical Operations at AMAG Pharmaceuticals. “These CMOs, along with our own manufacturing facility, will provide redundancy and increased flexibility to meet unanticipated changes in demand.”
In the U.S., Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult chronic kidney disease (CKD) patients. The Company is also working towards gaining marketing approval for Feraheme in several additional regions, including the EU, Canada and Switzerland.
McMillan continued, “As we prepare for global expansion, it is critical to have worldwide manufacturing capabilities to ensure adequate and scalable product supply.”
In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009, and was commercially launched by AMAG in the U.S. shortly thereafter. In 2010, the Company reported U.S. Feraheme net sales of $59 million.
