Xellia Pharmaceuticals, a manufacturer of specialty anti-infective treatments, said that its manufacturing site in Cleveland, OH is now commercially operational and has released the first anti-infectives manufactured at the site, to be distributed for use by U.S. hospitals.
 
The anti-infective is the first drug product to be manufactured at the Cleveland site since it was bought by Xellia in 2015 and extensively rebuilt. The state-of-the-art facility is now commercially active after operations commenced following the passing of a comprehensive cGMP inspection by the FDA in 2020.
 
“The release of the first commercial product manufactured at our Cleveland facility is a significant milestone for Xellia,” said Carl-Ake Carlsson, president and CEO, Xellia Pharmaceuticals. “We acquired the site to fulfil an ambition to provide U.S. hospitals and patients with critical care products made locally. We are proud to be producing high quality, key anti-infectives and we look forward to working with more partners who are aligned with Xellia’s purpose to save patient lives.”
 
Xellia has made significant investments at the Cleveland site since its acquisition in 2015 to create a modern, state-of the art facility. In addition to commencing commercial supply, the facility is also preparing ramp-up of its newly installed aseptic bag manufacturing line. The site is strengthening Xellia’s ability to provide a reliable and consistent supply of critical medicines across the U.S., with a core emphasis on quality.
 
Patrick Brunner, Xelia’s vice president of manufacturing operations in North America, said, “Xellia Cleveland is now commercially operational thanks to the hard work of our U.S. team and employees across Xellia. Now that the site is in full working order, we will continue to ramp up our U.S. operations to strengthen our market presence in anti-infective production and help provide the security of supply of vital drug products needed by U.S. hospitals and patients.”
 
Xellia has established a workforce of more than 300 employees at the Cleveland site. Recruitment has been ongoing since 2015 in the Cleveland area and has also attracted employees from other areas of the U.S. In addition, Xellia has been able to recruit graduates from local institutions such as The Ohio State University, Cleveland State University, Case Western Reserve University, Kent State University, University of Akron, and Cuyahoga Community College.
 
The Cleveland site operates alongside Xellia’s other manufacturing plants in Copenhagen, Denmark; Budapest, Hungary; and Taizhou, China, as part of its vertical integration strategy. The network provides a secure supply and one-stop shop for both active pharmaceutical ingredients (APIs) and finished dosage form (FDF) products for customers globally.