Xellia Cleveland
FDF manufacturing site
Since acquiring the Cleveland site in 2015, Xellia has made significant investment to create a modern, world-class facility that will allow the Company to continue to provide a reliable and consistent supply of its vital anti-infective products across the US. Xellia has worked closely with the FDA to resume activities at the site, and in January 2020, the FDA performed a comprehensive cGMP inspection of the facility. The Agency notified Xellia of the successful outcome of the cGMP inspection, enabling us to commence manufacturing of drug products at the site.
Xellia can now initiate commercial manufacturing at the Cleveland site and will use the facilities to maximize production of aseptic injectables. The increased capacity will be used to grow and scale Xellia’s own pipeline with dedicated production lines for its established and innovative anti-infective injectable drug products. Xellia will also use the site to widen its offering of CMO services for third-party injectables.
Xellia Cleveland will operate alongside the Company’s existing sterile injectable production plant in Copenhagen, Denmark.
Our Cleveland production site will operate alongside Xellia’s other existing production facilities and produce sterile injectable products. The site includes four manufacturing units for sterile injectables and has currently more than 200 employees across a range of departments, including; manufacturing, supply chain, distribution, quality, engineering, human resources and finance.