FDA Clears Xellia’s Ohio Operations
The US Food and Drug Administration (FDA) has notified Xellia Pharmaceuticals, a Copenhagen, Denmark-headquartered specialty pharmaceutical company focused on anti-infective treatments, that it is allowing the company to begin packaging and distribution of drug products at Xellia’s Cleveland, Ohio facilities.
The notice follows a cGMP inspection by the FDA conducted under the procedures of an agreement that Xellia entered into with the FDA in April 2016. Xellia acquired the Cleveland site in November 2015 and has been bringing the site back to compliance. The company can now initiate certain commercial activities that involve labelling, secondary packaging, and distribution of drug products manufactured at other sites.
Xellia will prepare to start the production of sterile anti-infective injectable products at the site during 2018. Xellia Cleveland will operate alongside the company’s existing sterile injectables production plant in Raleigh, North Carolina and Copenhagen, Denmark.
Source: Xellia Pharmaceuticals