FDA approves Xellia US facility for CMO injectables

The increased capacity will be used to grow and scale Xellia’s own pipeline as well as widening its offering of CMO services

Xellia site in Cleveland, Ohio

Xellia Pharmaceuticals has received approval from the US FDA allowing the company to commence manufacturing of drug products at its Cleveland, Ohio site. Headquartered in Denmark, Xellia is a specialty pharmaceutical company focusing on providing important anti-infective treatments against serious and often life-threatening infections.

Since acquiring the Cleveland site in 2015, Xellia has made a significant investment to create a modern, world-class facility that will allow it 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 this inspection this month, with the approval to commence drug product manufacturing.

Xellia can now initiate commercial manufacturing at the Cleveland site and will use the facilities to maximise production of aseptic injectables.

Xellia has invested substantially in the company’s manufacturing and commercial capabilities in the US over recent years

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.

Carl-Åke Carlsson, Xellia’s CEO said: “This FDA approval marks a major milestone for us, enabling us to manufacture our established and innovative anti-infective injectable products at the site.”

Carlsson added that Xellia has invested substantially in the company’s manufacturing and commercial capabilities in the US over recent years. “We firmly believe in the importance of consistent and reliable manufacturing of critical, life-saving medicines locally in the US for use by US physicians for their patients,” he said.

Up until now, the focus at the Cleveland site was on packaging, labelling and distributing drug products manufactured at other Xellia facilities, following the first FDA approval for the facility in 2016.

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Xellia Pharmaceuticals (more information, website)