Xellia Pharmaceuticals, a company that manufactures specialty anti-infective treatments and critical care therapies, has been granted approval by the U.S. FDA for the manufacture of its first premix bag products at its facility in Cleveland, OH. Production has commenced and the first commercial batches have been released.

Xellia has worked closely with the FDA to bring the Cleveland facility into operation, gaining approval for the commercial manufacturing of its first injectable drug products in March 2020 and now for its first premix bags, following regular inspections.
 
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 and wholly owned supply chain.

According to the company, the network provides a secure supply for both active pharmaceutical ingredients (APIs) and finished dosage form (FDF) products for customers globally.

Michael Kocher, CEO at Xellia Pharmaceuticals, said, “This FDA approval and the release of our first commercial batches from the Cleveland site are significant milestones for Xellia. It is the culmination of eight years of hard work by the team to establish our state-of-the-art manufacturing capabilities there. We are one of very few manufacturers with the ability to produce aseptically filled premix products and are proud to now be able to do so in the U.S. for U.S. customers, with all the safety and speed of use benefits that they provide.”