Xellia Pharmaceuticals Enters Into FDA Modified Consent Decree for Former Ben Venue FacilityBy
Xellia Pharmaceuticals, a specialty pharmaceutical company headquartered in Copenhagen, Denmark, has entered into a Modified Consent Decree with the US Food and Drug Administration, for its recently acquired facility in Cleveland, Ohio, the former facilities of Ben Venue Laboratories Inc.
The modified decree sets out the process with which Xellia must comply to begin manufacturing at the site. Reaching an agreement with the FDA on the Modified Consent Decree is an important step in the company’s plan to resume operations in the new manufacturing units at the site.
The original Consent Decree for the Cleveland site was entered into by the FDA and the previous owner, Ben Venue Laboratories Inc. in January 2013. Ben Venue subsequently ceased manufacturing in December 2013.
Xellia acquired major parts of the site in November 2015 and is investing in the facilities to begin manufacturing of sterile injectable anti-infective products by the end of 2017. The company said it was working closely with the FDA to ensure a timely and controlled start-up at the facility.
Once up and running, the Cleveland site will considerably increase Xellia’s production capacity for sterile injectable products in the US. It will operate alongside the company’s existing sterile injectables production plant in Raleigh, North Carolina.
The US is an important market for Xellia, with the US generating more than 40% of total sales in 2015.
Source: Xelia Pharmaceuticals