Xellia Pharmaceuticals (‘Xellia’), a specialty pharmaceutical company focusing on providing important anti-infective treatments against serious and often life-threatening infections, has entered into a Modified Consent Decree with the US Food and Drug Administration (FDA) for its recently acquired manufacturing facilities in Cleveland, Ohio.
The modified decree sets out the process with which Xellia must comply in order to commence manufacturing activities at the site. Reaching an agreement with the FDA on the modified 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., (BVL) in January 2013.BVL subsequently ceased manufacturing in December 2013.
Xellia acquired major parts of the site in November 2015 and is investing significantly in the facilities to commence manufacturing of sterile injectable anti-infective products by the end of 2017. The Company is 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.
Carl-Åke Carlsson, CEO, Xellia said: “The Modified Consent Decree is the result of a constructive dialogue between Xellia and the FDA and is an important step in our plan to resume manufacturing at the Cleveland site.
“We are making considerable progress at the site and have already established an experienced team of more than 50 employees. Our focus is on recruitment and training of the new organization to drive operations and ensure GMP compliance at the site. We anticipate having a workforce of 170 new employees at the site by the end of 2017.”
The US is an important market for Xellia, generating over 40% of total sales in 2015. By developing the Cleveland site, the Company will be well positioned to meet the growing needs of its US customers, alleviate supply shortages for vital anti-infectives, and enable future pipeline expansion.
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