FDA reaches agreement with Xellia on troubled manufacturing plant
- Xellia Pharmaceuticals, a Danish specialty pharma company, has reached an agreement with the Food and Drug Administration which should pave the way for the resumption of manufacturing at a Bedford, Ohio site shut down by the FDA in 2013.
- The facility was previously owned by a subsidiary of Boehringer Ingelheim but was closed after the FDA required upgrade to remedy manufacturing and sterility violations, notes FiercePharma.
- Xellia acquired the site in November of last year and plans to make sterile injectable anti-infective products there by the end of 2017.
The modified "consent decree" with the FDA lays out the steps for Xellia to restart manufacturing.
"“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," said Xellia CEO Carl-Ake Carlsson.
The company plans to hire 170 employees in total when it finally ramps up production. But that pales in comparison to the 1,100 workers Boehringer laid off when it shut down the plant in 2013, which was one of the largest pharma layoffs in 2013, according to Fierce Pharma.
Xellia plans to use the plant to complement its US headquarters facility in Raleigh, North Carolina. Both sites will focus on sterile injectables.
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