After nearly five years and significant investment, commercial production is again underway at a plant that was once the poster-child of pharma production quality failures. Following a January inspection, the FDA has given its nod of approval for Xellia Pharmaceuticals to start manufacturing at the sterile injectables plant in the Cleveland, Ohio suburb of Bedford.
The Copenhagen, Denmark-based Xellia says it will use the greater capacity to scale up its approved pipeline of antiinfectives and to produce injectable drugs on contract. It has more than 200 employees at the plant after investing more than $200 million to revamp it, a spokesman said in an email.
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“This FDA approval marks a major milestone for us, enabling us to manufacture our established and innovative anti-infective injectable products at the site,” Xellia CEO Carl-Åke Carlsson said in a statement. “We have 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.”
Xellia specializes in drugs for difficult to treat infections. Last year, it got FDA approval for a premixed vancomycin injection in a ready-to-use bag. The drug had been awarded a Qualified Infectious Disease Product (QIDP) designation, which provides fast-track review and an additional five years of exclusivity for drugs that address antibiotic-resistant infections.
Xellia bought the plant in 2015, two years after Boehringer Ingelheim had closed it and laid off its 1,100 workers because a federal consent decree had made the cost of upgrades onerous. The consent decree was issued because of sterility lapses that had led to dozens of drug recalls. The company’s contract manufacturing business was so vast that the closure led to a host of drug shortages.
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The German company had already invested about $350 million in facility improvements but projected it would take another $700 million more in operating losses over the next five years to keep it open.
Xellia actually bought a portion of the plant from Hikma, which got it as part of a $300 million deal to get Boehringer Ingelheim’s U.S. generic injectables business. But Hikma didn’t want it and sold off some of the upgraded portions to Xellia, which wanted a U.S. manufacturing site to better serve the U.S. market. Xellia current uses two of the four buildings it acquired from Hikma.
The feds eased some of the decree's requirements and in 2016 Xellia was allowed to use it for labeling and packaging while it made manufacturing improvements dictated by the FDA.