Two years ago, Boehringer Ingelheim was glad to be done with the Ben Venue sterile injectables plant in Ohio that was operating under a consent decree because of a history of quality failings. Now Denmark's Xellia says it is glad to be opening it again.
Xellia picked up the facility in Bedford, OH, from Hikma Pharmaceuticals, which in turn got it when the Jordan-based company paid $300 million for Boehringer Ingelheim's Bedford Laboratories generic injectables business last year. Boehringer had closed the plant at the end of 2013 and laid off its 1,100 workers when the burden of FDA-required upgrades began adding up to more than it wanted to invest.
Xellia says it will hire 170 people to operate the nearly new sterile injectable lines Boehringer installed before abandoning the effort. Xellia would not disclose what it paid for the plant, one of the largest sterile drug manufacturing facilities in the country, but said it intends to invest heavily to get it ready for production in the next 24 months.
"The U.S. is a very important market for us, and as a region with a strong manufacturing heritage and a uniquely skilled and specialized workforce, Bedford, Ohio is an ideal location to expand our manufacturing capabilities," Carl-Åke Carlsson, CEO of the anti-infectives specialist, said in a statement.
Hikma is holding on to the rest of the facilities at the massive site, including the Quality and Development Center, but Xellia said it is getting substantial parts of the site, including the new manufacturing units for sterile injectables, which are not currently operational. Xellia says it will work closely with the FDA as it prepares the plant to manufacture again.
The FDA is very familiar with the plant, which operated under a court-ordered consent decree issued in 2013, two years after FDA citations led Boehringer Ingelheim to voluntarily close the facility to make improvements that would resolve problems there. By that point, the contract facility had issued more than 40 recalls in 9 years and the FDA had outlined a long list of issues which left its sterile drugs open to contamination, including finding a 10-gallon container of urine in a storage facility, ostensibly used by employees to avoid bathroom breaks.
After investing about $350 million in plant improvements, Germany-based Boehringer announced in the fall of 2013 that it would close the plant. The company explained that the "magnitude of continued investment and time required to overcome the systemic manufacturing challenges is not viable." It projected it would rack up $700 million more in operating losses over the next 5 years to keep it open.
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