The notorious ex-Boehringer Ingelheim plant in Bedford, OH, is still governed by a court-ordered consent decree ordering improvements to be made before it is serviceable again. But Denmark’s Xellia, which bought the plant last year, says the FDA is cutting it some slack on the provisions so it can ready the facility for manufacturing next year.
Xellia announced last week that it had entered into a Modified Consent Decree with the FDA for upgrades that must be made at the parts of the plant that the company intends to bring back online. It says it is investing heavily in the facility and “working closely with the FDA to ensure a timely and controlled start-up at the facility.” It expects to be manufacturing its sterile injectable, anti-infective drugs there by the end of 2017.
“The Modified Consent Decree provides a simplified process for commencing drug manufacturing at the newer parts of the facility--the so-called Phase IV and Phase V units,” Xellia spokesperson Eileen Paul said today in an email. “Xellia only plans to resume operations at these units and aims to commence operations at the site by the end of 2017. The modification to the consent decree is an important step in realizing the plans for the site.”
Boehringer Ingelheim shut the plant down at the end of 2013 and laid off its 1,100 workers when the burden of FDA-required upgrades got to be more than it could tolerate. At that point, it had invested about $350 million in facility improvements and projected it would rack up $700 million more in operating losses over the next 5 years to keep it open.
The court-ordered consent decree was issued in 2013, two years after FDA citations led BI to voluntarily close the contract manufacturing facility to get on top of manufacturing and sterility lapses that had led to dozens of drug recalls over the years. The company’s contract manufacturing business was so vast that the closure led to a host of drug shortages.
Hikma got the facility in 2014 as part of a $300 million deal to buy Boehringer’s Bedford Laboratories generic injectables business. The Jordan-based company decided to keep the R&D center and its staff for drug development but said it had no intention of restarting the facility. Instead, it moved some of the new equipment in the plant to its other production sites.
Then in November 2015, Hikma sold parts of the plant to Xellia, which wanted a U.S. manufacturing site. Xellia said it intends to hire 170 people back to operate the nearly new sterile injectable lines Boehringer installed before abandoning the effort.
“We are making considerable progress at the site and have already established an experienced team of more than 50 employees,” Xellia CEO Carl-Åke Carlsson said in a statement. “Our focus is on recruitment and training of the new organization to drive operations and ensure GMP compliance at the site.”
- read the release
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