Xellia expects ex-Boehringer sterile plant to be ready for production in 2018

Denmark’s Xellia has made another stride in its work to restore the former Boehringer Ingelheim plant in Ohio into a sterile drug producing facility that the FDA will again approve. It has also brought on 90 employees as it prepares to reopen the plant for production in 2018.

The company said today that the FDA has given it a thumbs-up to package and distribute drugs at the site in the Cleveland suburb of Bedford, OH. With the FDA approval, Xellia said it is now able to do labeling, secondary packaging and distribution of products manufactured at its other facilities, even as it works to get the plant approved again for commercial production.

“The permission by the FDA to commence packaging and distribution of drug products at this site is a huge achievement for the Cleveland team on our journey towards resuming sterile product manufacturing,” Xellia CEO Carl-Åke Carlsson said on Monday in a statement.  

The U.S. already accounts for 40% of Xellia sales, and it already has sterile injectables production facilities in Raleigh, NC, and Copenhagen, Denmark. But its capacity for the anti-infectives that it makes will be significantly boosted when the Cleveland site is approved, Carlsson said.  

In addition to investing in equipment upgrades and the facility design, Xellia said it has hired a team of more than 90 employees that it will expand to about 170 over the next 12 months as it prepares to start production during 2018.

Xellia bought the plant, which Boehringer Ingelheim had shut down in 2013 after investing about $350 million in the facility in response to an FDA-instigated consent decree issued that year, in 2015. In 2014, Jordan-based Hikma got the facility as part of a $300 million deal to buy Boehringer’s Bedford Laboratories generic injectables business. It stripped out some of the equipment and then sold off portions of the facility to Xellia.

The consent decree remains in place, but the FDA modified it earlier this year to help Xellia with its plans to reopen the facility.

Suggested Articles

Merck KGaA has big plans for a site in Switzerland where it intends to knit together biologics development and manufacturing. 

Biocon’s key biosimilars plant in Bengaluru, India, has gotten mixed reviews from the FDA and has now received a Form 483 with five observations.

Krystal Biotech has started on a new manufacturing facility for eventual commercial supply of gene therapies in its pipeline.