Ben Venue Laboratories, a Bedford, Ohio-based subsidiary of Boehringer Ingelheim that produces sterile injectables, has announced it will cease production by the end of 2013. Despite the ongoing support of the FDA, dedicated employees and investments in facility upgrades, the company cannot return to sustainable production.
Although interim controls implemented to assure product quality have been effective to date, in the long term they are not sustainable. The magnitude of continued investment and time required to overcome systemic manufacturing challenges is not viable. Given the age and condition of some of the facilities, combined with the findings from third-party current Good Manufacturing Practice (cGMP) experts and ongoing remediation needs, Ben Venue projects, in addition to the more than $350 million invested to date, anticipated additional cumulative operating losses of approximately $700 million over the next five years.
Ben Venue will ensure that critical medicines produced by the company continue to reach patients. The company has notified the FDA and is working to minimize the potential impact the closure may have on patients, providers and employees.
The closure will affect all of Ben Venue's employees, approximately 1,100, over a phased reduction starting in October and continuing into 2014.