Value through Innovation07 April 2014
October 16, 2012

Ben Venue Laboratories, Inc. Resumes Limited Drug Manufacturing

Bedford, OH – October 16, 2012 – Ben Venue Laboratories (Ben Venue) has resumed production on a limited number of manufacturing lines in the company’s Bedford, Ohio facilities. Ben Venue continues to make progress toward upgrading the company’s manufacturing facilities and anticipates that production will resume on additional lines as lasting corrective measures to address facility and equipment issues are implemented. For most of the products we manufacture, supplies will not be available for at least several months. Specific product availability updates are available at www.bedfordlabs.com.

Ben Venue continues to work in close collaboration with the United States Food and Drug Administration (FDA) and other global regulatory agencies with the shared goal of bringing the medicines we make back to market as quickly as possible with the highest attention to quality and product safety. Following the FDA’s inspection of Ben Venue’s manufacturing operations in May 2011, we began the implementation of a comprehensive remediation effort with the assistance of top-tier external experts in current Good Manufacturing Practice. We have invested more than $300 million to upgrade our facilities, making necessary improvements and changes to our processes to resolve the manufacturing-related issues that resulted in our voluntary shutdown last year.

As makers of medically necessary drugs, Ben Venue recognizes that patients are counting on us, and we will not be distracted from our core purpose – bringing critical medicines to the people who need them.