The management of Ben Venue Laboratories (BVL) has elected to exit the contract manufacturing business. The company manufactured sterile injectables and cytotoxic products and will transition out of that business during the next several years. BVL’s facility in Bedford, OH has been in continuous service since 1938.

According to a company statement, “BVL is working with its customers to develop and implement comprehensive long-term transition plans in order to minimize potential impact of product supply. Throughout this transition process, our highest priority will remain the supply of medically necessary products for patients.”

Once that transition is complete, BVL’s facility will be dedicated to manufacturing product for its Bedford Laboratories generic injectable business. BVL spent more than $150 million on facility expansions in the past decade.

The facility has had compliance issues with several regulatory agencies in recent years, including a 483 notice from the FDA in 2009. On August 17, Health Canada banned importation of some BVL drugs and warned doctors and hospitals of resulting shortages. The agency’s letter noted:

“A recent assessment by Health Canada has identified deficiencies in the area of Good Manufacturing Practices (GMP) at the BVL manufacturing site. In light of these deficiencies, Health Canada is allowing only the importation of drugs deemed medically necessary . . . from the BVL site. These deficiencies may have an impact on product quality and have led to manufacturing capacity limitations which could affect the supply of medically necessary drugs imported into Canada.”

Health Canada’s letter noted that the deficiencies raised concern with product quality, but that no specific health risk was identified. A BVL spokesman assured me that the Health Canada letter had no impact on the choice to exit the CMO business, noting, “The decision to exit came only after months of review and consideration.”

BVL is a subsidiary of Boehringer Ingelheim Corp., but the company statement noted that this decision is specific to BVL facility and “does not alter Boehringer Ingelheim’s dedication and firm commitment to its global contract manufacturing business and its valued customers.”