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Ben Venue Extends Manufacturing Stoppage

Quality issues to derail sterile injectables till 4Q12

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Ben Venue Laboratories will extend the voluntary suspension of manufacturing at its Bedford, OH facility. The site is one of the largest sterile injectable facilities in the world, with aseptic filling, lyophilization and cytotoxic manufacturing in four factories.

The suspension, originally announced on November 19, 2011, was prompted after an internal review indicated that routine preventive maintenance and requalification of some manufacturing equipment was overdue. Those issues were also noted in recent inspection findings by the FDA, EMA, and other global regulatory agencies. The company “is now in a position where it can no longer continue to manufacture and remediate simultaneously and must direct its focus on addressing manufacturing-related issues,” according to a Ben Venue statement.

The company plans to get some manufacturing online in 1Q12, but noted that its north facility, which makes several sterile injectables that are in short supply, will not manufacture any new products before 4Q12. The north facility “requires major reconstruction that may take up to nine months to complete,” said a company spokesman.

In August 2011, the company announced plans to leave the contract manufacturing space in a multi-year transition.

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