After a voluntary shutdown of facilities last November, Ben Venue Laboratories has revived limited manufacturing at its Bedford, OH, operation as the contract manufacturing unit of the German drugmaker Boehringer Ingelheim resolves remaining issues there. Yet Ben Venue said that supplies for most of its products won't be available for several months or more, the company announced on its website Oct. 16.
Ben Venue published availability status of products from the Bedford facilities this week. It's resumed a limited number of manufacturing lines there amid a major push to correct deficiencies that brought facilities to a halt last year and triggered shortages of drugs such as Johnson & Johnson's ($JNJ) anti-cancer drug Doxil with potential impacts on patients and drug developers. As Dow Jones Newswires reports, J&J recently revealed that it would dip into its own reserves to meet demand for the drug, with Ben Venue expected to provide future supplies for J&J.
"We've made significant progress on our plans to resupply the market with newly manufactured Doxil and anticipate seamlessly bridging to newly manufactured product in the near future," Janssen Products President Robert Bazemore said in the statement, as quoted in an article from The Plain Dealer. "The solution includes product from an innovative collaboration between Ben Venue Laboratories and another supplier to complete end-to-end production of Doxil."
FDA inspectors found numerous problems at Ben Venue's facilities last year. Dow Jones highlighted some of the notable deficiencies, including meds containing metal particles, batches tainted with bacteria and a container that left inspectors with the hunch that it was there to hold urine. Such embarrassments prompted Ben Venue to take serious measures to improve its operations, which were apparently in need of some restoration. And the company said Tuesday it's working with the FDA and other regulators "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."
Ben Venue says that it has 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."
- here's the statement
- see Dow Jones' report
- and The Plain Dealer article
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UPDATED: With quote from Janssen's Bazemore and link to The Plain Dealer's article.