EMA makes interim recommendations to deal with shortcomings at Ben Venue Labs
The European Medicines Agency (EMA) is currently reviewing shortcomings in quality assurance identified during a Good Manufacturing Practice (GMP) inspection at Ben Venue Laboratories' manufacturing site in Ohio, USA, and their impact on centrally authorized medicines manufactured at this site. Ben Venue is a contract manufacturing subsidiary of independent German drug major Boehringer Ingelheim.
The EMA’s recommendations include precautionary recall for remaining batches of Pierre Fabre’s Busilvex (intravenous busulfan), Johnson & Johnson’s Velcade (bortezomib) and Celgene’s Vidaza (azacitidine) manufactured at Ben Venue. No new patients to be treated with Merck & Co’s Caelyx (pegylated liposomaldoxocrubin hydrochloride).
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