European Medicines Evaluation Agency Wants Two More Drugs Moved From Ben Venue Laboratories Due to Ongoing Manufacturing Practice Concerns

The European Medicines Agency (EMA) has recommended the transfer of Caelyx and Ceplene manufacturing processes from the Ben Venue Laboratories in Ohio, US, to alternative facilities, due to shortcomings in quality assurance at the site. The anticancer medicines Caelyx from Janssen-Cilag and Ceplene made by EpiCept are considered to be essential for patients and no alternative suppliers or alternative formulations are presently available, the pharma letter reported. The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that, while the transfers are ongoing, the marketing authorizations of the two drugs be maintained.

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