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news.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.
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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.
During the transfer, Caelyx and Ceplene continue to be manufactured at the Ben Venue facility, the interim measures introduced in November and December 2011 be continued.
The CHMP has also announced that no new patients to be started on Caelyx from the plant and for Ceplene, the manufacturing process should be transferred by the end of 2013.
Ben Venue is a contract manufacturing subsidiary of independent German drug company, Boehringer Ingelheim.