EMA Deals with Manufacturing Deficiencies for Cancer Medicine - - BioPharm International

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EMA Deals with Manufacturing Deficiencies for Cancer Medicine



The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals’ San Diego site. The deficiencies identified relate to adequate sterility assurance in the manufacturing process of DepoCyte. Production and batch release of the medicine are currently on hold, and new batches will only be manufactured once the deficiencies have been resolved and GMP compliancy confirmed by a reinspection.

According to a press release from EMA, there has been no evidence of any microbial contamination of DepoCyte on the market. The recall is being implemented as a precautionary measure in countries where suitable alternatives are available. For countries without therapeutic alternatives, DepoCyte will remain on the market, but with specific recommendations for monitoring patient safety and any signs of infection.

The inspection was conducted jointly by regulators from France and the UK at the DepoCyte manufacturing site in San Diego in July 2012. The EMA’s Committee for Medicinal Products for Human Use (CHMP) believes that the lack of sterility assurance poses a theoretical risk of sterility failure. Current data, however, have not suggested that there has been any Negative impact on the finished product.

DepoCyte is a prolonged release liposomal suspension for injection containing cytarabine for the intrathecal treatment of lymphomatous meningitis. The medicine was authorized in the EU in July 2001.

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