Regulator investigates Nanjing plant

China's State Food and Drug Administration (SFDA) is investigating quality concerns at a Simcere Pharmaceutical Group (NYSE: SCR) plant in Nanjing. Production operations were suspended by the drugmaker's subsidiary, Jiangsu Yanshen Biological Technology, at the end of November.

At issue is the manufacturing of a human use rabies vaccine (vero cell). Four batches made between July and October 2008 "have been found to have quality problems," the company says in an announcement. Further details are currently unavailable.

The regulator ordered the drugmaker to halt marketing and production of all products made at the facility, including the human use rabies vaccine, "and has organized experts to provide an assessment of risks presented by the problem vaccine."

The week prior to the start of the SFDA investigation, Simcere says it had urged the board of Jiangsu Yanshen to replace its general manager and head of quality assurance. The internal suspension of operations followed.

- see the Simcere announcement


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