China Fines Simcere For Substandard Vaccine

Simcere Pharmaceutical Group said Monday it is being fined $3.7 million by Chinese authorities due to the production of substandard rabies vaccines.

NEW YORK (AP) -- Simcere Pharmaceutical Group said Monday it is being fined 25.6 million yuan ($3.7 million) by Chinese authorities due to the production of substandard rabies vaccines.

The company, based in China, said Changzhou Food and Drug Administration imposed the fine on its Jiangsu Yanshen Biological Technology Stock Co. Ltd. unit.

Jiangsu Yanshen also will bear the cost of patient revaccinations up to 23 million yuan ($3.4 million). Also, members of Jiangsu Yanshen's management team and employees directly involved in the production of the substandard vaccines will be prohibited from making or marketing pharmaceutical products for 10 years.

There is also a criminal investigation under way, the company said.

Simcere agreed to buy a controlling stake in Jiangsu Yanshen in October 2009 and subsequently discovered quality control problems related to the production of the company's human use rabies vaccine. The following month, Simcere said it urged Jiangsu Yanshen's board to replace its general manager and head of quality assurance and demanded that Jiangsu Yanshen suspend production to fix its quality systems.

The company said Jiangsu Yanshen has been cooperating with authorities on the investigation. There have been no reported adverse events related to the vaccine batches in question. Jiangsu Yanshen's operations remain suspended.

Shares of Simcere rose 2 cents to $8.03 in afternoon trading.

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