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Sunday, July 27, 2008

China says Baxter holding up heparin investigation

(Page 2)

"I was very surprised," said Jin. "This is extremely regrettable."

A company spokeswoman said that was not the case.

"So far, Baxter has agreed to provide samples to the State Food and Drug Administration in respect to their requests," said Xing Rongwang, associate director of communications for Baxter in China.

"We have been cooperating with all parties involved in the heparin situation," she said by telephone.

But the case has raised questions over both the oversight of foreign plants manufacturing products for U.S. drugmakers and the nature of China's ability to monitor pharmaceuticals.

China says the supplier, Changzhou SPL Co Ltd., is a holding of the U.S.'s Scientific Protein Laboratories LLC, which should bear responsibility for the plant.

It also says Changzhou was not registered with China's State Food and Drug Administration because of a loophole in which the company is considered a chemical-maker, rather than a maker of pharmaceutical products.

But U.S. Undersecretary of Commerce Christopher Padilla has said Chinese regulators must strengthen oversight to ensure they have authority over both makers of active pharmaceutical ingredients as well as makers of bulk chemicals which may be used in pharmaceuticals.


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