China Didn’t Check Drug Supplier, Files Show

Curtains are up. Here is more about the Chinese drug factory linked to four deaths in the States. From The New York Times:

A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews.

Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either — a violation of its own policy — before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States…

China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration. However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese drug agency’s jurisdiction.

See also related articles: Heparin Trail: Pig Intestines From China Via Wisconsin from the Wall Street Journal and Wisconsin firm tied to troubled blood drug from Chicago Tribune.

February 15, 2008 10:33 PM
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