When it comes Chinese-made APIs, Western drugmakers are between a rock and a hard place. They know Chinese oversight of bulk APIs is insufficient to snuff out substandard producers, but since China produces more APIs than any other country, they can't live without them.
"If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty," Guy Villax, CEO of Hovione, tells Reuters. The Portuguese API supplier has factories in China, as well as the U.S. and Ireland.
After 80 U.S. patient deaths were tied to tainted Chinese heparin in 2008, Chinese authorities pledged to crack down on API suppliers. But a Reuters investigation finds that while China is doing more, the fact that many Chinese APIs are substandard or counterfeit is an open secret. "Illegal ingredients in bulk are a big problem, but nobody talks about it," Villax says.
Read more: Dangers aside, drugmakers can't live without Chinese APIs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/dangers-aside-drugmakers-cant-live-without-chinese-apis/2012-09-03#ixzz25iHugod3
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