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When a suspected carcinogen was detected by a U.S. drugmaker last summer in the API it had acquired to make blood pressure drugs, it first appeared to be another issue of tainted products produced in China. Since then
China’s Zhejiang Huahai Pharmaceutical for years enjoyed the upside of the U.S. pharmaceutical market, selling its valsartan API to drugmakers producing blood pressure meds for the market.
The FDA last month went back into China's Zhejiang Huahai Pharmaceutical and produced a Form 483 with observations that strike at the heart of its manufacturing changes.
The European Medicines Agency has piled onto China’s Zhejiang Huahai, finding its manufacturing out of compliance for the valsartan API that has been recalled globally after being found to contain a suspected carcinogen.