South Korea’s Ministry of Food and Drug Safety on Monday banned the sale of additional 59 locally-manufactured high blood pressure drugs containing valsartan made from active ingredients imported from China that are suspected to have high level of a cancer-causing substance.
A recent probe conducted by the country’s drug safety watchdog found that above-permitted levels of a chemical that could cause cancer were found in locally-manufactured valsartan made with the Chinese ingredient. Following the latest finding, the ministry temporarily banned the sale of 59 high blood pressure treatments containing the valsartan manufactured by 22 Korean pharmaceutical firms.
This is the second time the Korean drug safety ministry has suspended the sale and production of high blood pressure treatments containing valsartan. Last month, it banned the sale or production of 115 high blood pressure treatments containing valsartan supplied by China’s Zhejiang Huahai after problematic level of cancer-inducing N-Nitrosodimethylamine (NDMA) was found in the specific valsartan. The health authorities across the world, including the U.S. and Europe, have taken similar actions against the hypertension drugs that contained a cancer-prone chemical.
The latest probe found that some batches of valsartan produced by Korea’s Daebong LS contained more than the standard 0.3 parts per million of NDMA. The pharmaceutical firm had been selling valsartan of the same name in Korea after importing ingredients from China’s Zhuhai Rundu Pharmaceutical, the ministry said. It imported the active crude ingredient from China to produce raw material drug valsartan for hypertension drugs in Korea. Daebong LS has accounted for about 3.5 percent of the country’s market for raw material valsartan over the past three years.
By Won Ho-sup and Lee Eun-joo
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