FDA Issues Warning Letter to Zhejiang Huahai in Valsartan Recall
2018年12月13日 - 12:33AM
Dow Jones News
By Colin Kellaher
The U.S. Food and Drug Administration on Wednesday said it
issued a warning letter to Zhejiang Huahai Pharmaceutical Co.
(600521.SH), which made the active pharmaceutical ingredient
involved in the recall of the blood-pressure drug valsartan.
The agency said the letter outlines several manufacturing
violations at the company's plant in Chuannan, China, including
impurity control, change control and cross contamination from one
manufacturing process line to another.
Several drug makers, including Mylan N.V. (MYL), Teva
Pharmaceutical Industries Ltd. (TEVA) and Torrent Pharmaceuticals
Ltd. (500420.BY), have recalled drugs containing the ingredient due
to the detection of trace amounts of a potentially cancer-causing
impurity.
The recalls of valsartan, found in commonly prescribed heart
medicines, began in July due to the presence of
N-nitrosodimethylamine, a substance that occurs naturally in
certain foods, drinking water, air pollution, and industrial
processes, and has been classified as a probable human
carcinogen.
The FDA, which noted that it is still looking into the root
cause of the impurity, said the violations at Zhejiang Huahai's
plant "reveal a disturbing lack of oversight at this API
manufacturer that puts patients at risk."
The agency put the plant on import alert in September, stopping
all active pharmaceutical ingredients made there and finished drug
products made using the ingredients from legally entering the U.S.
The FDA said it may withhold approval of any new applications or
supplements listing Zhejiang Huahai as a drug manufacturer until
the violations are corrected.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 12, 2018 10:18 ET (15:18 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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