EMA Finds Probable Cancer-Causing Agent in More Chinese Medicines
Liao Shumin
DATE:  Aug 14 2018
/ SOURCE:  Yicai
EMA Finds Probable Cancer-Causing Agent in More Chinese Medicines EMA Finds Probable Cancer-Causing Agent in More Chinese Medicines

(Yicai Global) Aug. 14 -- The European Medicines Agency has detected N-nitrosodimethylamine, a probable human carcinogen known as NDMA, in blood pressure treatments produced by Tianyu Pharmaceutical -- the second Chinese company found to be making subpar hypertension drugs in less than six weeks.

The impurities found in the Zhejiang-based firm's valsartan were much lower in quantity than those found last month in medicines made by Huahai Pharmaceutical, the EMA said in a statement online on Aug. 10. Huahai began recalling the drug in multiple countries after NDMA was discovered in its valtarsan.

The agency is working with international partners to evaluate the impact the NDMA in Tianyu's drugs may have, but said there was no immediate risk to patients and that they should not stop taking the medication without consulting their physician or pharmacist.

On Aug. 3, Taiwan's Food and Drug Administration announced that it had found NDMA in batches of Tianyu's valsartan. There was no product recall as the medicines had not yet made it to market, but local authorities decided to suspend imports of valsartan made by Tianyu.

The firm made more than CNY96 million (USD14 million) from sales of the drug last year, making up 8.1 percent of all revenue. CNY1.4 million of that came from exports to Taiwan.

Editor: James Boynton

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Keywords:   European Medicines Agency,Zhejiang Tianyu Pharmaceutical,Valsartan,NDMA,Human Carcinogen,Cancer