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The results have already triggered recalls in more than 50 countries, affecting several Chinese and Indian companies.
(IStock)
European and North American regulators said they were examining a second potentially carcinogenic substance in a widely used blood pressure drug, manufactured by China's Zhejiang Huahai Pharmaceuticals.
Statements from health regulators from the EU, the US and Canada add to concerns raised earlier this year when valsartan contained traces of N-nitrosodimethylamine ( NDMA), probably carcinogenic to humans, in 2012.
The results have already triggered recalls in more than 50 countries, affecting several Chinese and Indian companies.
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On Thursday, the European Medicines Agency (EMA) said that a similar impurity had been detected in products manufactured before 2012.
"In addition to NDMA, EMA is evaluating the impact of a related substance, N-nitrosodiethylamine (NDEA), which has been detected in valsartan manufactured by Zhejiang Huahai using its previous manufacturing process before its introduction in 2012" . declaration.
"Data on NDEA levels are currently very limited and EMA will provide additional information that its presence will have an impact on the risk assessment once additional information becomes available."
The watchdog also said that a further risk assessment had confirmed that the cancer risk associated with exposure to NDMA levels detected in valsartan was considered low.
A representative of Torrent Pharmaceuticals declined to comment.
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