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European Medicines Agency

Impurity found in valsartan manufactured by second company in China, EMA says

Low levels of the potentially harmful impurity N-nitrosodimethylamine (NDMA) have been detected in batches of valsartan produced by a second pharmaceutical company, the European Medicines Agency (EMA) has learnt.

Originally, NDMA was found in the active substance manufactured by Chinese pharmaceutical company Zhejiang Huahai Pharmaceutical, but now the impurity has been detected in valsartan manufactured by another Chinese company, Zhejiang Tianyu Pharmaceutical.

However, the NDMA levels detected in batches of valsartan from Zhejiang Tianyu are much lower than levels seen in the active substance from Zhejiang Huahai, which triggered a recall of several valsartan medicines in July 2018.

The EMA said it is working closely with international partners to review the impact of the NDMA detected in valsartan manufactured by Zhejiang Tianyu and will communicate its findings as soon as possible.

According to the EMA, there is “no immediate risk to patients” and “patients should not stop taking any valsartan medicines without consulting their doctor or pharmacist”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205317

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