The European medicines Agency (EMA) is examining medicines containing valsartan supplied by one of the companies in China, after they have been detected by an impurity that potentially causes cancer, according to PharmaTimes.
Chinese company Zhejiang Huahai was found N-nitrosodimethylamine (NDMA) in some batches of the active substance (API) valsartan, supplied to a number of manufacturers of valsartan drugs, circulating in the EU market.
These drugs are used in patients with high blood pressure to prevent heart attack and stroke, as well as in patients with heart failure or who have experienced acute coronary syndrome.
According to the EMA experts, the presence of NDMA in the active substance, which is a potential carcinogen, was a surprise. The reason for the appearance is associated with a change in the production process of API.
Currently, drugs delivered by the company Zhejiang Huahai containing valsartan, Supervisory authorities revoked Tran the EU. In parallel with this, analyzes of the NDMA content in the drugs begin.