European regulators pull Mylan’s manufacturing license for valsartan after impurities found
European authorities have suspended Mylan’s (MYL -0.5%) manufacturing certificate for hypertension med valsartan after NDEA, a suspected carcinogen at high doses, was found in certain lots made at the company’s facility in Hyderabad, India. The action effectively prohibits the use of valsartan in medicines sold in the EU.
Investigators believe that the impurities are linked to the synthesis of a specific ring structure called tetrazole that is present in some sartan medicines.
Authorities have started recalling the affected batches and are conducting additional tests to determine the extent of the contamination. They add that patients should continue taking the medication until they can consult with their doctors since they are in no immediate risk.
Earlier this month, Novartis’ Sandoz unit recalled one lot of losartan made in China due to the presence of NDEA.