Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity

November 19, 2018 – Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India. EDQM1 has now suspended the manufacturer’s CEP2 (a certificate of compliance with European standards for quality testing), effectively prohibiting the use of its valsartan in EU medicines. In addition, national authorities in the EU have started recalling affected … (leggi tutto)