Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part VII)
- 22 ноября 2018
- active substance, API, cancer, candesartan, carcinogen, CEP, drug product, EDQM, EMA, FDA, GC-MS/MS, GMP, human, hypertension, impurity, inspection, intermediate, irbesartan, losartan, MAH, manufacturer, manufacturing, manufacturing site, marketing authorisation holders, medicinal product, medicines, method, Mylan Laboratories Limited, N-nitrosodiethylamine, N-nitrosodimethylamine, NDEA, NDMA, nitrosamine, non-compliance, olmesartan, recall, review, sartans, specific ring structure, statement, suspension, test, tetrazole, valsartan, Zhejiang Huahai Pharmaceuticals,
EMA 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. EDQM Following new information recently received by EDQM about the detection of low levels of N-nitrosodiethylamine (NDEA) in Valsartan manufactured by Mylan Laboratories Ltd, the