THE European Medicines Agency has banned valsartan made by Mylan in India for use in EU medicines, after the discovery of N-nitrosodiethylamine (NDEA) in some batches of the ingredient made by Mylan Laboratories Limited in Hyderabad, India.
National authorities across Europe have started recalling affected batches of medicines containing Mylan's valsartan, and are conducting further tests to determine the extent of the contamination.
NDEA and the related compound N-nitrosodimethylamine (NDMA), which have been seen in "sartans" from other manufacturers (PD 11 Jul, 16 Jul 2018) are classified as probable human carcinogens.
The presence of the impurities is thought to be linked to the synthesis of a specific ring structure (tetrazole) which is present in some sartan medicines, with the EMA also working with manufacturers to help eliminate them in future.
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