The EMA report also contains information on the third nitrosamine contamination by NMBA. In the beginning of July 2019, the new Sartan monographs were included in the European Pharmacopoeia. However, the monographs only take NDMA and NDEA into account. On August 20, 2019, the EMA released additional limits for the structurally related nitrosamines NMBA, DIPNA and EIPNA.
In February 2019, the Committee for Medicinal Products for Human Use (CHMP) of the EMA published a first conclusion on the case of valsartan and other sartanes contaminated with nitrosamines. Soon after, there were further batch recalls of losartan in both Germany and the USA. However, NMBA was found in these batches, not NMDA and NDEA.
Glossary of nitrosamines:
NMBA: N-nitroso-N-methylamino butyric acid
EMA: Report on new limits