by In2Pharma | Aug 10, 2021 | News
Europe Marketing authorisation holders should review their manufacturing processes for all products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine...
by In2Pharma | May 6, 2021 | News
Europe In a final assessment report, the EMA has published important information for marketing authorisation holders of angiotensin II receptor antagonists (sartans) regarding nitrosamine contamination limits and deadlines for risk mitigation measures. On 2 April...
by In2Pharma | Aug 10, 2020 | News
Europe In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in blood pressure medicines known as ‘sartans’. This led to some product recalls and strict new manufacturing requirements for sartans, based on a regulatory...
by In2Pharma | Jun 11, 2020 | News
Europe Marketing authorisation holders (MAHs) are asked to take precautionary measures to mitigate the risk of nitrosamine formation or presence during the manufacture of all medicines containing chemically synthesised active substances. The MAHs were obliged to...
by In2Pharma | Jun 10, 2020 | News
Europe The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended the suspension of all ranitidine medicines in the European Union due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA)....
