The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of N-nitrosodimethylamine (NDMA) in a source of active substance valsartan.
Following the complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related active substances (e.g. losartan, olmesartan medoxomil, candesartan cilexetil), the EDQM has firstly contacted those CEP holders whose substances may present a contamination risk and has requested that they investigate and address the possible presence of NDMA.
Read in detail about the actions taken by the EDQM in the press release.
- More information about the certification procedure (CEP)
- More information about the European Pharmacopoeia (Ph. Eur.)
- More information about the European Network of Official Medicines Control Laboratories (OMCLs)