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European Pharmacopoeia / General | News | 18 September 2018 | Strasbourg, France
The EDQM has provided a platform for European and international medicine manufacturers to discuss new regulatory approaches in China on pharmaceutical excipients selection and quality control. During a workshop on 18 September in Strasbourg, the Chinese Pharmacopoeia (ChP) delivered the most complete picture of their roadmap on the quality of excipients in China. The ChP illustrated the...
European network of OMCLs | News | 14 September 2018 | Strasbourg, France
The EDQM continues investigating and defining actions to address the presence of all kinds of nitrosamines, including NDMA and NDEA in valsartan and other sartans which may be affected. As mentioned in a previous press release, the EDQM has contacted those manufacturers holding CEPs (Certificates of Suitability to the monographs of the European Pharmacopoeia) and whose substances may present a...
Products and Services | News | 07 September 2018 | Strasbourg, France
9 new Ph. Eur. Reference Standards (RS) were released in August 2018
Certification of suitability (CEP) | News | 28 August 2018 | Strasbourg, France
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.