Product certification

Our mesalazine is approved in more than 90 countries, including Europe, the United States, Canada, Japan and Australia and our product complies with pharmacopoeias in Europe (Ph. Eur.), USA (USP) and Japan (JP).

Syntese has obtained a Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines (EDQM) for our mesalazine. In addition, we have been approved by the US Food and Drug Administration (FDA), which is a significant recognition of our product quality and compliance with international standards.