GALEN-N Earns CEP for Naturally Sourced Galantamine Hydrobromide

GALEN-N EOOD is proud to announce that EDQM has granted CEP 2024-450, Rev 00 for our galantamine hydrobromide isolated from natural sources, issued on March 19, 2026.

For pharmaceutical companies, evaluating an API supplier requires confidence in both the ingredient and the systems behind its production. This achievement adds an independently assessed reference to that evaluation.

What the Certificate Means for Our Partners

A Certificate of Suitability (CEP) confirms that the substance’s quality can be adequately controlled using the relevant European Pharmacopoeia monograph, together with any additional requirements specified in the certificate. It supports regulatory documentation in markets that accept CEPs.

Our manufacturing approach combines documented production processes with incoming, in-process, and final laboratory testing. Full traceability connects raw materials from growers in the Netherlands to the finished API, supporting transparency throughout the supply chain.

For our team, this certificate is an important milestone. For our partners, it provides a further basis for technical discussions, supplier qualification, and long-term collaboration.

Contact our team to discuss your galantamine hydrobromide requirements and documentation needs.