Zelira Therapeutics Ltd has achieved a major milestone with Zenivol® receiving formal approval from German regulatory authority BfArM, (the Federal Institute for Drugs and Medical Devices) for commercialisation by Adjupharm GmbH, with which it has a five-year exclusive distribution agreement.
The approval gives ZLD the opportunity to enter the German market, one of the world’s largest markets for cannabinoid-based medicines and Europe’s largest market. It also expands the availability of Zenivol® beyond Australia for the first time.
Zenivol® is a leading cannabinoid-based medicine for the treatment of chronic insomnia.
Strong validation
The approval not only expands the availability of Zenivol® but also highlights Zelira’s expertise in quality and pharmaceutical production and supports its strategy of further validating the safety and efficacy of Zenivol® and Zelira’s other clinically, real-world data-backed cannabinoid-based medicines.
“The formal approval of Zenivol® by BfArM in Germany marks a major milestone for our business. Germany is one of the largest global markets for cannabinoid-based medicines, and also one of the highest quality global regulatory markets for pharmaceuticals,” Zelira Therapeutics managing director Dr Oludare Odumosu said.
“We look forward to working with our partner, Adjupharm in launching Zenivol® in Germany and supporting patients and physicians in treating chronic insomnia in a safe and effective manner. With formal regulatory approval for Zenivol® now received in Germany, we continue to progress activities to license Zenivol® into other global markets.”