Zelira Therapeutics Ltd’s (OTCQB:ZLDAF) (ASX:ZLD) insomnia medication Zenivol has achieved formal approval from German regulatory authority BfArM to launch in the German medical cannabis market.
According to the company, Zenivol is the world's first and only clinically validated, pharmaceutical-grade, cannabis-based sleep medication. Zenivol's clinical research was peer reviewed in the Journal of Sleep. It is currently available by prescription in Australia under the country's legal cannabis regulations.
"The formal approval of Zenivol by BfArM in Germany marks a major milestone for Zelira; Germany is one of the largest global markets for cannabinoid-based medicines, and also one of the highest quality global regulatory markets for pharmaceuticals," stated Zelira CEO Dr. Oludare Odumosu. "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."
Zelira Therapeutics is a leading global therapeutic medical cannabinoid company. The company is focused on developing branded cannabinoid-based medicines for the treatment of a variety of medical conditions in its Rx business, including insomnia, autism and chronic non-cancer pain.
The company has two proprietary formulations under the HOPE brand that are generating revenues in Australia, Pennsylvania and have been licensed in Louisiana and Washington D.C., with other states in the US expected to follow.
Adjupharm GmbH has more than 30 years of experience as a service provider for the pharmaceutical industry. Since then, the range of products and services has expanded to focus on contract manufacturing for importers of pharmaceuticals in the EU. Adjupharm's range of services include the production and marketing of pharmaceutical dietary supplements.
In 2018, Adjupharm began work in the cannabis sector in Germany and has all the relevant licenses for the contract manufacturing of medical cannabis. Adjupharm uses its experience in the manufacture of medical cannabis to deliver high quality products to pharmacies and pharmaceutical wholesalers. Adjupharm has been a subsidiary of International Medical Cannabis since 2019.
Photo: Courtesy of Zelira Logo PRNewsfoto/Zelira Therapeutics
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