Zenabis Global has successfully received EU-GMP approval for its Atholville facility and expects to commence commercial export to the European Union in the third quarter of 2020. In addition, the Company is announcing Health Canada approval of additional growing and processing areas at Zenabis Langley.
Kevin Coft, Chief Executive Officer of Zenabis stated, “We are very excited to be able to announce that Zenabis, in conjunction with our European Union partners Natrix Sciences Ltd. (formerly Starpharma Ltd. Malta) and ZenPharm Ltd., have received EU-GMP approval. This is a tremendous milestone for the Company as it will allow us to supply bulk dried medicinal cannabis to the European market and allow ZenPharm the supply needed to serve their customers throughout Europe. I would like to extend my thanks to the entire Zenabis team who have made this major achievement possible as well as to our European partners for their continued support in this process. With our extremely competitive cost of cultivation at $0.63 per gram in the first quarter of 2020, we believe we can be incredibly competitive in the export of cannabis to the European Union.”
Receipt of EU-GMP Approval
Zenabis Global has obtained EU-GMP approval through its Malta-based European partner, ZenPharm Limited. "This milestone enables Zenabis to supply the European market with bulk dried medicinal cannabis flower through its ZenPharm joint venture," the team with the company explains. "Zenabis is a 43.5% owner of ZenPharm. ZenPharm is located within an existing EU-GMP facility in Europe managed by the other 43.5% owner of ZenPharm, Natrix Sciences Limited Malta. ZenPharma is regulated by the Maltese ‘Production of Cannabis for Medicinal and Research Purposes Act’, which allows for the cultivation, import, processing, and production of cannabis intended for medicinal and research purposes. Zenabis’ EU-GMP approval provides ZenPharm with an approved supplier which will allow it to undertake the necessary regulatory requirements in order to achieve its own GMP certification for the packaging and processing of cannabis from the Maltese Medicines Authority. The approval came after an intense 4-day inspection of the facility, which provided ZenPharm with confidence in the Zenabis GMP Quality Management Systems (“QMS”) and products."
Although this EU-GMP approval only pertains to cannabis supplied to ZenPharm, Zenabis’ now proven QMS provides the Company the ability to ship to GMP facilities worldwide for further processing and packaging, subject to the successful completion of QMS audits by other potential international clients.
Alan Mayo, Chief Quality & Compliance Officer of Zenabis stated, “Zenabis’ achievement demonstrates the commitment that the Company has towards a robust QMS and Quality in general. It is the result of investment by senior leadership and eight months of hard work, dedication, and perseverance by a group of individuals, most of whom had little to no previous GMP experience. I am so proud of the team because they have all come a long way. In less than a year they overcame the challenge of obtaining such a strict pharmaceutical standard like GMP.” Angele Azzopardi, Chief Executive Officer of ZenPharm said, “This milestone solidifies ZenPharm, a Zenabis subsidiary, as a vertically integrated seed to sale European pharmaceutical company that specializes in the development and delivery of cannabis-based treatments rooted in the fundamental medicinal standards of safety, quality and efficacy. This achievement would not have been possible without the relentless efforts of the entire Company. Furthermore, Malta has strategically put in place the regulatory gold standard for the European medicinal cannabis industry. ZenPharm’s incorporation shows confidence from Zenabis, as a Canadian licensed producer, in the value of setting up this operation in a jurisdiction that not only demonstrates a pioneering energy but also encompasses, through its competent authorities, a valuable ethos that is practical but not permissive”.