Medical marijuana tyro MGC Pharmaceuticals has started production of its first batch of the marijuana based epilepsy fighting drug, CannEpil, from its European laboratory and manufacturing facility.
In a development hailed by the ASX-listed company as a “major milestone”, MGC said the batch would be independently inspected by the Agency for Medicinal Products and Medical Devices, the GMP regulatory body that validates GMP protocols.
MGC Pharma said, “This is the final regulatory process before full GMP certification can be granted to MGC Pharma’s European manufacturing facility.”
Once this is granted, MGC Pharma said it will be able to commence with the full-scale commercial production of CannEpil and will be able to produce additional pharmaceutical grade medical cannabis products for use in clinical studies, research pipelines and additional medicinal products licensed for distribution.
CannEpil is MGC Pharma’s first pharmaceutical grade medical cannabis product targeted at drug resistant epilepsy, which accounts for approximately 30% of the estimated 240,000 people diagnosed with epilepsy in Australia each year.
The company said it expected to generate revenues of approximately AU$1million per annum from its first full year of distributing CannEpil as part of its agreement with Australian pharmaceutical distributor, HL Pharma.
In a recent market update, the MGC management said: “GMP certification for our laboratory and production facility will give us a significant competitive advantage globally and particularly across European markets as it joins a handful of such medical cannabis facilities in Europe and becomes the only one to be certified to this level for medical cannabis production.”
Roby Zomer, MGC Pharma co-founder and CEO, added: “This is an exciting final step for MGC Pharma as we focus on completing full GMP certification of our manufacturing facility to allow us to produce CannEpil in Europe and focus on significantly progressing our medical research and development of our pharmaceutical products pipeline. The production of our first CannEpil batch is a milestone and leaves us well positioned to achieve certification and commence full scale commercial production in the next few months.”
