Biopharma company MGC Pharmaceuticals (ASX: MXC) has received its GMP certification and formal manufacturing licence to produce Good Manufacturing Practice (GMP) grade medical cannabis medicines containing tetrahydrocannabinol (THC) and cannabidiol (CBD) APIs at its European production and compounding facility.
In April, MGC took a big step towards securing its operational future by securing access to a modern state-of-the-art production facility in Malta.
The Maltese Government gave the company the go-ahead to construct and operate a cultivation facility on the Mediterranean island and awarded MGC a contract to establish a 4,000-square-metre facility.
Receipt of a GMP licence is, therefore, an important milestone for MGC as it looks to piece the puzzles pieces together to embark upon a successful commercial foray into medical cannabis.
The news means MGC can immediately commence production under this manufacturing licence for pharmaceutical grade products.
Importantly, receipt of the formal manufacturing licence also permits MXC to produce additional medicinal cannabis-based pharmaceutical products, for use by MXC in clinical studies, research pipelines and product development. These will be distributed into the global market and target the increasing demand for such products.
As it stands, MGC is an EU-based biopharma developer with a burgeoning presence in the medical cannabis industry. Its founders were key figures in the global medical cannabis industry and the core business strategy is to develop and supply high-quality Cannabinoids based pharmaceuticals products for the growing demand in the medical markets in Europe, North America and Australasia.
Receiving its GMP licence is rather timely for MGC as the company has just completed the final tests on its proprietary drug-resistant epilepsy medication CannEpil. The completion of final tests has resulted “in receipt of this formal manufacturing licence for its European facility,” according to MGC.
The awarding this licence signifies compliance with strict European quality standards for production and manufacturing of pharmaceutical grade products and the handling of cannabis-based medicines.
This full GMP certification and formal manufacturing license “represents the completion of the final step” ahead of starting commercial scale production and means MGC’s facility will be one of the most advanced European facilities of its kind when it finally goes into production later this year or in 2019.
“We are delighted to have been awarded our formal GMP Certificate and manufacturing licence and to commence production at our cutting-edge European Facility, this is one more step in our Seed to Pharma strategy to become a leading BioPharma company with formulated medicines to sell into the global market,” said Roby Zomer, co-founder and managing director of MGC Pharmaceuticals.
The news had an immediate impact on MGC’s market valuation, with investors taking its shares up around 10% to $0.069 in early morning trade today.