MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has achieved several key milestones recently throughout its EU GMP production facilities and with its network distribution.
One key highlight was the upgrade and completion of MGC Pharmaceuticals' GMP-certified production facility in Slovenia, with formal EU GMP re-certification to be finalised in November.
Further to this, a GMP audit of the company’s new Maltese GMP production facility has satisfied all key audit requirements and is expected to be formally certified in early 2023.
On the distribution side, distribution partner Sciensus Rare has expanded its supply and distribution agreement with MGC to include new European markets and Middle Eastern territories increasing the potential market for CannEpil® and CogniCann®.
And just to make sure it is expanding its reach, MXC has also fast-tracked production to deliver 50,000 units of ArtemiC™ Rescue to AMC Holdings in a single shipment, with AMC experiencing higher demand than anticipated.
Let’s break this down.
Facilities in Slovenia upgraded
MGC Pharma, which specialises in the production and development of plant-inspired medicines has increased the plant production capacity of its production facility in Slovenia by 200%.
The restart of production at the facility has also been approved by the regulatory authority, which means the facility is back in production. This will enable MGC to meet increasing demand for its cannabinoid medicine products alongside its ongoing clinical trials.
The company has also received good news for its facility in Malta.
The audit of the Maltese GMP facility has been completed and critically met all key GMP audit criteria.
As a result, formal EU GMP certification as a production facility is now expected in early 2023 and will give the company two, high-quality, EU GMP-certified production facilities from which it will be able to manufacture and distribute its proprietary IMP products CimetrATM, CannEpil® and CogniCann® across the EU, and globally.
Commercial orders to come
MGC’s distribution partners, including Sciensus Rare, have undertaken a separate audit and inspection of both facilities as part of their Quality Assurance process, to ensure that Malta and Slovenia will be able to take commercial orders for MGC Pharmaceutical’s products produced in either facility for distribution across each partner’s respective networks.
MGC has expanded its partnership with Sciensus Rare to cover additional territories across Central and Eastern Europe, along with the Middle East and North Africa.
This expanded remit, and the subsequent opening of early access into untapped markets, will enable MGC to deliver proprietary IMP products CannEpil® and CogniCann® to the new markets to help treat patients with severe medical needs.
AMC Holdings contract update
Finally, MGC’s US-based distribution and marketing partner AMC Holdings is amending the terms of its US$1 million order of ArtemiC™ Rescue, with the product now to be delivered in a single shipment, rather than multiple shipments, so that it is ready for immediate supply to the US owing to increasing demand.
MGC well placed in the market
MGC continues to deliver on its goals with managing director and CEO Roby Zomer saying, “Following the completion of the GMP and customer audit of the company’s Slovenian GMP Production facility, following the recent production capacity upgrade, MGC Pharma is extremely well placed to deliver its products across both the EU, and globally, to meet increasing demand.
“This will be further enhanced by the formal GMP certification of MGC’s Malta facility, which is now forecast to occur in early 2023.
"What is clear from our discussions with both Sciensus Rare and AMC Holdings, is that demand for our products is strong, and it is important that the business is well positioned to service this demand, both in terms of our production capacity, and the progress of our products through the clinical pipeline.”