The licence reinforces MGC Pharma’s ability to deliver on its target production of 5,000 units per month by the start of 2021 from existing supply and distribution deals in place.
MGC Pharmaceuticals Ltd’s Slovenian production and compounding facility has been awarded a landmark three-year Good Manufacturing Practice (GMP) licence from EU authorities for the production of pharma grade cannabinoid-based medicines and products.
The renewal follows the completion of a regulatory audit by JAZMP, the Slovenian government agency of medicinal products and medical devices licence, for EU compliance of its Slovenian production and compounding facility.
On target for production
The licence provides material certainty on MGC Pharma’s capacity to produce EU GMP cannabinoid-based Investigational Medicinal Products (IMP) including CannEpil® and CogniCann® from its facility, future commercial development, intellectual property (IP) and unique EU manufacturing asset valuation.
It also reinforces the company’s ability to deliver on its target production of 5,000 units per month by the start of the calendar year 2021 from existing supply and distribution agreements in place.
MGX Pharma’s co-founder and managing director Roby Zomer said: “Authorities usually issue GMP licences with a one-year term so receiving a three-year GMP licence is a great achievement and a real testament to the quality of our products, staff and the facility.”
The EU GMP licence is the most highly credentialled in the world for compliance and is essential for the production and manufacturing of pharma grade medicinal products.
It confirms compliance with strict European quality standards for production and manufacturing of pharmaceutical-grade products.
The European-based bio-pharma company can now continue to research, develop, produce and manufacture its suite of proprietary CBD and THC products from its Slovenian EU GMP production facility.