The Malta production facility owned by MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has been granted formal EU-Good Manufacturing Practice (GMP) certification.
MXC is a European based pharmaceutical company specialising in the production and development of plant inspired medicines.
Its production facility in Birżebbuġa Malta is capable of compounding and bottling oral dose form of products as well as both primary and secondary packaging in a fully automated environment.
It also provides analytical services and product release in a fully modern and compact site.
“The formal grant of EU-GMP certification for the Malta facility is a major milestone for the company today, and further enhances the MGC production capabilities for its future expansion, guaranteeing its ability to supply large volumes of its products to its customers and distribution partners of high pharma standards, and quality into the future,” managing director and CEO of MGC Pharmaceuticals said.
Fulfilling commercial needs
Certification will give MXC the boost it needs to meet its commercial aspirations.
The largescale production facility will be able to produce over 20,000 units a day (over 6,000,000 units a year) of MGC’s medicines such as CannEpil® and CimetrA™ and fulfil all future commercial manufacturing needs in house.
Future demand of CannEpil® from named patient requests by clinicians on the GMC Special list in the UK will also be well catered.
Being awarded GMP accreditation – the highest standard that a medicinal product manufacturer needs to meet in production processes – could open other doors outside Europe.
As the certification ensures that the products are of a high quality and are appropriate for their intended use, it is thus recognised by the USA Food and Drug Administration (FDA).
For MGC this means all products produced at the facility can be imported for sale in the US.
MGC will also be able to provide third party production services to other pharmaceuticals companies and maximise its manufacturing capacity potential to give it an important additional new revenue stream.
The production facility, built with the support of an 80% total cost EU cash grant from Malta Enterprise, integrates the full MGC value chain of research, investigational medicinal products, and commercial production.