GMP Certified
MGC Pharmaceuticals Ltd (‘MGC Pharma’), a European pharmaceutical company specialising in plant-inspired medicines, has announced that its Malta production facility has received formal EU-Good Manufacturing Practice (GMP) certification. The facility, located in Birżebbuġa Malta, is capable of compounding and bottling oral dose form of products, as well as providing analytical services and product release in a modern, fully automated environment.
The facility has the capacity 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 can fulfil all future commercial manufacturing needs of the company in-house. MGC can now also provide third-party production services to other pharmaceutical companies, creating a new revenue stream for the company.
Roby Zomer, Managing Director and CEO of MGC Pharmaceuticals, commented: “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.”
GMP certification is a crucial accreditation that ensures that medicinal products are of high quality and appropriate for their intended use. The certification is recognised by the US Food and Drug Administration (FDA), enabling MGC Pharmaceuticals to import its products for sale in the US.
The Malta production facility was built with the support of an 80% total cost EU cash grant from Malta Enterprise and integrates the full MGC value chain of research, investigational medicinal products, and commercial production.