MGC Pharma’s recently-acquired  EU-Good Manufacturing Practice (GMP) certification will allow the company to sell in the US, and provide third party production services to other pharmaceutical companies.

European-based biotech MGC Pharma (ASX:MXC) announced that the company’s Malta production facility has been granted formal EU-Good Manufacturing Practice (GMP) certification.

Good Manufacturing Practice accreditation is the highest standard that a medicinal product manufacturer can achieve to meet in-production processes.

A formal international GMP accreditation guarantees high quality, standardised production protocols, and further enables quality control of MGC proprietary products within key markets globally.

Importantly, the GMP certification is recognised by the USA Food and Drug Administration (FDA), enabling products produced at the facility to be imported for sale in the US.

“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, “said MGC Pharma CEO, Roby Zomer.

“This facility guarantees our ability to supply large volumes of products to our customers and distribution partners of high pharma standards and quality into the future.”

New potential revenue stream

Located in the seaside town of Birżebbuġa in Malta, the well equipped facility is capable of compounding and bottling oral dose form of products, as well as both primary and secondary packaging in a fully automated environment.

The facility was built with the support of an 80% total cost EU cash grant from Malta Enterprise in 2022 –  integrating the full MGC value chain of research, investigational medicinal products, and commercial production.

The large scale production facility will also 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 of the company in house once marketing authorisation is obtained in the US and Europe.

In addition, the facility will also be able to support future demand of CannEpil from named patient requests by clinicians on the GMC Special list in the UK.

In April, MGC Pharma made a breakthrough in the UK after its proprietary product, CannEpil, was made available in the country via the Named Patient Request, allowing it to be prescribed by UK doctors who are listed on the General Medical Council (GMC) specialist register.

As a fully GMP Pharmaceuticals certified facility, MGC will also now be able to provide third party production services to other pharmaceuticals companies and to maximise its manufacturing capacity potential – adding a new potential revenue stream for the company.

This article was developed in collaboration with MGC Pharma, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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