MGC Pharmaceuticals - Malta Production Facility Receives EU-GMP Approval

Argent BioPharma

02/05/2023 07:00

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RNS Number : 0589Y  MGC Pharmaceuticals Limited  02 May 2023

 

MGC Pharmaceuticals Ltd.

Malta Production Facility Receives EU-GMP Approval

02 May 2023

ASX, LSE: MXC

 

Key Highlights:

·     MGC's Maltase fully automated, large scale pharmaceutical
production facility has now been granted EU-Good Manufacturing Practice (GMP)
certification.

·     Formal grant of GMP accreditation, an internationally recognised
standard, guarantees high quality, standardised production protocols and
further enables quality control of MGC proprietary products within key markets
globally.

·     The facility was built with the support of an 80% EU cash funded
grant from Malta Enterprises, with the facility commissioned during 2022.

·     The facility will be able to produce all MGC medicines and
supplements and will be able to provide third party production services for
other pharmaceuticals companies - adding a new potential revenue stream for
MGC Pharma.

·     MGC's in house production capacity in Malta is now over 20,000 units
a day of finish dose forms, which can support all future needs of CannEpil®
and CimetrA™ once marketing authorisation is obtained in USA and Europe.

 

MGC Pharmaceuticals Ltd ('MGC Pharma' or 'the Company') a European based
pharmaceutical company specialising in the production and development of plant
inspired medicines, is pleased to announce that the Company's Malta production
facility has been granted formal EU-Good Manufacturing Practice (GMP)
certification.

 

The facility, which is situated 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. The facility also
provides analytical services and product release in a fully modern and compact
site. 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
of the company in house. The facility will be able to support future demand of
CannEpil® from named patient requests by clinicians on the GMC Special list
in the UK (as announced 11(th) April 2023).

 

Good Manufacturing Practice accreditation is the highest standard that a
medicinal product manufacturer needs to meet in production processes. This
certification ensures that the products are of a high quality and are
appropriate for their intended use. 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.

 

As a fully GMP Pharmaceuticals certified facility, MGC will also be able to
provide third party production services to other pharmaceuticals companies and
to maximise its manufacturing capacity potential and deliver an important
additional new revenue stream to the Company.

 

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.

 

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."

--Ends-

 

Authorised for release by the Managing Director, for further information
please contact:

 

 MGC Pharmaceuticals Ltd                                        MGC Pharmaceuticals Ltd

 Roby Zomer                                                     Arron Canicais / Rowan Harland

 CEO & Managing Director                                        Joint Company Secretaries

 +61 8 6382 3390                                                +61 8 6382 3390

 info@mgcpharma.com.au (mailto:info@mgcpharma.com.au)           info@mgcpharma.co.uk (mailto:info@mgcpharma.co.uk)

 UK PR Advisors                                                 UK Brokers

 Tavistock                                                      Peterhouse Capital

 Charles Vivian / Tim Pearson                                   Charles Goodfellow / Lucy Williams / Duncan Vasey

 +44 207 920 3150                                               +44 207 469 0930

 mgcpharma@tavistock.co.uk (mailto:mgcpharma@tavistock.co.uk)   cg@peterhousecap.com (mailto:cg@peterhousecap.com) / lw@peterhousecap.com
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 UK Financial Consultant

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About MGC Pharma

MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based
pharmaceutical company, focused on developing and supplying accessible and
ethically produced plant inspired medicines, combining in-house research with
innovative technologies, with the goal of finding or producing treatments to
for unmet medical conditions.

 

The Company's founders and executives are key figures in the global
pharmaceuticals industry and the core business strategy is to develop and
supply high quality plant inspired medicines for the growing demand in the
medical markets in Europe, North America and Australasia.

 

MGC Pharma has a robust development pipeline targeting two widespread medical
conditions and has further products under development.

 

MGC Pharma has partnered with renowned institutions and academia to optimise
the development of targeted plant inspired medicines, to be produced in the
Company's EU-GMP Certified manufacturing facilities.

 

MGC Pharma has a growing patient base in Australia, the UK, Brazil and Ireland
and has a global distribution footprint via an extensive network of commercial
partners meaning that it is poised to supply the global market.

 

Follow us through our social media channels:

Twitter: @MGC_Pharma

Facebook: @mgcpharmaceuticals

LinkedIn: MGC Pharmaceuticals Ltd.

Instagram: @mgc_pharma

 

 

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