MGC Pharma scores GMP licence: kicks off commercial-scale production
Published 13-JUL-2018 10:20 A.M.
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2 minute read
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Diversified ASX pot-stock, MGC Pharmaceuticals (ASX:MXC), has now secured full Good Manufacturing Practice (GMP) certification for its European production and compounding facility – the final step towards kicking off a commercial-scale production operation.
This is a pivotal milestone for the $88 million-capped biotech growth story. GMP certification means that MXC is now fully licenced to manufacture cannabis-based medicine containing both THC (tetrahydrocannabinol) and CBD (cannabidiol) active pharmaceutical ingredients (APIs).
This also puts MXC in a unique position as now one of the only companies with ‘seed-to-pharma’ capabilities, making its Slovenian production facility one the most advanced of its kind within Europe.
Following the completion of all criteria in the production process of pharmaceutical-grade cannabis, this licence signifies MXC’s compliance with Europe’s strict quality standards for production, manufacturing and handling of pharmaceutical-grade, pot-based products.
MXC can now begin production of pharma-grade medicinal cannabis products, beginning with a full-scale manufacturing operation of CannEpilTM — its first medicinal cannabis treatment for drug-resistant or refractory epilepsy.
Final tests on the first batch CannEpil have been completed, and the drug will go through final independent validation by Slovenia’s National Institute of Chemistry before being provided to patients in both Slovenia and Australia.
The first batch is expected to be completed in the third quarter of the year, with exportation into Australasia beginning shortly thereafter.
As always, it should be noted that MXC is an early stage play and anything can happen, so seek professional financial advice if considering this stock for your portfolio.
MXC will also produce cannabinoid-based IMPs (Investigational Medicinal Products) for use across the entire MGC clinical studies and research pipelines.
MGC Pharmaceuticals co-founder and managing director, Romy Zomer, commented: “We are delighted to have finally completed the inspection procedures — this is one more step in our ‘seed-to-pharma’ agenda as a leading bio-pharma company with formulated medicines in the global market.”
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