Bioxyne earns international GMP certification, strikes $5.6m German API supply deal
Bioxyne (ASX: BXN) has received certificates of Good Manufacturing Practice (GMP) compliance under mutual recognition agreements with five countries.
The company’s wholly owned subsidiary Breathe Life Sciences – a GMP-licensed manufacturer, wholesaler, importer and exporter of controlled substances including medicinal cannabis, psilocybin and MDMA – earned the certification.
Agreements with Singapore, the European Union, Canada, the UK and the Eurozone recognise that Breathe Life Sciences’ manufacturing practices meet the requirements of these regions.
Alternative therapeutics
Breathe Life Sciences was created in 2018 to focus on alternative therapeutics and investigational medicines.
The company produces final dose form medicines at licensed manufacturing, sales and distribution centres in Australia, Japan, the UK and the Czech Republic.
It sources raw materials and active pharmaceutical ingredients (APIs) from suppliers on five continents and is Australia’s leading manufacturer of medicinal cannabis, consumer health products and novel cannabis-based foods.
German API contract
Bioxyne has marked its entry into the German market with a commercial agreement to supply a minimum of 1,600 kilograms of GMP medicinal cannabis flower and finished product to Farmakem and Adrex Pharmaceuticals GmbH.
The $5.6 million contract commits Farmakem and Adrex to purchase and distribute the API manufactured by Breathe Life Sciences in financial year 2026.
Breathe Life Sciences and Adrex have registered 14 Australian-manufactured cannabis strains with European drug approval authority BfArM, authorising the import and distribution of the product to the German market.
The first delivery of 580kg will occur in September and the company has scheduled a second shipment in November.
Market growth
The German medicinal cannabis market has grown rapidly following its deregulation earlier this year and analysts soon expect it to overtake Australia’s $1 billion-per-year market.
Cannabis flower represents over 95% of medicinal cannabis sales in Germany and suppliers must manufacture all product the country imports under GMP certification.
Bioxyne said Breathe Life Sciences had scale and cost advantages that would allow it to win significant future business in Germany and other European markets.