Highlights
- Bioxyne secures global GMP certification for its manufacturing arm
- Signs $5.6 million supply deal with German pharmaceutical firms
- Strategic entry positions Bioxyne in rapidly expanding EU cannabis market
Bioxyne (ASX:BXN) has taken a significant leap on the international stage, securing key certifications and a major commercial agreement, reinforcing its status as a notable player in the alternative therapeutics space.
International GMP Certification
The company’s wholly owned subsidiary, Breathe Life Sciences, has earned Good Manufacturing Practice (GMP) compliance recognized by five major jurisdictions: Singapore, the European Union, the UK, Canada, and the Eurozone. These certifications were granted under mutual recognition agreements, acknowledging that the company’s manufacturing meets international standards.
Breathe Life Sciences is a licensed manufacturer, wholesaler, importer, and exporter of controlled substances, including medicinal cannabis, MDMA, and psilocybin. The company has established a strong footprint with licensed facilities in Australia, the UK, Japan, and the Czech Republic, enabling the production and global distribution of novel medicines.
$5.6 Million German Market Entry
In a major milestone, Bioxyne has signed a commercial agreement to supply at least 1,600 kilograms of GMP-certified medicinal cannabis flower and finished product to German pharmaceutical firms Farmakem and Adrex Pharmaceuticals GmbH. The deal, valued at $5.6 million, spans financial year 2026 and includes two scheduled shipments: 580kg in September and another in November.
As part of the agreement, Breathe Life Sciences and Adrex have registered 14 cannabis strains with Germany’s drug regulatory body, BfArM. This regulatory clearance facilitates the import and distribution of the Australian-manufactured product within Germany, one of the most promising markets in Europe.
Tapping into a Booming European Market
Following deregulation earlier this year, Germany's medicinal cannabis market is experiencing exponential growth. Industry experts project it could soon outpace Australia’s $1 billion annual cannabis sector. Notably, cannabis flower accounts for over 95% of the medicinal cannabis sales in Germany, making it a critical product category.
All medicinal cannabis products imported into Germany must meet GMP standards—an area where Breathe Life Sciences has already gained traction. The company believes its cost and manufacturing scalability will enable it to secure further opportunities across Germany and broader European regions.
This expansion comes as part of Bioxyne’s broader strategy to serve the growing demand for alternative therapies globally. Its competitive edge and recent milestones make it a standout in the evolving health and pharmaceutical landscape.
For those tracking emerging pharmaceutical players alongside established ASX200 stocks, Bioxyne’s entry into new global markets may be worth watching in the context of broader market movements.