Bioxyne (ASX:BXN) has announced that its subsidiary, Breathe Life Sciences (BLS), has been awarded a Good Manufacturing Practice (GMP) license for the production of medical cannabis.
The company said the license also encompasses the manufacturing of psilocybin and MDMA.
The TGA granted BLS the GMP license covering parts 1 and 2. This authorises the company to manufacture MDMA and psilocybin active pharmaceutical ingredients (APIs) as well as final dose capsules.
Bioxyne CEO Sam Watson said, "This license is a testament to our commitment to responsibly manufacturing alternative medicines that offer new hope for those battling mental health conditions resistant to conventional treatments."
Macdarragh O’Neill, Head of GMP Production, added, "Achieving this GMP license is a monumental step for both Breathe Life Sciences and Bioxyne. It's the culmination of three years of dedicated effort and positions us to scale our operations significantly, both in Australia and internationally."
Bioxyne said it aims to become the premier supplier of Psilocybin and MDMA for clinical trials and authorised prescribers by 2025.