Chemical Manufacturing, Manufacturing News, Medical Manufacturing

First GMP license secured for Psilocybin and MDMA manufacturing

Bioxyne Limited, a pioneer in the Australian life sciences, pharmaceutical, and consumer health products sector, announced that its subsidiary, Breathe Life Sciences (BLS), has been awarded a Good Manufacturing Practice (GMP) license for the production of medical cannabis.

This landmark license also encompasses the manufacturing of Psilocybin and MDMA, marking a significant milestone as Australia’s first GMP certification for these substances.

The Therapeutic Goods Administration (TGA) has granted BLS the GMP license covering parts one and two, authorising the company to manufacture MDMA and psilocybin active pharmaceutical ingredients (APIs) as well as final dose capsules. These products are intended for supply to authorised prescribers and clinical trials, setting a new precedent in the treatment options available for mental health disorders.

Bioxyne’s foray into medical cannabis manufacturing began in 2022, with the company swiftly establishing a robust brand and distribution network within Australia. This latest license is the most comprehensive to date, covering a wide range of final product forms and showcasing Bioxyne’s leadership in innovative therapeutic solutions.

With the TGA’s authorization since July 2023, prescribers can now prescribe MDMA and Psilocybin outside of clinical trials. MDMA is showing promising outcomes in treating PTSD, while Psilocybin has been linked to significant, sustained reductions in depressive symptoms following just a few sessions of therapy.

Bioxyne CEO, Sam Watson expressed his enthusiasm for the achievement, stating, “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.”

Head of GMP production, Macdarragh O’Neill, said, “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 aims to become the premier supplier of Psilocybin and MDMA for clinical trials and authorised prescribers by 2025. The company is actively pursuing partnerships with veteran groups, universities, trial sponsors, and authorised prescribers both in Australia and globally.

This breakthrough offers a substantial opportunity to address the gaps in current treatment options for mental health disorders, promising a brighter future for patients worldwide.

Send this to a friend