- Bioxyne (ASX:BXN) subsidiary Breathe Life Sciences secures a GMP license to manufacture medical cannabis
- The TGA GMP license covers two phases, one to manufacture MDMA, Psilocybin and cannabis, and the other to prepare a final dose in capsule form for clinical trials
- The company’s medical cannabis manufacturing license is the largest issued to date in terms of scope covering final product dose forms
- Bioxyne is aiming to export the medicinal drugs in 2024 for supply to universities, clinical trials and companies worldwide
- BXN shares are up 50 per cent, trading at 1.8 cents at 11:20 am AEDT
Bioxyne (ASX:BXN) subsidiary Breathe Life Sciences (BLS) has secured a good manufacturing practice (GMP) license to manufacture medical cannabis.
The Therapeutic Goods Administration (TGA) GMP license covers two phases, allowing it to manufacture the active pharmaceutical ingredients (APIs) for MDMA and psilocybin and to prepare final doses in the form of capsules to supply to prescribers and clinical trials.
Breathe Life Sciences has been building its medical cannabis brand and distribution in Australia since 2022.
The company’s medical cannabis manufacturing license is the largest issued to date in terms of scope covering final product dose forms.
“This award demonstrates BLS commitment to the responsible manufacture of alternative medicines, which can provide solutions to mental health disorders resistant to current treatments,” BXN CEO Sam Watson said.
“BLS aims to be the leading supplier of Psilocybin and MDMA for clinical trials and authorised prescribers, focusing on partnerships with veteran groups, universities (in Australia and abroad), and trial sponsors.
“There is a significant market for these products worldwide which have the potential to plug the gap in existing treatment options.”
Bioxyne plans to register the Psilocybin and MDMA capsules on the Australian Register of Therapeutic Goods for export in 2024 to supply companies, universities, and clinical trials worldwide.
BXN shares were up 50 per cent, trading at 1.8 cents at 11:20 am AEDT.