PharmAla Biotech is the only company in the world with the ability to ship GMP MDMA and Psilocybin today
Vancouver, BC – Feb 3, 2023 – PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE:
MDMA) applauds the Australian Therapeutic Goods Administration (TGA) in allowing for
specially-licensed psychiatrists to prescribe MDMA and Psilocybin. PharmAla is the only
publicly-traded company currently manufacturing and exporting clinical-grade MDMA,
and the only entity in the world that offers its customers GMP MDMA and GMP
Psilocybin.
“This is a critically important announcement by the TGA, allowing for the direct
prescription and treatment of patients with PTSD and Treatment-Resistant Depression
with Psychedelic molecules,” said Nick Kadysh, CEO of PharmAla. “As the registered
supplier to three different Australian clinical trials using MDMA – more than any other
Psychedelics API supplier - PharmAla is the only company which has both GMP MDMA
and Psilocybin in inventory, and stands ready to ship these molecules to Australia.”
PharmAla is the first publicly traded company to manufacture GMP MDMA, and is the
first company to make available to customers two clinical-grade Psychedelic APIs.
Before being authorized by the TGA under this scheme, psychiatrists must obtain
approval for the use of the substances for patients under their care by a human
research ethics committee (HREC) that is registered by the National Health and Medical
Research Council (NHMRC). PharmAla has already been contracted to supply several
HREC-approved trials.
“The TGA decision absolutely sets a new global standard for treatment with molecules
like MDMA and Psilocybin,” said Dr. Shane Morris, COO of PharmAla Biotech. “Allowing
specially-licensed psychiatrists to prescribe these molecules directly to patients is an
excellent approach, and will certainly help drive other countries to re-assess how they
regulate these molecules to meet patients’ medical needs.”
Customers interested in acquiring MDMA or Psilocybin for human use under the new
TGA guidance should contact PharmAla’s Head of Sales, David Purcell, at
sales@pharmala.ca
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.
Nicholas Kadysh, CEO
press@pharmala.ca