Drug developer Benuvia has received approval from the DEA to manufacture psychedelic Active Pharmaceutical Ingredients (APIs).
Benuvia will manufacture the APIs in its 83,000 square foot manufacturing facility that is permitted by the US DEA for Schedule I to III Controlled Substances. The facility is FDA registered and a cGMP facility.
Primarily specialising in cannabinoids, with the approval, Benuvia has begun focusing on four primary psychedelic ingredients: psilocybin, 5-MeO DMT, DMT, and MDMA.
Benuvia CCO, Joe Shupp, commented: “We are excited to announce our approval by the DEA to manufacture Psilocybin, MDMA and DMT for emerging providers of psychedelic-based drugs focused on neural and mental illness indications.
“As pharmaceutical companies become more aware of the positive effects of cannabinoids and psychedelic compounds for therapeutic use, the demand for APIs is expected to grow. Our diversified portfolio of APIs and entry into the development of novel psychedelic compounds aims to strengthen Benuvia’s position as a drug developer and provider of APIs focused on cannabinoids and psychedelics.”
With this approval, Benuvia is now able to offer the APIs to drug developers and research organisations under the CSA, and it will also enable the company to advance its life cycle management services to drug developers for their psychedelic development programmes.
The company has stated that it intends to develop novel intellectual property formulations of these psychedelic compounds, and will provide full toxicology, chemistry, manufacturing and controls, or CMC, and full data analysis.
Through its partners, Benuvia also intends to manage all research and development, manufacturing, analytical methods, intellectual property capture, placebo manufacture, randomisation and assistance with clinical trials, which will enable it to create custom technologies that allow rapid and cost-effective scale up of commercial operations for production in anticipation of research success.
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