Benuvia Files Psilocybin DMF Number 040053
Published on September 29, 2026
Advancing Access to GMP Neuroplastogen APIs for Clinical Research
ROUND ROCK, Texas, September 29, 2026 – Benuvia Operations, LLC, a leading contract development and manufacturing organization (CDMO) specializing in controlled substances, today announced the filing of its U.S. Drug Master File (DMF) for psilocybin, DMF number 040053.
The filing of this DMF underscores Benuvia’s commitment to providing investigators with high-quality, cGMP psilocybin active pharmaceutical ingredient (API) to support rigorous clinical research and the development of potential new therapies for mental health conditions and other areas of unmet medical need.
In addition to the DMF filing, Benuvia has entered into multiple supply agreements to provide GMP psilocybin API to clinical investigators and has issued Letters of Authorization (LOAs) for qualified parties to reference DMF 040053 in their regulatory submissions. These tools are designed to streamline development timelines, reduce regulatory burden, and support the advancement of safe, high-quality research in this important and rapidly evolving field.
“Our filing of DMF 040053 underscores Benuvia’s commitment to providing investigators in this space with GMP neuroplastogen APIs and the regulatory tools needed to advance rigorous clinical research. Our purpose is to help enable programs with the potential to alleviate human suffering, and we welcome investigators who believe Benuvia can help move their work forward,” said Terry Novak, Chief Executive Officer of Benuvia.
Benuvia welcomes interest from academic institutions, biotech and pharmaceutical companies, and other qualified investigators who are exploring psilocybin and other neuroplastogens for the treatment of serious mental health conditions. Our team is available to discuss how our GMP API, regulatory documentation, and development expertise can support your program.
About Benuvia
Benuvia Operations, LLC is a global contract development and manufacturing organization (CDMO) that helps pharmaceutical and biotech companies deliver life-changing therapies to patients in need. We provide end-to-end development and manufacturing services for active pharmaceutical ingredients (APIs) and finished dosage products and have deep expertise with cannabinoids, psychedelics, and other controlled substances.
Our 83,000-square-foot, state-of-the-art, cGMP facility in Round Rock, Texas is purpose-built to manufacture Schedule I–V compounds, offering comprehensive solutions throughout the entire drug development lifecycle-from early development, API synthesis, and clinical trial supply to commercial production. Benuvia is committed to quality, regulatory excellence, and scientific partnership to advance innovative therapies that can improve lives.
Contact:
Eric Kizior, ekizior@benuvia.com
SOURCE Benuvia Operations, LLC