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The Texas-based contract growth and manufacturing group Benuvia Operations has been awarded a five-year contract by the Nationwide Institutes of Well being (NIH)’s Nationwide Institute on Drug Abuse (NIDA) for good manufacturing follow (GMP) synthesis of the naturally occurring psychedelic compound psilocybin, which comes from sure varieties of mushrooms, in addition to different bulk drug substances (1).
Benuvia mentioned in a press launch on March 25, 2025 that the contract helps R&D of high-quality APIs for substance use problems and psychological well being circumstances, initially specializing in synthesis and scale-up of psilocybin, which is a Schedule I substance below the Managed Substances Act (1). Psilocybin was granted breakthrough remedy designation by FDA in 2018 for treatment-resistant melancholy, and 2019 for main depressive dysfunction.
“This contract highlights our management within the growth and manufacturing of managed substances below GMP circumstances,” Terry Novak, Benuvia CEO, mentioned within the press launch (1). “We’re honored to assist NIH’s efforts in advancing groundbreaking analysis into revolutionary therapies for substance use problems and psychological well being circumstances. Our state-of-the-art capabilities allow us to produce the highest-quality pharmaceutical compounds that meet probably the most rigorous regulatory requirements.”
The contract stipulates that Benuvia Operations will manufacture and ship GMP-grade psilocybin for NIDA preclinical toxicity research in addition to scientific trials (1). Scientific research are presently evaluating psilocybin as a possible therapy for melancholy, nervousness, and substance use problems.
“Our mission at Benuvia is to supply high-purity, federally authorized substances for scientific analysis and pharmaceutical growth,” Novak mentioned. “We sit up for working with the NIH to assist consider psilocybin’s therapeutic potential for the tens of millions of sufferers affected by these circumstances.”
Beforehand, on March 11, 2025, Benuvia Operations introduced that it obtained a GMP certification (Certificado de Boas Práticas de Fabricação [CBPF]) from Brazil’s Nationwide Well being Surveillance Company (ANVISA), such certification being important, in accordance with the corporate, as a regulatory prerequisite for pharmaceutical corporations to fabricate and distribute merchandise in Brazil (2).
“Reaching ANVISA’s CBPF certification underscores Benuvia’s strategic dedication to offering high-quality, compliant pharmaceutical manufacturing particularly tailor-made to Brazil’s quickly rising healthcare market,” Novak mentioned on the time (2). “ANVISA CBPF certification permits us to be the popular supplier for corporations in search of a accomplice with faster market entry, diminished regulatory hurdles, and stronger credibility amongst regulatory our bodies, healthcare suppliers, and pharmaceutical prospects.”
In June 2023, FDA printed a draft steering, “Psychedelic Medicine: Issues for Scientific Investigations,” regarding using such medicine—psilocybin amongst them—for therapy of varied medical circumstances, together with psychiatric and substance use problems (3).
“Psychedelic medicine present preliminary promise as potential remedies for temper, nervousness and substance use problems. Nevertheless, these are nonetheless investigational merchandise,” Tiffany Farchione, director, Division of Psychiatry, Middle for Drug Analysis and Analysis, FDA, mentioned in a press launch saying the draft steering (3). “The objective is to assist researchers design research that can yield interpretable outcomes that shall be able to supporting future drug purposes.”
The opposite bulk drug substances beside psilocybin that shall be future areas of focus for Benuvia below the contract with NIDA weren’t disclosed by identify within the Benuvia press launch (1).
References
1. Benuvia Operations. Benuvia Operations Awarded NIH Contract for GMP Synthesis of Psilocybin and Different Bulk Drug Substances. Press Launch. March 25, 2025.
2. Benuvia Operations. Benuvia Operations Granted GMP Certification from Brazil Nationwide Well being Surveillance Company (ANVISA). Press Launch. March 11, 2025.
3. FDA, Draft Steering for Trade, Psychedelic Medicine: Issues for Scientific Investigations (CDER, June 2023).
