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Research, Drug Development & Manufacturing
Pharmaceutical ManufacturingEstablished ManufacturersLab Testing, Quality Control & Production Standards
Research, Drug Development & Manufacturing

Benuvia

Also known as: Benuvia Therapeutics, Benuvia Operations

Benuvia is a US-based contract development and manufacturing organization (CDMO) and API supplier specialising in psychedelic and controlled-substance therapeutics. Operating an 83,000 sq ft GMP facility in Round Rock, Texas, the company holds DEA authorisation to manufacture psilocybin, psilocin, DMT, MDMA, and 5-MeO-DMT. In March 2025, Benuvia was awarded a five-year NIH/NIDA contract for GMP psilocybin synthesis and received ANVISA GMP certification from Brazil. The company also holds the FDA-approved cannabinoid drug SYNDROS®.

Manufacturing Snapshot

Established CDMO / Manufacturer

Scope & Capabilities

API ProductionDrug Product ManufacturingFormulation DevelopmentAnalytical / QC TestingRegulatory / CMC SupportCDMO ServicesControlled Substance Logistics

Supply Use Cases

Clinical TrialsResearch UseCommercial / Licensed Supply

GxP / Compliance

DEA Controlled-Substance ComplianceGeneral GxP

Facilities & Access

US-based controlled-substance CDMO with integrated API, manufacturing, and regulatory services.

Manufacturing Details

Supported Substances

Controlled substances across Schedules I-V, including psychedelic APIs and related drug products.

Regulatory Authorizations

1 authorization

United States - DEA

Active

Controlled Substances Handling (Schedules I-V)

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Manufacturing Sources

Benuvia

https://benuvia.com/

Quick Facts

Type
Private Biotech
Website
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