Benuvia Operations Signs Commercial Supply Agreement with Leading U.S. Pharmaceutical Company for Dronabinol API

ROUND ROCK, Texas, May 13, 2025 /PRNewswire/ -- Benuvia Operations, LLC (Benuvia), a U.S.-based global Contract Development and Manufacturing Organization (CDMO) and Active Pharmaceutical Ingredient (API) supplier, today announced the execution of a multi-year supply agreement with a prominent U.S. pharmaceutical company. Under the agreement, Benuvia will provide its Dronabinol API to support the company's product development activities.

The agreement enables the pharmaceutical company to reference Benuvia's U.S. Drug Master File (DMF) for Dronabinol in regulatory filings with the U.S. Food and Drug Administration (FDA). The collaboration is expected to advance the development of a cannabinoid-based drug product, with the shared goal of improving patient access to high-quality treatment options.

Benuvia's APIs, including Dronabinol, are recognized for their manufacturing quality, regulatory compliance, and supply reliability. From early-stage development through to commercial production, Benuvia partners with clients across the pharmaceutical landscape to deliver cannabinoid-based and other small-molecule, controlled-substance solutions that meet stringent industry standards.

"This partnership underscores Benuvia's position as a trusted source of pharmaceutical-grade cannabinoid APIs," said Terry Novak, CEO of Benuvia. "As the demand for quality U.S.-made pharmaceutical cannabinoid ingredients and other controlled substances continues to grow, we remain committed to enabling our partners' development strategies through scientific excellence and operational reliability."

Benuvia operates a fully integrated, FDA-audited, and DEA-registered manufacturing facility in Round Rock, Texas. The company provides comprehensive services including drug substance and drug product manufacturing, analytical development, stability programs, and regulatory support for DEA Scheduled I-V controlled substances.

About Benuvia Operations, LLC
Benuvia Operations, LLC is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) and Active Pharmaceutical Ingredient (API) supplier servicing pharmaceutical and biotech companies. The company provides development and manufacturing services for small-molecule APIs and finished dosage products with extensive experience with cannabinoids, psychedelics, and other controlled substances. Benuvia operates an 83,000 square foot best-in-class manufacturing facility in Round Rock, Texas that can safely and securely handle Schedule I-V controlled substances products, offering comprehensive solutions for companies throughout the entire drug development lifecycle - from API synthesis, clinical trial supply, through commercial production. Learn more at www.benuvia.com.

Forward Looking Statements
This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "anticipate', "believe", "could", "estimate", "upcoming", "expect", "intend", "may", "plan", "redirect", "project", "will", and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties many of which are outside our control and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements should be considered together with the risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

Contact
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Kellie Walsh
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kwalsh@kwmcommunications.com

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SOURCE Benuvia Operations, LLC