- Benuvia Operations has executed a multi-year agreement to supply its Dronabinol API to a prominent U.S. pharmaceutical company.
- The deal allows the partner to reference Benuvia’s U.S. Drug Master File (DMF) for regulatory filings with the FDA, supporting cannabinoid-based product development.
Benuvia Operations, LLC, a U.S.-based global CDMO and API supplier, today announced it has entered a multi-year supply agreement with a leading U.S. pharmaceutical company. Under the terms, Benuvia will deliver its Dronabinol API to support the customer’s product development and clinical programmes.
The agreement permits the pharmaceutical partner to reference Benuvia’s U.S. Drug Master File (DMF) for Dronabinol in filings with the U.S. Food and Drug Administration (FDA). This regulatory route is expected to accelerate the development of a cannabinoid-based therapy and enhance patient access to quality treatments.
Benuvia’s APIs are recognised for manufacturing quality, compliance, and reliable supply. From early-stage development through commercial manufacturing, the CDMO delivers controlled-substance solutions that meet industry standards. The company’s fully integrated, FDA-audited and DEA-registered facility in Round Rock, Texas, underpins its operational reliability.
“This partnership underscores Benuvia’s position as a trusted source of pharmaceutical-grade cannabinoid APIs,” said Terry Novak, CEO of Benuvia. He added that growing demand for U.S.-made cannabinoid ingredients makes the collaboration “a natural extension of our scientific excellence and operational capabilities.”
In addition to Dronabinol supply, Benuvia offers end-to-end services including drug substance and product manufacturing, analytical development, stability studies, and regulatory support for DEA Scheduled I–V substances. This breadth of contract manufacturing and CDMO expertise positions the company to support a wide range of small-molecule and cannabinoid drug programmes.
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