Benuvia Operations, LLC, a US-based global Contract Development and Manufacturing Organisation (CDMO) and Active Pharmaceutical Ingredient (API) supplier, announced on Tuesday that it has entered into a multi-year supply agreement with a prominent US 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 US Drug Master File (DMF) for Dronabinol in regulatory filings with the US Food and Drug Administration (FDA). The companies say that the partnership is intended to advance the development of a cannabinoid-based drug product, with the shared goal of improving patient access to high-quality treatment options.
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.
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