Benuvia Operations supports FDA IND filing by Mandara Biopharma for dronabinol oral solution in Alzheimer's Agitation

Benuvia Operations, LLC (Benuvia), a U.S.-based pharmaceutical development and manufacturing company specializing in regulated and controlled-substance drug products and active pharmaceutical ingredients (APIs), today announced its role as manufacturing partner supporting Mandara Biopharma Inc.’s (Mandara) filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate clinical development of a dronabinol oral solution formulation for the treatment of agitation associated with Alzheimer’s disease.

The dronabinol oral solution formulation was developed by Benuvia and licensed to Mandara under an exclusive agreement. Under the collaboration, Benuvia will serve as Mandara’s manufacturing partner for the clinical and potential commercial supply of the product.

This IND filing underscores Benuvia’s ability to support complex, highly regulated drug programs from formulation development through clinical and commercial manufacturing,” said Terry Novak, CEO of Benuvia Operations. “We have deep expertise in the GMP manufacturing of controlled-substance therapies, including cannabinoid-based products, and we are pleased to support Mandara as this program advances into clinical development.