Benuvia-CDMO

About Benuvia-CDMO

Benuvia - A full service CDMO.  Based in Round Rock, just north of Austin, Texas, is an FDA, DEA and ANVISA registered cGMP site for manufacturing, testing and packaging of API's and drug product.

We serve non-controlled and controlled, schedule I-V drug products. Our unified services platform was purpose-built for developing and manufacturing and distributing small molecule API's glob...

Read more Show less
Certifications
  • FDA
    FDA
  • GMP
    GMP
  • Other
More certifications Show less
Sales Markets
Show more Show less
Categories
more categories Show less
  • Country/Region:
    United States
  • On CPHI since:
    2025
  • Certificates:
    3
  • Employees:
    50 - 99
Company types
CMO/CDMO
Engineering
Primary activities
Analytical Services
API Producer
Biopharmaceutical
Contract Manufacturer
Cosmeceuticals
Custom Manufacturing/Custom Synthesis
Generic APIs producer
Intermediates Manufacturer
Natural Extracts
Nutraceuticals
Packaging & drug delivery
Pharmaceutical Company (generic finished products)
Regulatory Affairs
Transport/Logistics/Distribution
Contact info
Show contact info Hide contact info

Products from Benuvia-CDMO (1)

  • Dronabinol

    Product Dronabinol

    Physical Properties: Appearance: Viscous oil at room temperature Solubility: Practically insoluble in water; soluble in ethanol, ether, and other organic solvents Melting Point: Approx. 66°C when crystalline Stability: Light- and air-sensitive; must be stored under nitrogen/in amber containers

Benuvia-CDMO Resources (2)

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

    News 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.

    6 May 2026
  • CS_Delivering Scalable Manufacturing with Increased Stability and Reduced Costs

    Brochure CS_Delivering Scalable Manufacturing with Increased Stability and Reduced Costs

    How Benuvia Revolutionized Psilocin and Psilocybin Production.