Dronabinol

Dronabinol
Product Description

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

  • 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
Specifications
  • CAS Registry Number
    1972-08-3
  • Details
    1. Chemical Identity: Name: Dronabinol IUPAC Name: (−)-trans-Δ⁹-tetrahydrocannabinol (Δ⁹-THC) Molecular Formula: C₂₁H₃₀O₂ Molecular Weight: 314.46 g/mol CAS Number: 1972-08-3

    2. Pharmaceutical Formulations: Typically available as:

    Oral capsules (e.g., Marinol®)

    Oral solutions

    Investigational inhalation/aerosol forms

    3. Regulatory Classification: United States (FDA): Schedule II or III controlled substance depending on formulation European Union: Controlled under national narcotics laws; available via special prescription

  • Supplied from
    United States
  • Measured In
    gram; kilogram

Benuvia-CDMO

  • 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

Benuvia-CDMO resources (2)

  • 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.