Benuvia Manufacturing
U.S.-based contract development and manufacturing organization (CDMO) focused on small-molecule active pharmaceutical ingredient (API) and finished drug product development and manufacturing, including licensed handling of Schedule I–V controlled substances. Provides integrated IND-enabling services from API route design and formulation through analytical development, ICH-aligned stability programs, cGMP manufacturing, regulatory submissions, and commercialization support. Facilities and programs emphasize scalability, regulatory compliance, and secure controlled-substance operations.
Industries
Nr. of Employees
medium (51-250)
Benuvia Manufacturing
Services
Process design, optimization and scale-up for small-molecule APIs to support IND-enabling work and commercial supply.
Formulation design across oral, topical, injectable and sublingual dosage forms with stability and manufacturability considerations.
Analytical method development, validation, transfer and ICH-compliant stability study design/execution with QA oversight and reporting suitable for regulatory submissions.
cGMP manufacturing of APIs and finished drug products at clinical and commercial scales, including fill-finish for oral liquids and inhalation products and capabilities for regulated controlled substances.
Regulatory strategy development and preparation of global submission dossiers, regulatory intelligence and correspondence support.
Commercial readiness services including scale-up planning, packaging, serialization, distribution planning and market-entry support.
Process design, optimization and scale-up for small-molecule APIs to support IND-enabling work and commercial supply.
Formulation design across oral, topical, injectable and sublingual dosage forms with stability and manufacturability considerations.
Analytical method development, validation, transfer and ICH-compliant stability study design/execution with QA oversight and reporting suitable for regulatory submissions.
cGMP manufacturing of APIs and finished drug products at clinical and commercial scales, including fill-finish for oral liquids and inhalation products and capabilities for regulated controlled substances.
Regulatory strategy development and preparation of global submission dossiers, regulatory intelligence and correspondence support.
Commercial readiness services including scale-up planning, packaging, serialization, distribution planning and market-entry support.
Expertise Areas
- API process development and scale-up
- Formulation development (oral, topical, injectable, sublingual)
- cGMP manufacturing and fill-finish for clinical and commercial supply
- Controlled-substance handling and DEA-regulated operations
Key Technologies
- High-performance liquid chromatography (HPLC)
- Gas chromatography (GC) and GC–MS
- Inductively coupled plasma mass spectrometry (ICP–MS)
- UV–visible and FTIR spectroscopy
News & Updates
Agreement to provide pharmaceutical-grade DMT fumarate API to support academic research programs.
Company commentary on standards and regulatory frameworks needed to advance cannabinoid therapeutics.
Discussion of a Texas public-private funding opportunity for ibogaine R&D and positioning for DEA‑licensed CDMO partnerships.
Analysis of supply chain trends driving interest in onshoring pharmaceutical manufacturing and CDMO partnerships.
Whitepaper on traceability approaches for pharmaceutical-grade hemp products.
Whitepaper on regulatory frameworks and oversight for CBD products.
Agreement to provide pharmaceutical-grade DMT fumarate API to support academic research programs.
Company commentary on standards and regulatory frameworks needed to advance cannabinoid therapeutics.
Discussion of a Texas public-private funding opportunity for ibogaine R&D and positioning for DEA‑licensed CDMO partnerships.
Analysis of supply chain trends driving interest in onshoring pharmaceutical manufacturing and CDMO partnerships.
Whitepaper on traceability approaches for pharmaceutical-grade hemp products.
Whitepaper on regulatory frameworks and oversight for CBD products.