Recro Gainesville
A contract development and manufacturing organization (CDMO) focused on small-molecule drug product design, development, and cGMP manufacturing. Services span preformulation, formulation, analytical development, particle engineering (including spray drying), clinical and commercial oral solid/liquid manufacturing, packaging, technology transfer, and regulatory-quality systems across U.S. sites in Oregon, Georgia, and Florida.
Industries
Nr. of Employees
large (251-1000)
Recro Gainesville
Gainesville, Florida, United States, North America
Services
Preformulation characterization, excipient compatibility, process architecture, risk-based parameter definition, and scale-up strategy to support development and transfer.
Method development, verification/validation, QC testing, ICH stability studies, and a suite of analytical instrumentation for release and characterization.
Formulation design and prototype screening for oral solids and liquids, topicals, powders for inhalation, pediatric formulations and taste-masking approaches.
Feasibility, process development, and scale-up of spray-dried dispersions and respirable powders for bioavailability enhancement and inhalation delivery.
cGMP production of clinical supplies (Phase 1–3) and commercial batches for oral solids and liquids with packaging and serialization.
Cross-functional transfer of manufacturing, analytical methods, documentation and supply chain planning to enable site-to-site or new-site commercial production.
Preformulation characterization, excipient compatibility, process architecture, risk-based parameter definition, and scale-up strategy to support development and transfer.
Method development, verification/validation, QC testing, ICH stability studies, and a suite of analytical instrumentation for release and characterization.
Formulation design and prototype screening for oral solids and liquids, topicals, powders for inhalation, pediatric formulations and taste-masking approaches.
Feasibility, process development, and scale-up of spray-dried dispersions and respirable powders for bioavailability enhancement and inhalation delivery.
cGMP production of clinical supplies (Phase 1–3) and commercial batches for oral solids and liquids with packaging and serialization.
Cross-functional transfer of manufacturing, analytical methods, documentation and supply chain planning to enable site-to-site or new-site commercial production.
Expertise Areas
- CMC development for small molecules
- Oral dosage form design (immediate and modified release)
- Particle engineering and spray-dried dispersions
- Multiparticulate systems and pellet technologies
Key Technologies
- Spray drying
- Amorphous solid dispersions (SDD)
- Hot-melt extrusion
- Fluid-bed and Wurster coating
News & Updates
Exhibit and meetings at CPhI Worldwide (October 28–30, 2025).
Announcement of four new process development and manufacturing suites expanding cGMP capabilities in Oregon for spray drying, particle engineering, and complex oral dosage forms.
Press release describing addition of commercial spray drying and granulation capabilities at the Georgia site.
Exhibit and meetings at CPhI Worldwide (October 28–30, 2025).
Announcement of four new process development and manufacturing suites expanding cGMP capabilities in Oregon for spray drying, particle engineering, and complex oral dosage forms.
Press release describing addition of commercial spray drying and granulation capabilities at the Georgia site.