CoreRx
A contract development and manufacturing organization (CDMO) focused on small-molecule drug design, development, and cGMP manufacturing for oral solids, oral liquids, topicals, and inhalation products. Offers end-to-end services from preformulation and particle engineering through analytical development, clinical and commercial manufacturing, packaging, technology transfer, and regulatory-ready quality systems across multiple U.S. sites.
Industries
Nr. of Employees
medium (51-250)
CoreRx
Clearwater, Florida, United States, North America
Services
Target product profile definition, selection of bioavailability enhancement strategies, modified-release and multiparticulate design, and holistic formulation/process architecture to ensure manufacturability and regulatory viability.
Preformulation and process design, analytical method development and validation, stability programs, prototype screening, and formulation development for oral solids, liquids, topicals, and inhalation.
cGMP manufacturing for clinical supplies and commercial production of oral solids and liquids, packaging and serialization, and supply chain coordination to support regulatory-ready product release.
End-to-end transfer planning and execution including knowledge transfer, gap analysis, risk mitigation, regulatory and quality strategy, and operational readiness for commercial supply transfers.
On-site analytical development, QC testing, method validation, and ICH stability storage and testing to support development and regulatory submissions.
Primary packaging and kitting for clinical and commercial programs including automated bottling, blistering, sachets, labeling, serialization and aggregation under a single quality system.
Target product profile definition, selection of bioavailability enhancement strategies, modified-release and multiparticulate design, and holistic formulation/process architecture to ensure manufacturability and regulatory viability.
Preformulation and process design, analytical method development and validation, stability programs, prototype screening, and formulation development for oral solids, liquids, topicals, and inhalation.
cGMP manufacturing for clinical supplies and commercial production of oral solids and liquids, packaging and serialization, and supply chain coordination to support regulatory-ready product release.
End-to-end transfer planning and execution including knowledge transfer, gap analysis, risk mitigation, regulatory and quality strategy, and operational readiness for commercial supply transfers.
On-site analytical development, QC testing, method validation, and ICH stability storage and testing to support development and regulatory submissions.
Primary packaging and kitting for clinical and commercial programs including automated bottling, blistering, sachets, labeling, serialization and aggregation under a single quality system.
Expertise Areas
- cGMP clinical supply manufacturing
- Commercial pharmaceutical manufacturing
- Oral dosage form design (solids and liquids)
- Particle engineering and spray drying
Key Technologies
- Spray drying (pilot and commercial)
- Spray-dried dispersions (SDD)
- Hot-melt extrusion (HME)
- Fluid-bed coating and Wurster processing
News & Updates
Press release announcing workforce growth and community investment.
Press release describing a development agreement for an oral controlled release dosage form.
Press release announcing the opening of four new process development and manufacturing suites to expand cGMP capabilities including spray drying and particle engineering.
Press release announcing workforce growth and community investment.
Press release describing a development agreement for an oral controlled release dosage form.
Press release announcing the opening of four new process development and manufacturing suites to expand cGMP capabilities including spray drying and particle engineering.