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Greenville, South Carolina
Greenville, SC is experienced at process development and chemical production of intermediates and APIs for clinical and commercial supply under cGMP and ISO conditions. This 23 acre site was built in 1998, and is fully cGMP compliant.
Production scales ranging from 2 kg to metric tons
cGMP manufacturing of clinical and commercial materials
Raw Material sourcing and specifications
Process optimization; registration and validation campaigns
Design of Experiment (DoE) and Quality by Design (QbD) studies
Process safety studies
Analytical method development and phase appropriate method validations
Regulatory submission assistance
Development & commercial scale capabilities include:
Clinical Phase Small Molecule API (Phase I-III)
Process & Analytical Development
Clinical Batch API Manufacture
Process Scale Up & Optimization
Commercial API Manufacture
High Potency (HPAPIs) and Cytotoxic Compounds
Greenville, SC is routinely inspected by its clients and USA regulatory agencies, and has a history of strong regulatory inspection performance.
Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.