The facility is fully compliant with all applicable regulations and meets the most stringent production, quality, cGMP (current Good Manufacturing Practices), safety and environmental standards.
State-of-the-art Active Pharmaceutical Ingredients (API) Manufacturing Facility
Campus includes 7 main buildings and encompasses ~1400 acres (~560 hectares), of which ~115 acres (~46 hectares) have been developed for operations
Highly flexible, state-of-the art facility featuring drug substance technical development, pilot plant, clinical and commercial manufacturing capabilities
FDA approved, cGMP compliant, and inspection experience with US, EU, and Japanese health authorities
Total investments since site inception exceed USD $850,000,000
Scalable production capabilities, short lead time capacity expansion, available small molecule drug substance production and milling capacity, as well as high potency manufacturing
Excellent safety and environmental compliance history, which is ensured through a continuous process that includes employee participation, process safety management, shared leadership, instruction, training, education, and self evaluation
A premier presence in South Carolina and our dedicated and competent personnel have been recognized both internally and at state and national levels for our accomplishments in safety, environmental stewardship, and operational excellence
This site features a strong regulatory inspection history from all major domestic and international regulatory agencies.
Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.