The site offers API process development from preclinical to commercial manufacturing. It also supports drug product R&D and manufacturing including solid-state development, pre-formulation, formulation development, manufacturing, packaging, and labeling as well as distribution for various oral and parenteral dosage forms. The analytical teams support both API and drug product from preclinical to commercial manufacturing.
Our Waigaoqiao site has successfully passed numerous inspections by the US FDA, China NMPA, Japan PMDA, and South Korea MFDS.
