STA Pharmaceutical

STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading small molecule pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), STA offers our worldwide partners efficient, flexible and high-quality solutions for small molecule Active Pharmaceutical Ingredients (APIs) and finished dosage forms. As the world’s largest process chemistry organization, our highly skilled 1,000+ research scientists will help you to solve a wide range of challenges such as: Route scouting Process development, optimization and scale-up Develop control strategy for Regulatory Starting Materials (RSMs), intermediates and APIs Process validations Our state-of-the-art manufacturing facilities are capable of producing advanced intermediates and innovative APIs under cGMP from kilo to metric ton scale. Large Capacity: 400m3 reactor volume in Shanghai Jinshan site, adding 1,000+ m3 reactor volume in newly opened Changzhou site. Overall our customers have access to 200 reactors ranging from 5 L to 20,000 L which ensure shorter production lead time. Global Standard Quality System: our Shanghai Jinshan production site has been approved by 8 global regulatory agencies to produce innovative APIs and advanced intermediates: U.S. FDA, CFDA, EMA, Australia TGA, Health Canada, Japanese MHLW, Swiss medic, New Zealand MPI. Our cutting-edge drug product R&D and manufacturing facility in Shanghai offers formulation research development from preclinical to commercial as well as the clinical batches manufacturing, packaging and labeling. Fast IND enabling developability assessment studies integrated with WuXi AppTec medicinal chemistry, DMPK and biology units Expertise in developing low soluble drugs and pediatric formulations Experienced in manufacturing clinical supplies for oral solid dosages