The R&D center is designed by a team of experts from Delexcel in India and established in full compliance with FDA standards. It comprises an API synthesis pilot laboratory, a small volume injection R&D laboratory, and an R&D analysis laboratory. The center boasts standardized laboratories and pilot workshops for analysis, synthesis, formulation, and research, equipped with comprehensive pharmaceutical research instruments and equipment such as high-performance liquid chromatography (HPLC), dissolution testers, UV spectrophotometers, infrared spectrometers, and Corning high-throughput microchannel reactors. The R&D center has established a drug R&D quality management system, encompassing comprehensive management systems and processes for project research, pilot development, pilot scale-up, process validation, quality research, and registration and application, ensuring the smooth progress of drug R&D. The company possesses solid R&D capabilities, with a core R&D management team experienced in pharmaceutical industry R&D, including extensive experience in the R&D of active pharmaceutical ingredients (APIs), injections, and solid dosage forms, as well as experience in drug registration and application in the United States, the European Union, and China. The team comprises over 30 senior R&D personnel, including foreign R&D scientists, PhDs, and senior engineers, with over 20% holding master's degrees or above, forming a reasonable R&D talent echelon.
The company boasts a contract development and manufacturing organization (CDMO) platform for small-volume injections and solid dosage forms. It can offer "one-stop" services encompassing drug research and development, pilot scale-up, process validation, and commercial production.