Small molecule drugs CDMO platform
The small molecule CMC preparation platform complies with FDA and NMPA GMP standards, and has the ability of small molecule preparation research, clinical sample production and commercial production capabilities to serve the international market.
Service: pilot trials of poorly soluble drug solutions, oral and injection dosage forms (tablets, capsules, granules, small-volume injections, oral solution, etc.) , clinical sample production and commercial production services to support drug companies, MAH holders and generic drug R&D companies to conduct drug R&D, generic drug consistency evaluation and R&D application.
（二）Platform function introduction
The platform has 4 floors, with a total construction area of 6651.54m2.
（三）Platform hardware introduction
Pilot and commercial production workshops include oral liquid, volumetric injection, oral preparation line, granulation and coating workshop, motion center, storage center (finished product warehouse, packaging material warehouse, raw and auxiliary materials warehouse, spare parts warehouse, shade warehouse , consumable warehouse); R&D office includes positive control room, microbial limit room, sterile testing room, instrument analysis room, physical and chemical laboratory, endotoxin testing room, microbial preparation room, stability laboratory and QA archive room, etc.