Simcere possesses 6 pharmaceutical bases in China, which can perform pharmaceutical practices by integrating drug substances and drug products, engage in the late-stage development and commercial manufacturing of macromolecular and micromolecular drugs, and perform manufacturing and quality control as per the stringent international standards. All production workshops have passed GMP certification, the base in Hainan has passed EU GMP certification for multiple times in succession, and the manufacturing base for small-molecule drugs in Nanjing has passed FDA's on-site inspection with "zero 483" (zero defect).
The Company has established a management system overseeing the entire production cycle from raw material procurement to drug product delivery, so as to ensure the whole-process compliance, continuously improve quality specifications, and safeguard patient safety.