Stock code：301201
Quality policy: to produce high-quality products, provide the best service, and ensure the sustainable development of the company.
Quality management system: integrating the requirements of drug cGMP (ICH Q7), ISO9001, FSSC22000, FAMI-QS, etc., a quality management system meeting the requirements of drugs, food, feed, etc. has been established to support the sustainable development of the company's businesses.
Quality audit history: The company successfully passed the on-site inspection of FDA APIs in 2013, 2016 and 2020 respectively; The company has successively passed the on-site inspection by Chinese NMPA, Japanese PMDA, Malaysia NPRA and other medical regulatory agencies. The company receives 30-50 quality audits from customers in Europe, America and other countries every year, and is widely recognized. The process of "air flotation+hydrolytic acidification+AO+oxidation" is adopted to realize "DCS" automatic control in the whole process.
Product registration: The company's API registration application has passed the technical review of drug regulatory authorities in various countries, such as FDA, EDQM, PMDA of Japan, CDE of China, HC of Canada, AIFA of Italy, etc. Based on the requirements of the ICH registration technical guidelines, the company has established a scientific and rigorous quality control strategy to serve the terminal preparation customers with superior product quality.
