Quality Assurance

The company has an independent quality management department and has established a comprehensive quality management system in accordance with GMP requirements, as well as ISO9001, ISO14001, and ISO45001 management systems. First passed EHS system certification in 2018. In 2020, the drug production license was approved. In 2022, the active pharmaceutical ingredient Diquin Chloride passed the GMP compliance inspection and on-site verification by the National Medical Products Administration. In 2023, the active pharmaceutical ingredient Diquin Chloride passed the registration review by the National Medical Products Administration. At present, the raw materials (potassium sulfate, protein iron succinate, furosemide, dihydroxypropyl theophylline, sodium thiosulfate, potassium metabisulfite) have completed process validation batch production and are under review for market application by the National Medical Products Administration.