Tianshu Pharmaceutical's Dapagliflozin API Accepted for CEP Certification by EDQM

　　Recently, the Dapagliflozin Propylene Glycol Monohydrate API, independently developed and manufactured by Hubei Tianshu Pharmaceutical Co., Ltd. (Tianshu Pharmaceutical), has officially obtained the acceptance notice for the CEP to the European Pharmacopoeia issued by the EDQM. This milestone marks a crucial step forward for Tianshu Pharmaceutical in API R&D, registration, quality management and international compliance capabilities, further enhancing the company's competitiveness in the high-end API sector.

　　Dapagliflozin, the world's first approved SGLT-2 inhibitor, was originally researched and developed by AstraZeneca. It is widely applied in the treatment of Type 2 diabetes mellitus, chronic kidney disease and heart failure. Included in China's National Essential Medicines List and centralized VBP, the drug provides an important therapeutic option for a large number of patients. At present, most dapagliflozin adopted in China's domestic centralized procurement is amorphous salt form, which differs from the original reference listed drug (RLD) salt form and faces challenges such as poor stability, high production costs, and easy degradation to produce impurities during long-term storage. In contrast, Tianshu Pharmaceutical’s self-developed and produced Dapagliflozin Propylene Glycol Monohydrate is consistent with the salt form of the original drug, featuring superior structural stability, and its full quality control system complies with European Pharmacopoeia standards.

　　Previously, the domestic application for Tianshu Pharmaceutical’s Dapagliflozin API has been transferred to Category A review by the CDE of the NMPA. The acceptance of the CEP certification represents international recognition of Tianshu Pharmaceutical’s R&D and manufacturing strength, and lays a solid foundation for the company to further deepen its global layout and participate in competition in the high-end pharmaceutical market. Upholding the mission of "Empowering Global Customers with Differentiated Technologies", Tianshu Pharmaceutical will continue to launch more high-quality pharmaceuticals to the market and serve patients worldwide.