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Tianshu Pharmaceutical Completes NMPA Registration On-site Inspection for Dapagliflozin API

2024-12-24

Recently, Hubei Tianshu Pharmaceutical Co., Ltd. (Tianshu Pharmaceutical) successfully completed the registration on-site inspection for dapagliflozin API.

This registration on-site inspection lasted for four days. In accordance with the requirements of CDE and CFDI of the National Medical Products Administration, and adhering to the principles of fairness, openness, and transparency, the inspection team conducted a careful, detailed, and in-depth static inspection on the consistency and authenticity between the relevant contents (such as plant facilities, production equipment, process research, technology transfer, material management, quality control, data reliability, and stability research) of Tianshu Pharmaceutical and the application materials.

The successful completion of the registration on-site inspection for dapagliflozin API is another important milestone for Tianshu Pharmaceutical in the industrialization of regulatory APIs. Tianshu Pharmaceutical will take this as a new starting point, uphold the spirit of excellence, as always, regard product quality as the lifeline of the company's development, and continuously provide high-quality products for customers.