Nanjing Vcare Subsidiary Production Base Tianshu Pharmaceutical Completes On-Site Registration Inspection for Dapagliflozin API by NMPA

2024-12-24

　　Recently, Hubei Tianshu Pharmaceutical Co., Ltd. (Tianshu Pharmaceutical), a production subsidiary of Nanjing VcarePharmaTech Co., Ltd. (Nanjing Vcare), successfully completed the on-site registration inspection for its dapagliflozin API.

　　The four-day inspection was conducted by the review team in strict compliance with the requirements of the CDEand the CFDIof the NMPA. Adhering to principles of fairness, transparency, and impartiality, the team performed a meticulous and comprehensive static review of Tianshu Pharmaceutical's facilities, production equipment, process development, technology transfer, material management, quality control, data integrity, stability studies, and other relevant aspects to verify their consistency and authenticity with the submitted documentation.

　　The successful completion of this on-site registration inspection marks another significant milestone for Tianshu Pharmaceutical in the regulatory-compliant industrialization of APIs. It fully demonstrates the company's critical role within Nanjing Vcare’s integrated "Chemistry+Pharmacy+Medicine" one-stop CRO/CDMO full-industry-chain framework. Moving forward, Tianshu Pharmaceutical will take this achievement as a new starting point, upholding the pursuit of excellence and maintaining product quality as the lifeline of its development, thereby continuously delivering high-quality products to its clients.

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