Tianshu Pharmaceutical Approved for "Drug Production License"

Recently, Hubei Tianshu Pharmaceutical Co., Ltd. (Tianshu Pharmaceutical) successfully passed the comprehensive review of the Hubei Provincial Drug Administration and was approved for the "Drug Production License" (Category D). This signifies that Tianshu Pharmaceutical will assume greater responsibilities in the "Chemistry + Pharmacy + Medicine" one-stop CRO/CDMO service platform built by its parent company Nanjing Vcare PharmaTech Co., Ltd. (Nanjing Vcare), and also provides an important guarantee for the rapid implementation of Tianshu Pharmaceutical's innovative drug CDMO service business and future commercial production.

　　Tianshu Pharmaceutical has always adhered to the quality policy of "Quality First, Scientific Management, Pursuit of Excellence, and Customer Satisfaction", and fully implements international pharmaceutical production quality management. Its plant facilities are designed and constructed in strict accordance with relevant guidelines and standards such as cGMP, FDA, and ICH. It has independent clean workshops and a quality inspection and R&D center (including a clean area for microbial testing), and has established and strictly implemented a comprehensive quality management system. The production standard operating procedure documents cover all links such as production, materials, equipment and facilities, and inspection, realizing full-process control from design and development, raw material procurement, production process control to product sales.

　　The approval of this Category D license indicates that the compliance of Tianshu Pharmaceutical's software and hardware construction, such as production management and quality management systems, has been recognized by regulatory authorities. It lays the foundation for the subsequent promotion of drug commercial production, and is expected to provide safe, effective and accessible drugs for patients at an early date, helping to address unmet clinical needs.