Tianshu Pharmaceutical, the Production Base of Nanjing Vcare, Was Approved for the "Drug Production License", Adding a New Engine to the Whole-Industrial-Chain Layout

2024-01-08

 

Recently, Hubei Tianshu Pharmaceutical Co., Ltd. ("Tianshu Pharmaceutical"), a subordinate production base of Nanjing Vcare, successfully passed the comprehensive review by the Hubei Provincial Drug Administration and was approved for the "Drug Production License" (Type D License). This marks a new starting point for Nanjing Vcare on the road of R&D and production services throughout the whole industrial chain and the whole life cycle of chemical drugs, and it is also an important milestone for Nanjing Vcare to become an internationally competitive science and technology-based drug R&D service enterprise.

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

The approval of the Type D License this time indicates that the compliance of the software and hardware construction, such as the production management and quality management system of Tianshu Pharmaceutical, the production base of Nanjing Vcare，has been recognized by the regulatory authorities, laying a foundation for promoting the commercial production of drugs in the future. It is expected to provide patients with safe, effective and accessible drugs as soon as possible and help to address unmet clinical needs.

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