Recently, Lianyungang Runzhong Pharmaceutical, a wholly-owned subsidiary of Zhengda Tianqing Pharmaceutical Group, passed the on-site inspection of the U.S. Food and Drug Administration (FDA) with "zero defects", which means that the company's quality management system has once again been recognized by international authoritative drug regulatory agencies. Previously, Runzhong Pharmaceutical has passed the FDA on-site inspection with zero defects twice in 2014 and 2018.

FDA is recognized as one of the most authoritative and strict agencies in the world for drug quality supervision.2024 From January 22 to January 26, FDA conducted pre-approval inspections on two antineoplastic products of Runzhong Pharmaceuticals, as well as supervisory inspections on four products commercialized in the U.S. market, namely, aminophosine, fosaprepitant dimeglumine, phosphonate, and fulvestrant. At the final meeting on January 26, the inspector announced on-site that R&Z passed the inspection with zero defects.

It is understood that during this on-site inspection, the FDA inspector conducted a comprehensive, rigorous and professional inspection of the company's quality assurance system, facilities and equipment system, material system, production system, packaging and labeling system, laboratory control system and other six systems, and highly valued the orderly operation of Runzhong Pharmaceutical's quality system, effective control of key processes, and rapid response to meet the inspection information.

Lianyungang Runzhong Pharmaceutical is a wholly-owned subsidiary of China Biopharmaceutical's Zhengda Tianqing Pharmaceutical Group, which is mainly engaged in the research and development, production and sales of chemical APIs and sterile APIs, and not only dozens of products are sold in China, but also more than ten products are listed in the U.S. and the European Union market or are in the review stage. In addition, R&Z Pharmaceuticals has passed nearly 50 on-site inspections by the China National Drug Administration (NMPA) since its establishment.

"China Biopharmaceutical and Zhengda Tianqing have always placed the quality of medicines in a crucial position, because strictly guarding the quality of medicines is guarding the lifeline." Xie Chengrun, Chief Executive Officer of China Biopharmaceutical and Chairman of Zhengda Tianqing Pharmaceutical Group, said that being able to pass three consecutive on-site inspections by the FDA with zero defects signifies that Runzhong Pharmaceutical's quality system construction and quality management capabilities have been internationally recognized, which will help the company's products to further develop domestic and international markets.

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