Recently, Shandong Lixin Pharmaceutical Co., Ltd. received an on-site inspection report issued by the US Food and Drug Administration (hereinafter referred to as "FDA"), which clearly indicates that the quality management system of Shandong Lixin Pharmaceutical Co., Ltd. complies with the cGMP standard of the U.S. FDA and successfully passed the on-site inspection of the U.S. FDA with "zero defects. "The relevant information is as follows:

Enterprise Name: Shandong Lixin Pharmaceutical Co., Ltd.

Inspection address: No. 9 Jinyang Road, Gaoqing County Economic Development Zone, Zibo,Shandong Province 256300, P.R. of China.

Inspection category: Pre approval inspection

Inspection period: May 15th to May 19th, 2023

Inspection scope: 4-[2-(2-Amino-4,7-Dihydro-4-Oxo-1H-Pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoic Acid

Inspection conclusion: Passed the pre-approval inspection

This on-site inspection is the first time that Shandong Lixin Pharmaceutical Co., Ltd. has passed an FDA on-site inspection, and it is also the third time that Lixin Pharmaceutical has passed an FDA on-site inspection, once again proving that Lixin Pharmaceutical has always maintained an international high level of quality system. Lixin Pharmaceutical always adheres to the principle of "quality first", establishes and improves a quality assurance system, and strictly implements standardized, procedural, and standardized management in accordance with GMP specifications.

Lixin Pharmaceutical adheres to global standards and has been certified by authoritative institutions such as FDA, EDQM, EMA, and PMDA multiple times. In the future, Lixin Pharmaceutical will further accelerate its internationalization process, enhance its product market share and influence in the international market, and provide high-quality integrated services for global partners.