Shandong Lixin Pharmaceutical Co., Ltd. recently successfully passed the drug GMP compliance inspection organized by Shandong Provincial Drug Administration, and received the "Drug GMP Compliance Inspection Result" approved and issued by Shandong Food and Drug Evaluation and Inspection Center.

From August 23 to 25, 2021, the expert group of the Food and Drug Evaluation and Inspection Center of Shandong Province inspected the GMP compliance of our capecitabine products in accordance with the requirements of the "Good Manufacturing Practice for Drugs (2010 Edition)". The expert group conducted a comprehensive and detailed review on site and documents in terms of the dynamic production process of capecitabine, material management, production management, product testing and release, equipment and facilities, verification and confirmation, etc., so as to obtain a true, scientific and accurate evaluate. Shandong Lixin successfully passed the GMP on-site inspection with its institutionalized quality management system, specialized production equipment and process flow, and standardized quality management procedures.

The successful passing of this inspection fully proves that our team is a team with excellent skills, reasonable division of labor, clear responsibilities, cohesion, and strong execution. It also marks a key step in the direction of scientific, standardized and rigorous production quality management of the company!

Capecitabine, as our dominant product, has completed the submission of EU CEP registration documents. The successful passing of the GMP compliance inspection further proves that the production and quality management of this product meet the requirements of domestic and foreign laws and regulations, and can meet the consistency evaluation and marketing needs of domestic and foreign preparation customers.

Shandong Lixin will take this inspection as a new starting point, continue to improve the quality management system of pharmaceutical production, optimize product technology, seize opportunities in the face of challenges, take advantage of the trend, and provide customers with more competitive products and services, and continue to create value for customers.