Recently, capecitabine API of Shandong Lixin Pharmaceutical Co., Ltd. received the European Pharmacopoeia Applicability Certificate (CEP Certificate) issued by the European Medicines Quality Agency (EDQM), indicating that the product quality and technical capabilities of the API have been recognized. It is recognized by the European standard market and marks that the API has obtained the qualification for sales in the European market.

API Name: Capecitabine

Certificate Number: No. R0-CEP 2021-316-Rev 00

Expiration Date: From October 19, 2022, the validity period is 5 years

Capecitabine is an oral drug with selective activity on tumor cells.,which is mainly used for the treatment of advanced or metastatic gastric cancer and colon cancer, and metastatic breast cancer after chemotherapy failure.

This variety is our company's dominant variety, whose product quality and impurity research meet international requirements, and meet the consistency evaluation and marketing needs of domestic and foreign preparation customers. According to the product strategic layout, the domestic registration [registration number Y20170000125] of our capecitabine API has been approved for marketing in August 2021, realizing domestic market sales. This capecitabine CEP certificate is the first approved CEP certificate of Shandong Lixin Pharmaceutical! The company will take this as an opportunity to continuously optimize and improve the technology and quality of products, deeply cultivate and expand domestic and foreign markets, and meet the needs of domestic and foreign preparation customers.

As a high-end specialty raw material pharmaceutical company, Lixin Pharmaceuticals has been approved to market several varieties in major international markets such as Europe, America, Japan, and China, and its quality system has passed the official GMP certifications of China, FDA, EMA, EDQM, and Japan. It is believed that the capecitabine produced by our company will benefit more patients and a wider pharmaceutical market.