Recently, Sichuan Xieli Pharmaceutical Co., Ltd. received the European Pharmacopoeia Adaptability Certificate (Test "CEP") for Gefitinib (API) issued by the European Drug Quality Administration ("EDQM" for short). The certificate number is R0-CEP 2018-281-Rev 00. It is the fifth CEP certificate obtained by our company after Diosmin, troxerutin, irinotecan hydrochloride and anastrozole. At present, in the form of stricter policy supervision and higher quality requirements in the global pharmaceutical industry, the company has successfully obtained the CEP certificate of Gefitinib API, which shows the affirmation of the European drug regulatory authorities on the quality of the company's raw materials, and fully reflects the company's excellent process research and development and quality control capabilities.

     Our company, Gefitinib, has completed the DMF registration with US FDA, and the DMF status is "A". Now it has also obtained the CEP certificate of Gefitinib (API). Downstream preparation users in the EU region can directly use the API to apply for and change the marketing license of preparation products, and the review authority will no longer approve the API; And it also has reference significance for customers in other countries and regions. These will enhance the competitiveness of our company's products, improve the efficiency of customer development, and facilitate the company's further exploration of the international market.