Shandong Xinhua Pharmaceutical Company Limited has recently received the Notification of Approval for Marketing Application for Chemical Raw Material Drugsof Febuxostat approved and issued by the National Medical Products Administration. Relevant information is now announced as follows: API Name: Febuxostat; Applicant: Shandong Xinhua Pharmaceutical Company Limited; Application Matter: Application for listing domestic production of chemical API; Reception Number: CYHS2160671; Registration Number: Y20210001232; Notification Number: 2023YS00658. Review Conclusion: According to the Drug Administration Law of the People's Republic of China, after examination, the Product meets the relevant provisions of generic drug approval, and the production of the Product is approved.

Quality standards, packaging labels and production processes shall be carried out in accordance with the Notification of Approval for Marketing Application for Chemical Raw Material Drugs of febuxostat.