Shandong Xinhua Pharmaceutical Company Limited has recently received the Notice of Approval of Marketing Application for Chemical Raw Material Drugs of alogliptin benzoate (hereinafter referred to as the "Product") issued by the National Medical Products Administration. Relevant information is now announced as follows: Basic information: API Name: Alogliptin benzoate - Applicant: Shandong Xinhua Pharmaceutical Company Limited - Application Matter: Application for lauching domestic production of chemical API - Acceptance Number: CYHS2160633 - Registration Number: Y20210001145 - Notification Number: 2023YS00358 - Approval 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 as attached.