Recently, Shandong Xinhua Pharmaceutical Co., Ltd. (the "Company" or "Xinhua Pharmaceutical") has received the Approval Notification for Market Application of Chemical API in respect of Alogliptin Benzoate (the "Product"), issued and approved by the National Medical Products Administration ("NMPA"). Relevant information is announced as follows:
1. Basic Information
Name of API: Alogliptin Benzoate
Applicant: Shandong Xinhua Pharmaceutical Co., Ltd.
Application Type: Market application for domestically manufactured chemical API
Acceptance No.: CYHS2160633
Registration No.: Y20210001145
Notification No.: 2023YS00358
II. Other Relevant Information
The product is indicated for the treatment of type 2 diabetes mellitus.
