Recently, Beijing Fuyuan Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") has received the "Approval Notice for Marketing Authorization Application of Chemical Active Pharmaceutical Ingredient (API)" for Meglumine API, officially approved and issued by the National Medical Products Administration (NMPA) of the People's Republic of China.
I. Other Relevant Information About the API
In July 2023, the technical review application for Meglumine API submitted by the Company to the NMPA was accepted. Recently, the Company obtained the aforementioned "Approval Notice for Marketing Authorization Application of Chemical API" issued by the NMPA. The registration status of this API on the Center for Drug Evaluation (CDE)'s Excipients, APIs and Packaging Materials Registration Information Platform is listed as "A".
Meglumine is indicated for intravenous and retrograde urography; angiography of cerebral, thoracic, abdominal, and extremity blood vessels; venography; and computed tomography (CT) imaging.
