Recently, Hefei Lifang Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company" or "Lifang Pharmaceutical") has received the Acceptance Notice for the Marketing Application of Azilsartan Potassium Active Pharmaceutical Ingredient issued by the National Medical Products Administration (NMPA). The relevant details are hereby announced as follows:
I. Main Contents of the Acceptance Notice
Application Item: Marketing Authorization
Product Name: Azilsartan Potassium
Acceptance Remarks: In accordance with the provisions of Article 32 of the Administrative Licensing Law of the People's Republic of China, after review, it is decided to accept the application.
Registration Number: Y20240001141 (Acceptance Number: CYHS2460***)
II. Relevant Information on Azilsartan Potassium
Azilsartan Potassium is a prodrug that is rapidly converted into its active moiety, azilsartan, following oral absorption. Its pharmaceutical preparations are indicated for the treatment of essential hypertension in adults. Originally developed by Takeda Pharmaceutical Company Limited, this product is an active pharmaceutical ingredient intended for the production of generic versions of pharmaceutical preparations already marketed in the territory of China.
