Recently, Baiyunshan Chemical Pharmaceutical Factory, a branch of Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd. (hereinafter referred to as "the Company"), has received the Approval Notice for the Marketing Application of Tenofovir Alafenamide Fumarate Active Pharmaceutical Ingredient, which was officially verified and issued by the National Medical Products Administration (NMPA). Relevant details are hereby announced as follows:
I. Basic Information of the Drug
Name of Active Pharmaceutical Ingredient: Tenofovir Alafenamide Fumarate
Packaging Specifications: 10kg/drum, 15kg/drum, 20kg/drum, 25kg/drum
Approval Notice Number: 2024YS00139
Acceptance Number: CYHS2260041
Registration Standard Number of Active Pharmaceutical Ingredient: YBY61632024
Validity Period: 36 months
Manufacturer: Baiyunshan Chemical Pharmaceutical Factory of Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd.
Manufacturing Address: No. 78 Tongbao Road, Tonghe Street, Baiyun District, Guangzhou
Validity Period of Approval Notice: Until February 26, 2029
Application Item: Marketing application for domestically manufactured active pharmaceutical ingredient
Approval Conclusion: In accordance with the Drug Administration Law of the People's Republic of China and relevant regulations, upon review, this product meets the relevant requirements for drug registration and is approved for production.
II. Other Relevant Information of the Drug
Tenofovir Alafenamide Fumarate is an agent indicated for inhibiting hepatitis B virus (HBV). It was approved for marketing by the U.S. Food and Drug Administration (FDA) in November 2017 under the trade name Vemlidy, for the treatment of patients with chronic hepatitis B infection accompanied by compensated liver disease.
