Sailong Pharmaceutical Group Co., Ltd. (hereinafter referred to as the "Company") announces that its wholly-owned subsidiary, Hunan Sailong Pharmaceutical Co., Ltd., has recently obtained the "Approval Notice for Marketing Authorization Application of Chemical Active Pharmaceutical Ingredient (API)" for Famotidine, issued upon official approval by the National Medical Products Administration (NMPA) of the People's Republic of China. Relevant details are hereby announced as follows:
I. Basic Information of the API
Chemical API Name: Famotidine
Notice No.: 2024YS01370
Registration No.: Y20230000305
Acceptance No.: CYHS2360314
Registration Standard No. for Chemical API: YBY77052024
Validity Period: 18 months
Packaging Specification: 2kg/bag
Application Item: Marketing Authorization Application for Domestically Produced Chemical API
Approval Conclusion: In accordance with the Drug Administration Law of the People's Republic of China and relevant regulations, after review, this product meets the relevant requirements for drug registration and is approved for registration. The quality standard, labels, and production process shall be implemented in accordance with the attached documents.
Validity Period of the Notice: Until December 30, 2029
II. Other Relevant Information
Famotidine formulations are mainly indicated for the treatment of upper gastrointestinal bleeding caused by peptic ulcers, as well as erosive bleeding of the gastric and duodenal mucosa resulting from various causes except tumors and esophageal/gastric fundal varices.
