Zhejiang Hisun Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") announced that its wholly-owned subsidiary, Hisun Pharmaceutical Nantong Co., Ltd. (hereinafter referred to as "Hisun Nantong"), received the Approval Notice for the Marketing Application of Chemical Active Pharmaceutical Ingredients for oseltamivir phosphate API, duly approved and issued by the National Medical Products Administration (hereinafter referred to as the "NMPA"), on February 28, 2024. We hereby announce the relevant details as follows:
I. Basic Information of the Drug
Name of the chemical API: Oseltamivir PhosphateRegistration Number: Y20220000102Notice Serial Number: 2024YS00159Registration Standard Number of the Chemical API: YBY61842024Packaging Specification: 3 kg/bagApplication Item: Marketing application for domestically-manufactured chemical APIManufacturer: Hisun Pharmaceutical Nantong Co., Ltd.Approval Conclusion: In accordance with the Drug Administration Law of the People's Republic of China, upon review, this product complies with the relevant provisions for the approval of generic drugs, and the production of this product is hereby approved.
II. Relevant Information of the Drug
Oseltamivir phosphate is a prodrug of its active metabolite (oseltamivir carboxylate), which is a selective neuraminidase inhibitor against influenza viruses. It is indicated for the treatment of influenza A and B in adults and children aged 1 year and above, as well as the prevention of influenza A and B in adults and adolescents aged 13 years and above. Its original research manufacturer is Roche Holding AG. At present, the major domestic manufacturers of oseltamivir phosphate API include Hunan Eurasia Pharmaceutical Co., Ltd. and Hangzhou Firstir Pharmaceutical Co., Ltd., among others.
