浙江仙琚制药：获雌二醇片境内生产药品注册证书

Core Viewpoint - Zhejiang Xianju Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Estradiol Tablets, which is expected to enhance the company's product line and competitiveness [1] Group 1: Product Approval - The approved product is Estradiol Tablets with a specification of 1mg and a tablet dosage form [1] - The registration classification is categorized as a Class 4 chemical drug, with the approval number being Guoyao Zhunzi H20255491 [1] - The reference formulation was approved by the FDA in the United States on October 22, 1997, and is indicated for estrogen deficiency-related diseases and the prevention of osteoporosis [1] Group 2: Market Impact - The approval is beneficial for enriching the company's product portfolio and enhancing its competitive edge in the market [1] - However, the company acknowledges that drug development is subject to uncertainties influenced by policies and market factors [1]