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金城医药(300233.SZ):金城金素注射用头孢哌酮钠舒巴坦钠获得药品补充申请批准通知书

Shandong Jincheng Pharmaceutical Group (300233.SZ): Jincheng Jinsuo injectable Cefoperazone Sodium and Sulbactam Sodium has obtained the approval notification for the Pharmaceutical supplementary application.

Gelonghui Finance ·  Dec 20 02:49

Gelonghui, December 20th丨Shandong Jincheng Pharmaceutical Group (300233.SZ) announced that its controlling subsidiary, Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd. (hereinafter referred to as 'Jincheng Jinsu'), recently received the national drug administration's approval notice for the supplementary application of injectable cefoperazone sodium and sulbactam sodium (certificate numbers: 2024B05973, 2024B05974). After review, this product has passed the consistency evaluation of generics in terms of quality and efficacy.

This product is indicated for the treatment of infections of the upper and lower respiratory tracts caused by sensitive bacteria; infections of the upper and lower urinary tracts; peritonitis, cholecystitis, cholangitis, and other intra-abdominal infections; sepsis; meningitis; skin and soft tissue infections; bone and joint infections; pelvic inflammatory disease, endometritis, gonorrhea, and other reproductive tract infections, etc.

This time, Jincheng Jinsu's injectable cefoperazone sodium and sulbactam sodium has obtained the approval notice for the supplementary application of the pharmaceutical and will add specifications of 2.25g and 3.0g based on the original 0.375g, 0.75g, and 1.5g specifications, further enriching the company's product categories, providing more options for market promotion of this variety, which is conducive to enhancing the market competitiveness of this pharmaceutical.

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