Consistency evaluation of cefuroxime axetil capsule

On December 2, Shanghai Hyundai Pharmaceutical Co., Ltd announced that its holding subsidiary, Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd (hereinafter referred to as "Sinopharm Zhijun"), had received the approval document for supplementary application of cefuroxime axetil capsule (0.125g) approved and issued by the State Food and drug administration, and approved the drug to pass the consistency evaluation Cefuroxime capsule (trade name: dalixin) is an anti infective drug of cephalosporin It is mainly used to treat infectious diseases caused by sensitive bacteria, including upper respiratory tract infection, lower respiratory tract infection, urinary tract infection, skin and soft tissue infection, ear and nose infection, acute gonorrhea without complications, etc The original research product is cefuroxime ester tablets of GlaxoSmithKline, and the drug trade name is "xilixin" According to the announcement, in 2018, the global sales volume of cefuroxime ester was 664 million US dollars; the sales volume of domestic sample hospitals was 92632300 yuan In 2018, the sales revenue (excluding tax) of Zhijun cefuroxime axetil capsule (0.125g) was about 70 million yuan In China, there are 7 enterprises with cefuroxime ester capsule (0.125g) specification drug production approval, such as Renfu pharmaceutical, Shenzhen Lijian pharmaceutical, Hainan rizhongtian pharmaceutical, etc However, according to the data of yaozhi.com, at present, no other company with the same specification drug has passed the consistency evaluation except for Sinopharm Zhijun The announcement also revealed that up to now, the cumulative input cost of Zhijun, a Chinese herbal medicine, for the consistency evaluation of cefuroxime axetil capsule (0.125g) is about 15 million yuan (Unaudited) Mengmeng's article is the integrated content of yaozhi.com, and the copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.