Shanghai pharmaceutical enalapril maleate tablets passed the consistency evaluation
On April 19, Shanghai pharmaceuticals issued an announcement stating that xinya minhang, its holding subsidiary, had received the "notice of aprovel of drug supplement application" (notice) issued by the state food and drug administration regarding enalapiril maleate tablets (5mg, 10mg). Book number:2021B00893, 2021B00894), the drug passed the generic drug quality and efficacy consistency evaluation. The announcement shows that enalapril maleate tablets are mainly suitable for primary hypertension, endovascular hypertension, heart failure at all levels, prevention of symptomatic heart failure, and prevention of coronary ischemia events in patients with left ventricular insufficiency, developed by merck & Co., Inc. was first marketed in France in 1984. In July 2019, xinya minhang submitted an application to the state food and drug administration for the consistent evaluation of the generic drug and was accepted. As of the date of this announcement, the company has invested approximately RMB 9,652,300 in research and development expenses for the consistent evaluation of the drug. As of the date of this announcement, the main manufacturers of the drug in China are yangzijiang pharmaceutical group Jiangsu pharmaceutical Co., Ltd., CSPC ouyi pharmacetical Co., Ltd., and hunan qianjin xiangjiang pharmaceutical Co., Ltd., ets. According to the IQVIA database, the hospital purchase amount of this medicine oral tablets in 2020 is RMB 121.89 milllion. In 2020xinya minhang's sales revenue of this drug will be RMB 13.66 million.
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