The application for production of ivabradine hydrochloride tablets, a class 3.1 chemical drug of eurypharma, has been accepted

According to the website of the State Food and Drug Administration (CFDA) on April 17, ivabradine hydrochloride, a class 3.1 chemical drug, which was declared to be produced by the European pharmaceutical industry under the group, was accepted At present, there is no domestic enterprise to produce the product, and the original research drug has not entered China Ivabradine hydrochloride tablet is mainly used to treat chronic stable angina pectoris with normal sinus rhythm By reducing oxygen consumption to restore the balance of oxygen supply and demand of ischemic myocardium, it can significantly prolong the diastolic time and maintain the coronary artery expansion during exercise, improve the coronary artery perfusion and oxygen supply to myocardium In 2005, French Servier's ivabradine was first approved by the European Drug Administration (EMEA) and 27 EU countries The product is now on the market in the UK and Ireland and registered in other EU countries Among them, Servier applied for the clinical approval of the product in China in 2009 and was approved in 2010 According to CFDA, at present, there are more than 10 pharmaceutical enterprises applying for ivabradine hydrochloride tablets in China, in addition to stone Pharmaceutical Group, among which only stone Pharmaceutical Group and Hengrui pharmaceutical are applying for production Ouyi Pharmaceutical Co., Ltd of Shiyao group is a comprehensive enterprise mainly engaged in the production of chemical synthetic APIs and pharmaceutical preparations It has more than 200 kinds of preparations, and its treatment fields include severe infection, cancer pain, osteoporosis, hypertension, etc.