Beijing Jialin "atorvastatin calcium tablets" first passed the consistency evaluation!

On the evening of May 15, Dezhan health released a notice that Beijing Jialin Pharmaceutical Co., Ltd., a wholly-owned subsidiary of the company, applied for "conformity assessment of quality and efficacy of generic drugs", and recently received the approval document for supplementary drug application for the chemical "atorvastatin calcium tablet" approved and issued by the State Food and drug administration According to the relevant national policies, the drug varieties through the consistency evaluation are supported in drug bidding, medical insurance payment and other aspects The indication of Lipitor (atorvastatin calcium tablet) is primary hypercholesterolemia In 1985, Bruce Roth first synthesized atorvastatin calcium Lipitor was first approved for use in the UK in 1997, and then listed in the US Lipitor became the fifth statin approved by the US FDA for the treatment of high cholesterol patients Lipitor became the leader of the lipid-lowering market in the first three months From 1998 to 2017, the total sales of the drug in the world was nearly 140 billion US dollars, which was the first heavyweight drug in the history of medicine whose total sales exceeded 100 billion US dollars In 2017, its sales reached US $2.11 billion, up 6.03% year on year It ranked fourth in cardiovascular system drug sales in 2017 In recent years, the growth slowed down, because the compound patent of the drug expired in 2011, and then a large number of generic drugs were listed, which affected the market share of the original research products The drug entered the Chinese market in 1999 and obtained administrative protection In the same year, the same kind of Jialin pharmaceutical product "alle" was approved for market as a national class II new drug and the first domestic generic development, and enjoyed an administrative protection period of 8 years, during which no other similar generic drugs were approved for market At present, there are 25 production approvals for atorvastatin calcium capsule, atorvastatin calcium dispersible tablet, atorvastatin calcium tablet and atorvastatin calcium API in China, involving about 20 manufacturers including Jialin pharmaceutical, Zhejiang Haizheng, yixuandong sunshine, etc At present, Jialin pharmaceutical industry has become the first enterprise that has passed the consistency evaluation, and has been in the front end, occupying the domestic market At present, the consistency evaluation of Zhejiang new Donggang pharmaceutical industry is under review and approval.