[exclusive] progress analysis of the consistency evaluation of rosuvastatin calcium tablets, there are soldiers in front of the mountain and behind the mountain

Latest: on June 7, 2018, the third batch of centralized procurement bidding results of Shanghai medical institutions were announced, and risuvastatin calcium tablets of Zhejiang Jingxin Pharmaceutical Co., Ltd won the bid, but the price was very low, a record low Why did you write about bidding at the beginning? Just want to express that there are many policies for consistency evaluation in each province at present In addition to focusing on the approval of consistency varieties, we also need to focus on the market access of varieties through consistency evaluation The drug examination center of the State Drug Administration has accepted the consistency evaluation of 9 rosuvastatin calcium tablets from 5 enterprises; at present, 3 acceptance numbers from Nanjing Zhengda Tianqing and Zhejiang Jingxin pharmaceutical have been approved The overall progress of the consistency evaluation is shown in the following table: 1 Briefly describe that rosuvastatin calcium tablets were initially developed by AstraZeneca in the United Kingdom and approved to be listed in the United States in 2003; they were approved to enter China in 2006, with the trade name of Crestor The domestic imitated products first obtained the approval for listing in 2008, and they belong to Lunan Beite, Nanjing Zhengda Tianqing and Zhejiang Jingxin pharmaceutical At present, there are 13 domestic approval numbers of rosuvastatin calcium tablets: 5 of 5mg, 5 of 10mg, 3 of 20mg; 12 of the import registration numbers (3 subpackages), with specifications of 5mg, 10mg, 20mg, including 9 of the original research enterprise AstraZeneca 2 First of all, let's look at the reference preparation published by CFDA Because the original research of this product is relatively clear and there are imported drugs in China, CFDA chose Crestor as the reference preparation Looking at the reference preparation filing, there are 24 reference preparation filing information from 9 enterprises that can be queried at present All enterprises have selected AstraZeneca UK Limited as the reference preparation 3 There are 10 enterprises recording be test information of rosuvastatin calcium tablets: 5 enterprises are used for the record of generic drug consistency evaluation test, and the other 5 enterprises are newly declared At present, there are 21 bioequivalence tests of rosuvastatin calcium tablets registered by the national drug clinical trial registration and information publicity platform, and 6 consistency evaluation be tests have been completed It is a coincidence that the three companies all chose "the Second Affiliated Hospital of Zhejiang University Medical College" as the clinical trial institution to carry out clinical trials, and the time did not conflict 4 The latest progress of CDE acceptance conformity evaluation information the latest progress of CDE acceptance conformity evaluation varieties is shown in the table below Zhengda Tianqing and Jingxin pharmaceutical passed the conformity evaluation in the first batch and the second batch respectively It is noteworthy that Haizheng Pharmaceutical Co., Ltd issued the supplement on April 4, 2018, and was re undertaken on April 28 and May 14, 2018 It is expected that it will become the next enterprise to pass the consistency evaluation On April 25, 2018, Shandong new era, a brother company of lunanbeite, obtained FDA's anda number with application number of 207375, which is currently only temporarily approved Finally, we need to pay attention to the situation being declared: at present, 7 acceptance numbers of 4 enterprises have entered the CDE review, including Baiyunshan in Guangzhou, Wansheng in Beijing, Changzhou pharmaceutical and Heyuan in Hefei Among them, rosuvastatin calcium tablet of Changzhou pharmaceutical was approved by FDA as early as October 31, 2016, anda was listed, application number is 207408, specification is 5mg, 10mg, 20mg, 40mg And it has been included in the priority review in China, which will undoubtedly become a potential competitor The above is a brief analysis of rosuvastatin calcium, welcome to correct in the message area at the end of the article.