[good medicine record] weekly trend of consistency evaluation: the first evaluation of 10 billion market-oriented varieties, 5 drugs in the near future, 12 drugs accepted

As of June 6, 1166 acceptance numbers (348 varieties of 365 enterprises, calculated according to supplementary application, the same below) of CDE's acceptance numbers have passed the consistency evaluation, including 209 acceptance numbers (94 varieties) This week, there were 3 varieties that had been evaluated, 16 acceptance No 12 variety application was accepted, and 5 varieties were about to pass The first 10 billion varieties passed the consistency evaluation this week (May 30 to June 6), including acarbose capsule of LVYE pharmaceutical, fudosten tablet of Sichuan Kelun pharmaceutical and Cefalexin capsule of Luoxin pharmaceutical Acarbose capsule is a kind of α - glucosidase inhibitor, which is mainly used to treat type II diabetes and reduce postprandial blood sugar of people with low glucose tolerance The original research enterprise is Bayer, which was listed in Europe and America in 1994 and entered China in 1995 At present, there are three dosage forms of acarbose on the market in China: chewable tablets, tablets and capsules In addition to chewable tablets, Acarbose Tablets and acarbose capsules have been included in the national basic drug catalog and included in the national medical insurance category a It is reported that the total market value of Chinese acarbose products in 2018 is estimated to be about 10 billion yuan Acarbose capsule of LVYE pharmaceutical is the third most commonly used acarbose product in China and the ninth largest oral hypoglycemic drug In addition, according to the pharmaceutical intelligence data, at present, except Bayer, the original manufacturer, the domestic enterprises only have the market approval of Acarbose Tablets, and the chewing tablets only have the production approval of Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.; the formulation of acarbose capsules is held by LVYE Pharmaceutical Co., Ltd At present, one product specification of Acarbose Tablets of Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd has passed the consistency evaluation, and the other one has been approved recently, and the review is imminent; meanwhile, the acarbose capsule of LVYE Pharmaceutical Co., Ltd has recently obtained the supplementary application approval, and passed the consistency evaluation It is worth noting that at present, only two varieties of LVYE pharmaceutical have been applied for conformity assessment, among which acarbose capsule is the first one that has passed the conformity assessment Details of the consistency evaluation of green leaf pharmaceutical products fudosten tablets fudosten belongs to myxolysis agent, the latest Stan drugs, clinical first-line therapeutic drugs; mainly used for expectorant treatment of various respiratory diseases such as asthma, chronic bronchitis, bronchiectasis, etc Developed and produced by SSP company of Japan and welside company of Mitsubishi, it was first listed in Japan in 2001 In 2009, China's first generic drug was listed on the market, and the drug was listed in the national medical insurance class B in 2017 According to the pharmaceutical intelligence data, there are currently five market approvals for domestic fudosten tablets, involving five enterprises, namely, Disha pharmaceutical, Zhengda Fenghai, Kelun, Yangzi River and Zhengda qingqingqingbao In addition to Zhengda Qingbao, which has not yet applied for conformity evaluation, the other four enterprises have applied for acceptance, including Zhengda Fenghai, which was the first evaluated in March this year, the second evaluated in Kelun pharmaceutical this week, and successfully occupied the top three places To enhance the competitiveness of products Cefalexin capsule is the first generation cephalosporin It is mainly used in the treatment of mild infections caused by sensitive bacteria, such as acute tonsillitis, angina, otitis media, sinusitis, bronchitis, pneumonia and other respiratory infections, urinary tract infections and skin and soft tissue infections At present, Cefalexin capsule has been included in the national basic drug catalog and national medical insurance catalog class A According to the pharmaceutical intelligence data, there are 345 market approvals for domestic cephalexin capsules in China, involving 233 manufacturers, of which 41 enterprises have carried out the consistency evaluation reference filing, 14 have applied for acceptance, the first one in Hunan Kelun pharmaceutical industry has been evaluated, another one in this week's evaluation, and the second one in Shandong Luoxin pharmaceutical industry has successfully arrived at the other side of the consistency evaluation Note: the chart only shows the progress of the enterprises that have applied for acceptance It is worth mentioning that in addition to the two enterprises that have been evaluated, 10 enterprises have completed the be test Huazhong pharmaceutical and Shanghai Xinya pharmaceutical just applied for acceptance this week In addition, according to the registration and acceptance database of smart drugs, the product of Shanghai Fuda Pharmaceutical Co., Ltd has been in the state of "approved to be certified" No accident, it will be the third enterprise to pass the consistency evaluation of Cefalexin capsule 2 Review and approval 5 varieties are in the process of over evaluation Another variety has approved the first Cefalexin capsule of Shanghai Fuda pharmaceutical and acarbose tablet of Hangzhou Zhongmei Huadong pharmaceutical, and 3 varieties have also been in the status of pending certification Details are as follows: update details of this week's consistency evaluation review and approval status Although simvastatin tablets have been applied for conformity assessment by five enterprises, three enterprises, including sanders (China) Pharmaceutical Co., Ltd., Shanghai Xinyi Vientiane Co., Ltd and Zhejiang Jingxin Co., Ltd., have completed be test, and Haizheng Pfizer is the first enterprise that has completed the examination and approval In January this year, Haizheng Pfizer has already issued the acceptance No 1, and this week, there are another acceptance No 3, which has been approved at the same time If it goes well, it will be selected First, first to be judged Clindamycin hydrochloride capsule has been evaluated by Chongqing Yaoyou and Sichuan Kelun Pharmaceutical Co., Ltd before that, Yichang humanwell may be in the top three places In addition, four enterprises of montmorillonite have been evaluated, namely Yangzijiang Pharmaceutical Co., Ltd., Sichuan Weiao Pharmaceutical Co., Ltd., Shandong hongjitang Pharmaceutical Co., Ltd and Xiansheng Pharmaceutical Co., Ltd., which have been approved by Kangenbei in Hangzhou this week and will soon join the evaluation queue 12 varieties applied for acceptance were accepted, and 16 new acceptance numbers of consistency evaluation were added to CDE this week, involving 12 varieties One of the new varieties is Levamlodipine besylate tablets of Zhejiang onlycon Pharmaceutical Co., Ltd and three injections are propofol medium / long chain fat emulsion injection of Guangdong Jiabo Pharmaceutical Co., Ltd., azithromycin for injection of national drug Guorui, and oxaliplatin for injection of Yangtze River Pharmaceutical Co., Ltd Details of acceptance of this week's conformity assessment declaration note: the red part is the new varieties of this week It is worth noting that azithromycin for injection is the first and only injection that has passed the consistency evaluation according to the supplementary application This week, Sinopharm Guorui Pharmaceutical Co., Ltd., after Hainan Puli Pharmaceutical Co., Ltd., has accepted the second application It is worth looking forward to whether, on the basis of Hainan Puli Pharmaceutical Co., Ltd as the pioneer, it can pass the customs quickly before the injection consistency evaluation is officially opened At the same time, this week, CDE released the catalogue of the 22nd batch of reference preparations, totaling 495 products, including 230 injection reference preparations, accounting for 46%; in addition to 244 injection reference preparations in the catalogue of the 21th batch of reference preparations, CDE released a total of 474 injection reference preparations When the 21st batch of reference preparations was published, the industry's hot discussion on the consistency evaluation of injections will be officially implemented This CDE will increase the number of reference injections, and the consistency evaluation of injections may be implemented soon Some sources of information content: Internet public information such as yaozhi.com, enterprise announcement, etc data sources: Internet public information such as enterprise announcement, etc statement: this point of view only represents the author and does not represent the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please note the author and source of the article.