[good medicine record] the competition of consistency evaluation is intensified! This variety has reached 4 through enterprises, and 11 289 varieties have been undertaken this week

As of October 18, there were 451 acceptance numbers of consistency evaluation accepted by CDE, involving 178 varieties of 166 enterprises, and 72 (41 varieties) passed the acceptance number, while only 19 varieties of 289 catalog drugs passed the acceptance This week, there are 22 new acceptance numbers, 19 varieties, and 11 drugs in 289 catalog In addition, this week, another 2 drugs passed the consistency evaluation, among which, Xiansheng pharmaceutical became the fourth enterprise that passed the risuvastatin calcium tablet, and risuvastatin calcium tablet also became the first variety that reached 4 enterprises 1 The two drugs passed the consistency evaluation The first four enterprises passed the consistency evaluation this week, and another two drugs passed the consistency evaluation They are risuvastatin calcium tablet of Xiansheng pharmaceutical and amoxicillin capsule of Kangenbei biopharmaceutical in Jinhua, Zhejiang Province See the details with the editor On October 16, risuvastatin calcium tablet, the official website of Xiansheng pharmaceutical company announced that its subsidiary, Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd., had received the supplementary application approval document from the State Drug Administration, and "shufutan ® - risuvastatin calcium tablet" passed the consistency evaluation of generic drugs Rosuvastatin is a selective and competitive HMG-CoA reductase inhibitor, which is one of the latest statins It is suitable for primary hypercholesterolemia or mixed dyslipidemia The original research company is AstraZeneca, which was listed in the United States in 2003 According to IMS data, the global sales volume of rosuvastatin calcium tablets in 2017 is about 4.191 billion US dollars, including 428 million US dollars in China; the global sales volume in January March 2018 is about 876 million US dollars, including 129 million US dollars in China According to the pharmaceutical intelligence data, at present, there are 13 domestic approval documents for rosuvastatin calcium tablets and 5 manufacturers, all of which have applied for conformity assessment At present, only lunanbeite pharmaceutical is still under review Nanjing Zhengda Tianqing, Zhejiang Jingxin, Zhejiang Haizheng and Nanjing xianshengdongyuan pharmaceutical have passed the review one after another It is worth mentioning that Nanjing xianshengdongyuan pharmaceutical is the fourth approved enterprise of this variety, and rosuvasta Ting calcium tablet became the first product with 4 enterprises passing the consistency evaluation On the evening of October 11, amoxicillin capsule, Zhejiang Kangenbei Pharmaceutical Co., Ltd announced that its holding subsidiary Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd had received the approval document for supplementary application for amoxicillin capsule issued by the State Drug Administration The drug passed the consistency evaluation of generic drugs, and the second enterprise passed after Zhuhai United Pharmaceutical Co., Ltd Amoxicillin capsule, 289 catalogue drug, is a penicillin antibiotic, which is suitable for the respiratory tract infection, urogenital tract infection, skin and soft tissue infection caused by sensitive bacteria (no β lactamase producing strains) and the eradication of Helicobacter pylori with other drugs According to the network data, the market scale of amoxicillin capsule in China is about 2.44 billion yuan, and the market share is more than 80% According to the pharmaceutical intelligence data, at present, there are 241 domestic approvals and 144 manufacturers of Amoxicillin Capsules in China, among which 61 are the enterprises for the consistency assessment of be record, 11 are the enterprises for the consistency assessment, only two enterprises, Zhuhai United pharmaceutical and Kangenbei, have passed Next, who will take the last place among the nine enterprises in the trial and become the third one is worth looking forward to (Note: due to the limited space, only the progress bar of the conformity evaluation of the declared enterprises is displayed.) 2 The conformity evaluation of 19 varieties is accepted, and there are 11 drugs in 289 catalogue This week, 22 Acceptance numbers were added to the consistency evaluation, involving 19 varieties of 18 enterprises, including 11 drugs in 289 catalogue; in addition, the first application varieties were 7, namely, China Resources double crane cefixime dispersible tablets, vancomycin hydrochloride for injection in Zhejiang medicine, Zhejiang Haizheng Pharmaceutical Co., Ltd., mycophenolate mofetil capsule, Sinopharm group Compound Glycyrrhiza tablet, and Zhejiang medicine levofloxacin lactate chloride Hua Na injection, Ruiyang pharmaceutical ranitidine hydrochloride tablets and Baiyunshan carboxymethylstan tablets, the details are as follows: acceptance details of this week's consistency evaluation cefixime dispersible tablets October 17, the consistency evaluation of China Resources Shuanghe cefixime dispersible tablets was undertaken by CDE Cefixime is the third generation of cephalosporin antibiotics, which is used in respiratory system and urinary system infection caused by sensitive bacteria The original research enterprise is Fujisawa Pharmaceutical Co., Ltd According to network data, in 2017, the sales volume of domestic hospitals reached 1 billion yuan, ranking the second in the sales of oral cephalosporins According to the pharmaceutical intelligence data, at present, China has 11 market approvals for cefixime dispersible tablets, 12 manufacturing enterprises, 7 enterprises with consistency evaluation reference filing, and the first application of Huarui Shuanghe has been accepted On October 16, the consistency evaluation of vancomycin hydrochloride for injection in Zhejiang medicine was undertaken by CDE Vancomycin hydrochloride for injection is a peptide antibiotic, which is the first-line drug for the treatment of methicillin resistant Staphylococcus aureus infection Originally developed by Lilly company, it was the first (sugar) peptide antibiotic variety approved by FDA in 1958 It was introduced into the Chinese market in 1997 According to the pharmaceutical intelligence data, at present, there are only 3 domestic approval documents for vancomycin hydrochloride for injection, and the manufacturing enterprises are Zhejiang Pharmaceutical and Zhejiang Haizheng pharmaceutical Now Zhejiang Pharmaceutical has been accepted as the first to apply for the conformity evaluation If it passes the evaluation successfully, it will enjoy the policy dividend and further improve the market competitiveness On October 15, the consistency evaluation of mycophenolate capsule of Zhejiang Haizheng Pharmaceutical Co., Ltd was undertaken by CDE Mycophenolate mofetil is an immunosuppressant, which can be used in the prevention of rejection and treatment of refractory rejection in kidney transplantation patients It can be used simultaneously with cyclosporine and adrenocortical hormone Developed by Roche, it was first approved by FDA in 1995 According to IMS data, the global sales volume of mycophenolate capsule (250mg specification) in 2016 was about 366 million US dollars, of which the sales volume in domestic market was about 121 million US dollars; the global sales volume from January to June 2017 was about 171 million US dollars, of which the sales volume in domestic market was about 56.84 million US dollars According to the pharmaceutical intelligence data, there are 11 domestic approvals and 11 manufacturing enterprises for mycophenolate capsule, among which 6 are for reference and filing of consistency evaluation, the first application of Zhejiang Haizheng pharmaceutical industry has been accepted, and it is worth mentioning that Zhejiang Haizheng pharmaceutical industry has been approved for listing by the US FDA in November last year On October 12, the consistency evaluation of Compound Glycyrrhiza tablet of State Pharmaceutical Group was undertaken by CDE Compound Liquorice Tablets, listed in 289, is a commonly used antitussive and expectorant drug According to the pharmaceutical intelligence data, at present, there are 36 market approvals for compound liquorice tablets in China, involving 33 manufacturing enterprises, of which 2 enterprises are involved in the consistency evaluation reference filing, and the first application of Sinopharm group has been accepted On October 12, the consistency evaluation of levofloxacin lactate and sodium chloride injection of Zhejiang medicine was undertaken by CDE Levofloxacin lactate and sodium chloride injection, with wide antibacterial spectrum and strong antibacterial effect, is used for moderate and severe infections caused by sensitive bacteria It is reported that levofloxacin lactate and sodium chloride injection are the largest quinolones sold in the world and China According to the pharmaceutical intelligence data, at present, there are 190 domestic approvals for levofloxacin lactate and sodium chloride injection, 82 manufacturers, and Zhejiang Pharmaceutical is the first to apply for conformity assessment, seizing the opportunity On October 12, the consistency evaluation of ranitidine hydrochloride tablets of Ruiyang pharmaceutical was undertaken by CDE Ranitidine hydrochloride tablet, 289 catalogue drug, is a strong histamine H2 receptor antagonist, which is used to relieve stomach pain, heartburn (heartburn) and acid regurgitation caused by excessive gastric acid Developed by GlaxoSmithKline, it was first listed in the UK in 1981 According to drug intelligence data, ranitidine hydrochloride tablets currently have 79 domestic approvals and 76 manufacturers, with fierce competition However, only the consistency evaluation of application of Ruiyang pharmaceutical is available On October 12, the consistency evaluation of Baiyunshan carboxymethylstan tablets was undertaken by CDE Carboxymethylstan tablets, 289 catalog varieties, is a kind of sputum regulator, can affect the secretion of bronchial glands, reduce the viscosity of sputum It is used to treat the symptoms of thick sputum and difficult expectoration caused by chronic bronchitis and asthma According to the pharmaceutical intelligence data, there are 117 domestic approvals for carboxymethylstan tablets and 113 manufacturing enterprises, among which 5 enterprises are involved in the consistency evaluation and reference filing, and Baiyunshan is the first one to declare and accept the application Information, data sources: Pharmaceutical intelligence database, enterprise announcement, network public information and other statements: this point of view only represents the author, not the position of pharmaceutical intelligence network, welcome to exchange and supplement in the message area; 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