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    Home > Medical News > Latest Medical News > [exclusive] in the rush of consistency evaluation: in October, the number of applications broke the history again, and amoxicillin capsule, a 289 drug, was scrambled for the report; 7 varieties were reviewed again, and 2 varieties formed a tripartite confrontation

    [exclusive] in the rush of consistency evaluation: in October, the number of applications broke the history again, and amoxicillin capsule, a 289 drug, was scrambled for the report; 7 varieties were reviewed again, and 2 varieties formed a tripartite confrontation

    • Last Update: 2018-11-14
    • Source: Internet
    • Author: User
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    The time is just like a fleeting gap Suddenly, the blink of an eye passes quietly in October In 2018, there is no doubt that it has entered the countdown mode In the critical year of consistency evaluation, every update of CDE on the dynamics of consistency evaluation affects the hearts of medical people In October, the consistency evaluation was pushed forward rapidly, breaking through history again In October, the consistency evaluation broke the history again, 81 acceptance No 51 variety was undertaken According to the database of drug registration and acceptance, as of November 9, CDE has accepted 523 acceptance numbers of consistency assessment, involving 191 varieties of 197 enterprises, of which 81 were accepted in October, the same as that in September, while 51 varieties were declared, once again breaking through the history of declaration, increasing 4 varieties compared with that in September; in addition, it is worth mentioning the 289 catalogue drugs in October The product declaration was even more rapid, with No 55 acceptance and No 31 varieties being undertaken, an increase of 54.55% and 63.12% year on year in September Amoxicillin capsule into the consistency evaluation declaration of the pop money varieties According to the drug registration and acceptance database of drug intelligence data, in October, amoxicillin capsule, metformin hydrochloride, amlodipine besylate tablets and other star 289 catalog drugs became the hot products sought by enterprises, among which amoxicillin capsule was the most popular product In October, there were 6 enterprises applying, followed by amlodipine besylate tablets and metformin hydrochloride tablets, Three new enterprises are to be declared See the following table for details: Top 7 of the number of drug declaration enterprises in October 289 It is worth mentioning that up to now, amoxicillin capsule has 22 application consistency assessment acceptance numbers, ranking first in the list of application consistency assessment acceptance numbers, with 16 application enterprises, among which 2 enterprises have passed, including Zhejiang Jinhua Kangenbei biopharmaceutical and Zhuhai federal pharmaceutical; amlodipine besylate tablet has 19 acceptance numbers, involving 17 Enterprises, and 3 enterprises have been evaluated, including China Resources SECCO, Yangtze River and Jiangsu Huanghe pharmaceutical industry, however, failed to reduce the enthusiasm of other enterprises to declare; there are 12 application acceptance numbers of metformin hydrochloride tablets, 11 application enterprises, and 2 enterprises have passed, which are used to make drugs for Ouyi (deemed to pass) and Beijing Sihuan In addition, according to the pharmaceutical intelligence data, the consistency evaluation of metformin hydrochloride tablets in South China Pharmaceutical Industry in Guangdong Province recently The processing status is displayed as "certificate preparation completed - to be issued for approval" If there is no accident, it will become the third enterprise that has passed the consistency evaluation of the drug The consistency evaluation of injection was eye-catching, and 5 varieties were undertaken for the first time In October, in addition to the 289 list of drugs, the application for injection consistency evaluation was also a bright spot According to the pharmaceutical intelligence data, in October, there were a total of 16 injection application acceptance numbers, involving 11 varieties, including the heavyweight products of Qilu pharmaceutical, Zhengda Tianqing, Jiangsu aosaikang, Jiangsu Haosen and other enterprises In addition, in October, the first application of six varieties was undertaken, namely, Nanjing Xiansheng Dongyuan pharmaceutical Edaravone injection, Hubei Kelun pharmaceutical potassium chloride injection, Nanjing Zhengda Tianqing compound sodium acetate ringer injection, Hubei pharmaceutical levofloxacin lactate sodium chloride injection, Guangdong Jiabo pharmaceutical propofol emulsion injection and Zhejiang Pharmaceutical vancomycin hydrochloride for injection For more details, see the following table: details of consistency evaluation of injection declaration in October According to the statistics of pharmaceutical intelligence data, in October, a total of 10 acceptance 7 varieties passed the consistency evaluation See the following figure for details: the details of consistency evaluation passed in October Among them, Zhejiang Jingxin pharmaceutical's sertraline hydrochloride tablets and Zhejiang Huahai pharmaceutical's donepezil hydrochloride tablets are the first evaluated varieties It is worth noting that the donepezil hydrochloride tablets of Huahai pharmaceutical are classified according to the new registration of generic drugs (the quality and efficacy of the drugs are the same as the original research), and are included in the priority review of the approved varieties as "the same production line, listed in the United States in 2011", and pass by the corner In addition, the consistency evaluation of irbesartan tablets and escitalopram oxalate tablets were collected According to the data of pharmaceutical intelligence, up to now, there are seven drugs that have passed the consistency evaluation of three enterprises, among which rosuvastatin calcium tablet is the first product that has passed the consistency evaluation of four enterprises The details are as follows: The consistency evaluation has passed the data source of drug details list of three enterprises: drug intelligence data statement: this view only represents the author, not the position of drug intelligence network, welcome to exchange and supplement in the message area; 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