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    Home > Medical News > Latest Medical News > [hot spot] analysis of enterprises for consistency evaluation of rosuvastatin calcium tablets

    [hot spot] analysis of enterprises for consistency evaluation of rosuvastatin calcium tablets

    • Last Update: 2018-11-06
    • Source: Internet
    • Author: User
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    Rosuvastatin calcium tablet was initially developed by AstraZeneca in the UK, and was approved to be listed in the United States in 2003, and approved to enter China in 2006 According to IMS data, the global sales of rosuvastatin calcium tablets in 2017 reached about 4.191 billion US dollars, and China accounted for about 428 million US dollars, accounting for a very high proportion, with a considerable market prospect Rosuvastatin calcium tablets were first approved for marketing in China in 2008, which were respectively owned by Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd., Zhejiang Jingxin Pharmaceutical Co., Ltd and lunambert Rosuvastatin is a selective HMG CoA reductase inhibitor It is one of the latest statins It can effectively reduce blood lipid, reverse atheromatous plaque, reduce atheromatous inflammatory index, and reduce the incidence and mortality of cardiovascular events in high-risk and low-risk patients According to the database of pharmaceutical intelligence, at present, there are 13 domestic approvals and 5 manufacturing enterprises for rosuvastatin calcium tablets, including Nanjing Zhengda Tianqing, Zhejiang Jingxin, Zhejiang Haizheng, Nanjing Xiansheng Dongyuan pharmaceutical and Lunan Beite pharmaceutical, all of which have applied for conformity evaluation, Shanghai Novartis has also applied for the consistency evaluation of rosuvastatin calcium tablets At present, lunambert pharmaceutical and Shanghai Novartis are still in the process of evaluation, and other four enterprises have passed the evaluation one after another, so the drug has become the first product that has passed the evaluation by four enterprises Although four enterprises have passed the evaluation, from the perspective of the application status, there is a high probability that all enterprises applying will pass the evaluation Sexual evaluation Figure 1 consistency evaluation of rosuvastatin calcium tablets according to the needs of the industry, in the consistency evaluation progress database recently, after the progress analysis of drugs, the enterprise progress analysis has been added to the drug intelligence network This function can intuitively understand the progress details of the current consistency evaluation varieties of each enterprise, which is simple and clear Let's take a look at the progress of the enterprise applying for the consistency evaluation of rosuvastatin calcium tablets 1、 Progress analysis of consistency evaluation of Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd Figure 2 Analysis of progress enterprises of consistency evaluation of Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd As can be seen from Figure 2, there are two varieties of Nanjing Zhengda Tianqing that have passed the consistency evaluation at present, namely, rosuvastatin calcium tablets and irbesartan hydrochlorothiazide tablets, and three that have been applied for acceptance, namely entecavir capsule, olmesartan ester tablets and compound sodium acetate ringer injection solution Rosuvastatin calcium tablets were approved on December 29, 2017, and irbesartan hydrochlorothiazide tablets were approved on March 26, 2018 Entecavir capsule was undertaken on May 18, 2018, olmesartan ester tablet was undertaken on June 4, 2018, and compound sodium acetate ringer injection was undertaken on October 22, 2018, which is currently under review and approval 2、 Progress analysis of consistency evaluation of Zhejiang Jingxin pharmaceutical industry figure 3 Analysis of progress enterprises of consistency evaluation of Zhejiang Jingxin pharmaceutical industry From Figure 3, it can be seen that there are three varieties that have passed the consistency evaluation of Zhejiang Jingxin Pharmaceutical Co., Ltd., namely, rosuvastatin calcium tablets, levetiracetam tablets and sertraline hydrochloride tablets There are two varieties that have been declared, namely amlodipine besylate tablets and cefuroxime axetil tablets At present, all of them are under the review and approval In addition, there are eight varieties for reference and filing, of which simvastatin tablets have completed be test Test, azithromycin tablets have also been carried out be test, more details can be seen in Figure 3 3、 Analysis of consistency evaluation progress of Zhejiang Haizheng pharmaceutical Figure 4 Analysis of consistency evaluation progress of Zhejiang Haizheng pharmaceutical from Figure 4, it can be seen that there is one variety of Zhejiang Haizheng pharmaceutical that has passed the consistency evaluation, which is rosuvastatin calcium tablet, approved on July 24, 2018, and tacrolimus capsule has not been approved in the consistency evaluation Two varieties have been applied for acceptance, namely glucosamine sulfate capsule and mycophenolate mofetil capsule, which are under review and approval; in addition, five varieties have been submitted for reference and filing, among which anastrozole tablet be experiment is being recruited, and letrozole tablet is in be filing status 4、 Progress analysis of consistency evaluation of Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd Figure 5 Analysis of progress enterprises of consistency evaluation of Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd From the above figure, it can be seen that rosuvastatin calcium tablet of Nanjing Xiansheng Dongyuan pharmaceutical passed the consistency evaluation on October 22, 2018 It is worth mentioning that it is the fourth enterprise to pass the product In addition, according to the registration and acceptance database of intelligent drugs, there is also an acceptance number in the review and approval of rosuvastatin calcium tablet of Nanjing Xiansheng Dongyuan pharmaceutical In addition, its heavy-duty product edaravone injection The liquid was also accepted on October 30 Data source: Pharmacy intelligence consistency evaluation progress database v analysis chart of lunambert pharmaceutical consistency evaluation progress 6 Analysis of lunambert pharmaceutical consistency evaluation progress enterprises According to the consistency evaluation database of pharmaceutical intelligence, up to now, lunambert pharmaceutical has not passed the consistency evaluation From Figure 6, it can be seen that there are two declared varieties, isosorbide nitrate tablets and rosuvastatin calcium tablets, which are under review and approval There are 4 varieties of be to be declared, including montelukast sodium chewable tablets, cetirizine hydrochloride tablets, mosapride citrate tablets and amoxicillin clavulanate potassium tablets In addition, 7 varieties have been registered 6、 Progress analysis of Shanghai Novartis consistency evaluation According to the progress database of consistency evaluation of pharmaceutical intelligence, up to now, Shanghai Novartis Trading Co., Ltd has applied for conformity evaluation of 5 varieties, among which only amlodipine besylate tablets have carried out intermediate work, but they are still in the process of be filing In addition, Shanghai Novartis has 9 varieties of reference filing, among which atorvastatin calcium tablets have completed be filing, more details can be seen in the following figure: 7 Shanghai Novartis consistency evaluation progress details the database can analyze the progress details of consistency evaluation from both the enterprise and the variety Both ways work together without any details From the variety analysis, we can know the details of each enterprise applying for the variety, and at the same time, we can know the progress of the competitive enterprise of the variety at any time, and adjust the work of our own enterprise; from the enterprise analysis, we can see the progress details of all varieties of the consistency evaluation of each enterprise at a glance In a word, enterprise analysis of consistency evaluation progress database is a powerful assistant for consistency evaluation Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.
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