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    Home > Medical News > Latest Medical News > [good medicine record] the consistency evaluation acceptance number has broken through 600299 and is 289 varieties; this week, Kelun has 2 billion varieties and Fosun is the first one

    [good medicine record] the consistency evaluation acceptance number has broken through 600299 and is 289 varieties; this week, Kelun has 2 billion varieties and Fosun is the first one

    • Last Update: 2018-12-13
    • Source: Internet
    • Author: User
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    As of December 13, there are 616 application acceptance numbers of CDE acceptance consistency evaluation (calculated according to supplementary application, the same below), 217 varieties of drugs involving 235 enterprises; 299 (82 varieties) of 289 catalog drug acceptance numbers; there are 98 acceptance numbers, 46 varieties have passed the consistency evaluation, and only 22 varieties have passed the consistency evaluation This week (December 6 to December 13), there are two 289 categories of drugs that have been evaluated, three of which have been approved, and there are 36 acceptance No 23 varieties that have been accepted More details can be seen with the editor Consistency evaluation processing status update This week, the first drug potassium chloride granules in Chongqing Yaoyou 289 catalog passed the consistency evaluation before the deadline, and amoxicillin capsule (0.25g (calculated according to c16h19n3o5s)) of Sichuan Kelun passed the consistency evaluation, becoming the fourth evaluated enterprise of the specification; in addition, there are three varieties "approved - to be certified", which will soon be passed, including Hengrui's two heavy-duty injections, It is docetaxel injection and irinotecan hydrochloride injection See the table below for details Details of review and approval of this week's consistency evaluation amoxicillin capsule December 13, amoxicillin capsule declared by Hunan Kelun Pharmaceutical Co., Ltd passed the consistency evaluation Amoxicillin capsule is a 289 catalog drug, which is a category A and 2018 version of basic drug catalog drug for medical insurance In 2017, amoxicillin capsule sales in China reached about RMB 2.059 billion According to the data of pharmaceutical intelligence, the application of consistency evaluation is very hot There are 19 enterprises applying, and the acceptance number is 26 At present, with the addition of Kelun, there are 4 enterprises passing the application Amoxicillin capsule passed the consistency evaluation details potassium chloride granules on December 5, the first drug potassium chloride granules of Chongqing Yaoyou, a subsidiary of Fosun Pharmaceutical, passed the consistency evaluation According to the notice of Fosun Pharmaceutical, in 2017, the sales volume of Chongqing Yaoyou pharmaceutical in China (excluding Hong Kong, Macao and Taiwan) was about 710000 yuan (Unaudited) As of October, Fosun Group has invested about 1.54 million yuan (Unaudited) in R & D for the consistency evaluation of the drug Potassium chloride granules are mainly used to treat hypokalemia and prevent hypokalemia They are also suitable for digitalis poisoning causing frequent, multiple premature beats or tachyarrhythmia According to the domestic drug database of Yaozhi, there are only three domestic potassium chloride granule producers, which are Wuhan Taifu pharmaceutical, Chongqing Yaoyou and Xinghui Tianli (Hangzhou) pharmaceutical At present, Chongqing Yaoyou is the first one to declare and have been evaluated In addition, in addition to the granular potassium chloride preparations, 90 domestic enterprises hold the production approval of potassium chloride injection, 10 enterprises hold the production approval of potassium chloride sustained-release tablets, and 13 enterprises hold the production approval of potassium chloride tablets On December 10, docetaxel injection, according to the registration and acceptance database of smart drugs, the consistency evaluation of one acceptance number of docetaxel injection of Jiangsu Hengrui Pharmaceutical Co., Ltd "approved pending certification" Docetaxel is a semisynthetic product of taxane, which is an anticancer drug acting on microtubules It is mainly used for the treatment of advanced or metastatic breast cancer, advanced or metastatic non-small cell lung cancer with cisplatin based chemotherapy failure Developed by Sanofi Aventis in France, it was first listed in the European Union in November 1995 In May 1996, FDA approved the listing, and in 2002, Hengrui pharmaceutical was approved to be listed in China It is reported that Hengrui pharmaceutical is the ninth approved generic pharmaceutical company According to the database of home-made drugs for pharmaceutical intelligence, at present, there are 39 domestic docetaxel injection production approvals and 20 manufacturers According to the statistics of registration and acceptance database of pharmaceutical intelligence, only Zhengda Tianqing and Jiangsu Hengrui have applied for conformity evaluation so far It is worth noting that the review status of Zhengda Tianqing has been updated to "issued" in September, but has not been eliminated The information notice has been evaluated, and this time Hengrui has also completed the review and approval Whether it will be evaluated or not is worthy of attention According to the registration and acceptance database of intelligent drugs, another acceptance number of consistency evaluation of Jiangsu Hengrui medicine's irinotecan hydrochloride injection was "approved pending certification" Irinotecan hydrochloride injection is a chemotherapeutic drug for gastrointestinal cancer The original research company is Pfizer (Perth) Pty Limited in Australia It is reported that at present, the domestic market of irinotecan hydrochloride injection is mainly occupied by Hengrui, Pfizer and Qilu pharmaceutical, of which Hengrui accounts for more than 60% According to the domestic drug database of pharmaceutical intelligence, there are 9 domestic approvals and 5 production units for irinotecan hydrochloride injection in China At present, only Qilu and Hengrui pharmaceutical apply for conformity assessment Previously, two acceptance numbers of Qilu pharmaceutical have been approved, and one acceptance number of Hengrui shows that it has been approved Now another acceptance number has been approved Who will be the top two enterprises and wait for the official announcement On December 10, according to the registration and acceptance database of intelligent drugs, Zhejiang Jinhua Kangenbei biopharmaceutical oxalicum citalopram tablet was "approved pending certification" According to the drug registration and acceptance database, up to now, there are four enterprises applying for the consistency evaluation of escitalopram tablets, among which Sichuan Kelun Pharmaceutical Co., Ltd., Hunan Dongting Pharmaceutical Co., Ltd and Shandong Jingwei Pharmaceutical Co., Ltd have been evaluated successively This time, Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd will become the fourth evaluated enterprise if it passes successfully Details of the consistency evaluation of escitalopram oxalate tablets This week, CDE added 36 acceptance numbers for consistency evaluation, involving 23 varieties, including 16 acceptance numbers (12 varieties) for 289 catalogue drugs; another 5 application consistency evaluations were accepted, among which 3 were the first application, including gelasetron hydrochloride injection of Qilu pharmaceutical, octreotide acetate injection of Benxi Hengkang pharmaceutical and Nadroparine calcium for injection of Yantai Dongcheng north pharmaceutical; and In addition, Northeast Pharmaceutical Group Shenyang first pharmaceutical zidovudine tablet, Yantai Wanrun pharmaceutical's norfloxacin capsule, Suzhou Sinochem pharmaceutical's cefaclor capsule, Southwest Pharmaceutical's morphine hydrochloride sustained-release tablet are also the first accepted varieties, so this week there are seven first reported drugs Take a look at some of the drugs below: this week's application for conformity assessment was accepted in the form of details of granisetron hydrochloride injection December 10, and the conformity assessment of granisetron hydrochloride injection of Qilu pharmaceutical was undertaken by CDE Granisetron hydrochloride, the first generation of 5-HT3 receptor antagonist, is used for nausea and vomiting caused by radiotherapy and cytotoxic chemotherapy According to the original research of Roche, according to the data of pharmaceutical intelligence, there are 40 domestic approvals and 34 manufacturers of granisetron hydrochloride injection At present, only Qilu pharmaceutical has applied for conformity assessment, and no other enterprises have participated in the filing On December 10, the consistency evaluation of octreotide acetate injection of Benxi Hengkang pharmaceutical was undertaken by CDE Octreotide acetate injection is a synthetic octapeptide compound, which is a 14 peptide human somatostatin analog It is a national class B medical insurance drug It is mainly used in the treatment of pancreatitis, esophageal gastric varices bleeding, gastrointestinal and pancreatic fistula and other symptoms Octreotide was first synthesized by chemist Wilfried Bauer in 1979 The original research unit is Novartis, and its target is GHRF and SSTR It was approved to be listed in 1988 under the name of Suning According to the data of pharmaceutical intelligence, there are 28 domestic approvals for octreotide acetate injection in China, 16 manufacturers, only Benxi Hengkang Pharmaceutical Co., Ltd has applied for the consistency evaluation of the drug, and Sinopharm Yixin Pharmaceutical Co., Ltd and Shanghai Novartis Trading Co., Ltd have made reference records On December 6, the consistency evaluation of nadroparin calcium for injection of Yantai Dongcheng north pharmaceutical Co., Ltd was undertaken by CDE Nadroparin calcium is a new antithrombotic drug It is obtained by depolymerization of heparin extracted from pig intestinal mucosa and belongs to low molecular weight heparin preparation The original research enterprise is speedelin of GlaxoSmithKline It is reported that nadroparin is one of the three low molecular weight heparin preparations with the largest sales volume in the world, and the global sales volume exceeds 300 million US dollars The market model of natroxobin calcium preparation (including low molecular weight heparin calcium) in China is about 2 billion yuan, and sulpirin occupies nearly half of the market share According to the domestic database of pharma intelligence, at present, only Yantai Dongcheng north pharmaceutical Co., Ltd has the domestic approval document, which is the only naltrexaparin calcium powder injection type owned in China Moreover, the approval of this dosage form of naltrexaparin calcium has been stopped by the state, so Yantai Dongcheng north pharmaceutical Co., Ltd will be the permanent exclusive If the conformity evaluation of this application is successful, it will consolidate its market position and impact on the original R & D On December 10, the application for conformity evaluation of zidovudine tablets in 289 catalogue of Shenyang first pharmaceutical Co., Ltd of Northeast Pharmaceutical Group was undertaken by CDE Zidov is defined as an antiviral drug for the treatment of AIDS or AIDS related syndromes and HIV infection Originally developed by GlaxoSmithKline and approved by FDA in 1987, it is the first anti AIDS drug approved by FDA in the world Because of its precise efficacy, it has become the most basic combination of "cocktail" therapy According to the domestic database of pharmaceutical intelligence, there are 8 domestic approval documents and 6 manufacturing enterprises of Qiduofu Ding tablets in China In addition, according to the progress database of consistency evaluation of pharmaceutical intelligence, Shanghai deseno biomedical has participated in the consistency evaluation of filing The first application of Shenyang No.1 Pharmaceutical Co., Ltd of Northeast Pharmaceutical Group has been accepted It is worth mentioning that the variety can be exempted from be test, which is expected to accelerate the 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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