The acceptance no. of conformity assessment is over 1000; 6 varieties have passed the assessment, 11 varieties have broken through the pass; Yangzijiang, Qilu, hausen, Hengrui, etc

As of March 20, there are 1000 acceptance numbers of CDE acceptance consistency evaluation (calculated according to supplementary application, the same below), involving 304 varieties of 332 enterprises, of which 167 acceptance numbers (80 varieties) have passed the consistency evaluation This week, another 6 varieties have been evaluated, 11 varieties have been approved, and 10 varieties have been accepted Review details 6 varieties, 3 first This week (3.14-3.20), another 8 products (6 varieties) passed the consistency evaluation, tamoxifen citrate tablets and alatrazole tablets in Yangtze River, isosorbide mononitrate tablets in lunanbete, donepezil hydrochloride tablets in Chongqing Zhien pharmaceutical, indapamide tablets in Guangdong anno pharmaceutical and temozolomide capsules in Jiangsu tianshidiyi Among them, four varieties of Yangzi River, Lunan Beite and Jiangsu tianshidiyi Pharmaceutical Co., Ltd are the first ones that have been evaluated The details are as follows: this week's consistency evaluation details table tamoxifen citrate tablets tamoxifen is a non sterol anti estrogen and anti-tumor drug Most of them are used in the treatment of breast cancer with progesterone receptor (PR + and ER + developing sexually In 1966, it was synthesized by the laboratory of chemical industries (ICI) Ltd Pharmaceutical Division (now AstraZeneca company) in the UK It was listed in the United States in 1977 In 2015, it was recommended by the ago guidelines to use the first-line drugs to assist in the treatment of postmenopausal HER2 negative metastatic breast cancer after AI In 2017, it was included in the new version of China's national medical insurance catalog class a drugs According to the domestic drug database of pharmaceutical intelligence, there are 13 domestic market approvals for tamoxifen citrate tablets, 13 manufacturing enterprises, 3 enterprises for consistency evaluation and reference filing, Yangzijiang Pharmaceutical Co., Ltd., Beijing Silian Pharmaceutical Co., Ltd and Shanghai Fudan Fuhua Pharmaceutical Co., Ltd are the first to apply for and have been evaluated Anastrozole tablet is an endocrine therapy drug, which is a powerful non steroidal aromatase inhibitor It is mainly used in the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer Developed by anipharmaceutical Inc, it was approved to be listed in the United States in 1995 At present, it is a class B national medical insurance drug, and it is recommended by many authoritative experts and diagnosis and treatment guidelines According to the network information, 89% of the market of anastrozole tablets is occupied by the original research enterprises, followed by Yangtze River, accounting for about 8% of the market At present, only four enterprises of Yangzijiang, Zhejiang Haizheng, Chongqing Huabang and Zhejiang Wansheng pharmaceutical hold 4 production approval documents for domestic anatrazole tablets Chongqing Huabang pharmaceutical has completed be test, Zhejiang Haizheng pharmaceutical application has been accepted, Yangzijiang is the first to be evaluated, and it is expected to launch an impact on the original research market Isosorbide mononitrate tablet isosorbide mononitrate is a new generation of long-acting nitrate anti angina drug, which is suitable for the long-term treatment of coronary heart disease; the prevention of angina pectoris; the treatment of persistent angina after myocardial infarction; combined with digitalis and / or diuretics to treat chronic congestive heart failure Isosorbide mononitrate tablets, originally developed by Pfizer, have been included in the 2017 national basic medical insurance category B At present, there are 21 domestic approvals and 17 manufacturers of isosorbide mononitrate tablets Lunan Beite occupies the main market of the drug According to the official news of Lunan Beite, the company's product was approved for listing in July 1994, and it is the company's main product, with 43 patents Since the approval for listing, the sales volume has increased year by year By 2018, it has market share of similar products, Accounting for more than 78%, this time it was the first one to pass the consistency evaluation, which undoubtedly strengthened its market position In addition, isosorbide mononitrate tablets of Shijiazhuang Yiling Pharmaceutical Co., Ltd are under evaluation, and be test has been completed, and the evaluation is expected Temozolomide capsule temozolomide is the second generation of oral imidazolium and tetrazine anti-tumor alkylation drugs It is generally used in the treatment of newly diagnosed glioblastoma multiforme, and it is the first-line drug for the treatment of gliomas in the world According to the latest data of iqviachpa, the sales volume of temozolomide products in domestic sample hospitals in 2018 was 1.532 billion people, an increase of 16.7% compared with the same period in 2017, with texel and MSD occupying the main market share According to the pharmaceutical intelligence data, the domestic temozolomide capsules are only two enterprises of Jiangsu tianshidiyi Pharmaceutical Co., Ltd and Beijing Shuanglu Pharmaceutical Co., Ltd., both of which have applied for the consistency evaluation Jiangsu tianshidiyi Pharmaceutical Co., Ltd is the first one to pass the evaluation, further improving the market competitiveness of the product Donepezil hydrochloride tablets donepezil hydrochloride tablets are mainly used for the treatment of dementia symptoms of mild or moderate Alzheimer's disease It was developed by Eisai and listed in the United States in 1996 According to IMS data, the sales volume of the drug in the U.S market in 2017 was about US $25.6052 million There are 9 market approvals and 7 manufacturers of domestic donepezil hydrochloride tablets in China, among which Huahai has been approved in October last year according to the application of new chemical drugs, and it is regarded as the first enterprise that has passed the consistency evaluation Chongqing Zhien Pharmaceutical Co., Ltd has been approved this week according to the supplementary application, and has become the second enterprise that has passed the consistency evaluation of this variety Indapamide tablet indapamide tablet is mainly used in the treatment of essential hypertension According to the latest data of iqviachpa, in 2017, the sales volume of indapamide tablets in China was about 69.18 million yuan According to the statistics of domestic drug database of pharmaceutical intelligence, at present, there are 30 domestic indapamide tablets production approvals, involving 30 manufacturers, among which 21 enterprises have made reference records for consistency evaluation, 14 enterprises have accepted the application, Chongqing Yaoyou has made the first evaluation of the product, and Guangdong anno pharmaceutical passed the second one this week, which is expected to expand market share After the review and approval, 11 varieties have been approved, and the injection will be piled up for review? In addition to the eye-catching overrated varieties this week, the second major focus is on 11 drugs that have been approved, including 6 heavyweight injections from Hengrui, hausen, Qilu, and Zhejiang Haizheng Not surprisingly, six varieties of epirubicin hydrochloride for injection from Haizheng Pharmaceutical Co., Ltd., ditabin for injection from hausen, ambroxol hydrochloride injection from Hainan Quanxing Pharmaceutical Co., Ltd., ditavirin hydrochloride injection from Yangzhou Pharmaceutical Co., Ltd., iodroxol injection from Hengrui Pharmaceutical Co., Ltd and levofloxacin lactate tablet from Xinchang pharmaceutical factory of Zhejiang Pharmaceutical Co., Ltd will win the first prize and pass the consistency evaluation; xianshengdong, Nanjing Another specification of rosuvastatin calcium tablet of metapharma is about to be evaluated; in addition, there are three polyethylene glycol 4000 powder full members in the near future, and the eighth evaluated enterprise of amlodipine besylate tablet will also be born Details of the review and approval of this week's conformity assessment note: the red part is the first "issued" drug after the review and approval of conformity assessment In addition, it is worth mentioning vinorelbine tartrate injection According to the registration and acceptance database of pharmaceutical intelligence, in addition to the conformity evaluation of Qilu Pharmaceutical (Hainan) declaration, Haosen pharmaceutical also declared to be accepted, and in January, the review and approval processing status showed "sent" At present, there is no official news of Haosen's evaluation of this variety This time, Qilu Pharmaceutical (Hainan) is following up, After approval, it remains to be seen who will give priority to good news Changchun Ruibin tartrate injection consistency evaluation application acceptance details application acceptance No 11 acceptance No 10 varieties were undertaken again, Hainan Quanxing Pharmaceutical Co., Ltd was eye-catching this week, the total acceptance no of consistency evaluation successfully went up to 1000, CDE added acceptance No 11, involving 10 varieties, including 3 varieties in 289 catalog, 3 injections, and 4 others See the table below for details: This week's details of the application for acceptance of the consistency evaluation attracted people's attention this week: ambroxol hydrochloride injection of Hainan Quanxing Pharmaceutical Co., Ltd., a classic clinical expectorant, is suitable for acute and chronic lung diseases with abnormal sputum secretion and poor sputum discharge function Its original research enterprise is German bringer Ingelheim company, which was listed in Germany in 1980, and then in France, Italy, Japan, Spain and other countries According to the data of HDM system, in 2016, the amount of ambroxol used in public hospitals in key cities in China was 774 million yuan, accounting for half of the expectorant drug market In 2016, ambroxol injection in domestic sample hospital market accounted for 91.67% This week's application of Hainan Quanxing Pharmaceutical Co., Ltd was accepted for the third application of the consistency evaluation of the variety The acceptance numbers of the two previous applications were in the status of "issued", and it only took four months from the time of undertaking to the time of sending However, there is no good news from the review This week's application again, whether the three acceptance numbers won the first in one fell swoop is worth looking forward to Details of the consistency evaluation of ambroxol hydrochloride injection