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    Home > Medical News > Latest Medical News > [good medicine record] the consistency evaluation of Hengrui heavyweight chemotherapy potential injection was undertaken, and the first 6 drugs passed the consistency evaluation!

    [good medicine record] the consistency evaluation of Hengrui heavyweight chemotherapy potential injection was undertaken, and the first 6 drugs passed the consistency evaluation!

    • Last Update: 2018-05-25
    • Source: Internet
    • Author: User
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    This week (May 17 to May 23), the consistency evaluation was reported frequently According to the statistics of pharmaceutical intelligence data, as of May 23, 160 acceptance numbers of conformity assessment have been registered in CDE, involving 71 varieties of 75 pharmaceutical enterprises, and 41 acceptance numbers have been approved This week (May 17 to May 23) a total of 7 acceptance numbers have been undertaken by CDE, and 12 acceptance numbers have passed the examination and approval Compared with the previous week, 10 acceptance numbers have passed the examination and approval See the details with the editor Update of undertaking status: 7 acceptance No 6 varieties were undertaken this week, another 7 generic drugs were undertaken by CDE (based on acceptance No.), belonging to Zhengda Fenghai, Zhengda Tianqing, Hengrui, Novartis and other enterprises Details are shown in the table below: Isoniazid Tablets on May 23, the application for consistency evaluation of isoniazid tablets of Huazhong Pharmaceutical Co., Ltd was undertaken Isoniazid tablet is a kind of antituberculous drug It can be used in combination with other antituberculous drugs for the treatment of various types of tuberculosis, and only for the prevention of various types of tuberculosis According to the database of pharmaceutical intelligence, only one isoniazid tablet of Huazhong Pharmaceutical Co., Ltd has been accepted for CDE consistency evaluation On May 21, the application for consistency evaluation of cefadroxil capsule was accepted by Aomei pharmaceutical factory Cefadroxil capsule is suitable for the treatment of urinary tract infection, skin soft tissue infection, acute tonsillitis, acute pharyngitis, otitis media and lung infection caused by sensitive bacteria According to the database of pharmaceutical intelligence, only one cefadroxil capsule from Aomei pharmaceutical factory has been accepted by CDE On May 21, Zhengda Tianqing's application for the consistency evaluation of fordostan tablets was accepted This medicine is a new kind of phlegm dissolving medicine, which is mainly used in the expectorant treatment of respiratory diseases In 2016, the market of fudosten, a public hospital in key cities in China, exceeded 33.3 million yuan, ranking the top 5 in the expectorant drug market At present, there are only 5 domestic enterprises that have obtained the production approval documents of fordostan tablets, including Changjiang pharmaceutical, Disha pharmaceutical, Zhengda qingqingbao, Sichuan pearl and Zhengda Tianqing, and only one enterprise that has applied for the consistency evaluation of the drug is Zhengda Tianqing On May 18, the application for consistency evaluation of docetaxel injection of Hengrui medicine was accepted Docetaxel injection is a kind of microtubule inhibitor, which is mainly used to treat advanced or metastatic breast cancer with failure of advanced chemotherapy, advanced or metastatic non-small cell lung cancer with failure of cisplatin based chemotherapy In 2015, the sales volume of docetaxel injection in the U.S market was $154 million, while that in China was $318 million In 2017, docetaxel injection of Hengrui medicine was approved for marketing in the United States Docetaxel injection is one of the most potential drugs in the tumor chemotherapy market At present, there are 18 domestic enterprises that have obtained the production approval documents of docetaxel injection However, according to the drug intelligence database, only one enterprise in Jiangsu Hengrui has applied for the consistency evaluation, which will bring the absolute advantage of docetaxel injection to the domestic market On May 18, the application for the consistency evaluation of rosuvastatin calcium tablets of Novartis Shanghai was accepted Rosuvastatin calcium is a selective HMG CoA reductase inhibitor, which can be used to treat primary hypercholesterolemia (type Ⅱ a, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type Ⅱ b) In 2017, the drug sales in domestic sample hospitals was 67.8 million Up to now, there are 5 companies applying for generic drugs of rifastatin calcium tablets, including Shanghai Novartis, Nanjing Xiansheng Dongyuan, Zhejiang Haizheng, Zhejiang Jingxin and Nanjing Zhengda Tianqing Among them, Zhejiang Jingxin and Nanjing Zhengda Tianqing pharmaceutical have passed the consistency evaluation Update of the review status of the detailed evaluation form for the consistency of rosuvastatin calcium tablets: the first approval of 12 acceptance 6 drugs On May 22, the State Drug Administration announced the fourth batch of conformity evaluation drugs, involving 12 drug specifications of 9 enterprises, including Zhejiang Huahai, Zhengda Tianqing, Shanghai Desano, Zhejiang Jingxin, Beijing Jialin, Jiangxi Qingfeng, Hunan Dongting, Shiyao Ouyi, Jiangsu Haosen, among which 6 drugs were the first to pass, namely, atorvastatin calcium tablets and Shiyao Ouyi of Beijing Jialin Tramadol hydrochloride tablets, olanzapine tablets from Haosen, Jiangsu, zuoeilacetan tablets from Jingxin Pharmaceutical Co., Ltd., efaviron tablets from desenol bio, and nevirapine from Huahai Pharmaceutical Co., Ltd The details are as follows: atorvastatin calcium tablets are the first to pass the consistency evaluation in Beijing Jialin atorvastatin (the good news of consistency evaluation in the good medicine record compiled last week is continuous, the first to pass Jialin "alo" and 5 varieties have been undertaken) Atorvastatin calcium tablet is suitable for patients with primary hypercholesterolemia It is the leader in the lipid-lowering market It is the only statins with a lipid-lowering range of more than 50% and the only one with indications for coronary heart disease in China According to statistics, from 1998 to 2017, the total sales volume of the drug in the world was nearly 140 billion US dollars, the first total sales volume in the history of medicine to exceed 100 billion US dollars The weight of the drug In 2017, its sales reached US $2.11 billion, up 6.03% year on year It ranked fourth in cardiovascular system drug sales in 2017 At present, only two enterprises apply for conformity assessment, namely Beijing Jialin and Zhejiang xindonggang pharmaceutical This time, Jialin pharmaceutical's atorvastatin calcium tablets passed the consistency evaluation, seized the opportunity of domestic market, and will compete with Pfizer's "Lipitor" market Details of the consistency evaluation of atorvastatin entecavir dispersible tablets (capsules) on May 22, Zhengda Tianqing and Jiangxi Qingfeng entecavir dispersible tablets (capsules) passed the consistency evaluation Entecavir dispersible tablet (capsule) is a nucleoside hepatitis B treatment drug According to the public data, in 2017, the sales of drugs in domestic sample hospitals of entecavir was 5 billion, with Zhengda Tianqing accounting for the highest proportion of drug manufacturers, accounting for 43.46% According to the statistics of pharmaceutical intelligence database, at present, there are 5 enterprises applying for entecavir consistency evaluation, namely, Zhengda Tianqing, Anhui shell biology, Sichuan hisico, Suzhou Dongrui pharmaceutical and Jiangxi Qingfeng Only Zhengda Tianqing and Jiangxi Qingfeng passed the consistency evaluation Details of the consistency evaluation of entecavir dispersible tablets (capsules) tramadol hydrochloride tablets on May 22, the first tramadol hydrochloride tablets of the stone drug Ouyi passed the consistency evaluation Tramadol is an opiate, mainly used as an analgesic, which can relieve ordinary to severe pain According to public data, in 2017, the sales volume of tramadol hydrochloride in domestic sample hospitals was 109 million, and the highest proportion of hospital drug manufacturers was Mundipharma (Mundi), accounting for 71.92% According to the statistics of pharmaceutical intelligence database, at present, only one company from Ouyi group has applied for conformity assessment Through the consistency evaluation, it is expected to break the monopoly of the drug import Olanzapine film on May 22, Jiangsu Haosen's olanzapine film passed the consistency evaluation for the first time Ornithine is the largest variety in the field of psychotherapy in China It is mainly used in the acute and maintenance treatment of schizophrenia and other psychosis with serious positive symptoms (such as delusion, hallucination, thinking disorder, hostility and suspicion) and / or negative symptoms (such as emotional apathy, emotional and social withdrawal, speech poverty) According to the public data, in 2017, the sales volume of olanzapine tablets in domestic sample hospitals was 1.837 billion, and the proportion of hospital drug sales manufacturers was the highest in Jiangsu Haosen pharmaceutical industry, accounting for 59.98% According to the statistics of pharmaceutical intelligence database, at present, only one enterprise of Jiangsu Haosen Pharmaceutical Co., Ltd has applied for conformity assessment On May 22, zuoxiracetam tablets of Zhejiang Jingxin Pharmaceutical Co., Ltd passed the consistency evaluation for the first time Levetiracetam is the only antiepileptic drug that can prevent epilepsy According to the public data, in 2017, the drug sales volume of domestic sample hospitals of levetiracetam tablets was 900 million, and the highest proportion of drug sales manufacturers in hospitals was UCB (optimal time ratio), accounting for 94.16% According to the statistics of pharmaceutical intelligence database, at present, only one enterprise in Zhejiang Jingxin Pharmaceutical Co., Ltd applies for conformity assessment Zuoxiracetam has a huge market prospect, and Beijing new pharmaceutical industry is the first to pass the consistency evaluation, which has an absolute market advantage in China Escitalopram oxalate tablets of Hunan Dongting Pharmaceutical Co., Ltd., a subsidiary of Fosun, passed the consistency evaluation on May 22 Escitalopram oxalate tablet is an antidepressant and a single right-handed optical isomer of racemic citalopram, a derivative of dicyclohydrophthalein According to the public data, in 2017, the sales volume of the drug in domestic sample hospitals was 1.2 billion, and the highest proportion of drug manufacturers in hospitals was H lumdbeck (Lingbi), 59.94% According to the statistics of pharmaceutical intelligence database, at present, there are three enterprises applying for the consistency evaluation of escitalopram oxalate tablets, namely Shandong Jingwei, Hunan Dongting and Sichuan Kelun pharmaceutical, among which two enterprises of Hunan Dongting and Sichuan Kelun pharmaceutical have passed the consistency evaluation Details of the consistency evaluation of escitalopram oxalate tablets nevirapine tablets on May 22, Zhejiang Huahai pharmaceutical's nevirapine first passed the consistency evaluation Nevirapine is an anti AIDS drug According to the data, the domestic market scale of nevirapine tablets in 2016 was 367000 yuan At present, only one enterprise of Zhejiang Huahai Pharmaceutical Co., Ltd applies for conformity assessment On May 22, efaviron tablets were the first to pass the consistency evaluation Efeverene is a selective non nucleoside reverse transcriptase inhibitor of human immunodeficiency virus type 1 (HIV-1) It has high oral bioavailability and long half-life It is clinically used in the treatment of HIV-1 infected adults, adolescents and children over 3 years old It is a global first-line anti AIDS drug At present, only one enterprise of Shanghai Di Sano biology has applied in China, and only two enterprises in China have obtained production approval documents, namely, Shanghai Di Sano biology and Zhejiang Huahai pharmaceutical [good medicine record] column for you to track the latest trend of consistency evaluation in a week! 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