[good medicine record] the acceptance number of consistency evaluation is broken 1100, the first evaluated varieties of Xinhua Pharmaceutical and kangkeri are born; the domestic unique varieties will pass the customs; the first imitated varieties of Jingxin will be undertaken, and

As of May 16, the second week of May, there were 1104 acceptance numbers of CDE acceptance consistency evaluation (337 varieties of 347 enterprises, calculated according to supplementary application, the same below); among them, 199 acceptance numbers (92 varieties) passed the consistency evaluation, with the completion rate of 18.03% This week, another variety passed the consistency evaluation, 3 varieties were approved, and the past evaluation was imminent; another 14 varieties were applied for acceptance, and Beijing New Pharmaceutical Co., Ltd has undertaken the first heavy anti Parkinson drugs, and has completed the be test, which has passed the evaluation period 01 details of the review: Xinhua Pharmaceutical and Chongqing kangkeri's first reviewed product were born this week (may 9-may 16) The same product glimepiride tablets of Shandong Xinhua Pharmaceutical and Chongqing kangkeri pharmaceutical passed the consistency evaluation one after another, among which the product of kangkeri pharmaceutical passed the specification of 1mg, while Shandong Xinhua Pharmaceutical passed the specification of 1mg and 2mg The details of this week's consistency evaluation are worth mentioning that this product is the first drug that has passed the consistency evaluation by each of the two enterprises; and so far, there are three enterprises that have passed the consistency evaluation of glimepiride tablets with the specifications of 1mg and 2mg (1mg: Jiangsu Wanbang biochemical medicine, Chongqing kangkeri pharmaceutical, Xinhua Pharmaceutical; 2mg: Jiangsu Wanbang biochemical medicine, Yangzi River Guangzhou Hairui pharmaceutical, Xinhua Pharmaceutical) glimepiride tablets are suitable for type 2 diabetes mellitus, which can not fully control blood sugar in diet control, exercise therapy and weight loss Glimepiride tablets are not suitable for the treatment of type 1 diabetes (e.g diabetes patients with a history of ketoacidosis), diabetic ketoacidosis or diabetic precursor coma or coma Sanofi Aventis Deutschl and GmbH (Sanofi Aventis Deutschl and GmbH) held the original research certificate, which was first listed in Sweden in 1995 It is a safe and effective long-term hypoglycemic drug In 1996, Sanofi Aventis, together with Pharmacia (now Pfizer), was listed in Denmark, Germany and the United States as Amaryl ® In 2000, Sanofi Aventis Deutschl and GmbH was listed after its real estate in China In 2017, the domestic sales volume of glimepiride tablets was about RMB 970 million According to the statistics of pharmaceutical intelligence data, at present, there are three import approvals for glimepiride tablets, among which the import enterprise is German Aventis pharmaceutical company; there are 17 domestic market approvals, involving 13 enterprises, including Yangzi River, Xinhua Pharmaceutical, Chongqing kangkel, etc Among them, 11 enterprises have been put on record for consistency evaluation reference In addition to four enterprises that have been evaluated, namely Yangzi River, Jiangsu Wanbang, Chongqing kangkeri and Xinhua Pharmaceutical, five enterprises have applied, among which four enterprises have completed be test 02 review and approval 3 varieties have been approved, and berberine hydrochloride tablets, a unique domestic variety, will be the first one In addition to the consistency evaluation of glimepiride tablets, there are 3 varieties approved this week, namely isoniazid tablets of South China Pharmaceutical and Yichang humanwell pharmaceutical, fluconazole tablets of Shijiazhuang No.4 pharmaceutical, and berberine hydrochloride tablets of Yunnan Xitao green pharmaceutical Details are as follows: Review and approval details of this week's conformity assessment According to the drug registration and acceptance database, isoniazid tablets have been evaluated by two enterprises in China Pharmaceutical Industry and Shenyang Hongqi pharmaceutical industry It is worth looking forward to who will be the first in South China Pharmaceutical Industry and Yichang humanwell pharmaceutical industry to break into the top three Fluconazole tablets, the first approved by Sichuan Kelun pharmaceutical industry before, are the second evaluated enterprise
It is worth noting that no enterprise of berberine hydrochloride, a unique domestic product, has passed the consistency evaluation before There are 969 domestic approvals for the drug, 588 manufacturers are involved, and 35 enterprises are involved in the consistency evaluation and reference filing Up to now, only Yunnan Xitao green Pharmaceutical Co., Ltd and Guangdong South China Pharmaceutical Co., Ltd have applied for acceptance, and South China Pharmaceutical Co., Ltd is still in the process of review and approval If the process goes well, Yunnan Xitao green pharmaceutical industry will become the first enterprise that has passed the consistency evaluation of the product Details of consistency evaluation of Berberine Hydrochloride Tablets This week, CDE added 17 acceptance numbers of consistency evaluation, involving 14 varieties of 14 enterprises It is noteworthy that two acceptance numbers of linezolid glucose injection of hausen have been approved in April and are in "issued" status Now, another two acceptance numbers have been applied for acceptance In addition, 4 varieties of prednisone acetate tablets of Tianjin TIANYAO, pramipexole hydrochloride tablets of Jingxin pharmaceutical, atorvastatin calcium dispersible tablets of Guangdong encyclopedia pharmaceutical, and omeprazole enteric coated tablets of Shandong new era are newly added Note: the red font is the new product of this week Prednisone acetate tablet is glucocorticoid, which is mainly used for allergic and autoimmune inflammatory diseases It is suitable for connective tissue disease, systemic lupus erythematosus, severe bronchial asthma, dermatomyositis, vasculitis and other allergic diseases, acute leukemia, lymphoma and other adrenocortical hormone drugs Developed by Schering plough and Upjohn, prednisone was first listed in the United States in 1955 In 2012, the patent of prednisone was authorized by horizon Pharma to Mundipharma According to the pharmaceutical intelligence data, there are 186 market approvals for prednisone acetate tablets, 184 manufacturers, of which only 7 enterprises have the drug consistency evaluation reference record, and Tianjin TIANYAO's first application has been accepted Pramipexole hydrochloride is a dopamine receptor agonist, which can be used to treat the signs and symptoms of Parkinson's disease; it can also be used to treat the symptoms of some moderate to severe restless legs syndrome The original research enterprise is bringer Ingelheim of Germany In August 2018, Zhejiang Jingxin Pharmaceutical Co., Ltd was approved for listing It is the first manufacturer in China to obtain the production approval of pramipexole hydrochloride tablets, and the first Parkinson's disease drug of its company At present, domestic pramipexole hydrochloride tablets are only produced in Zhejiang Jingxin Pharmaceutical Co., Ltd., and the product has been included in the national medical insurance category B drug catalog Now Beijing New Pharmaceutical Co., Ltd is working hard to apply for conformity assessment, stabilize its position of first imitation and further enhance its product competitiveness Atorvastatin calcium dispersible tablets atorvastatin is a new type of selective HMG CoA reductase inhibitor for patients with hypercholesterolemia, coronary heart disease or other critical diseases (such as diabetes, symptomatic atherosclerotic diseases, etc.) combined with hypercholesterolemia or mixed dyslipidemia The original research enterprise is Pfizer pharmaceutical, which was approved to be listed at the end of 1996 and entered the Chinese market in 199 From the listing of atorvastatin to 2017, the global cumulative sales of atorvastatin is about 150 billion US dollars, the first heavyweight drug with a total sales volume of more than 100 billion US dollars Atorvastatin calcium dispersible tablet is a unique dosage form of Guangdong encyclopedia Pharmaceutical Co., Ltd This application for consistency evaluation has been accepted If it passes the evaluation successfully, it will help it win a place in the centralized purchase of 4 + 7 drugs and expand its market share Omeprazole enteric coated tablet omeprazole, proton pump inhibitor, suitable for gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis and Zhuo syndrome (gastrinoma) Omeprazole, developed by AstraZeneca, was first listed in Switzerland in 1988, in the United States in 1989, and then in other European countries and Japan No enteric coated tablets were found in the original manufacturer According to pharmaceutical intelligence data, at present, there are 16 market approvals for omeprazole enteric coated tablets made in China, involving 13 enterprises such as Shandong new era, Sinopharm and Beijing Yabao biopharmaceutical industry, among which 8 enterprises have applied for consistency evaluation, and the first application of Shandong new era pharmaceutical industry has been accepted Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; 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