[good medicine record] weekly trend of consistency evaluation: Amlodipine Besylate tablets are competitive; another 5 varieties are under review; 14 varieties have been undertaken, Hengrui, Guoyao, Shiyao, Ouyi

This week, generic reference preparations were announced one after another, and the consistency evaluation continued to follow up As of August 29, the acceptance number of CDE acceptance consistency evaluation reached 1388 (393 varieties of 409 enterprises, calculated according to supplementary application, the same below); the acceptance number of evaluation has reached 240 (100 varieties) This week (August 22 to August 29), there were three varieties that had been evaluated, five varieties were approved, and 14 varieties were accepted Three varieties of amlodipine besylate tablets have been evaluated in detail Another three varieties of amlodipine besylate tablets have passed the consistency evaluation this week The aluminum magnesium carbonate chewable tablets of Watson pharmaceutical, clindamycin hydrochloride capsules of treasure pharmaceutical and amlodipine besylate tablets of national drug Rongsheng pharmaceutical have passed the consistency evaluation This week's consistency evaluation details: the aluminum magnesium carbonate chewable tablet is an over-the-counter anti acid and gastric mucosa protection medicine, which is used for chronic gastritis; the treatment of stomach discomfort related to gastric acid, such as stomachache, heartburn (heartburn), acid belching, fullness and so on First line drugs for digestive system, 2018 national essential drugs list drugs, 2019 national medical insurance list drugs It is worth mentioning that according to the domestic database of pharma intelligence, there are 30 domestic market approvals and nearly 30 manufacturing enterprises in China The aluminum magnesium chewable tablets of Huasen Pharmaceutical (weidemai) are the first to be imitated in China, with the largest market share in China From the perspective of consistency evaluation varieties, magnesium aluminum carbonate chewable tablets are exempt from be test However, at present, Huasen pharmaceutical is once again in the forefront, the first to apply for the first evaluation From the perspective of enterprises, there are two varieties of Huasen pharmaceutical that have passed the consistency evaluation, and the aluminum magnesium carbonate chewable tablet is the second drug that has been evaluated by the company The details are as follows: clindamycin hydrochloride capsule clindamycin hydrochloride capsule is an anti infective drug, mainly used for infectious diseases caused by sensitive strains such as Streptococcus, Staphylococcus and anaerobic bacteria It has been listed in the national basic drugs in 2018 and the class a medical insurance in 2019 According to the announcement of treasure pharmaceutical enterprises, the domestic market scale of clindamycin preparation reached 3.319 billion yuan in 2018 According to the data of pharmaceutical intelligence, there are 151 domestic clindamycin hydrochloride capsules and 111 manufacturers, among which 10 have been accepted for the application of consistency evaluation, including treasure pharmaceutical, and 4 have been evaluated Details of consistency evaluation of clindamycin hydrochloride capsules: the variety of Zhenbao pharmaceutical is the first one that passed the consistency evaluation of the company, and also the first oral chemical variety that passed the be experiment in 289 catalogue of consistency evaluation in Heilongjiang Province Amlodipine besylate tablets amlodipine besylate tablets are suitable for the symptomatic treatment of hypertension and coronary heart disease The original manufacturer is Pfizer, and the drug trade name is "luohuoxi" According to the statistics of PDB, the global sales volume of amlodipine besylate tablets in 2018 is US $6.499 billion, including US $1.024 billion in sales revenue of Pfizer pharmaceutical and RMB 779 million in sales volume of domestic sample hospital drugs in 2018 According to the pharmaceutical intelligence data, including the national drug Rongsheng, amlodipine besylate tablets have been evaluated by 10 enterprises, and this week, amlodipine besylate dispersible tablets, the first application of Nantong Jiuhe pharmaceutical industry was accepted The consistency evaluation of the drug permeates all dosage forms, and the competition is white hot In addition, amlodipine besylate tablet is the first one in China The review and approval of 5 varieties have been completed, and the review and approval of 5 varieties will be completed this week, among which 2 varieties are in the status of "certificate preparation completed pending approval" and 3 varieties are in the status of "issued" Review and approval details of this week's conformity assessment It is worth noting that according to the consistency evaluation database of medicine and intelligence, at present, there is no enterprise review on four varieties of codeine phosphate tablets, risperidone orally disintegrating tablets, dexamethasone acetate tablets and metronidazole tablets, and it is not surprising that the first review enterprise of four varieties will be born in the near future; in addition, there are seven enterprises review on montmorillonite powder, and Hunan qianjinxiangjiang pharmaceutical industry may pass the eighth review It can be expected to wait 14 varieties of application acceptance were undertaken, and 18 (14) new acceptance numbers of consistency evaluation were added to CDE this week, including ozagrel sodium for injection of Hainan Beite Pharmaceutical Co., Ltd., sulpiride tablets of Jiangsu tiansiliyi Pharmaceutical Co., Ltd., amlodipine besylate dispersible tablets of Nantong Jiuhe Pharmaceutical Co., Ltd., codeine phosphate tablets of China Pharmaceutical Co., Ltd as the first application acceptance varieties Details of acceptance of this week's conformity assessment declaration (Note: the red font is the new variety of this week) In addition, this week, the State Drug Administration and CDE released the catalog of the 22nd batch and 23rd batch of chemical generic reference preparations, half of which are injections According to statistics, since the catalog of the 21st batch of reference preparations, there are 630 injections involved in the catalog, including 196 in the 21st batch, 264 in the 22nd batch and 170 in the 23rd batch It can be seen that the evaluation of injection consistency is speeding up This week, the consistency evaluation of four injections was accepted, namely, irinotecan hydrochloride injection of Hengrui medicine, ozagrel sodium for injection of Hainan Beite, moxifloxacin hydrochloride and sodium chloride injection of Shijiazhuang fourth medicine, and clindamycin phosphate for injection of Hainan general Kongli pharmaceutical Whether the four varieties can pass quickly on the basis of the list of injection reference preparations We'll see In addition, two acceptance numbers of irinotecan hydrochloride injection of Hengrui pharmaceutical have been reviewed and showed the status of "issued" Now another acceptance number is added to fight against Qilu pharmaceutical Data source of the acceptance details of the application for the conformity assessment of irinotecan hydrochloride injection: enterprise announcement and other online public information statement: the opinion of this article only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; 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