[good medicine record] consistency evaluation weekly trends: hot varieties add competitors, 1 billion level general anesthesia auxiliary drugs debut, and

With the promotion and implementation of centralized procurement across the country, the consistency evaluation work has been continuously promoted As of July 25, there are 1314 acceptance numbers of CDE acceptance consistency evaluation (379 varieties of 391 enterprises, calculated according to supplementary application, the same below), and 230 acceptance numbers (96 varieties) have been passed This week (July 18 to July 25), another 3 varieties have been evaluated, and 2 varieties have been approved After that, 16 varieties were applied for acceptance More than 5 billion amlodipine besylate tablets have been added to the list of competitors This week, another three products passed the consistency evaluation, namely, metformin hydrochloride sustained-release tablets of Zhengda Tianqing and Nanjing Yihua Pharmaceutical Co., Ltd., zuoxitirizin hydrochloride tablets of Suzhou Dongrui Pharmaceutical Co., Ltd and Hangzhou Minsheng Pharmaceutical Co., Ltd., and amlodipine besylate tablets of Zhejiang Weikang Pharmaceutical Co., Ltd In recent two weeks, metformin hydrochloride sustained-release tablets have been reviewed one after another In addition, this week's Zhengda Tianqing and Nanjing Yihua Pharmaceutical Co., Ltd., there have been seven enterprises that have reviewed the product In the conformity evaluation of generic drugs, there is a policy that directly affects whether the products can be put on the Internet After the conformity evaluation of generic drugs of the same variety reaches three enterprises, in principle, no more products without conformity evaluation will be purchased This policy has been implemented in many places, especially under the condition that centralized procurement is about to be promoted in the whole country, it is urgent for generic drugs to pass the conformity evaluation In addition, this week, the new generation of antihistamines, levocetirizine hydrochloride tablets, successfully exceeded the number of employees, with 4 enterprises having passed the evaluation; the hospital market scale is more than 5 billion yuan, and amlodipine besylate tablets, a hot product for consistency evaluation, is another competitor, with 9 enterprises having passed the evaluation According to the pharmaceutical intelligence data, there are 66 market approvals for amlodipine besylate tablets in China, involving 60 manufacturers, that is to say, 60 enterprises need to do consistency evaluation According to the statistics of consistency evaluation progress database of pharmaceutical intelligence enterprise edition, up to now, 56 enterprises have participated in the consistency evaluation of amlodipine besylate tablets, 9 enterprises have been evaluated, and 27 enterprises have applied for acceptance, and 21 of them have completed the be test, and the evaluation seems to be around the corner In addition, amlodipine besylate tablets ranked first in terms of application acceptance number and number of enterprises applying for varieties Source of data chart: the review and approval of the analysis database of generic drug consistency evaluation system of pharmaceutical intelligence data enterprise edition are in the process of two varieties of over evaluation One injection will complete the approval of the first over evaluation this week, in addition to the three varieties that have already been evaluated, and present "certificate preparation completed - pending approval document" Details of approval of consistency assessment this week Among them, sodium acetate ringer injection is a new type of acetate electrolyte balance solution, the fourth generation crystal solution, which is used for the supplement of circulating blood volume and tissue fluid to reduce the extracellular fluid and metabolic acidosis It is the crystal solution product closest to the extracellular fluid in clinic at present The product is widely used in anesthesia, surgery, burn, emergency department and other departments, and has been recommended by many domestic and international guidelines and consensus 。 In 2010, the product was put on the market in China At present, there are 11 domestic approvals for sodium acetate ringer injection and 5 manufacturers The first application consistency evaluation of Kelun Pharmaceutical Co., Ltd was accepted, and the second application of Silver Lake of Shiyao Co., Ltd was accepted, but it was approved by Kelun first If there is no accident, it will be the top one in consistency evaluation of the product In addition, the specification of 0.5g of Cefalexin tablet of Ouyi has been evaluated before, and it is predicted that the specification of this evaluation is 0.125g After the evaluation, the product pipeline of Ouyi consistency evaluation will be further enriched 16 varieties applied for acceptance were accepted, and 25 new acceptance numbers for consistency evaluation of heavy-duty general anesthesia auxiliary drugs were included in this week's CDE, involving 16 varieties of 15 enterprises The injection still accounts for one third, reaching six varieties, namely, palonosetron hydrochloride injection of Zhengda Tianqing, rocuronium injection of Zhejiang Xianju pharmaceutical, methylprednisolone sodium succinate injection of Liaoning hisico pharmaceutical, Cefminox Sodium Injection of Yangtze River Pharmaceutical, ambroxol hydrochloride injection of Shandong Luoxin pharmaceutical and meropenem injection of Hanhui pharmaceutical Kublammonium injection is the declared variety this week In addition, the new varieties this week include ceftazidime hydrochloride capsule of Huazhong Pharmaceutical Co., Ltd and phenytoin sodium tablet of Suzhou Hongsen Pharmaceutical Co., Ltd for details, please see the following table: details of the declared acceptance of consistency evaluation this week (Note: the red font part is the new varieties of this week) It has to be mentioned that rocuronium injection is an auxiliary drug for general anesthesia, a drug listed in the national class B Medical Insurance catalogue, which is used for tracheal intubation during routine induction anesthesia and for maintaining neuromuscular block of skeletal muscle during operation Developed by organon, it was approved to be listed in the United States, the United Kingdom and the Netherlands in 1994 According to IMS data, in 2017, the global market sales volume of rocuronium injection was about US $209.6 million; in addition, according to PDB database, the sales volume of domestic market was about RMB 340 million At present, the main domestic manufacturers of rocuronium injection include Huabei pharmaceutical, Zhejiang Xianju pharmaceutical, Fuan Pharmaceutical Group qingyutang pharmaceutical, etc 8 enterprises have 13 domestic market approvals Zhejiang Xianju Pharmaceutical Co., Ltd is expected to obtain policy benefits and increase the competitiveness of its products and share more market share Part of the information sources: drug intelligence network, enterprise announcement and other network public information data sources: drug intelligence data, enterprise announcement and other network public information points "read the original", enter the drug intelligence data enterprise version generic drug consistency evaluation and analysis system database 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.