[good medicine record] consistency evaluation weekly trend: 5 varieties have been evaluated; there will be 15 enterprises that have been evaluated; Yangtze River special research injection, many varieties gather together

This week, the State Food and Drug Administration and CDE announced the 23rd, 24th, 25th and 26th batch of generic reference preparations According to the statistics of pharmaceutical intelligence data, up to now, there are 2822 reference preparations involved in 26 batch directories This week, four batches of reference preparation directories were issued successively, which is no doubt not a signal In 2020, the pace of consistency evaluation will continue to accelerate steadily Up to now, there are 1764 acceptance numbers of CDE acceptance consistency evaluation (462 varieties of 485 enterprises, supplementary application count, the same below), and 333 acceptance numbers (129 varieties) that have passed the consistency evaluation This week, another 5 varieties have been evaluated, 12 varieties have been approved, 32 varieties have been applied for acceptance, and amlodipine besylate tablets have been evaluated by 15 enterprises Yangzi River is focusing on the consistency evaluation of injections, and many varieties have been undertaken again There are 5 kinds of over evaluation details, 2 of which are the first to receive good news this week (January 2 to January 10) 5 kinds have passed the first evaluation of two kinds of consistency evaluation There are 3 enterprises that have passed the evaluation of paracetamol tablets and finasteride tablets In addition, Cefradine capsule and paracetamol tablets are the second batch of drugs to be purchased This week's consistency evaluation details table Cefradine capsule Cefradine belongs to the first generation of cephalosporin, which is applicable to acute pharyngitis, tonsillitis, otitis media, bronchitis, pneumonia and other respiratory tract infections, urogenital tract infections, skin and soft tissue infections caused by sensitive bacteria According to the pharmaceutical intelligence data, there are 241 approval documents for the production of cefradine capsules in China, and 11 enterprises have accepted the application for conformity assessment In addition, according to the notice of Lufan pharmaceutical enterprises, from January to September 2019, the domestic sales volume of cefradine capsule is about 326 million yuan, and the sales revenue of Lufan pharmaceutical is 82.3162 million yuan At present, six enterprises including Lukang Pharmaceutical have passed the consistency evaluation It is worth noting that the drug is in the second batch of drugs with volume procurement catalogue, and the maximum number of the second batch of drugs with volume procurement can be up to six It remains to be seen whether the six evaluated enterprises can win the bid on January 17 Norfloxacin is a quinolone antibiotic, which is suitable for urinary tract infection, gonorrhea, prostatitis, intestinal infection, typhoid and other Salmonella infections caused by sensitive bacteria It belongs to the category of national medical insurance catalogue (2019 version) and national basic drug catalogue (2018 version) According to drug intelligence data, there are 691 domestic market approvals for Norfloxacin Capsules From 2016 to 2019, the sales volume of domestic sample hospitals of the drug increased year by year In 2018, the sales volume of sample hospitals reached 4.5519 million, an increase of 21.09% year on year, of which Baiyunshan Pharmaceutical Factory accounted for 27.59% of the total However, at present, only Yantai Wanrun Pharmaceutical Co., Ltd and Fuzhou haiwangfu Pharmaceutical Co., Ltd apply for the consistency evaluation of registration, and Yantai Wanrun Pharmaceutical Co., Ltd is the first to pass the consistency evaluation Dextromethorphan Hydrobromide tablet Dextromethorphan Hydrobromide tablet is an over-the-counter antitussive drug, belonging to class a over-the-counter drug, which is suitable for dry cough, including cough caused by upper respiratory tract infection (such as cold and pharyngitis), bronchitis, etc In 1956, it was listed as an over-the-counter drug by the U.S Food and Drug Administration (FDA) and honored as "the safest central antitussive drug in modern times"; in 1961, it was designated as a non narcotic drug at the world narcotics Conference; in 1989, the World Health Organization considered "dextromethorphan as a antitussive drug to replace codeine" At present, there are only 10 domestic market approvals for Dextromethorphan Hydrobromide tablets, involving 10 enterprises such as Lizhu pharmaceutical factory, Shanghai Shangyao Xinyi, Shijiazhuang Yiling pharmaceutical and Guangdong South China pharmaceutical, among which only Guangdong South China Pharmaceutical has applied for conformity assessment and the first one has been assessed, and according to the South China Pharmaceutical announcement, dextromethorphan's sales volume in 2018 was selected into the town of 2019 medical insurance catalogue without compound expectorant Cough medicine ranks first in the list This time, South China pharmaceutical industry has reviewed this product, which is expected to obtain policy dividend and occupy more market share Finasteride tablet finasteride tablet is mainly used to treat the existing symptoms of benign prostatic hyperplasia (BPH) The original manufacturer is mosadong company, with the trade name of "baoliezhi" It was first listed in the UK in 1992 and approved to be listed in China in 1994 Finasteride sales were $183 million in 2015 According to the hospital sales database of pharmaceutical intelligence data Enterprise Edition, the sales volume of finasteride sample hospitals in 2018 reached 498 million yuan, of which the original research enterprises accounted for 96.03% At present, there are 35 domestic market approvals for domestic finasteride tablets, 31 manufacturers, and 9 enterprises that have accepted the application for conformity assessment Among them, 3 enterprises have passed the assessment and are expected to break the original research barriers and seize hundreds of millions of markets The review and approval of 12 varieties have been completed, and amlodipine besylate has been reviewed and approved by 15 enterprises This week, 18 acceptance numbers (12 varieties) have been reviewed and approved, and they will be successful soon Among them, ambroxol hydrochloride dispersible tablets and glucosamine hydrochloride capsules will welcome the birth of the first enterprise In addition, it is worth noting that paracetamol tablets and amlodipine besylate tablets Northeast Pharmaceutical Shenyang No.1 Pharmaceutical Co., Ltd this week took the lead in the third review, grabbed the top three places of policy and welfare, and successfully won the second batch of on volume purchase tickets Shanxi Zhendong ante biopharmaceutical Co., Ltd., Sichuan Tongyuan Pharmaceutical Co., Ltd., Qingdao Huanghai Pharmaceutical Co., Ltd and China Pharmaceutical Co., Ltd followed closely The approval of acetaminophen tablets was completed The review news is imminent, which means whether it can be in a new round Focus on blooming and play a key role Amlodipine besylate tablets have always been a hot competitive product for consistency evaluation Up to now, there have been 13 evaluated enterprises, which have not been ranked first in the list Now Jiangxi pharmaceutical and Shanghai Tianfu biology have been approved Once evaluated, there will be 15 evaluated enterprises, which will further increase the competition of products 32 varieties of application acceptance were accepted, 36 (32 varieties) of new consistency evaluation acceptance numbers were added in Yangzijiang injection this week, and 4 varieties were the first application acceptance varieties; in addition, according to the application dosage form, the application acceptance of injection is still the focus and highlight, 11 injection applications were accepted this week The details of acceptance of this week's consistency evaluation declaration include: Yangzi Pharmaceutical Group Co., Ltd launched this week, and five injections were undertaken, including edaravone injection of Yangzi pharmaceutical haini, thymosin for injection of Yangzi pharmaceutical Hairui, moxifloxacin hydrochloride sodium chloride injection, esmeralazole sodium for injection and gemcitabine hydrochloride for injection According to the pharmaceutical intelligence data, up to now, there are 35 injection acceptance numbers in the Yangtze River, ranking among the top three enterprises that have been accepted in the application More information about the acceptance of the Yangtze River injection consistency evaluation can be found at https://vip.yaozh.com/introduction? GA source = VIP & GA name = VIP? PC to enter the drug intelligence data consistency evaluation and analysis system, one click search, intelligent analysis, clear and intuitive access to the progress details of each drug, competition situation ~ 37 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.