[good medicine record] New Year's gift package for consistency evaluation: 6 kinds of customs clearance, 6 enterprises have passed the evaluation of amlodipine besylate tablets; 4 kinds of approval, 30 varieties have been accepted, and heavyweight injections are piled up

As of January 31, according to the statistics of drug registration and acceptance database, there are 872 acceptance numbers of CDE acceptance consistency evaluation (283 varieties of 299 enterprises, calculated according to supplementary application, the same below), and there are 135 acceptance numbers and 68 varieties that have passed the consistency evaluation; this spring will come, the consistency evaluation "presents" constantly, 6 varieties have been evaluated, and the number of the first varieties has reached 3; 4 varieties After the examination and approval, another 3 varieties will be collected; another 30 varieties will be undertaken, and the consistency evaluation of injections and 289 basic drugs will be accelerated Consistency evaluation, over evaluation and renewal, 6 varieties passed the consistency evaluation, and the first 6 enterprises had over evaluated drugs According to the pharmaceutical intelligence data, another six drugs passed the consistency evaluation this week, namely, glimepiride tablets of Wanbang biochemical medicine, citalopram hydrobromide capsules of Kelun pharmaceutical, tenofovir dipivoxil fumarate tablets of Anhui Baker biology, docetaxel injection solution of Sichuan Huiyu and amlodipine besylate tablets of Chenxin pharmaceutical; citalopram hydrobromide of Sichuan Kelun pharmaceutical Capsule, docetaxel injection of Sichuan Huiyu and apasaban tablet of Jiangsu Haosen Pharmaceutical Co., Ltd are all the first ones to pass the evaluation In addition, Jiangsu Wanbang biochemical medicine is the first one to pass the evaluation of glimepiride tablet with a specification of 1mg, and amlodipine besylate tablet is the first one to pass the evaluation of consistency with six enterprises See the following table for details: Table 1 details of this week's evaluation of consistency It is worth mentioning that docetaxel injection of Sichuan Huiyu is approved to be listed in accordance with four categories of new chemical drug registration, and is deemed to have passed the consistency evaluation according to relevant policies According to the registration and acceptance database of smart drugs, at present, there are two enterprises applying for the consistency evaluation of this variety, namely, Zhengda Tianqing and Jiangsu Hengrui, which have not been evaluated yet, but Sichuan Huiyu pharmaceutical is the first one to take the lead; Sichuan Huiyu pharmaceutical is the only enterprise that has two injections (docetaxel injection and pemetrexed disodium for injection) passing the consistency evaluation, two products All species are unusual and win the first place At the same time, Jiangsu Haosen's apixaban tablets were included in the catalogue of Chinese listed drugs, which was deemed to have passed the consistency evaluation Apixaban tablet is a new generation of oral anticoagulant It is the first generic drug of hausen pharmaceutical industry According to the analysis of Ping An Securities Research Report, in the past five years, global sales of apixaban has been rising rapidly In 2015, it broke through the $1 billion threshold, and in 2016, it has increased to $3343 million Although the drug has been approved for marketing by Howson pharmaceutical, due to the expiration of Bristol Myers Squibb apixaban compound patent No in September 2022, Howson pharmaceutical can not be sold at present However, Howson's early layout, winning the first imitation and deemed to pass the consistency evaluation, will help it attack the original research after the expiration of the patent, and carve up a large share of the cake in the domestic market Consistency evaluation review approval status update 4 varieties approved, 3 will be the first This week, 4 varieties were approved, 3 processing statuses were shown as "issued" and one as "approved to be certified" They are ondasetron hydrochloride tablets of Qilu pharmaceutical, amlodipine besylate tablets of Chenxin pharmaceutical, levocetirizine hydrochloride tablets of Chongqing Huabang pharmaceutical, olmesartan ester tablets of Nanjing Zhengda Tianqing and ranitidine hydrochloride capsules of Jiangxi Huiren pharmaceutical Among them, ranitidine hydrochloride capsule will form a three pronged trend, and the first enterprise to pass the consistency evaluation of ondansetron hydrochloride tablets, levocetirizine hydrochloride tablets and olmesartan ester tablets will come out soon See the following table for details: Table 2: the details of review and approval of this week, application for conformity assessment, application for renewal of 30 varieties, application for injection clustering This week, CDE added 44 acceptance numbers for consistency assessment, involving 30 varieties of 24 enterprises, of which 289 catalog varieties accounted for half, reaching 22 Acceptance numbers (16 varieties) In addition, there are 19 product specifications and 10 injection application consistency assessments, including the successful bortezomib for injection sold by Nanjing Zhengda Tianqing in Hainan Province Among the 10 injections declared this week, only one enterprise of dexmedetomidine hydrochloride injection passed the consistency evaluation The enterprise is Yangzijiang pharmaceutical, and Yangzijiang pharmaceutical's product is a new chemical 3-class drug approved and issued by CFDA It is deemed to have passed the consistency evaluation after entering the catalogue of drugs listed in China According to China's iqvia database, in 2017, China's anesthetics market volume was about 11.8 billion yuan, mainly including propofol, fentanyl and dexmedetomidine, among which dexmedetomidine accounted for 15.49% of the total anesthetics market, and the domestic sales in 2017 exceeded 1.8 billion yuan In addition, the remaining nine injections have not yet been evaluated by the enterprise, and five of them are new varieties this week, the first application has been accepted, and Yichang humanwell Pharmaceutical Co., Ltd occupies three, namely, remifentanil hydrochloride for injection, hydromorphone hydrochloride injection, sufentanil citrate injection, moxifloxacin hydrochloride sodium chloride injection of zhengdafenghai and Hanhan Etibatide injection of Yuyao Pharmaceutical Co., Ltd Table 3 details of application and acceptance of injection consistency assessment this week This week, in addition to the first application of five injections, six varieties of the first application were accepted, namely, phenolphthalein tablets of Tongyuan pharmaceutical, verapamil hydrochloride tablets of central pharmaceutical, methylprednisolone tablets of Tianjin TIANYAO, diphenhydramine hydrochloride tablets of Yichang humanwell pharmaceutical, lorazepam tablets and amoxicillin clavulanate potassium dry suspension (7:1) Table 4 details of the acceptance of the first declaration of conformity assessment in this week attachment: panorama of the acceptance of the first declaration of conformity assessment in this week (red font refers to the varieties of the first declaration of acceptance) part of the information source: enterprise announcement, drug intelligence network, network public information source: drug intelligence data 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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