[good medicine record] great change, just reviewed! Jingxin amlodipine won the bidding of 4 + 7 volume procurement in advance. This week, 4 drugs passed the consistency evaluation, and 10 289 drugs were undertaken

As of December 6, there are 580 acceptance numbers of CDE acceptance consistency evaluation, of which 289 acceptance numbers account for 283 (79 varieties) of 210 varieties involving 221 enterprises; 95 acceptance numbers and 45 varieties have passed the consistency evaluation (calculated according to the supplementary application, the same below), and only 21 varieties of 289 varieties have passed the consistency evaluation, the completion rate is only 7.27% In this week's consistency evaluation, 12 acceptance No 12 varieties were added, with 289 varieties accounting for 80%; in addition, 6 acceptance No 5 varieties were clustered for evaluation 5 Drugs passed the consistency evaluation, and the first five evaluated varieties were released This week (Nov 29-dec 6), consistency evaluation was carried out in a heap No 6 acceptance No 5 variety was assessed Amlodipine besylate tablet became the first 289 catalogue drug with 5 enterprises passing the consistency evaluation The fourth enterprise of entecavir dispersible tablet also appeared Sichuan Kelun Pharmaceutical Co., Ltd issued two consecutive bulletins, one of which was the first one, and This week's consistency evaluation passed the details of amlodipine besylate tablets on December 3 According to the intelligence data, the consistency evaluation conclusion of amlodipine besylate tablets (5mg (calculated as c20h25cln2o5)) of Zhejiang Jingxin Pharmaceutical Co., Ltd showed that it was "approved and supplemented", and the drug passed the consistency evaluation Just today (December 6), the 4 + 7 volume purchase led by the state health insurance bureau was opened in Shanghai 11 cities were selected as the pilot cities for this volume procurement, including Beijing, Shanghai, Tianjin and Chongqing, and 7 cities including Guangzhou, Shenzhen, Shenyang, Dalian, Xi'an, Chengdu and Xiamen Involving 31 drugs, the "only bid winning" mode makes pharmaceutical companies feel pressure Fortunately, Jingxin has just passed the consistency evaluation and was listed in the pre bid winning list, with prominent market advantages According to the database of drug registration and acceptance, amlodipine besylate is the first enterprise that has passed the consistency evaluation up to now It is worth noting that 18 enterprises have applied for the consistency evaluation of the drug In addition to the 5 enterprises that have already been evaluated, 10 enterprises have completed the be test It is not surprising that the subsequent evaluation will be carried out successively, but they are in centralized procurement, etc It's worth looking forward to whether we can seize a place Details of consistency evaluation of amlodipine besylate tablets entecavir dispersible tablets December 3, according to the consistency evaluation conclusion of entecavir dispersible tablets (0.5mg) of Anhui Baker bio, the drug passed the consistency evaluation Entecavir is an oral guanine nucleoside analogue for the treatment of hepatitis B virus infection According to the domestic database of pharmaceutical intelligence, at present, there are 7 domestic entecavir dispersible tablets manufacturers, 4 of which have applied for conformity assessment so far, and all of them have passed the assessment Anhui Baker bio is the fourth one that has ever been assessed It is worth mentioning that entecavir, in addition to dispersible tablets, is not willing to lag behind in terms of capsules There are also 3 such enterprises The details are as follows: On December 3, according to the registration and acceptance database of smart drugs, clindamycin hydrochloride capsules of Sichuan Kelun Pharmaceutical Co., Ltd showed "approved supplement", which passed the consistency evaluation of quality and efficacy of generic drugs According to the pharmaceutical intelligence database, up to now, there are 5 enterprises applying for the consistency evaluation of clindamycin hydrochloride capsules, among which Chongqing Yaoyou is the first one to pass the evaluation, Sichuan Kelun pharmaceutical is the second one to pass the evaluation, in addition, there are 3 enterprises applying, among which Yichang humanwell pharmaceutical Co., Ltd and Harbin Zhenbao Pharmaceutical Co., Ltd have completed the be test, and the evaluation is just around the corner Clindamycin hydrochloride capsule is an anti infective drug, which is mainly suitable for infections caused by sensitive strains such as Streptococcus, Staphylococcus and anaerobic bacteria According to the latest data of iqviachpa, the sales volume of clindamycin preparation in China in 2017 was about 1.13 billion yuan And the specifications of clindamycin hydrochloride capsules passed this time are 0.15g and 0.075g, of which 0.15g is 289 catalogue Citalopram hydrobromide tablets on December 3, according to intelligence data, citalopram hydrobromide tablets of Sichuan Kelun Pharmaceutical Co., Ltd showed "approved supplement", and the drug passed the consistency evaluation of quality and efficacy of generic drugs According to the domestic database of pharmaceutical intelligence, there are 8 domestic enterprises holding the approval documents of the drug However, according to the registration and acceptance database of pharmaceutical intelligence, at present, only Sichuan Kelun and Shanghai Novartis trade are the enterprises applying for the conformity evaluation of citalopram hydrobromide tablets Sichuan Kelun took the lead in the evaluation, and will enjoy the policy dividend and take the lead in the volume procurement Citalopram hydrobromide tablet is one of the most tolerable antidepressants in the new antidepressants, and it is the first-line antidepressant recommended by the authoritative guide at home and abroad Manufactured by Lingbei Pharmaceutical Co., Ltd of Denmark, with the trade name of shipumi In 2017, the sales volume in China was about RMB 304 million On December 3, tenofovir fumarate dipivoxil capsule showed "approved supplement" according to the intelligence data of drugs The drug passed the consistency evaluation of quality and efficacy of generic drugs According to the domestic drug database of pharmaceutical intelligence, domestic tenofovir dipivoxil fumarate capsule is only produced by Fujian guangshengtang, and it is the first domestic enterprise to imitate tenofovir capsule It is worth mentioning that, according to the contents of the announcement issued by guangshengtang, in the supplementary application for consistency evaluation of guangshengtang, AIDS indications have also been added, and it will have the opportunity to participate in the new round of designated large-scale procurement of national AIDS drugs 12 varieties have been undertaken, 10 of which are 289 catalogue varieties This week, CDE added 12 new consistency assessment acceptance numbers (12 varieties) In addition to cefixime granules and gencicinovir sodium for injection, the remaining 10 varieties are 289 drug categories It can be seen that the year is approaching, and 289 drug categories are in a hurry In addition, the first declared drugs this week are 6, diclofenac sodium sustained release tablets for Chinese drug Zhijun, Chengdu dushengdi pharmaceutical salt Levofloxacin acetate tablets, dexamethasone acetate tablets of Tianjin Pharmaceutical, scopolamine Racer tablets of Hangzhou Minsheng pharmaceutical, amoxicillin tablets of Kunming Yuanrui pharmaceutical and Ganciclovir Sodium for injection of Hainan Puli pharmaceutical For more details, let's take a look at: details of this week's application for consistency evaluation acceptance On December 3, the application for consistency evaluation of diclofenac sodium sustained-release tablets of Guoyao Zhijun (Shenzhen) Pingshan pharmaceutical was accepted Diclofenac sodium is one of the most widely used nonsteroidal anti-inflammatory drugs in the world It has anti-inflammatory, analgesic and antipyretic effects From 1972 to 1973, it was developed by Ba Zaki (Ciba-Geigy), and was listed in Japan in 1974 In 1988, Diclofenac Sodium Sustained Release Tablets (trade name Voltaren) was listed in the United States In 1999, Diclofenac Sodium Gel was listed in China, and its name was comfortable At present, diclofenac sodium has been listed in more than 120 countries around the world, and diclofenac sodium sustained-release tablets are listed as 289 drugs, which need to be re evaluated by the end of 2018 According to the domestic database of pharmaceutical intelligence, there are 12 approval documents and 12 manufacturers of diclofenac sodium sustained-release tablets In addition, according to the progress data of consistency evaluation of pharmaceutical intelligence, there are 4 enterprises participating in the consistency evaluation of reference and filing, among which only Sinopharm zhijunpingshan pharmaceutical has applied for acceptance, and has completed the be test, which is expected to be evaluated when the time limit comes On December 4, the consistency evaluation of dexamethasone acetate tablets was undertaken by CDE Dexamethasone acetate tablets, 289 catalogue drugs, are long-acting corticosteroids, mainly used for allergic and autoimmune inflammatory diseases, such as connective tissue disease, severe bronchial asthma, dermatitis and other allergic diseases, ulcerative colitis, acute leukemia, malignant lymphoma and so on In 1981, the 0.75mg tablet of Tianjin Huajin pharmaceutical factory was first listed in China According to the statistics of domestic database of pharmaceutical intelligence, at present, there are 122 domestic approvals for dexamethasone acetate tablets, involving 121 manufacturers, and the specifications of the production approvals are 0.75mg; according to the database of pharmaceutical intelligence consistency evaluation progress, there are 7 enterprises participating in the consistency evaluation of the registration, and the first application of Tianjin TIANYAO has been accepted On November 3, the consistency evaluation of racemic anisodamine tablets of Hangzhou Minsheng Pharmaceutical Co., Ltd was undertaken by CDE Racemic anisodamine tablet, 289 catalogue drug, and one of the unique varieties in China; anticholinergic drug, mainly used to relieve smooth muscle spasm, gastrointestinal colic, biliary spasm and organophosphorus poisoning According to the domestic database of pharmaceutical intelligence, at present, there are 52 domestic approval documents for racemic anisodamine tablets in China, 34 manufacturers, of which 2 enterprises participate in the consistency evaluation of reference filing and 1 enterprise has been accepted It is worth mentioning that the drug can be exempted from be test, and whether it can make a concerted evaluation remains to be seen On November 29, the consistency evaluation of amoxicillin tablets of Kunming Yuanrui pharmaceutical was undertaken by CDE According to the progress database of consistency evaluation of pharmaceutical intelligence, Kunming Yuanrui pharmaceutical is the first enterprise to apply for the consistency evaluation of amoxicillin tablets Before that, there have been many enterprises applying for granules and capsules, especially capsules, with 17 enterprises applying, and three enterprises have been evaluated, including Zhuhai United pharmaceutical, Zhejiang Jinhua Kangenbei and Sinopharm Amoxicillin tablets, like Amoxicillin Capsules, are 289 varieties At present, Kunming Yuanrui Pharmaceutical Co., Ltd has completed the be test, and it is impossible to have a review before the end of the year On November 29, the consistency evaluation of Ganciclovir Sodium for injection of Hainan Puli pharmaceutical was undertaken by CDE Ganciclovir is one of the most broad-spectrum anti DNA virus drugs, which is used to treat cytomegalovirus retinitis and prevent cytomegalovirus in organ transplant patients Originally researched by Roche, the terminal market sales exceed 700 million yuan According to the domestic database of pharmaceutical intelligence, there are only five domestic approvals for Ganciclovir Sodium for injection, and three manufacturers are Hainan Puli pharmaceutical, Hubei Qianlong pharmaceutical and Nanjing Haichen pharmaceutical At present, only Hainan Puli pharmaceutical has applied for conformity evaluation, and it is worth mentioning that Ganciclovir Sodium for injection is another domestic and foreign double reported variety after azithromycin, which passed the who in December 2012 Qualification pre confirmation procedure of the company; obtained the Dutch listing license in February 2014; obtained the German listing license in April 2014; obtained the Hong Kong listing license in January 2015; obtained the French listing license in December 2016; obtained the British listing license in February 2017; obtained the drug registration approval issued by the State Food and Drug Administration on May 23, 2018; approved for listing in the United States in November 2018; now It also applies for conformity assessment, which can accelerate over assessment and launch impact on the original research enterprise Part of information source: announcement data source of listed companies: the column of "good medicine record" in the pharmaceutical intelligence database will track the latest trend of consistency evaluation in a week for you! 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