[good medicine record] there are 16 enterprises that have been evaluated for this variety?! The first application of valsartan hydrochlorothiazide tablets was accepted

As of November 28, the acceptance number of CDE acceptance consistency evaluation reached 1616 (438 varieties of 457 enterprises) According to the supplementary application, the same below); 303 (120 varieties) have been evaluated and accepted This week (November 21 to November 28), there are 9 varieties that have been evaluated, and the hot varieties continue Metformin hydrochloride tablets will surpass and become the first variety in the evaluation; 10 varieties have been evaluated, and the results are on the way; 27 acceptance numbers and 16 varieties have been undertaken, and China Resources SECCO will "rush to eat" the original research, and valsartan hydrochlorothiazide tablets will be accepted for the first application consistency evaluation Over evaluation details: 9 kinds of over evaluation, another drug over evaluation enterprise reaches the end of 10 years, consistency evaluation enters the harvest season This week (November 21 to November 28), 9 varieties of 9 enterprises have received good news of evaluation, including fierce competition and key drugs Details are as follows: this week's consistency evaluation details table It is worth mentioning that this week, there are four varieties and the second one has been evaluated; two varieties and three full members are captopril tablets of Xinhua Pharmaceutical and indapamide tablets of Sinopharm; the fourth and the third of Cefalexin Capsules of Huamin pharmaceutical of North China Pharmaceutical and isoniazid tablets of Southwest Pharmaceutical of Hebei Province have been evaluated respectively, especially metformin hydrochloride tablets, with a total of 11 enterprises and 0.25g standard There have been 10 reviews The following focuses on the three and 11 evaluated varieties Indapamide tablet indapamide tablet is a sulfonamide diuretic with diuretic and calcium antagonistic effects It is a strong and long-acting antihypertensive drug, mainly used in the treatment of essential hypertension According to the data of PDB drug comprehensive database, the global sales of indapamide tablets in 2018 was $819 million, up 3.80% year on year According to the sales data of pharmaceutical intelligence hospital, from 2016 to 2019, the sales of indapamide tablets in domestic sample hospitals increased year by year, reaching 11.5222 million yuan in 2018, an increase of 18.87% year on year, of which Tianjin Lisheng pharmaceutical accounted for 56.45% At present, there are 32 market approvals for domestic indapamide tablets, involving 31 manufacturers, and 15 enterprises applying for acceptance of conformity assessment, among which Sinotech Co., Ltd is the third one Before that, Chongqing Yaoyou Pharmaceutical Co., Ltd and Guangdong anno Pharmaceutical Co., Ltd have reviewed the drugs of the same specification one after another Now, there is a three pronged trend and the competition pattern is intensified Captopril tablet captopril tablet is an antihypertensive drug, belonging to ACE inhibitor, class a medical insurance drug, mainly used to treat hypertension and heart failure The original research enterprise is Bristol Myers Squibb trade name "capotentm", which was approved by FDA in 1981 According to the sales data of pharmaceutical intelligence hospital, in 2018, the sales volume of domestic sample hospitals of captopril tablets reached 21.466 million yuan, of which 79.91% was from the original research drug industry, which means that the original research drug occupied the majority of the hospital sales market of the drug However, according to the domestic data of smart drugs, at present, there are 327 domestic market approvals for captopril tablets, involving 240 manufacturers, 35 for consistency evaluation reference filing, and 13 for application acceptance In addition to the three enterprises that have been evaluated, the enterprises that have applied for acceptance have completed the be test, and the enterprises that have been evaluated or will be ready in the near future Under the favorable policy dividend, it is possible to replace the original research and development, especially when deepening the reform of medicine and health and further expanding the scope of purchasing with volume Metformin hydrochloride tablet metformin hydrochloride tablet is a biguanide oral hypoglycemic drug, which is widely used in the population It belongs to category A of the national medical insurance catalog (2019 version) and the basic drug catalog (2018 version) According to the statistics of pharmaceutical intelligence data, up to now, there are 11 enterprises that have passed the evaluation of this product, among which 10 enterprises have passed the evaluation of 0.25g product planning Details of consistency evaluation of metformin hydrochloride tablets In addition, Taifeng pharmaceutical, konkel pharmaceutical, Haiwang pharmaceutical, and Kerui pharmaceutical are in the state of "certificate preparation pending approval" for consistency evaluation of the product Once the product has passed the evaluation, there will be 16 enterprises that have passed the consistency evaluation The product with no doubt will become the first product with more than 15 enterprises that have passed the evaluation, and will surpass the product with the most enterprises that have passed the evaluation Amlodipine besylate tablets (13 have been evaluated) The consistency evaluation of metformin hydrochloride tablets is about to be over evaluated The details are about to be over evaluated There will be 16 over evaluated enterprises of metformin hydrochloride tablets In addition to the approval of several enterprises of metformin hydrochloride tablets, there are 12 acceptance numbers and 9 varieties in this week's handling status, showing the status of "certificate preparation - pending approval" See the following table for details: This week, there are 27 new CDE acceptance numbers (16 varieties) in the application acceptance details of the detailed form after the approval of consistency evaluation Among them, the first two varieties are valsartan hydrochlorothiazide tablets of China Resources Secco and adrenaline hydrochloride injection of Tianjin Jinyao Pharmaceutical Co., Ltd This week's application for acceptance details of consistency evaluation form valsartan hydrochlorothiazide tablets valsartan hydrochlorothiazide tablets belong to the representative drugs of compound antihypertensive preparations (diuretics + angiotension receptor blockers), mainly used to treat mild to moderate essential hypertension with single drug unable to fully control blood pressure Developed by Novartis, it was listed in the United States in 1998 According to the sales data of Yaozhi hospital, the sales volume of domestic sample hospitals reached 30.3714 million yuan, and the proportion of original research products reached 89.13% According to the domestic database of pharmaceutical intelligence, at present, there are only 5 domestic market approvals for valsartan hydrochlorothiazide tablets, 5 of which are produced by Shaanxi Bailu Pharmaceutical Co., Ltd., China Resources SECCO Pharmaceutical Co., Ltd., Zhejiang yingle Pharmaceutical Co., Ltd., Changzhou siyao Pharmaceutical Co., Ltd and lunanbert Pharmaceutical Co., Ltd., among which the first application consistency evaluation of China Resources Shuanghe has been accepted If it passes the evaluation successfully, it will challenge the original R & D and carve up the original research market Epinephrine hydrochloride injection epinephrine hydrochloride injection is mainly suitable for severe dyspnea caused by bronchospasm, which can rapidly relieve anaphylactic shock caused by drugs, and can also be used to prolong the action time of infiltration anesthesia All kinds of causes of cardiac arrest for cardiopulmonary resuscitation of the main rescue drugs According to the sales data of Yaozhi hospital, in 2018, the sales volume of adrenaline hydrochloride injection in the domestic sample hospital was 11.9655 million yuan, of which Shanghai Hefeng Pharmaceutical Co., Ltd accounted for 38.67%; Jinyao Pharmaceutical Co., Ltd., the first enterprise applying for the consistency evaluation of this variety this week, ranked second, accounting for 25.69% It is worth noting that in February this year, one batch of adrenaline hydrochloride injection produced by Jinyao Pharmaceutical Co., Ltd was unqualified in the spot check of Yongcheng food and Drug Inspection Institute of Henan Province, and was published in the notice of Henan drug administration on three batches of unqualified drugs in the spot check (issue 2, 2019) Jinyao pharmaceutical company immediately started the call back after learning the unqualified information of product inspection The total number of adrenaline hydrochloride injection in the unqualified batch was 353000, and the feedback result of recall was 0 Now it is the first to apply for conformity assessment, which will improve product quality and seize more market share Data sources: network information sources such as drug intelligence data, Enterprise Bulletin and so on: network announcement of drug information network, enterprise announcement and so on The column will be transferred to the WeChat public number on the drug network The official account will be posted on the public address Editor in charge | 37 statement: this point of view only represents the author himself, 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.