[good medicine record] consistency evaluation weekly trend: 12 varieties passed 3 enterprises, and the highlights are still continuing

As of July 18, there are 1289 acceptance numbers (373 varieties of 383 enterprises, calculated according to the supplementary application, the same below), 225 acceptance numbers (96 varieties) have been passed; this week, another 4 varieties have been evaluated, 2 varieties have been approved, and 13 varieties have been applied for acceptance There are more than 3 enterprises that have passed the consistency evaluation this week, including isoniazid tablets of Shenyang Hongqi pharmaceutical, montmorillonite powder of Harbin pharmaceutical, bisoprolol fumarate tablets of Beijing HuaSu pharmaceutical and metformin hydrochloride sustained-release tablets of Tianfang pharmaceutical Details of this week's conformity assessment Among them, isoniazid tablets have previously passed the consistency evaluation by four enterprises, including Shenyang Hongqi Pharmaceutical Co., Ltd., which all passed the specification of 0.1g This time, Shenyang Hongqi Pharmaceutical Co., Ltd is the first one to enrich its product line through the consistency evaluation of 0.3g Under the current situation of nationwide linkage of centralized procurement, it is expected to further enhance its competitiveness In addition, this week's montmorillonite powder of Harbin Pharmaceutical Co., Ltd and metformin hydrochloride sustained-release tablets of Tianfang Pharmaceutical Co., Ltd were evaluated at the 6th and 5th respectively However, in the "4 + 7 Enterprise Symposium on centralized purchase and expansion" organized by the state health insurance bureau a few days ago, it was clearly pointed out that three generic drugs will be implemented in China and will no longer purchase the varieties that have not been evaluated after evaluation, "not only do not purchase, but also do not reimburse", which is not a rush for the lack of evaluation Among the top three enterprises, the pressure has increased According to incomplete statistics of pharmaceutical intelligence data, up to now, the number of enterprises that have passed the consistency evaluation of 12 varieties has reached 4 or more, among which amlodipine besylate tablet has the largest number of enterprises that have passed the evaluation The number of enterprises that have passed the evaluation again this week, including montmorillonite powder and metformin hydrochloride sustained-release tablet, is also at the top, with fierce competition, as shown in the figure below Source of data chart: after the review and approval of generic drug consistency evaluation and analysis system database of pharmaceutical intelligence data enterprise version, 2 varieties have been approved, another product will be the first? This week, in addition to the four varieties that have been evaluated, there are two varieties that have been reviewed and approved, showing the status of "certificate preparation completed - pending approval" Betahistine hydrochloride tablets are mainly used in Meniere's syndrome, vascular headache and cerebral arteriosclerosis, and can be used in the treatment of acute ischemic cerebrovascular diseases, such as cerebral thrombosis, cerebral embolism, transient cerebral blood supply insufficiency, etc.; upright vertigo and tinnitus caused by hypertension are also effective It is a national medical insurance category a drug At present, there are 20 domestic market approvals, involving 16 manufacturing enterprises, of which only 3 enterprises have made the consistency evaluation reference filing, and Lepu hengjiuyuan pharmaceutical and Shanghai Zhongxi three-dimensional pharmaceutical have been accepted However, according to the consistency evaluation progress database of enterprise version of pharmaceutical intelligence data, at present, Shanghai Zhongxi three-dimensional pharmaceutical be experiment is still in recruitment, which is under review After the approval, it's doubtful whether there will be any comments this time Data source: enterprise consistency evaluation progress database of pharmaceutical intelligence data Metformin hydrochloride sustained-release tablets as a good medicine for type 2 diabetes mellitus, there is no doubt that the competition is fierce There are 47 domestic market approvals, 46 manufacturers, 39 consistency evaluation references, 12 enterprise applications have been accepted, 5 enterprise reviews, and 4 enterprise be tests have been completed This week, Tianfang pharmaceutical industry overtook Zhengda Tianqing, the fifth one has been reviewed, and Zhengda Tianqing as the dominant product It remains to be seen whether a large number of enterprises can become the sixth in the coming second round of centralized drug purchase Application acceptance 13 varieties were undertaken, 5 injections in this week's CDE added 18 acceptance numbers of consistency evaluation, involving 13 varieties, among which 3 varieties were the first application acceptance varieties, namely bismuth potassium citrate capsule of Hunan Warner Pharmaceutical Co., Ltd., haloperidol tablet of Ningbo Dahongying Pharmaceutical Co., Ltd and cefprozil dispersible tablet of Shanghai Meiyou Pharmaceutical Co., Ltd In addition, this week's injection still became a bright spot in the application of consistency evaluation, and five varieties were undertaken: parrixib sodium for injection of Jiangsu aosaikang Pharmaceutical Co., Ltd., palonosetron hydrochloride injection of Zhengda Tianqing Pharmaceutical Co., Ltd., doxofylline injection of Anhui Xingxing Pharmaceutical Co., Ltd., moxifloxacin hydrochloride injection of Chengdu Tiantaishan Pharmaceutical Co., Ltd., and ceftriaxone sodium for injection of Peking University Pharmaceutical Co., Ltd It is worth mentioning that parecoxib sodium for injection is a non steroidal anti-inflammatory drug It is the first COX-2 inhibitor for intravenous and intramuscular injection in the world, which can effectively meet the clinical needs of rapid onset of postoperative analgesia and patients unable to eat It is widely used in general surgery, gynecology, orthopedics, stomatology and other departments to treat postoperative pain It is one of the basic drugs for clinical multimodal analgesia The product was jointly developed by Pfizer and famasia, and was first listed in Europe in 2002 The product is dynastat, with specifications of 20mg and 40mg At present, it has been listed in at least 15 countries such as Germany, France and the United Kingdom In 2008, it was approved to be listed in China, with the trade name of Trane, and it is a class B national medical insurance product In 2016, the sales volume of Tena in China was about 765 million yuan, and in 2017, the terminal sales volume of Tena in China's public medical institutions was 885 million yuan, which is expected to become a large variety of 2-3 billion level According to the pharmaceutical intelligence data, at present, there are 10 domestic enterprises of parixib sodium for injection, including well-known enterprises such as Zhengda Tianqing, Qilu pharmaceutical, Kelun pharmaceutical, etc., and 6 enterprises have applied for the consistency evaluation of the product It is worth noting that the product of Hunan Kelun Pharmaceutical Co., Ltd has been approved once in 2018 and is in the "issued" state, and then applied again It's worth looking forward to whether the newspaper can win the first prize by virtue of its first mover advantage At last, in order to pay attention to the consistency evaluation of friends Amway, we need to create a new enterprise version of pharmaceutical intelligence data, which is a generic consistency evaluation and analysis system database https://vip.yaozh.com/yzx/pjdt , comprehensive and multi-dimensional analysis chart, simple and intuitive overview consistency evaluation global action, and one click to generate visual data chart report 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.