[good medicine record] the fifth batch of consistency evaluation list has been published, with 5 289 catalog products listed, and the "tripartite confrontation" situation of rosuvastatin calcium tablets has become

More than half of 2018 has passed, and the deadline for consistency evaluation is approaching CDE and various pharmaceutical companies are working hard As of July 26, there were 261 application acceptance numbers of conformity assessment, involving 107 varieties of 111 enterprises This week (July 19 to July 26): the fifth batch passed the consistency evaluation list, among which the third one of ruishuvastatin calcium tablets from Haizheng, Zhejiang Province passed the consistency evaluation; in addition, the first one of terbinafine hydrochloride tablets from Qilu pharmaceutical will pass the consistency evaluation; in the new development of this week, 14 new consistency evaluation acceptance numbers involving 1 12 varieties of one enterprise See the details with the editor The fifth batch of conformity evaluation list was published today CDE released the fifth batch of conformity evaluation list, involving 8 varieties of 12 enterprises, including 5 varieties in 289 catalogue, namely, montmorillonite, captopril, alfacalcitol, amlodipine besylate and cefuroxime dipivoxil See Table 1 for details Table 1: the third batch of Zhejiang Haizheng ruishuvastatin calcium tablets passed the consistency evaluation list in the fifth batch It is worth mentioning that Zhejiang Haizheng ruishuvastatin calcium tablets passed the list According to the data of Yaozhi, there are 13 domestic approval numbers of rosuvastatin calcium tablets The main manufacturers are Lunan Beite, Zhengda Tianqing, Zhejiang Jingxin, Zhejiang Haizheng, etc There are 5 enterprises applying for conformity assessment (see Table 2 for details), and Zhejiang Haizheng passed the third one this time, which means that the "tripartite confrontation" situation of rosuvastatin calcium tablets has been formed and the advantage situation has been seized Table 2 acceptance details of application consistency evaluation of rosuvastatin calcium tablet is a selective HMG CoA reductase inhibitor, which can be used to treat primary hypercholesterolemia (type IIA, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIB) Initially developed by AstraZeneca in the UK, it was approved to be listed in the United States in 2003; in 2006, it was approved to enter China with the trade name of Crestor The domestic imitated products first obtained the approval for listing in 2008, and they belong to Lunan Beite, Nanjing Zhengda Tianqing and Zhejiang Jingxin pharmaceutical According to IMS database, the global sales volume of rosuvastatin calcium tablets in 2017 is about 4.191 billion US dollars, including 428 million US dollars in China; the global sales volume in January March 2018 is about 876 million US dollars, including 129 million US dollars in China Terbinafine hydrochloride tablets of Qilu pharmaceutical will pass the consistency evaluation recently According to Qilu pharmaceutical, the company's terbinafine hydrochloride tablets have been reviewed and approved by the State Administration, and are in the process of preparation and certification, and will pass the consistency evaluation soon Terbinafine hydrochloride tablet is the first oral acrylamine antifungal drug in the world The original research company is Novartis, Switzerland It was first listed in Japan in September 1997 It is clinically used for various skin and nail infections caused by superficial fungi The drug has broad-spectrum antifungal effect, strong bactericidal power, can significantly shorten the course of treatment of chronic mycosis and can effectively reduce the recurrence rate The clinical efficacy has been unanimously recognized by medical institutions and the majority of patients According to the pharmaceutical intelligence data, there are only 10 domestic market approvals for terbinafine hydrochloride tablets, the main manufacturers are Beijing Novartis, Qilu pharmaceutical, Haizheng Pfizer, etc., and only Qilu pharmaceutical has applied for the consistency evaluation If Qilu pharmaceutical is the first to pass the consistency evaluation, it will gain market advantage and occupy a larger market share The conformity evaluation of 12 varieties of 11 enterprises was accepted this week (July 19 to July 26) Another 14 acceptance numbers were undertaken by CDE conformity evaluation, involving 12 varieties of 11 enterprises See Table 3 for details Table 3 acceptance details of this week's consistency evaluation of docetaxel injection on July 23, the consistency evaluation of Zhengda Tianqing's docetaxel injection was accepted by CDE Docetaxel is a semi synthetic taxol derivative, which has been widely used in the treatment of a variety of malignant tumors in recent years It is considered to be one of the most effective anticancer drugs Docetaxel has achieved good curative effect in the clinical treatment of breast cancer, ovarian cancer, non-small cell lung cancer and other malignant tumors It is also one of the most active drugs in the treatment of advanced breast cancer It is reported that the sales volume of docetaxel injection in the U.S market in 2015 was $154 million, while that in China was $318 million According to the pharmaceutical intelligence data, at present, there are 38 domestic docetaxel injection Market approvals, involving 20 enterprises; only Jiangsu Hengrui and Zhengda Tianqing apply for the consistency evaluation, who will be the first to pass and seize the market share is worth looking forward to On July 20, the consistency evaluation of the injection was undertaken by CDE The injection is X-ray contrast agent, which is suitable for cone tube angiography, cardio cerebral angiography and intravenous urography Developed by Norske nacoming Pharmaceutical Co., Ltd., it was first listed in Sweden, Britain, Switzerland and other European countries in 1994, and has been listed in China, the United States, Japan, France and other countries and regions According to IMS data, in 2017, the global sales volume of iqsa injection was about 489 million US dollars, the sales volume in Europe was about 135 million US dollars, and the sales volume in China was about 173 million US dollars According to pharmaceutical intelligence data, at present, there are 10 market approvals for domestic iodixanol injection, involving 4 enterprises, namely Jiangsu Hengrui, Nanjing Zhengda Tianqing, Beijing Beilu and Yangtze River Pharmaceutical The enterprises applying for conformity assessment are only Jiangsu Hengrui pharmaceutical and have been accepted On July 20, the consistency evaluation of flupentixicine tablets of Sichuan hisic Pharmaceutical Co., Ltd was undertaken by CDE Flupentixol tablets, a compound preparation of Flupentixol and melitracen, are mainly used to treat anxiety and other diseases accompanied by anxiety symptoms, as well as antidepressant and excitatory properties Its original research company is Danish Lingbei pharmaceutical It was first listed in Austria under the trade name Deanxit (Deanxit ®) in 1971, then in Spain, Switzerland, Singapore and other countries and regions In 1998, it was approved to be listed in China It is reported that in 2017, the market share of piperacillin was about 882 million yuan, and the overall market share of Sichuan hisic pharmaceutical was 5.68%, 3.7 percentage points higher than that in 2016 According to the pharmaceutical intelligence data, at present, there are only three domestic market approvals for Flupentixol, involving three enterprises: Chongqing shenghuaxi Pharmaceutical Co., Ltd., Hainan Huineng Pharmaceutical Co., Ltd and Sichuan hisic Pharmaceutical Co., Ltd., and only Sichuan hisic Pharmaceutical Co., Ltd has applied for the consistency evaluation On July 20, the consistency evaluation of ibuprofen sustained-release capsules of Shanghai Xinyi balance Pharmaceutical Co., Ltd was undertaken by CDE Ibuprofen Sustained release capsule is a kind of antipyretic and analgesic drug, which belongs to non steroidal anti-inflammatory drugs It is used to relieve mild to moderate pain, such as headache, joint pain, migraine, toothache, muscle pain, neuralgia and dysmenorrhea According to pharmaceutical intelligence data, at present, there are 23 domestic market approvals for ibuprofen sustained-release capsules, with a large number of manufacturers Only Shanghai Xinyi Tianping Pharmaceutical Co., Ltd and Zhuhai Rundu Pharmaceutical Co., Ltd have applied for the consistency evaluation See Table 4 for details Table 4 acceptance details of consistency evaluation of Ibuprofen Sustained Release Capsules table metformin hydrochloride tablets July 20, the consistency evaluation of metformin hydrochloride tablets of Shanghai Xinyi balance Pharmaceutical Co., Ltd was undertaken by CDE Metformin hydrochloride tablets are used in patients with type II diabetes mellitus who are not satisfied with simple diet control, especially those who are obese and have hyperinsulinemia It can not only reduce blood sugar, but also reduce weight and hyperinsulinemia Metformin is a typical representative of biguanide drugs Because of its unique treatment advantages, it has been recommended by many countries and who as the first-line drug and the basic drug in combination drug for diabetic patients to control hyperglycemia In 1922, scientists synthesized metformin for the first time In 1957, Squibb was put on the market under the trade name of "gehuazhi" In 1958, it was listed in the UK, and in 1972, it was listed in Canada In 1994, the metformin hydrochloride produced by Squibb pharmaceutical was approved to be listed in the United States According to the public information, the sales volume of metformin sample hospitals in 2017 was about 280 million yuan According to experts' estimates, the annual market size of metformin can reach 3.5 billion yuan, including the retail market However, most of the market belongs to the original research drug gehuazhi, and the sales proportion of domestic enterprises is very small According to the drug intelligence data, there are currently 120 domestic approvals for Metformin Hydrochloride Tablets, with a large number of manufacturing enterprises There are 5 enterprises applying for consistency evaluation, and none of them have passed the consistency evaluation The details are shown in table five below Table 5 acceptance details of consistency evaluation of metformin hydrochloride tablets ropivacaine hydrochloride injection July 20, the consistency evaluation of ropivacaine hydrochloride injection of Guangdong Jiabo Pharmaceutical Co., Ltd was undertaken by CDE Ropivacaine hydrochloride is a new type of long-acting amide local anesthetic, and it is the leading variety of local anesthetic It is suitable for surgical anesthesia and acute pain control Ropivacaine, developed by Astra pharmaceutical company of Sweden, was first listed in the Netherlands in 1996, and was approved by FDA in the United States on September 24 of the same year It was listed in the United Kingdom in 1997 So far, it has been listed in dozens of countries According to the data of public hospitals in key cities, the sales of ropivacaine in the first three quarters of 2017 was 59.41 million yuan, and the original research drug AstraZeneca accounted for 81.26% of the absolute market share, while the domestic market share of generic drugs was very low According to the pharmaceutical intelligence data, at present, there are 19 domestic market approvals for ropivacaine hydrochloride injection, involving Renfu pharmaceutical, Qilu pharmaceutical, Jiangsu Hengrui and other enterprises, among which only Guangdong Jiabo pharmaceutical has applied for the consistency evaluation On July 20, the consistency evaluation of polyethylene glycol 4000 powder of Chongqing Sano bio Pharmaceutical Co., Ltd was undertaken by CDE Polyethylene glycol 4000 is a linear polymer of ethylene glycol, which is mainly used to treat the symptoms of constipation in adults and children over 8 years old (including 8 years old) According to pharmaceutical intelligence data, at present, there are only four domestic approvals involving four manufacturing enterprises, namely, Wuhan Mayinglong Pharmaceutical Co., Ltd., Chongqing Sinopharm Co., Ltd., Hunan Warner Pharmaceutical Co., Ltd and Chongqing Huasen Pharmaceutical Co., Ltd.; among them, three enterprises have applied for conformity assessment (see table for details) It remains to be seen who will be the first to get preferential policies and occupy a larger market share through consistency evaluation Table 6 acceptance details of consistency evaluation of PEG4000 powder indapamide tablets on July 20, the consistency evaluation of indapamide tablets of Tianjin Pacific Pharmaceutical Co., Ltd was undertaken by CDE Indapamide is a kind of sulfonamide diuretic, which has diuretic and calcium antagonistic effects It is a strong and long-term antihypertensive drug It is also used for the treatment of water and sodium retention in congestive heart failure * It was developed by SERVIER company in France Since its application in Europe in 1973, it has been used in more than 100 countries all over the world due to its definite curative effect, taking only 1 time a day and less adverse reactions According to the statistics of pharmaceutical intelligence database, at present, there are more than ten enterprises in China that have obtained the production approval documents of indapamide tablets, and three enterprises that have applied for the conformity evaluation, the details are shown in Table 7 Table 7 acceptance details of consistency evaluation of indapamide tablets cefixime Capsule on July 20, Chengdu Beite Pharmaceutical Co., Ltd undertook the consistency evaluation of cefixime capsule by CDE Cefixime capsule, a new third-generation cephalosporin oral antibiotic, is suitable for the following bacterial infectious diseases introduced by Streptococcus (except Enterococcus), pneumococcus, Neisseria gonorrhoeae, catablan, Escherichia coli, Klebsiella, Serratia, Proteus and bacilli influenzae, which are sensitive to cefixime Cefixime 1987