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    Home > Medical News > Latest Medical News > [good medicine] focus on injection! The first PPI injection consistency evaluation was undertaken, occupying 10 billion market; two "first" azithromycin for injection "were created in China US double newspapers and passed the consistency evaluation

    [good medicine] focus on injection! The first PPI injection consistency evaluation was undertaken, occupying 10 billion market; two "first" azithromycin for injection "were created in China US double newspapers and passed the consistency evaluation

    • Last Update: 2018-06-01
    • Source: Internet
    • Author: User
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    As of May 31, there are 171 acceptance numbers of conformity assessment drugs registered in CDE, involving 74 varieties of 80 enterprises, and 41 acceptance numbers have passed the conformity assessment This week (May 24 to May 31) another 11 acceptance numbers and 6 varieties were undertaken by CDE, including amoxicillin capsule of Huabei pharmaceutical, regelanide tablet of Haosheng, ceftriaxone sodium for injection of Shanghai Shangyao Xinya pharmaceutical, Mecobalamin tablet of Nanjing Hailing pharmaceutical, ranitidine hydrochloride capsule of Ouyi, pantoprazole sodium for injection of Jiangsu aosaikang In addition, azithromycin for injection of Puli pharmaceutical was the first to pass the consistency evaluation On May 27, Puli Pharmaceutical Co., Ltd announced that it had recently received the approval document for drug supplement application (approval document No.: 2018b02894) issued by the State Food and Drug Administration for conformity assessment of quality and efficacy of azithromycin for injection through generic drugs Azithromycin is a new generation of macrolide antibiotics, which was discovered in 1980 and launched in 1981 It is a broad-spectrum antibiotic obtained after the second generation of structural modification of erythromycin Its antibacterial spectrum is wider than erythromycin, and its effect on Haemophilus influenzae and Streptococcus is four times that of erythromycin Azithromycin 0.5g for injection of Puli Pharmaceutical (calculated by c38h72n2o12) is a double report variety registered in China and the United States at the same time It is the first successful export product transferred to China for approval It is also the first injection variety that has passed the conformity evaluation according to the six categories of old chemical registration and listing approval In 2012, Puli Pharmaceutical Co., Ltd submitted the registration application to the United States and China at the same time, and obtained the temporary approval from the U.S Food and Drug Administration (FDA) in October 2015, and obtained the priority review and approval qualification from the drug review center in September 2016 In August 2017, Puli Pharmaceutical Co., Ltd received the drug registration approval issued by the State Food and drug administration On May 27, 2018, it formally passed the injection consistency evaluation of chemical medicine category 6 According to the analysis of Guojin securities, the size of azithromycin in the domestic terminal market is about 1.5 billion yuan, and the number of people using azithromycin can reach 20 to 30 million According to the data of sample hospitals, the sales volume of azithromycin in 2017 was 489 million yuan According to the pharmaceutical intelligence database, there are many manufacturers of azithromycin for injection, but the largest market share is Northeast Pharmaceutical and Pfizer, accounting for 80% and 18% respectively This time, azithromycin for injection of Puli pharmaceutical took the lead in passing the consistency evaluation, which will impact the injection Market and segment a larger market share 11 acceptance No 6 varieties were undertaken, the first PPI drug injection consistency evaluation was undertaken this week (May 24 to May 30) 11 new acceptance no of CDE drugs, involving 6 varieties of 6 enterprises, see the following table for details: 1 Amoxicillin capsule consistency evaluation of North China Pharmaceutical was undertaken by CDE on May 30 Amoxicillin is a semi synthetic penicillin for anti infection treatment The original research company is Beecham Group PLC, which was first listed in 1972 At present, the Chinese market has been dominated by generic drugs Because of its good dissolution and low price, the capsule has become the main dosage form of amoxicillin, accounting for more than 80% of the market share Amoxicillin is a mature oral antibacterial drug In view of the maturity of amoxicillin market, most manufacturers are reluctant to give up their consistency evaluation According to the consistency evaluation database of pharmaceutical intelligence, there are five enterprises applying for the consistency evaluation of amoxicillin capsule, including Huabei pharmaceutical, Hunan Kelun pharmaceutical, Zhejiang Jinhua Kangenbei biopharmaceutical and Zhuhai federal pharmaceutical At present, only Zhuhai UL has passed the consistency evaluation with Sinopharm Table 2 details of the consistency evaluation of amoxicillin capsule On May 30, the consistency evaluation of Jiangsu Haosheng Pharmaceutical Co., Ltd was undertaken by CDE Repaglinide, the latest non sulfonylurea drug, is suitable for type 2 diabetes mellitus (non insulin dependent) patients whose diet control, weight loss and exercise can not effectively control their hyperglycemia The original research company is Novo Nordisk According to the public data, the largest global sales volume of reglanet is 4.96 billion US dollars, the largest sales volume of sample hospitals is 320 million yuan, and the sales volume of sample hospitals in 2017 is 210 million yuan According to the statistics of drug registration and acceptance database, at present, only three enterprises have obtained the production approval documents for regranet tablets, namely Beijing Wansheng, Beijing Beilu and Tianjin Kangrui pharmaceutical, and at present, only Jiangsu Haosen pharmaceutical has applied for conformity evaluation 3 On May 28, the consistency evaluation of four acceptance numbers of ceftriaxone sodium for injection of Shanghai Shangyao Xinya Pharmaceutical Co., Ltd was undertaken by CDE Ceftriaxone sodium (ceftriaxone sodium) is a long-acting, broad-spectrum third-generation cephalosporin drugs and unrestricted use class antibiotics, which belongs to class a of medical insurance and national 520 base drugs Developed by Roche company in Switzerland, it was first listed in Switzerland in 1982, approved by FDA in 1984, and then listed in Japan, Britain, Germany and other countries At present, ceftriaxone sodium has been approved for listing in more than 110 countries According to pharmaceutical intelligence data, at present, there are many domestic listed enterprises producing ceftriaxone sodium for injection, with more than 300 approval numbers; however, only two enterprises, Shanghai Shangyao Xinya Pharmaceutical Co., Ltd and Qilu Pharmaceutical Co., Ltd., apply for drug consistency evaluation Table 4 details of consistency evaluation of ceftriaxone sodium for injection Mecobalamin tablets on May 28, the consistency evaluation of mecobalamin tablets of Nanjing Hailing Pharmaceutical Co., Ltd was undertaken by CDE Mecobalamin, a therapeutic drug for peripheral neuropathy, belongs to vitamin B12 It can repair the injured peripheral nerve by promoting the synthesis of nucleic acid, protein and myelin sheath in nerve cells It has been widely used in clinic According to the drug registration and application database, there are 41 registration acceptance numbers of mecobalamin tablets at present, among which 15 are approved for production However, only Nanjing Hailing Pharmaceutical Co., Ltd applies for the consistency evaluation of mecobalamin 5 Ranitidine hydrochloride capsule on May 25, the consistency evaluation of ranitidine hydrochloride capsule of the stone drug Ouyi pharmaceutical industry was undertaken by CDE Ranitidine was developed by Allen & hanburys Co., Ltd., a subsidiary of GlaxoSmithKline, in 1977 It was first listed in the UK in 1981 and in China in 2007 At present, generic drugs are listed in Europe, the United States and other countries According to the drug registration and application database, there are 31 registration acceptance numbers of ranitidine hydrochloride, and only 3 enterprises are approved for production, namely, Lixin, Zhongnuo and Yiling pharmaceutical of Nanyang, and only two enterprises, namely, Ouyi and Huiren of Jiangxi, are applying for conformity evaluation Table 6 details of consistency evaluation of ranitidine hydrochloride pantoprazole sodium for injection was undertaken by Jiangsu aosaikang Pharmaceutical Co., Ltd on May 25 This is the first consistent evaluation application for PPI drug injection and it has been accepted Pantoprazole is a proton pump inhibitor It can specifically act on the proton pump (H + - K + - ATPase) on the surface of gastric mucosal wall cells It has a strong and lasting inhibitory effect on gastric acid secretion caused by various stimulation Compared with cimetidine, the effect of pantoprazole is 10 times stronger than cimetidine It can be used to treat acute upper gastrointestinal bleeding, such as reflux esophagitis, duodenal ulcer, gastric ulcer, acute gastric mucosal disease, compound gastric ulcer, etc It is reported that in 2017, pantoprazole's domestic hospital sales accounted for 28.43%, and the hospital sales volume was about 4 billion, ranking first in the sales volume of PPI drugs; at present, the largest sales volume is imported enterprise nekom, and in 2017, the domestic hospital sales manufacturers accounted for 26.77% Although Jiangsu aosaikang Pharmaceutical Co., Ltd also used pantoprazole for injection in the morning, its market share was very low, accounting for less than 1% of the total This time, the first application of pantoprazole sodium for injection consistency evaluation by Jiangsu aosaikang Pharmaceutical Co., Ltd was undertaken, seizing the opportunity of consistency evaluation and competing for the 10 billion market of PPI drugs [good medicine record] column for you to track the latest trend of consistency evaluation in a week! Please continue to pay attention to the information and data source of yaozh service (1569612300) wechat service no of yaozhi
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