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    Home > Medical News > Latest Medical News > [Yao Kejun] drug review week trend: heavy setbacks! India's generic drugs have been accepted for three varieties, including the 10 billion class heavyweight drugs and the most consistent varieties. Is it sunny and catching up? Bairituo first imitated or came

    [Yao Kejun] drug review week trend: heavy setbacks! India's generic drugs have been accepted for three varieties, including the 10 billion class heavyweight drugs and the most consistent varieties. Is it sunny and catching up? Bairituo first imitated or came

    • Last Update: 2019-07-29
    • Source: Internet
    • Author: User
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    Highlights: 1 Two joint products of Nantong Lianya Pharmaceutical Co., Ltd will be approved soon; 2 Zhengda Tianqing will catch up with and win the first imitation of bairituo; 3 Another enterprise, pemetrexed disodium for injection, has been approved; 4 Arabindou, one of the three largest pharmaceutical companies in India, will apply for three varieties within a week, and India's generic drugs will be killed 1 The review and approval of new developments this week (July 19 - July 26) reported to the production of drugs, a total of 6 acceptance numbers, 5 varieties of generic drug processing status update On July 23, the listing applications of [ethinylestradiol tablet] and [deoxypregnenylestradiol tablet] of Nantong Lianya Pharmaceutical Co., Ltd showed that "approval completed - to be prepared" The two applications were included in the priority review on July 17, 2018 on the basis of "production in the same production line, listed in the United States in 2013" Ethinylestradiol can be used to supplement estrogen deficiency, treat female gonadal dysfunction, amenorrhea, menopause syndrome, etc.; it can be used to treat advanced breast cancer (postmenopausal women) and prostate cancer; it can be used as a contraceptive when combined with progesterone drugs to inhibit ovulation Each tablet contains 0.15mg of deoxypregnene and 30 μ g of ethinylestradiol At present, only Shanghai Xinyi Tianping Pharmaceutical Co., Ltd holds the production approval for domestic ethinylestradiol tablets, while no enterprise holds the production approval for deoxypregnenylestradiol tablets If approved, Nantong Lianya Pharmaceutical Co., Ltd will become the first one in China Zhengda Tianqing [rivaroxaban tablets] on July 23, the [rivaroxaban tablets] of Zhengda Tianqing pharmaceutical group showed "under approval" Previously, on May 27, the [rivaroxaban tablets] of Suzhou No.3 pharmaceutical factory showed that they had been sent, but they did not receive the approval at last, and it is expected to catch up this time According to the pharmaceutical intelligence data, there are 24 acceptance numbers of rivaroxaban tablets according to the new four types of imitation application, involving 17 enterprises, with fierce competition The patent of rivaroxaban compound expires in 2020 If it is approved in 2019, it will be a certain time before the official sale Sales of rivaroxaban have been bullish, with sales equivalent to RMB 43.796 billion in 2018 Rivaroxaban, a selective clotting factor Xa inhibitor, was jointly developed by Bayer and Janssen It was approved by the European Drug Administration (EMA) on September 30, 2008, and listed in the United States by FDA on July 1, 2011 In June 2009, rivaroxaban produced by Bayer entered China (trade name: byritol) for adult selective total hip or total knee joint Prevention of venous thrombosis after replacement In May 2015, two new indications of rivaroxaban tablets were approved by CFDA, respectively, for the treatment and prevention of deep vein thrombosis and pulmonary embolism, and stroke prevention in patients with atrial fibrillation Chuang Nuo Pharmaceutical Co., Ltd [pemetrexed disodium for injection] on July 23, Shanghai Chuang Nuo Pharmaceutical Co., Ltd [pemetrexed disodium for injection] showed "approved - to be certified" Pemetrexed disodium was developed by lily company It was first approved by FDA on February 4, 2004, and then approved by EMA on September 20, 2004 On January 4, 2007, it was approved by PMDA of Japan and listed by Lilly in the United States The product is Alimta The approved indications of the drug are: local advanced or metastatic non-small cell carcinoma and pleural mesothelioma At present, 15 domestic enterprises hold production approval documents, among which Sichuan Huiyu has entered the catalogue of Chinese listed drugs and entered the 4 + 7 volume procurement At present, Jiangsu Haosen Pharmaceutical Group Co., Ltd., Qilu Pharmaceutical Co., Ltd and Yangzijiang Pharmaceutical Group Co., Ltd have applied for conformity assessment 2 of the drugs newly accepted for production in this week's report after review and approval, 28 acceptance numbers have been accepted It is worth noting that the Indian pharmaceutical company arabindu Pharmaceutical Co., Ltd has declared three imported products On July 22, cdbe accepted three drug import applications of arabindu, namely [finasteride tablets], [clopidogrel bisulfate tablets], [amlodipine besylate tablets], respectively [finasteride tablets], [clopidogrel bisulfate tablets], [amlodipine besylate tablets] [Finasteride Tablets] is suitable for treating benign prostatic hyperplasia (BPH) with symptoms *: improving symptoms, reducing the risk of acute urinary retention, and reducing the risk of transurethral resection of prostate (TURP) and prostatectomy At present, in addition to the imported drugs of mercksharp & Dohme limited, 31 domestic enterprises hold production approval documents, 10 of which have applied for conformity assessment, and Beijing Hanmei Pharmaceutical Co., Ltd has approved the clinical application [clopidogrel bisulfate tablet] is used to prevent and treat circulatory disorders of heart, brain and other arteries caused by high platelet aggregation According to minenet data, the terminal sales of clopidogrel bisulfate tablets in public medical institutions in China in 2018 was 12.24 billion yuan At present, sanoficlirsnc, actavisgroupptcehf and India's Dr Reddy ` slaboratories Limited are imported drugs approved in 2019 Seven domestic enterprises hold production approval documents, and Shenzhen xinlitai Pharmaceutical Co., Ltd and Lepu Pharmaceutical Co., Ltd have passed the application for conformity assessment Amlodipine besylate tablet is an antihypertensive drug In the treatment of hypertension, it can be used alone or in combination with other antihypertensive drugs The treatment of chronic stable angina and variant angina can be used alone or in combination with other anti angina drugs It is reported that the market scale of amlodipine besylate tablet hospital is more than 5 billion yuan At present, there are imported drugs of lekpharmaceuticsd D in China, there are 60 domestic enterprises holding production approval documents 36 enterprises apply for conformity evaluation, which is the hottest variety to apply, and has passed 9 enterprises Arabindu pharmaceutical is located in Hyderabad, central India Is one of the three largest pharmaceutical companies in India, is a large multinational company, in China, the United States, Europe, South America, South Africa with factories or offices Especially in recent years, most of alabingo's factories and products have passed the US FDA and EU cos certification, which makes alabingo's products move towards high technology, high added value and high-end market The scale of the enterprise is constantly expanding, and it has ranked the top in the pharmaceutical field in the world, with modern production and scientific research institutions It is the largest API manufacturer in Asia It is reported that it has There are 11 FDA certified plants Some information reference: Baidu Encyclopedia, enterprise announcement data source: Pharmaceutical intelligence data statement: this point of view only represents the author, does not represent the pharmaceutical intelligence network position, 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.
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