Brief analysis of sertraline hydrochloride tablets

Zhejiang Jingxin Pharmaceutical Co., Ltd (hereinafter referred to as "Jingxin pharmaceutical") sertraline hydrochloride tablets were approved on October 8, 2018 and passed the consistency evaluation of generic drugs Sertraline hydrochloride tablets, indications for sertraline used in the treatment of depression related symptoms, including depression with anxiety, with or without a history of mania Sertraline is also used to treat obsessive-compulsive disorder The original research enterprise of sertraline hydrochloride tablet is Pfizer pharmaceutical At present, the drug has been listed in many countries, Pfizer pharmaceutical still plays a leading role in the domestic market, and Beijing new pharmaceutical industry is the second According to the progress database of consistency evaluation of pharmaceutical intelligence data, there are five enterprises preparing for the consistency evaluation, including Zhejiang Jingxin Pharmaceutical Co., Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd., Shanghai Hengshan Pharmaceutical Co., Ltd., Zhejiang xindonggang Pharmaceutical Co., Ltd and Shanxi Qianyuan Pharmaceutical Co., Ltd currently, only Jingxin Pharmaceutical Co., Ltd has applied for and passed the consistency evaluation Progress chart of consistency evaluation of sertraline hydrochloride tablets 1 progress of consistency evaluation of sertraline hydrochloride tablets filing of sertraline hydrochloride tablets It is learned from the reference preparation filing database that the sertraline hydrochloride tablets are not included in the 289 catalog varieties, and the filing of Beijing new pharmaceutical industry sertraline hydrochloride tablets started in May 2016 with the specification of 50mg and the filing number of 2016050126; Zhejiang Huahai pharmaceutical industry sertraline hydrochloride tablets started the filing in July 2016 with the specification of 50mg and the filing number of 2016070472, as shown in Figure 2 for details Note: Chengdu lile Pharmaceutical Co., Ltd has no listing record and the record is not included in the progress of consistency evaluation Figure 2 clinical trial of sertraline hydrochloride tablets The clinical trials of sertraline hydrochloride tablets are as follows Zhejiang Jingxin Pharmaceutical Co., Ltd and Zhejiang Huahai Pharmaceutical Co., Ltd have completed the clinical trials The registration time of Zhejiang Jingxin Pharmaceutical Co., Ltd is October 31, 2017 The experimental institution is the clinical trial center of the Third Army General Hospital Indications: for depression, it can also be used to treat obsessive-compulsive disorder Test title: human bioequivalence test of sertraline hydrochloride tablets; Zhejiang Huahai Pharmaceutical Co., Ltd Industry was registered in the Third Army General Hospital on August 26, 2017 Indications: for the treatment of severe depression, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, premenstrual anxiety disorder and social phobia Test topic: bioequivalence test of sertraline hydrochloride tablets in human body under postprandial state, details are shown in Figure 3 Fig 3 clinical trials of sertraline hydrochloride tablets declaration of Zhejiang Jingxin sertraline hydrochloride tablets according to the registration and acceptance database of pharmaceutical intelligent drugs, there are 5 pieces of declaration information of Zhejiang Jingxin pharmaceutical industry, among which 3 pieces are supplementary applications, among which the declaration that was undertaken in November 2017 is the declaration of conformity assessment, which was approved for production on October 8, 2018, and passed the conformity assessment, as shown in Fig 4 Figure 4 drug registration and acceptance of sertraline hydrochloride tablets development process of Zhejiang Jingxin sertraline hydrochloride tablets Zhejiang Jingxin Pharmaceutical Co., Ltd passed the consistency evaluation from the clinical application in 2002 to October 8, 2018, during which, it passed the listing application, supplementary application, other tests, etc Figure 5 is the development process of sertraline hydrochloride tablets in Zhejiang Jingxin Pharmaceutical Co., Ltd Figure 5 research and development process of sertraline hydrochloride tablets in Zhejiang Jingxin Pharmaceutical Co., Ltd Zhejiang Jingxin pharmaceutical's first sertraline hydrochloride tablet will undoubtedly become a "star product" by consensus evaluation, and according to the relevant policies issued by the state in recent years, it will also obtain relevant dividends such as medical insurance payment, medical institutions, etc., and the varieties that pass the consistency evaluation in drug bidding will have certain advantages in bidding grouping, and the future development trend can be imagined 。 Introduction: Zhejiang Jingxin Pharmaceutical Co., Ltd is a cross regional, pharmaceutical research and development, production, sales in one of the pharmaceutical listed companies, national key high-tech enterprises With the core business philosophy of "creating excellent enterprises and building new brands in Beijing", the main business includes chemical preparations, APIs, traditional Chinese medicine, biological preparations and other major categories, including antibacterial, cardio cerebrovascular, neuropsychiatric and quinolone drugs Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; 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