Moxifloxacin hydrochloride tablets approved for marketing by Guowei Pharmaceutical Co., Ltd. are deemed to have passed the consistency evaluation

On January 11, the official website of Sichuan Guowei pharmaceutical company announced that the second tablet variety "moxifloxacin hydrochloride tablet" applied by its company on December 25, 2018 was successfully approved by the State Drug Administration for listing (drug approval No.: gyzz h20183530) Moxifloxacin hydrochloride tablets are second-line anti tuberculosis drugs, which are suitable for the treatment of adults (≥ 18 years old) with upper and lower respiratory tract infection, such as: acute sinusitis, acute attack of chronic bronchitis, community-acquired pneumonia, and skin and soft tissue infection Developed by Bayer company in Germany, the product is called avelox According to IMS data, the global sales volume of moxifloxacin hydrochloride tablets in 2017 was about US $23352600, of which the sales volume in the domestic market was about US $55313200; the global sales volume from January to June 2018 was about US $125390000, of which the sales volume in the domestic market was about US $34613800 According to pharmaceutical intelligence data, at present, only Beijing Wansheng Pharmaceutical Co., Ltd and Guangdong dongyangguang Pharmaceutical Co., Ltd have the domestic market approval documents, and the moxifloxacin hydrochloride tablets of the two enterprises are in the front-end with the new 6 categories of chemical drugs and the new 4 categories registered and approved for production through the priority review; in addition, the drugs of Jiangsu Tianyi pharmaceutical and Chongqing Huabang pharmaceutical have been approved It is listed as a priority drug for review and approval It is worth mentioning that the moxifloxacin hydrochloride tablets of Sichuan Guowei Pharmaceutical Co., Ltd are also approved with the new 4 types of registration Like Guangdong dongyangguang Pharmaceutical Co., Ltd., they are included in the national drug catalog They are deemed to have passed the consistency evaluation and become the second enterprise in China to pass the consistency evaluation of the quality and efficacy of the generic moxifloxacin hydrochloride tablets after Guangdong dongyangguang Pharmaceutical Co., Ltd According to the announcement, Guowei pharmaceutical now has a full range of products including moxifloxacin hydrochloride API, moxifloxacin hydrochloride injection, moxifloxacin hydrochloride sodium chloride injection and moxifloxacin hydrochloride tablets This time, moxifloxacin hydrochloride tablets of China Pharmaceutical Co., Ltd passed the consistency evaluation in the first place, which will enjoy the policy benefits, increase the company's competitive strength of the product, and gain more market share Information source: Announcement statement on the official website of the enterprise: the viewpoint of this article only represents the author, not the position of yaozhi.com, and you are 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.