On May 7, the State Food and Drug Administration announced that Jiangsu Tianye Pharmaceutical Co., LTD. Moxifloxacin hydrochloride tablets were approved successfully!
The clinical study of this variety was completed by Duzheng Biology "One-stop" (the third Xiangya Hospital of Central South University, a cooperative co-construction unit, was responsible for the clinical study, she Tong Intelligence was responsible for recruitment, The first lead medicine was responsible for SMO service, and weight-loss data management and statistical analysis). During the inspection, the project ISR (test sample reanalysis) reached 99.5%, far exceeding the international standard of 67%, and it took 70 days from sampling to submission of the report!
Moxifloxacin hydrochloride is a second-line anti-tuberculosis drug indicated for the treatment of adults (≥18 years old) with upper and lower respiratory tract infections, such as acute sinusitis, acute episodes of chronic bronchitis, community-acquired pneumonia, and skin and soft tissue infections. Developed by Bayer in Germany, the product is called "AVELOX." According to IMS data, the global sales volume of moxifloxacin hydrochloride tablets in 2017 was about 23,352,600 US dollars, of which the domestic sales volume was about 55.313,200 US dollars; During january-June 2018, the global sales volume was approximately $12,539,000, of which the domestic sales volume was approximately $3,4613,800.
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