Tosufloxacin

The iteration of quinolone antibacterial drugs has always focused on expanding the antibacterial spectrum and reducing toxic and side effects. As a representative variety of the third-generation quinolones, tosufloxacin inhibits the activities of bacterial DNA gyrase and topoisomerase IV to block the processes of bacterial DNA replication and transcription, and has strong antibacterial activity against Gram-positive bacteria, Gram-negative bacteria, anaerobes and some atypical pathogens. Clinically, it is mainly used to treat respiratory system infections, urinary system infections, digestive system infections, skin and soft tissue infections, etc. caused by sensitive bacteria, and the applicable population covers adult patients with bacterial infections. With low phototoxicity and good tissue permeability, it has unique clinical advantages in the treatment of mild to moderate community-acquired infections.

At present, the global market size of tosufloxacin is approximately USD 320 million, and the compound annual growth rate from 2021 to 2025 remains at around 4.1%. The growth momentum mainly comes from the release of demand for antibacterial drugs in primary medical institutions and the steady increase in the incidence of respiratory and urinary system infections. The domestic market is dominated by generic drug supply. At present, more than 10 enterprises have obtained preparation approvals, and the production of APIs is concentrated in Jiangsu, Zhejiang and other provinces. In recent years, it has not been included in the scope of national centralized procurement, and the price system is relatively stable.

The original research enterprise of tosufloxacin is Japan's Toyama Chemical Co., Ltd., and the original research trade name is "Ozex". The core compound patent expired in 2008 in major markets such as Japan and the United States. The main dosage form of the original research product is tablet, with specifications including 75mg, 150mg and 300mg. The original research tablet has been included in the Japanese Orange Book Reference Preparation Catalog, but it has not been included in the China Listed Drug Catalog Set yet. Domestically, there are nearly 10 domestic registration records of tosufloxacin APIs on the CDE API Registration Platform, most of which are in Status A, and the approved preparation varieties include tablets, capsules, etc. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and production quality control needs of tosufloxacin, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the whole-process quality control needs of pharmaceutical enterprises from pre-formulation research to generic drug consistency evaluation.