Gatifloxacin

In response to the clinical treatment needs of drug-resistant bacterial infections, fluoroquinolones have become an important choice due to their broad-spectrum antibacterial activity, and gatifloxacin is a representative fourth-generation variety of this class. Its mechanism of action is to inhibit bacterial DNA gyrase and topoisomerase Ⅳ, thereby blocking bacterial DNA replication and transcription, and it has strong bactericidal effects against Gram-positive bacteria, Gram-negative bacteria, anaerobes and atypical pathogens. Clinically, it is mainly used for the treatment of infectious diseases such as acute exacerbation of chronic bronchitis, community-acquired pneumonia, acute sinusitis and urinary tract infection, and the applicable population covers adult patients with no history of quinolone allergy.

After the patent expiration, the global gatifloxacin market is dominated by generic drugs. Public data shows that the sales volume of gatifloxacin preparations at the terminals of domestic public medical institutions was approximately 270 million yuan in 2023, and the growth rate in the recent 3 years has remained in the range of 4% to 6%. At present, there are more than 40 domestic approved manufacturers of gatifloxacin preparations. In centralized procurement bidding, the price of generic drugs has dropped by more than 85% compared with the peak price of the originator drug, and the main suppliers of API are domestic pharmaceutical enterprises. The overall market has sufficient competition and stable supply-demand relationship.

The originator company of gatifloxacin is Bristol-Myers Squibb, and the brand name of the originator drug is "Tequin". The expiration time of its core compound patent in the United States was 2006, and the Chinese compound patent also expired in 2006. The dosage forms approved for the originator drug include tablets and injections, with common specifications of 0.2g and 0.4g for tablets, and 20ml:0.2g and 100ml:0.2g for injections. The originator product has been included in the FDA Reference Listed Drug Catalogue, and is also included in the *Catalogue of Reference Preparations for Chemical Drugs* of China. According to the information on the domestic CDE API Registration Platform, 12 enterprises have completed the A-status registration of gatifloxacin API at present, and the domestic approved gatifloxacin preparations cover multiple dosage forms such as tablets, capsules, injections and eye drops. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for gatifloxacin API, covering all relevant impurities involved in the synthesis process and degradation pathways. The products simultaneously meet the requirements of the Chinese Pharmacopoeia and relevant FDA regulations. Most categories are in regular stock, and spot orders submitted before 16:00 can be shipped on the same day, which can provide stable reference material support for API R&D, quality research and consistency evaluation work.