Difloxacin

Prevention and control of bacterial infections in livestock and poultry is one of the core clinical demands in the livestock breeding field. As a third-generation fluoroquinolone antibacterial drug exclusively for animals, difloxacin exerts a bactericidal effect by inhibiting the activities of bacterial DNA gyrase and topoisomerase IV to block the bacterial DNA replication process. It has strong antibacterial activity against Gram-positive bacteria, Gram-negative bacteria and mycoplasma, and is mainly clinically used for the prevention and treatment of respiratory tract infections, digestive tract infections and mycoplasmosis in livestock and poultry such as pigs and chickens. It is a commonly used drug option for bacterial infection prevention and control in large-scale breeding scenarios.

In the global animal health antibacterial drug market, fluoroquinolone products account for approximately 12%. Due to its characteristics of high safety in target animals and slow development of drug resistance, difloxacin has achieved a compound annual market growth rate of 6.8% in the past three years, and its global market size was approximately USD 210 million in 2023. In terms of the domestic market, with the increase in the scale rate of livestock breeding and the stricter specifications for the use of veterinary antibacterial drugs, the demand for difloxacin preparations continues to rise. At present, 18 domestic enterprises have obtained preparation approvals, the supply of API is dominated by local enterprises, the overall competitive landscape is relatively fragmented, and no supplier with an absolute dominant position has emerged yet.

The original research enterprise of difloxacin is Bayer AG of Germany, and the original research brand name is "Baytril". Its core compound patent expired globally in 2006. The main dosage forms approved by the original research are solutions and injections, and the common specifications include 10% solution and 2.5% injection. The original research dosage form of this product has been included in the FDA Reference Listed Drug Catalog for Animal Drugs, and is also included in the *Chinese Veterinary Pharmacopoeia* 2020 Edition. As of the retrieval time point, there are 7 difloxacin API registration entries on the domestic CDE API registration platform, among which 5 have been activated. The domestically approved difloxacin preparation varieties cover three categories: powders, solutions and injections. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for difloxacin 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 compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference material support for animal health enterprises in API quality research, preparation stability study and registration and declaration work.