Lomefloxacin

Bacterial infectious diseases have long ranked among the most common clinical diseases. Quinolones are one of the core categories of anti-infective therapy. As a representative third-generation fluoroquinolone, lomefloxacin exerts a broad-spectrum antibacterial effect by inhibiting the activities of bacterial DNA gyrase and topoisomerase IV to block the processes of bacterial DNA replication and transcription. It has a good killing effect on Gram-negative bacteria, some Gram-positive bacteria and some anaerobic bacteria. Clinically, it is mainly used to treat various infectious diseases such as respiratory tract infections, urogenital tract infections, gastrointestinal infections, and skin and soft tissue infections, and its applicable population covers adult patients with bacterial infections. Due to its long half-life and strong tissue penetration, it only needs to be administered 1-2 times a day, which has a significant advantage in medication compliance.

At present, quinolone anti-infective drugs account for approximately 15% of the domestic anti-infective drug market. As a mature variety, the overall domestic market size of lomefloxacin is stable in the range of 600 million to 800 million yuan. As a generic drug whose patent has expired for many years, domestic generic drug manufacturers occupy a dominant position, and the production capacity of preparations and APIs is concentrated in East China and North China. At present, more than 30 enterprises have obtained lomefloxacin preparation approval documents, and there are more than 10 API manufacturers. The price of products selected in the centralized procurement has dropped by more than 90% compared with the original research period, and the clinical accessibility has been greatly improved.

The original research enterprise of lomefloxacin is Kyorin Pharmaceutical Co., Ltd. of Japan, with the original brand name "Bareon". The core compound patent of lomefloxacin expired worldwide in 1999. The main dosage forms approved for the original research include tablets, capsules and injections. The common specifications are 100mg and 200mg for tablets, and 100ml:0.2g for injections. The original research product has been included in the FDA Reference Listed Drug Catalog, and the original research preparation has not been imported into China. At present, the reference listed drug approved in China is the generic drug variety produced by domestic pharmaceutical enterprises. In China, lomefloxacin APIs from 12 enterprises have obtained A status through CDE registration and can be legally supplied to preparation manufacturers, and the API registration of another 3 enterprises is under review. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for lomefloxacin API, meeting the needs of the whole process of R&D declaration and quality control. Most impurity reference standards are in stock. Spot orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can be directly used for the submission of declaration materials, helping enterprises shorten the R&D cycle and reduce quality control costs.