Enoxacin

Bacterial resistance has become a core challenge in the treatment of infectious diseases worldwide, and fluoroquinolones occupy an important position in clinical practice due to their broad-spectrum antibacterial activity. Enoxacin is a third-generation fluoroquinolone antibacterial agent. It exerts a bactericidal effect by inhibiting bacterial DNA gyrase and topoisomerase IV, thus blocking the processes of bacterial DNA replication and transcription. Its antibacterial spectrum covers Gram-negative bacteria and some Gram-positive bacteria. Clinically, it is mainly used to treat respiratory tract infections, urogenital tract infections, gastrointestinal tract infections, and skin and soft tissue infections caused by sensitive bacteria. It is applicable to adult patients with no history of fluoroquinolone allergy, and is a common option for the treatment of community-acquired infections.

The global enoxacin market size has maintained stable growth for a long time. In 2023, the overall market size was approximately USD 120 million, among which the Asia-Pacific region accounted for more than 65%, making it the core consumer market. As this drug was launched early and its patents have expired comprehensively, the current market is dominated by generic drug supply. China and India are the main producers of enoxacin API in the world, with their combined production capacity accounting for more than 80% of the global total. For the domestic market, enoxacin preparations have been included in the local centralized procurement catalogs of multiple provinces, and the winning bid prices have dropped by about 42% compared with previous years. The demand of downstream preparation enterprises for cost-effective and compliant APIs continues to rise.

The original research enterprise of enoxacin is Daiichi Sankyo Co., Ltd. of Japan, with the original brand name "Flumark". Its core compound patent expired globally in 1999. The main dosage forms approved for the original research product include tablets, capsules and injections, with common specifications of 0.1g and 0.2g. The original research preparation has been included in the FDA Reference Listed Drug Catalog. For domestic API registration, at present, 6 enterprises have obtained A-status registration numbers for their enoxacin APIs after passing the approval of CDE, and the registration applications of another 3 enterprises are under review. On the preparation side, more than 20 enterprises have obtained approval for the marketing of enoxacin oral preparations, and a total of 7 enterprises have obtained approval for injections. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of enoxacin impurity reference standards, which meet the qualitative and quantitative requirements for impurities in the whole process from API R&D to quality control. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, which can effectively help enterprises shorten the R&D cycle and reduce the risk of quality research.