Ofloxacin

Bacterial drug resistance has become a core challenge in the treatment of global infectious diseases. Quinolones are a core category of broad-spectrum antibacterials, and ofloxacin is a representative variety of the second-generation fluoroquinolones among them. Its mechanism of action is to inhibit the activities of bacterial DNA gyrase and topoisomerase Ⅳ, block the process of bacterial DNA replication and transcription, and exert strong bactericidal effects on Gram-negative bacteria, some Gram-positive bacteria and atypical pathogens. It is widely used clinically in the treatment of multi-system infectious diseases such as respiratory tract infections, urogenital infections, digestive system infections, and skin and soft tissue infections caused by susceptible bacteria, covers the population of susceptible bacterial infections of all age groups in adults, and is a common choice for anti-infective treatment in primary and medical institutions at all levels.

The global ofloxacin market has entered a mature and stable period. In recent years, the overall market size has remained in the range of 1.2 to 1.5 billion yuan, with the domestic market accounting for about 42%. Due to the early expiration of patents, the current market is dominated by generic drug supply. There are more than 30 domestic manufacturers, among which Shandong, Jiangsu and Zhejiang are the core main production areas, with production capacity accounting for more than 75% of the national total production capacity. After the implementation of centralized procurement, the price of oral preparations has dropped by more than 80%, the market concentration of the upstream API market continues to increase, and the market share of the top 3 enterprises has reached 68%. The stability of the supply chain has become a core procurement consideration for downstream preparation enterprises.

The original research enterprise of ofloxacin is Daiichi Sankyo Co., Ltd., and the original research trade name is "Tarivid". Its core compound patent expired globally in 1999. At present, the main dosage forms of the original research marketed globally include tablets, injections, eye ointments, ear drops and ear drops. The common specifications of oral tablets are 0.1g and 0.2g. The original research tablets have been included in the *Catalogue of Chemical Reference Preparations* of China, and are also included in the FDA Reference Preparation Catalogue. At present, more than 20 domestic enterprises have obtained A status for their ofloxacin APIs through CDE registration, and the domestically approved preparation varieties cover all common dosage forms such as oral, injection and external use. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of ofloxacin impurity reference standards. The products simultaneously meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most impurities are available from stock, and in-stock orders placed before 16:00 can be shipped on the same day, which can fully meet the full-process R&D and production quality control needs of API manufacturers such as quality research, release testing and consistency evaluation.