Levofloxacin

Respiratory and urinary system infections, as clinically highly prevalent bacterial infectious diseases, have a long-standing rigid demand for highly effective broad-spectrum antibacterial agents. The clinical application of levofloxacin provides an important option for the treatment of such diseases. As a third-generation quinolone antibacterial agent, its mechanism of action is to inhibit the activity of bacterial DNA gyrase and block bacterial DNA replication. It has strong bactericidal effects on Gram-positive bacteria, Gram-negative bacteria and some atypical pathogens, and is widely used clinically to treat respiratory tract infections, genitourinary tract infections, skin and soft tissue infections, intestinal infections, etc. caused by sensitive bacteria. Its applicable population covers adult patients with bacterial infections. With definite efficacy and convenient administration, it is a commonly used first-line drug in clinical anti-infective treatment.

At present, the global market size of levofloxacin is stable at around USD 2.5 billion, and the domestic market size is approximately RMB 3.2 billion. In recent years, with the release of demand from the primary medical market, the compound annual growth rate has been maintained at around 2.3%. The patent of this variety has long expired, and the current market is dominated by generic drugs. There are more than 120 domestic manufacturers. After the centralized procurement, the price of preparations has dropped by more than 80%, and the competition in the upstream API market is sufficient. The production capacity of domestic manufacturers accounts for more than 65% of the global total production capacity, and China has become the world's major supplier of levofloxacin API.

The original research enterprise of levofloxacin is Daiichi Sankyo Co., Ltd., with the original brand name "Cravit". The core compound patent expired globally in 2010. The main dosage forms approved for the original drug include tablets, injections and eye drops, among which the tablet specifications are 0.1g and 0.5g, and the injection specifications are 0.3g/100ml and 0.5g/100ml. Multiple dosage forms have been included in the Chinese *Catalogue of Chemical Reference Preparations* and the FDA Reference Preparation Catalogue. At present, more than 40 domestic enterprises have obtained and activated CDE registration numbers for their levofloxacin APIs, and the approved preparation varieties cover all common dosage forms such as oral, injection and external use. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D, production and quality control needs of levofloxacin, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support enterprises' impurity research, quality standard establishment and compliance declaration work.