Norfloxacin

In response to the clinical challenge of rising bacterial resistance, quinolone antibacterial agents, with their broad-spectrum antibacterial activity, have become an important option for the treatment of community and nosocomial infections. Norfloxacin is the representative third-generation fluoroquinolone drug that was first put into clinical application. It exerts a bactericidal effect by inhibiting bacterial DNA gyrase and topoisomerase IV to block the processes of bacterial DNA replication and transcription. It has strong activity against Gram-negative bacteria (such as Escherichia coli, Klebsiella pneumoniae, Salmonella) and some Gram-positive bacteria. Clinically, it is mainly used for urinary tract infections, gonorrhea, prostatitis, intestinal infections, typhoid fever and other Salmonella infections caused by sensitive bacteria, and is a common treatment option for mild to moderate bacterial infections in adults.

At present, the global market size of norfloxacin preparations is stable at around 800 million US dollars, with the Chinese market accounting for more than 27%. In recent years, driven by the promotion of rational use specifications for antibacterial drugs in primary medical institutions, the market growth rate has maintained a stable range of 1.2%-1.8%. The competitive landscape is characterized by the dominance of generic drugs. There are more than 200 domestic preparation approvals, and API production is concentrated in North China and East China. The top 3 enterprises account for nearly 60% of the domestic supply share. In addition to meeting domestic demand, more than 40% of the production capacity is exported to emerging markets such as Southeast Asia and South America.

The original developer of norfloxacin is Merck Sharp & Dohme, with the original brand name Noroxin®. The core compound patent expired globally in 1995. The main dosage form approved for the original drug is tablet, with a specification of 400 mg. The original preparation has been included in the FDA Orange Book Reference Listed Drug Catalog, and the import of the original preparation has not been approved in China yet. According to the domestic API registration platform, a total of 37 enterprises have obtained approved registration (status A) for norfloxacin APIs at present, which can be associated with the marketing of 12 dosage forms of generic drugs in China. The domestically approved norfloxacin preparations cover multiple dosage forms such as tablets, capsules, creams, and eye drops, with sufficient clinical supply. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of norfloxacin impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They can fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable reference material support for API R&D, quality research and consistency evaluation.