Ciprofloxacin

Bacterial infection is one of the most common clinical disease types. Fluoroquinolones, with the characteristics of broad antibacterial spectrum and high oral bioavailability, are among the core drug categories for anti-infective treatment. Ciprofloxacin is a third-generation quinolone antibacterial agent. It exerts its bactericidal effect by inhibiting bacterial DNA gyrase and topoisomerase IV to block the process of bacterial DNA replication and transcription, and has particularly prominent activity against Gram-negative bacteria. Clinically, it can be used to treat sensitive bacterial infections in multiple sites such as respiratory tract infections, urinary system infections, gastrointestinal tract infections, and skin and soft tissue infections, covering the clinical needs of adult patients in various infection scenarios.

At present, the global market size of ciprofloxacin API exceeds 2.5 billion yuan, with an annual compound growth rate maintained at around 3%. The demand side maintains steady growth supported by the popularization of anti-infective drugs in primary medical care and the expansion of applications in the veterinary field. The competitive landscape presents the characteristics of a mature generic drug market. China is the world's largest producer and exporter of ciprofloxacin API, with production capacity accounting for more than 70% of the global total. Leading enterprises have mature processes and significant cost advantages, and their products are mainly supplied to mainstream markets such as Europe, America, and Southeast Asia. After the implementation of domestic centralized procurement, the price drop on the preparation side has further driven the demand for upstream APIs to concentrate on leading manufacturers, and the industry concentration continues to increase.

The original research enterprise of ciprofloxacin is Bayer AG of Germany, and the original brand name is "Cipro". The core compound patents have expired successively in major global markets from 2003 to 2004. The main dosage forms approved for the original drug include injections (200mg/100ml, 400mg/200ml) and tablets (250mg, 500mg, 750mg). Relevant dosage forms have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs*, and are also listed in the FDA Reference Preparations Catalogue. Up to now, there are more than 30 registration records of ciprofloxacin API on the API Registration Platform of China CDE, most of which are in the status of "A" (passed the associated review with preparations). A number of domestic enterprises have obtained approval for the marketing of ciprofloxacin oral preparations and injections. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for ciprofloxacin quality research and compliance declaration, CATO provides a full set of impurity reference standards for this API. 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 compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support impurity qualitative and quantitative research, stability tests, and the submission of registration declaration materials, helping R&D and production enterprises efficiently promote relevant projects.