Sparfloxacin

The iteration of quinolone antibacterial agents has always been centered on the expansion of antibacterial spectrum and the optimization of drug resistance. As a representative of the third-generation fluoroquinolones, sparfloxacin blocks bacterial replication by inhibiting bacterial DNA gyrase and topoisomerase IV, and has both broad-spectrum antibacterial activity and good tissue permeability. It has strong bactericidal effects on Gram-positive bacteria, Gram-negative bacteria, anaerobes, mycoplasma and chlamydia. Clinically, it is mainly used for respiratory tract infections, genitourinary tract infections, intestinal infections, skin and soft tissue infections caused by sensitive bacteria, and is especially suitable for patients with refractory infections that are resistant to other antibacterial drugs. The main administration route is oral, and patient compliance is significantly better than similar products that require intravenous administration.

The current global market size of quinolone antibacterial agents exceeds 8 billion US dollars, among which the third-generation products account for nearly 35% of the market share due to their clear clinical positioning, with a compound annual growth rate maintained at around 2.3%. In terms of the domestic market, sparfloxacin is currently in the mature application stage. The annual sales volume at the terminal of public medical institutions is about 270 million yuan. The competitive landscape is dominated by generic drugs, and more than 10 domestic enterprises have obtained the production qualification of preparations. After the implementation of centralized procurement, the price has dropped by 62%, and the penetration rate in primary medical institutions is gradually increasing. On the API supply side, domestic enterprises have become the main suppliers of sparfloxacin API in the world by virtue of their cost advantages, with the export share exceeding 70%.

The original research enterprise of sparfloxacin is Sumitomo Pharma Co., Ltd. of Japan, and the original research brand name is "Spara". Its core compound patent expired globally in 2010. The main dosage forms approved by the original research are tablets, with specifications of 100mg and 150mg. The original research tablets have been included in the Japanese Orange Book and the FDA Reference Listed Drug Catalog. In terms of the domestic market, 8 domestic enterprises have currently obtained CDE registration (status A) for sparfloxacin API, and the approved preparation varieties cover three categories: tablets, capsules and granules, all of which are generic drugs, and the original research preparations have not been approved for import in China. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of sparfloxacin impurity reference standards, covering all categories such as process impurities and degradation impurities. Most products can be supplied from stock. Orders for in-stock products paid 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 provide stable and reliable reference standard support for the quality research and consistency evaluation work of API and preparation enterprises.