Prulifloxacin

In response to the clinical treatment needs of infectious diseases caused by drug-resistant bacteria, quinolone antibacterial drugs are a commonly used first-line option. Prulifloxacin, as a third-generation fluoroquinolone prodrug, is hydrolyzed by intestinal esterases into the active metabolite nilfloxacin after oral administration, and exerts antibacterial activity by inhibiting bacterial DNA topoisomerase II and IV to block bacterial DNA replication and transcription. Compared with traditional quinolones, it has strong antibacterial activity against Gram-positive bacteria and Gram-negative bacteria including *Pseudomonas aeruginosa*, and reduces the risks of phototoxicity and central nervous system adverse reactions. Clinically, it is mainly used to treat respiratory tract infections, urogenital tract infections, biliary tract infections and skin and soft tissue infections caused by susceptible bacteria, and is applicable to infected patients over 18 years old with no history of quinolone allergy.

The global market size of prulifloxacin has maintained steady growth in recent years. In 2023, the overall market size was approximately USD 120 million, with a compound annual growth rate maintained at around 3.8%. The growth is mainly driven by the increasing demand for diagnosis and treatment of community-acquired infections and the optimization of treatment regimens for drug-resistant bacterial infections. In terms of the competitive landscape, the original research product is only marketed in a few countries such as Japan and South Korea, and the global market is dominated by generic drug supplies. China is the major producer and exporter of prulifloxacin API. The production capacity of domestic API enterprises accounts for more than 65% of the global total capacity, and the relevant capacity that has passed GMP certification exceeds 200 tons per year, with stable large-scale supply capacity.

The original research enterprise of prulifloxacin is Otsuka Pharmaceutical Co., Ltd. of Japan, with the original brand name "SWORD". The core compound patent expired in Japan in 2010, and the patents in other major global markets have all expired. The main dosage form approved for the original research product is oral tablet, with specifications including 100mg and 200mg. It has been included in the Japanese Orange Book Reference Preparation Catalogue, and the original research preparation has not been marketed in China. At present, prulifloxacin preparations from multiple domestic enterprises have been approved for marketing. According to the CDE API Registration Platform, there are 8 prulifloxacin API registration numbers, 5 of which have been activated and can be used for association with domestic preparation applications. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of prulifloxacin impurity reference standards, covering the whole chain of reference material requirements including synthetic starting materials, intermediates and degradation impurities. Most of the 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 regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support the needs of various stages of API R&D, quality research and compliance declaration.