Pazufloxacin

Bacterial infection is one of the most common clinical disease types. Quinolones occupy an important position in the field of anti-infective therapy by virtue of their broad-spectrum antibacterial activity. As a representative variety of the third-generation quinolone antibacterial drugs, pazufloxacin exerts its antibacterial effect by inhibiting the activities of bacterial DNA topoisomerase Ⅳ and DNA gyrase, and blocking the processes of bacterial DNA replication and transcription. It has strong antibacterial activity against Gram-positive bacteria and Gram-negative bacteria, and some anaerobic bacteria and mycoplasma are also sensitive to it. Clinically, it is mainly used to treat infectious diseases such as secondary infection of chronic respiratory diseases, pneumonia, pyelonephritis, complicated cystitis and prostatitis, and the applicable population covers adult infected patients without a history of quinolone allergy.

At present, the domestic market size of pazufloxacin preparations is about 1.2 billion yuan. In recent years, affected by the promotion of hierarchical diagnosis and treatment and the growth of demand for primary anti-infective drugs, the annual compound growth rate has remained at around 3.7%. In terms of the competitive landscape, more than 30 domestic enterprises have been approved to produce pazufloxacin preparations at present. Generic drugs account for more than 92% of the overall market share, while original research products only account for about 8% of the high-end hospital market. On the API side, domestic manufacturers are mainly concentrated in Jiangsu and Zhejiang provinces, with their combined production capacity accounting for 75% of the national total production capacity, and the independent domestic supply of APIs has been realized.

The original research enterprise of pazufloxacin is Toyama Chemical Co., Ltd. of Japan, and the original brand name is "Pasil". The core compound patent of pazufloxacin expired in 2011 in Japan, and the Chinese compound patent expired in 2013. At present, the main dosage forms approved in China include pazufloxacin for injection and pazufloxacin sodium chloride injection, with conventional specifications of 0.3g/piece and 0.5g/piece. The original research injection has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. As of now, 21 domestic enterprises have obtained CDE registration numbers for pazufloxacin APIs, among which 16 registration numbers are in status A and can be used for associated evaluation. More than 30 pazufloxacin preparation varieties have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for pazufloxacin, covering the full range of demands including synthetic process intermediates and degradation impurities. Most of the products have sufficient in-stock inventory, and in-stock products ordered before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support the quality control demands in the process of API R&D, quality research and production.