Pefloxacin

For moderate to severe infections caused by multidrug-resistant Gram-negative bacteria, there is always a rigid clinical demand for safe and efficient quinolone antibacterial drugs. Pefloxacin is a third-generation fluoroquinolone antibacterial drug. It exerts a bactericidal effect by inhibiting the activities of bacterial DNA gyrase and topoisomerase IV and blocking the processes of bacterial DNA replication and transcription. Its antibacterial spectrum covers common pathogenic bacteria such as Escherichia coli, Klebsiella pneumoniae, Proteus, and Salmonella. Clinically, it is mainly used to treat urinary tract infections, respiratory tract infections, digestive tract infections, bone and joint infections, and skin and soft tissue infections caused by sensitive bacteria. It can also be used for the treatment of systemic infections such as sepsis, and the applicable population is infected patients over 18 years old without a history of quinolone allergy.

The global pefloxacin market size is approximately USD 120 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at 2.1%. The growth momentum mainly comes from the release of diagnosis and treatment demand for infections in primary medical institutions and the expansion of applications in the field of veterinary antibacterial drugs. The domestic market is currently dominated by generic drug supplies. There are more than 30 existing pefloxacin preparation approvals, and API manufacturers are concentrated in Jiangsu, Zhejiang and other regions. In the 2022 provincial centralized procurement, the winning bid price of pefloxacin injection decreased by an average of 47% compared with the listed price, further promoting the improvement of clinical accessibility.

The original developer of pefloxacin is Novartis, and the original brand name is Peflacine. Its core compound patent expired globally in 2003. The main dosage forms approved for the original drug include injections (200mg/2ml, 400mg/5ml) and tablets (400mg/tablet). The original injection has been included in the FDA Reference Listed Drug Catalog, and the original drug has not been imported into China. At present, 7 domestic pefloxacin APIs have obtained CDE registration numbers (status A), and the corresponding approved preparation varieties include pefloxacin mesylate tablets, injections, creams and capsules, etc. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of pefloxacin impurity reference standards. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of the entire process of API R&D, quality research and consistency evaluation.