Sulbenicillin

As a broad-spectrum semi-synthetic penicillin anti-infective drug, sulbenicillin exerts a bactericidal effect by inhibiting the activity of bacterial cell wall mucopeptide synthetase and blocking the biosynthesis of the cell wall. It has good antibacterial activity against Gram-negative bacteria such as *Pseudomonas aeruginosa*, *Proteus*, *Escherichia coli* and some Gram-positive bacteria. Clinically, it is mainly used for respiratory tract infections, urinary tract infections, biliary tract infections, skin and soft tissue infections, sepsis and other diseases caused by susceptible bacteria. It is applicable to infected patients of all age groups without a history of penicillin allergy, and has a relatively high cost-effectiveness especially in the primary treatment scenario of *Pseudomonas aeruginosa* infections.

The domestic market size of sulbenicillin is approximately RMB 500 million. In recent years, driven by the expansion of demand for primary anti-infective drugs and the guidance of rational drug use policies, its compound annual growth rate has remained at around 4%. The competitive landscape is dominated by generic drugs, with more than 20 existing preparation approvals. API manufacturers are concentrated in North China and East China, and the top 3 enterprises account for over 70% of the market share. This variety has not been included in the national centralized volume-based procurement, so its price system is relatively stable, and the terminal demand fluctuates obviously with the incidence of seasonal respiratory tract infections.

The original research enterprise of sulbenicillin is Takeda Pharmaceutical Company Limited, Japan, with the original brand name Lilacillin, and the core compound patent expired in 1983. The domestic marketed dosage form is mainly sulbenicillin sodium for injection, with common specifications of 1g, 2g and 4g. The original dosage form has not been approved for import in China. At present, the domestic reference preparations are included in the *Collection of Listed Drugs in China*, all of which are generic varieties declared by domestic enterprises. According to the domestic API registration platform, there are currently 8 registration numbers of sulbenicillin sodium API, 6 of which are in "A" status and can be used in association with domestic preparation declarations, corresponding to a total of 27 approved preparation varieties. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full range of sulbenicillin impurity reference standards. The products strictly comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most impurities are in stock, and spot orders submitted before 16:00 can be shipped on the same day, which can fully meet the full-process R&D needs of pharmaceutical enterprises such as API quality research, preparation stability investigation and application document preparation.