Sulbactam

In response to the clinical treatment dilemma of multidrug-resistant bacterial infections, β-lactamase inhibitors are one of the core adjuvant drugs that enhance the activity of antibacterial agents. Sulbactam is a semi-synthetic β-lactamase inhibitor. It irreversibly binds to the β-lactamase produced by bacteria, blocks the hydrolytic effect of this enzyme on penicillin and cephalosporin antibacterial agents, and restores the bactericidal activity of antibacterial agents. It is often formulated into compound preparations with ampicillin, cefoperazone, etc., and is clinically used to treat respiratory tract, urinary tract, biliary tract, skin and soft tissue infections and sepsis caused by susceptible bacteria. It also has unique antibacterial activity against Acinetobacter infections, and is an important component in the combination drug regimen for severe infections.

The global market size of sulbactam and its compound preparations was approximately USD 1.87 billion in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain at around 4.2%. Driven by medical insurance coverage and the increasing demand for diagnosis and treatment of drug-resistant bacterial infections in the domestic market, the sales volume of sulbactam compound preparations in public hospital terminals exceeded RMB 6 billion in 2023, among which cefoperazone sodium and sulbactam sodium accounted for more than 85%. At present, domestic generic drug enterprises dominate the market, and there are more than 30 enterprises approved to produce sulbactam API. After the implementation of volume-based procurement, the stability of raw material supply has become one of the core competitive factors for preparation enterprises.

The original research enterprise of sulbactam is Pfizer Inc. of the United States, and the trade name of its original research compound preparation is "Unasyn" (ampicillin sodium and sulbactam sodium). Its core compound patent expired globally in 1991, and there is no core patent restriction at present. The original marketing dosage forms include injections, with common specifications of 0.75g (ampicillin 0.5g + sulbactam 0.25g) and 1.5g (ampicillin 1.0g + sulbactam 0.5g), which have been included in the China List of Marketed Chemical Drugs and the FDA Reference Preparations List. In terms of the domestic market, there are currently 32 A-status registration numbers for sulbactam API, and multiple enterprises have been approved to produce preparation varieties such as ampicillin-sulbactam and cefoperazone-sulbactam. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of sulbactam impurity reference standards, covering process impurities, degradation impurities and official reference substances. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet various reference substance needs for API R&D, quality research and consistency evaluation.