Sultamicillin

In response to the clinical treatment needs of infectious diseases caused by enzyme-producing drug-resistant bacteria, the compound β-lactam antibiotic sultamicillin has demonstrated unique clinical value. It is a prodrug with a diester structure composed of ampicillin and the β-lactamase inhibitor sulbactam. After oral administration, it can be rapidly hydrolyzed in vivo into active ingredients, which not only retains the broad-spectrum antibacterial activity of ampicillin, but also irreversibly inhibits β-lactamase produced by bacteria through sulbactam, solving the drug resistance problem of common Gram-positive bacteria and Gram-negative bacteria. It is mainly clinically used for upper respiratory tract infections, lower respiratory tract infections, urinary system infections, skin and soft tissue infections and gonorrhea caused by sensitive bacteria. The applicable population covers adults and children who meet the weight indications, and it is a common choice for oral anti-infective treatment.

The global sultamicillin market size is stably around USD 120 million, with a compound annual growth rate of approximately 3.2%. The growth momentum mainly comes from the continuous release of demand for anti-infective drugs in primary medical care. In terms of the domestic market, with the advancement of the centralized procurement policy, the price of oral dosage forms has gradually become affordable for the public. In 2023, the total sales of domestic public hospitals and retail terminals exceeded RMB 420 million, of which generic drugs accounted for more than 90% of the market share, and the original research products only occupied a niche market in high-end medical scenarios. At present, nearly 30 domestic enterprises have obtained approval for sultamicillin preparations, and the supply of APIs is mainly from domestic manufacturers, with a relatively scattered competitive pattern. The top three enterprises account for about 45% of the total market share.

The original research enterprise of sultamicillin is Pfizer, and the original research trade name is "Unasyn". Its core compound patent expired in major global markets in the late 1990s. The main dosage forms approved for the original research include oral tablets (0.375g) and powder for injection (0.75g, 1.5g, 3.0g), among which the 0.375g tablets and 0.75g injection have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. At present, 26 domestic sultamicillin APIs have completed registration with CDE and obtained A-status publicity, and another 12 dosage forms of domestic sultamicillin preparations have been approved for marketing, which can fully meet the domestic clinical medication demand. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for sultamicillin API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA at the same time, and provide stable and reliable reference standard support for API R&D, quality research and consistency evaluation work.