Cefadroxil

As a core variety of first-generation cephalosporin antibiotics, cefadroxil exerts a bactericidal effect by inhibiting the biosynthesis of bacterial cell walls, and has good antibacterial activity against Gram-positive bacteria such as staphylococci, *Streptococcus pneumoniae*, and some Gram-negative bacteria such as *Escherichia coli* and *Proteus mirabilis*. It is clinically mainly used for respiratory tract infections, urinary tract infections, skin and soft tissue infections and digestive tract infections caused by susceptible bacteria. Due to its good oral absorption, low incidence of adverse reactions, and applicable population covering adults and children, it is a common choice for anti-infective treatment at the primary level.

At present, the global market size of cefadroxil preparations is approximately USD 1.28 billion, with a compound annual growth rate of 3.2% in the past three years. The growth momentum mainly comes from the steady release of demand for anti-infective drugs in the primary medical market. In the domestic market, generic drugs account for more than 95%, and North China and East China are the core production clusters of API. With the implementation of multiple rounds of national centralized drug procurement, the price of preparations has dropped by more than 60%, and the supply stability and cost control of upstream APIs have become the core competitive elements for enterprises. In 2023, the total domestic production capacity of cefadroxil API was approximately 1,800 tons, with a self-sufficiency rate of 100%.

The original research enterprise of cefadroxil is Bristol-Myers Squibb, with the original brand name Duricef. Its core US compound patent expired in 1986, and the relevant Chinese preparation patent expired in 2003. The main dosage forms approved for the original product are tablets and capsules, with specifications including 0.125g, 0.25g and 0.5g. The original 0.5g capsule has been included in the FDA Reference Listed Drug Catalog, and is also included in the Chinese *Catalog of Reference Preparations for Chemical Drugs*. Up to now, there are 16 cefadroxil API registration records on the CDE API Registration Platform, of which 11 have been activated and are eligible for associated review, and more than 60 domestic enterprises have obtained marketing approval for cefadroxil preparations. (Data as of March 2025, please refer to the official CDE website for the latest information)

In response to the quality research and compliance declaration needs of this API, CATO can provide a full set of cefadroxil impurity reference standards. Most impurities are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable support for enterprises' impurity research, quality standard establishment and registration declaration.