Clavulanic acid

In response to the clinical treatment dilemma of infections caused by enzyme-producing drug-resistant bacteria, clavulanic acid, as a classic β-lactamase inhibitor, irreversibly binds to β-lactamase produced by bacteria to inactivate it, thereby protecting the antibacterial activity of β-lactam antibiotics such as amoxicillin and ticarcillin, and solving the drug resistance problem of common enzyme-producing bacteria. It is often formulated into compound preparations with penicillins in clinical practice for the treatment of various infectious diseases caused by sensitive bacteria, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, otitis media, etc. The applicable population covers adults and children, and it is an important component of anti-infective combination therapy regimens.

The global market size of clavulanic acid compound preparations exceeded USD 6.5 billion in 2023, with a compound annual growth rate maintained at around 3.2%, of which the Chinese market accounts for approximately 18%, and the demand continues to rise with the popularization of primary-level anti-infective diagnosis and treatment. On the production side, domestic enterprises account for more than 70% of the global API production capacity. Leading enterprises have significantly reduced production costs through process optimization. Against the background of centralized procurement, amoxicillin and clavulanate potassium preparations have been included in multiple batches of the national centralized procurement catalog, and the drop in the winning bid price has driven the steady expansion of upstream API demand.

The original research enterprise of clavulanic acid is GlaxoSmithKline, with the original brand name Augmentin (compound preparation combined with amoxicillin), and the core compound patent expired globally in 1985. The main dosage forms of the original marketed products include tablets, dry suspensions and injections, with common specifications of amoxicillin:clavulanic acid at 2:1, 4:1, 7:1, 14:1, etc. Relevant compound preparations have been included in the *Catalogue of Chemical Drugs* of China and the FDA Reference Listed Drug Catalog. At present, more than 30 domestic enterprises have obtained A status for clavulanic acid APIs through CDE registration, corresponding to more than 200 approved compound preparation varieties. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of clavulanic acid impurity reference standards. Most products are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use requirements in the whole process of API R&D, quality research and production.