Potassium Clavulanate

In response to the clinical treatment needs of infections caused by enzyme-producing drug-resistant bacteria, clavulanate potassium, as a core β-lactamase inhibitor, irreversibly binds to β-lactamase produced by bacteria to deprive it of the ability to hydrolyze penicillin and cephalosporin antibacterial drugs, thereby restoring the bactericidal activity of antibiotics. This drug is rarely used alone in clinical practice, and is usually formulated into compound preparations with β-lactam antibiotics such as amoxicillin and ticarcillin for the treatment of respiratory tract, urinary tract, skin and soft tissue, and gynecological infections caused by sensitive bacteria. It is applicable to the whole age group of adults and children, and is a key combined component for solving the problem of bacterial drug resistance.

The global market size of clavulanate potassium compound preparations is steadily above USD 2.5 billion. Driven by the improvement of the standardization of primary-level antibacterial drug use and the growing demand for pediatric infection treatment in recent years, the compound annual growth rate has maintained at around 3.2%. The production side shows a significant feature of concentrated production capacity. Chinese enterprises contribute more than 80% of the global supply of clavulanate potassium API. Among them, leading enterprises have outstanding cost advantages through fermentation process optimization, and have obtained certifications in the European and American regulated markets. At the domestic centralized procurement level, amoxicillin and clavulanate potassium oral preparations have been included in multiple batches of national centralized procurement lists, the demand of winning bidders for upstream compliant APIs continues to rise, and the market share of raw material suppliers with stable production capacity and compliant with multiple pharmacopoeia standards further increases.

The original research enterprise of clavulanate potassium is GSK (GlaxoSmithKline), and the brand name of its original research compound preparation is "Augmentin" (amoxicillin and clavulanate potassium). The core compound patent of clavulanate potassium expired globally in 1985. The mainstream dosage forms of the original marketed products include oral tablets, dry suspensions and injections, with common specifications of amoxicillin:clavulanate potassium ratios of 2:1, 4:1, 7:1 and 14:1. Relevant preparations have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA Reference Preparation Catalogue. According to the domestic API registration platform, nearly 30 enterprises have obtained A-status registration numbers for their clavulanate potassium APIs, and there are more than 500 domestic approval numbers for supporting compound preparations such as amoxicillin and clavulanate potassium. (Data as of June 2025, please refer to the official website of CDE for the latest information)

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