Amoxicillin

In the clinical treatment system for bacterial infectious diseases, β-lactam antibiotics have always been the basic medication option. Among them, amoxicillin, with its broad-spectrum antibacterial activity and high safety, has become one of the first-line drugs for community-acquired infections. It inhibits the activity of bacterial cell wall mucopeptide synthetase, blocks the cell wall synthesis process, and ultimately leads to bacterial swelling and death. It has a strong bactericidal effect on Gram-positive bacteria and some Gram-negative bacteria, and is clinically commonly used for respiratory tract infections, genitourinary tract infections, skin and soft tissue infections, acute uncomplicated gonorrhea and other diseases caused by sensitive bacteria. The applicable population covers patients from children to the elderly, and the medication safety for special populations has been verified by long-term clinical practice.

As the most widely used oral antibiotic variety in the world, the global market size of amoxicillin has been stably above 4 billion US dollars for a long time. As the world's largest producer and exporter of amoxicillin, China's annual output accounts for more than 80% of the global total output, with a high industry concentration and obvious production capacity advantages of leading enterprises. After the implementation of the centralized procurement policy, the price of amoxicillin oral preparations dropped significantly, and the demand for upstream API further concentrated on compliant leading production capacity. In 2023, the domestic demand for amoxicillin API increased by 7.2% year-on-year, and the average export price rose by 3.8% year-on-year, showing a development trend of "stable volume and price".

The original research enterprise of amoxicillin is GlaxoSmithKline (GSK), and the original research trade name is "Amoxil". The core compound patent expired globally in 1981. At present, the mainstream clinical dosage forms include tablets, capsules, dry suspensions and granules, with common specifications of 0.125g, 0.25g and 0.5g. The original research products have been included in the China Listed Drug Catalogue and the FDA Reference Preparation Catalogue. More than 60 valid amoxicillin API registration numbers can be queried on the domestic API registration platform, among which more than 30 are A-status registration numbers, and the corresponding approved oral preparation varieties exceed 600, with sufficient market supply. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of amoxicillin impurity reference standards, which meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most of the products are in stock all the year round, and orders placed before 16:00 can be shipped on the same day. It can provide stable and reliable impurity reference standard supply support for API manufacturers and preparation R&D institutions, helping customers efficiently complete quality research and registration and declaration work.