Ampicillin

As a classic broad-spectrum semi-synthetic penicillin of β-lactam class, ampicillin exerts its bactericidal effect by inhibiting the activity of bacterial cell wall mucopeptide synthetase and blocking the synthesis of bacterial cell walls. It has favorable antibacterial activity against Gram-positive bacteria and Gram-negative bacteria such as *Haemophilus influenzae*, *Escherichia coli*, and *Proteus mirabilis*. It is widely used clinically in the treatment of diseases including respiratory tract infections, gastrointestinal infections, urinary tract infections, soft tissue infections, meningitis, sepsis, and endocarditis caused by susceptible bacteria. Its applicable population covers adults and children, and it is a commonly used basic drug in the primary anti-infective treatment system.

At present, the global ampicillin market size maintains steady growth. In 2023, the global market size was approximately USD 1.28 billion, with a compound annual growth rate maintained at around 3.2%. In terms of the domestic market, ampicillin is included in the National Essential Medicine List. After the implementation of the centralized procurement policy, its price has returned to a reasonable range, and its clinical utilization rate has increased steadily. In 2023, the domestic consumption of its API exceeded 2,100 tons. The competitive landscape is dominated by generic drugs, with China and India being the two major production regions in the world. Domestic manufacturers have achieved large-scale mass production, with significant cost advantages, and their products are supplied to the global market in large quantities.

The original research enterprise of ampicillin is Beecham Research Laboratories in the United Kingdom (now affiliated with GlaxoSmithKline), and the original brand name is Penbritin. The core compound patent expired globally in 1979. At present, commonly used clinical dosage forms include capsules, injections, and dry suspensions. Common specifications are 0.25g and 0.5g capsules, 1g and 2g powder for injection, etc. The relevant original dosage forms have been included in the FDA Reference Listed Drug Catalog, and the same variety of reference listed drugs has been收录 domestically. Up to now, there are more than 30 ampicillin API registration information on the CDE API Registration Platform, among which more than 20 have been activated with A status. Multiple domestic manufacturers have obtained marketing approval for ampicillin oral preparations and injection preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of ampicillin impurity reference standards, which fully meet the needs of the whole process of API and preparation R&D, quality research, and registration declaration. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can help enterprises efficiently complete quality control and declaration work.