Pivampicillin

In response to the clinical treatment needs of drug-resistant bacterial infections, the optimization of bioavailability of semi-synthetic penicillins has been an important direction of antibacterial drug research and development in the past decade. Pivampicillin, as a double ester prodrug of ampicillin, can be hydrolyzed by esterase in vivo to rapidly release the active ingredient ampicillin, and exerts a bactericidal effect by inhibiting the synthesis of bacterial cell wall mucopeptides. Its oral absorption rate is more than 3 times higher than that of ampicillin, and it has good antibacterial activity against Gram-positive bacteria and some Gram-negative bacteria including Escherichia coli and Salmonella. Clinically, it is mainly used for oral treatment of mild to moderate infections such as respiratory tract infections, urinary system infections, skin and soft tissue infections caused by sensitive bacteria, and is especially suitable for outpatients who need sequential therapy and reduce intravenous administration.

In the current global oral antibacterial drug market, the annual compound growth rate of penicillin prodrug varieties remains at about 4.2%. Among them, pivampicillin, due to its convenient administration and low incidence of adverse reactions, has an increasing utilization rate year by year in primary medical scenarios in Southeast Asia and South Asia. At present, there are no large-scale pivampicillin preparations on the domestic market, and the development of related generic drugs is in the early stage. The compliant supply of APIs and impurity reference substances is the core rigid demand for the current variety research and development, and the existing market gap is about 27 tons per year.

The original research enterprise of pivampicillin is Pfizer, with the original brand name Pondocillin, and the core compound patent expired globally in 1993. The main dosage form of the original research that has been marketed is 250mg oral capsules, which has been included in the Reference Listed Drug Catalogue of the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, but has not yet been included in the *Catalogue of Chemical Drugs* of China. As of September 2024, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has no approved pivampicillin API registration number, and there are no pivampicillin preparation varieties approved for marketing in China. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for pivampicillin, which fully covers synthetic process intermediates, degradation impurities and related substance reference substances. 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 meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support the quality research and stability investigation work of generic drug research and development.