Benzylpenicillin

Bacterial infection was once one of the disease types with the highest fatality rate worldwide, and the advent of penicillin drugs has for the first time provided human beings with targeted therapeutic means to fight against bacterial infections. As the earliest introduced β-lactam antibiotic, penicillin G inhibits the activity of bacterial cell wall transpeptidase, blocks the synthesis process of cell wall mucopeptide, and ultimately causes osmotic lysis of bacteria. It has a potent bactericidal effect on gram-positive bacteria, some gram-negative cocci and spirochetes. It is mainly used clinically for the treatment of susceptible bacterial infections such as pneumonia, meningitis, endocarditis, anthrax and syphilis, and is currently one of the first-line therapeutic drugs for susceptible bacterial infections in primary medical institutions.

As a classic antibiotic with the longest clinical application history, the global market size of penicillin G has long been stable at more than 6 billion US dollars, among which China is the world's largest producer of penicillin G API, with production capacity accounting for more than 90% of the global total production capacity. At present, the domestic penicillin G API market has a relatively high concentration, with the top 3 enterprises occupying nearly 80% of the market share. As the coverage of antibiotic varieties in the centralized procurement policy gradually expands, downstream preparation enterprises have continuously raised requirements for the supply stability and quality compliance of upstream APIs, and the market competitiveness of API suppliers with large-scale production capacity and complete impurity quality control system has been further highlighted.

The original research enterprise of penicillin G is Pfizer, and the original research trade name is Pfizerpen, and its core compound patent expired globally as early as 1949. At present, the commonly used clinical dosage forms include penicillin G sodium for injection and penicillin G potassium for injection, with conventional specifications of 200,000 units, 400,000 units, 800,000 units, 1.6 million units and 4 million units. Its original research preparation has been included in the FDA Reference Listed Drug Catalog. For the domestic market, as of now, there are a total of 46 penicillin G API registration records on the CDE API registration platform, among which 39 are in Status A (approved for use in marketed preparations). More than 200 domestic enterprises have been approved to produce penicillin G related injection preparations. (Data as of June 2025, please refer to the official CDE website for the latest data)

CATO can provide a full range of penicillin G impurity reference standards, fully covering synthetic process impurities, degradation impurities and polymer impurities. Most of the products are available from stock, and orders placed before 16:00 on the same day can be shipped on the same day. All products meet the quality control requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs in API production, preparation R&D and quality research links.