Azlocillin

In response to the clinical treatment needs of moderate to severe infections caused by drug-resistant Gram-negative bacteria, azlocillin, a broad-spectrum semi-synthetic ureidopenicillin, is one of the preferred clinical options. Its mechanism of action is to inhibit the activity of bacterial cell wall mucopeptide synthetase, hinder the biosynthesis of the cell wall, and ultimately lead to bacterial swelling and death. This drug has strong antibacterial activity against common pathogenic bacteria such as Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae. It is clinically used mainly to treat sepsis, meningitis, endocarditis, purulent pleurisy, peritonitis, and infections in the lower respiratory tract, gastrointestinal tract, biliary tract, urinary tract, soft tissues and reproductive organs. It can also be used for preoperative infection prevention and the treatment of obstetric and gynecological infections, and the applicable population covers adult and pediatric patients with no history of penicillin allergy.

Currently, the global market size of azlocillin is approximately RMB 1.28 billion, with a compound annual growth rate of around 4.2%. The domestic market accounts for nearly 62% of the global share, making it the core consumption region for this drug. In terms of the competitive landscape, the domestic preparation market is dominated by generic drugs, with the original research product accounting for less than 3% of the market. So far, 11 domestic enterprises have obtained production approvals for azlocillin preparations, and domestic substitution has been achieved on the API production side, with high overall supply stability.

The original research enterprise of azlocillin is Bayer AG of Germany, with the original brand name Securopen, and its core compound patent expired globally in 1999. The main dosage form of the original marketed product is azlocillin sodium for injection, with conventional specifications including 0.5g, 1.0g and 2.0g, and the original product has been included in the FDA Reference Listed Drug Catalog. In China, there are currently 12 azlocillin API registration numbers, 8 of which are in A status and can support associated review. Meanwhile, generic azlocillin sodium for injection has been approved for marketing. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of azlocillin impurity reference standards, most of which are available from stock. In-stock orders placed before 16:00 can be shipped on the same day. All products meet the requirements of pharmacopoeial regulations of multiple countries including the Chinese Pharmacopoeia and FDA, and can fully meet the needs of the whole process such as API R&D, quality research and release testing.