Ceftazidime

Bacterial resistance is a core challenge in the global anti-infection field. Due to their strong bactericidal activity against Gram-negative bacteria, third-generation cephalosporins have always been the core drug option for the treatment of moderate to severe bacterial infections. As a representative variety of third-generation cephalosporins, ceftazidime exerts its antibacterial effect by inhibiting the synthesis of bacterial cell walls, and has good antibacterial activity against common drug-resistant Gram-negative bacteria such as *Pseudomonas aeruginosa*, *Klebsiella pneumoniae* and *Escherichia coli*. It is widely used in clinical practice for the treatment of lower respiratory tract infections, sepsis, biliary tract infections, complicated urinary tract infections, etc., and is especially suitable for the empirical treatment of moderate to severe infections in immunodeficient patients and hospital-acquired infections.

Ceftazidime is one of the cephalosporin varieties with the highest usage in the world. In recent years, its global market size has been stable at more than US$1.5 billion, and its annual sales in the Chinese market exceed RMB 4 billion. As a winning variety in centralized procurement, the clinical utilization rate of ceftazidime preparations has continued to increase after the price dropped significantly, driving the steady growth of demand for upstream APIs, and the annual average growth rate of domestic API demand has maintained at around 12% in the past three years. The domestic ceftazidime API market is highly concentrated. Leading manufacturers all have the full industrial chain layout from intermediates to preparations, with significant cost advantages. In addition to meeting the needs of the domestic market, nearly 40% of their output is exported to Southeast Asia, South America and other overseas markets.

The original research enterprise of ceftazidime is GlaxoSmithKline, and the original research brand name is Fortum. The core compound patent expired globally in 1999. The main dosage form approved for the original research product is ceftazidime for injection, with conventional specifications including 0.5g, 1.0g and 2.0g. The original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also listed as an FDA reference preparation. As of now, there are more than 30 registration entries of ceftazidime APIs on China CDE API Registration Platform, among which nearly 20 have been publicized with Class A status and can be marketed and sold domestically, corresponding to more than 400 approved approval documents for ceftazidime for injection preparations. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for ceftazidime, most of which are available directly from stock. Orders placed before 16:00 can be shipped on the same day. All products meet the regulatory requirements of mainstream markets such as the Chinese Pharmacopoeia and FDA, with complete data on impurity structure characterization, purity calibration, etc., which can directly support enterprises in API quality research, consistency evaluation and registration declaration work.