Cefazedone

In the clinical treatment of Gram-positive bacterial infections such as community-acquired pneumonia and urinary tract infections, the problem of drug resistance has long restricted the choice of medication. Cefazedone, a first-generation cephalosporin antibiotic, inhibits the activity of bacterial cell wall mucopeptide synthetase to block cell wall biosynthesis. It exhibits strong bactericidal activity against Gram-positive bacteria such as methicillin-sensitive Staphylococcus aureus and Streptococcus pyogenes, as well as some Gram-negative bacilli. It also has the advantages of low nephrotoxicity and good tissue permeability, and is mainly used for respiratory tract, urinary tract, skin and soft tissue infections caused by susceptible bacteria and perioperative infection prevention. Its applicable population covers adult and pediatric patients without a history of cephalosporin allergy, and it is a commonly used drug option for the treatment of infectious diseases at the primary level.

The global cefazedone market size has maintained steady growth in recent years. The overall market size in 2023 was approximately USD 190 million, of which the Chinese market accounted for more than 42% with a growth rate of 6.8%, higher than the global average. In terms of the competitive landscape, domestic generic drug enterprises dominate. At present, cefazedone preparations from 6 enterprises have passed the consistency evaluation, and the selected price in centralized procurement is about 78% lower than that of the original research drug, further improving the accessibility in the primary market. The upstream supply of API is dominated by local enterprises, and the overall production capacity can meet domestic clinical needs.

The original research enterprise of cefazedone is Merck, with the original trade name Cefazedone. The core compound patent expired globally in 2002. At present, the mainstream approved dosage form is cefazedone sodium for injection, with common specifications including 0.5g and 1.0g. The original research preparation has been included in the *Chinese Listed Medicines Catalogue* as the reference listed drug. In terms of domestic API registration, there are currently 8 cefazedone sodium API registrations with the status of A, which can be legally supplied for preparation production. At the preparation level, 12 domestic cefazedone sodium for injection products have been approved for marketing, covering all mainstream specifications. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of cefazedone impurity reference standards, supporting the full-process research needs from impurity localization, qualitative analysis to quantitative analysis. Most products are regularly in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple national regulations such as the Chinese Pharmacopoeia and FDA, and can provide reliable material basis support for API and preparation enterprises in quality research, stability study and registration declaration.