Cefepime

In response to the treatment challenges of severe infections brought by the rising drug resistance of Gram-negative bacteria, the clinical value of fourth-generation cephalosporin antibiotics has become increasingly prominent. As a representative variety of this category, cefepime exerts its bactericidal effect by highly affining to bacterial penicillin-binding proteins and inhibiting cell wall biosynthesis. Meanwhile, it has the characteristics of resistance to β-lactamase and balanced coverage of Gram-positive and Gram-negative bacteria. It is mainly used clinically to treat moderate to severe infections such as lower respiratory tract infections, urinary tract infections, skin and soft tissue infections, and sepsis caused by sensitive bacteria in adults and children aged from 2 months to 16 years old. It is one of the core drugs for dealing with complex infections in departments such as ICU and hematology department.

At present, the global cefepime market size is stable at around USD 1.2 billion, and the annual sales volume in the domestic market exceeds RMB 2 billion, with an average annual growth rate of 3% to 5%. In terms of the competitive landscape, the original research product accounts for about 15% of the high-end market share, and domestic generic drugs have become the main force in the market. At present, more than 30 domestic enterprises have been approved to produce cefepime for injection, among which nearly 20 products have passed the consistency evaluation of generic drugs. After the centralized procurement, the terminal price has dropped by more than 80%, which further improves the accessibility of the primary medical market.

The original research enterprise of cefepime is Bristol-Myers Squibb, and the original research trade name is "Maxipime". Its core compound patent expired in the United States in 2007, and the Chinese compound patent also officially expired in 2009. The original research dosage form is powder for injection, and the approved specifications include 0.5g and 1.0g. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by NMPA, and is also listed in the reference preparation list of the FDA Orange Book. According to the domestic API registration platform, 12 enterprises have obtained A-status registration numbers for cefepime APIs, which can be legally supplied for preparation production. The total number of domestic approved approval documents for cefepime for injection preparations exceeds 60. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cefepime impurity reference standards. Most products have sufficient stock, and spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of drug regulatory authorities of various countries such as the Chinese Pharmacopoeia and FDA, and can provide reliable reference standard support for API and preparation manufacturers in links such as quality research, stability study, and registration declaration.