Cefepime

Against the clinical dilemma of rising drug resistance in Gram-negative bacteria, cefepime, a fourth-generation cephalosporin antibiotic, with its unique permeability advantage, can rapidly penetrate the porin channels of the bacterial outer membrane, and maintains strong antibacterial activity against AmpC enzyme-producing Enterobacteriaceae, Pseudomonas aeruginosa and other bacteria. This drug is clinically mainly used to treat moderate to severe infections such as lower respiratory tract infections, urinary tract infections, skin and soft tissue infections, and sepsis caused by susceptible bacteria in adults and children aged 2 months to 16 years. It is a first-line choice for empirical treatment of patients with febrile neutropenia, providing a medication regimen that balances safety and efficacy for the clinical management of severe infections.

At present, the global market size of cefepime has exceeded 1.2 billion US dollars. Driven by the growing demand for the diagnosis and treatment of multidrug-resistant bacterial infections in recent years, its compound annual growth rate has remained at around 4.8%. In terms of the domestic market, the API has passed the patent cliff period. Existing manufacturers are concentrated in East China and North China, and the proportion of evaluated generic drugs accounts for more than 85%. It has been included in multiple batches of the national centralized procurement catalog, and the winning bid price has dropped by more than 70% compared with the original research drug, leading to a significant improvement in clinical accessibility. The demand of downstream preparation manufacturers for high-purity APIs and supporting impurity reference standards that meet the regulatory requirements of multiple countries continues to rise.

CATO can provide a full set of impurity reference standards for cefepime API. All products are in stock and meet the requirements of multiple regulatory regulations such as Chinese Pharmacopoeia and FDA. The products have accurate impurity structure identification and reliable purity calibration, and can be directly used for API quality research, stability study and registration declaration, helping manufacturers complete compliance verification efficiently and shorten the product launch cycle.