Cefuroxime

Bacterial infection is one of the most common infection types in clinical practice. Cephalosporin antibiotics have long occupied the core position in the antibacterial drug market due to their broad antibacterial spectrum and high safety. Cefuroxime is a second-generation cephalosporin antibiotic that exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls. It has good antibacterial activity against Gram-positive bacteria and some Gram-negative bacteria, and is widely used clinically in the treatment of respiratory tract infections, urinary tract infections, skin and soft tissue infections, otorhinolaryngological infections and perioperative infection prevention. It can cover multiple applicable groups such as adults and children, and is a first-line drug recommended by the diagnosis and treatment guidelines for multiple infectious diseases.

Cefuroxime is one of the cephalosporin varieties with the highest sales volume in the world. In 2023, the market size of cefuroxime preparations at the terminal of domestic public hospitals exceeded 8 billion yuan, and the compound growth rate in the past three years has remained at 4.2%. At present, the competition in the domestic market presents a pattern dominated by generic drugs. There are more than 120 approved cefuroxime generic preparations. Since 2020, cefuroxime axetil tablets and cefuroxime sodium for injection have been included in multiple rounds of national centralized procurement, with an average price reduction of more than 70% for the winning bids. The stability of upstream API supply and cost control have become the source of core competitiveness of downstream pharmaceutical companies.

The original research enterprise of cefuroxime is GlaxoSmithKline, and the original research brand name is "Zinacef". Its core compound patent expired globally in 2002. The main dosage forms approved for the original research include cefuroxime sodium for injection (0.25g, 0.75g, 1.5g) and cefuroxime axetil tablets (0.125g, 0.25g, 0.5g). Both dosage forms have been included in the China Listed Drugs Catalogue as reference preparations, and are also included in the FDA Reference Preparations Catalogue. Up to now, more than 30 domestic enterprises have obtained A status for their cefuroxime APIs through CDE registration, the number of approved domestic preparations has exceeded 130, and the original research preparations have also been approved for marketing in China for many years. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cefuroxime impurity reference standards, which fully meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most of the products are available in stock. Spot orders placed before 16:00 can be shipped on the same day, which can provide stable reference standard support for pharmaceutical enterprises in the stages of API R&D, quality research and commercial production.