Cefpirome

In response to the clinical treatment dilemma of multidrug-resistant Gram-negative bacterial infections, the fourth-generation cephalosporins have become an important option in the field of severe infections due to their broader antibacterial spectrum and stronger β-lactamase stability. As a representative variety of this category, cefpirome can rapidly penetrate the bacterial cell wall, bind to penicillin-binding proteins with high affinity, and inhibit the synthesis of cell wall mucopeptides, thereby exerting a bactericidal effect. It is clinically mainly used for the treatment of lower respiratory tract infections, urinary tract infections, skin and soft tissue infections, sepsis and other conditions caused by sensitive bacteria, and is particularly suitable for the treatment of severe infections in immunocompromised populations such as those with hospital-acquired pneumonia and neutropenia with fever. It can effectively cover common drug-resistant pathogenic bacteria such as Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

At present, the global market size of cephalosporin APIs is growing steadily, among which the market share of fourth-generation cephalosporins is increasing year by year. In 2023, the global market size of cefpirome-related preparations was approximately USD 320 million, with a compound annual growth rate of around 4.7%. In terms of the domestic market, with the advancement of hierarchical diagnosis and treatment and the improvement of diagnosis and treatment capacity for severe infections, the annual growth rate of the in-hospital usage of cefpirome preparations remains above 6%. In terms of the competitive landscape, domestic cefpirome API manufacturers are mainly local pharmaceutical enterprises. At present, 7 enterprises have obtained API production approvals. In addition to meeting the demand of domestic preparations, about 30% of the production capacity is exported to emerging markets such as Southeast Asia and Latin America. After the centralized procurement, the penetration rate of generic preparations has exceeded 90%, which puts forward higher requirements for cost control and quality compliance of APIs.

The original research enterprise of cefpirome is Hoechst AG (Germany), which was later merged into Sanofi, and the original brand name is "Cefrom". Its core compound patent expired globally in 2003. The main dosage form approved for the original product is cefpirome for injection, with specifications covering 0.25g, 0.5g and 1.0g. The original product has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (Third Batch)* of China. In terms of domestic API registration, 8 valid registration numbers (status A) for cefpirome APIs can be queried on the CDE platform at present, corresponding to 7 manufacturers. At the preparation level, there are 31 domestic approval documents for generic cefpirome for injection, all of which have passed or are deemed to have passed the consistency evaluation. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of cefpirome impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products can meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and provide reliable reference standard support for the whole-process R&D links of API and preparation enterprises, including quality research, stability study, registration and declaration, etc.