Cefamandole

Gram-negative bacterial infection is a key area of clinical anti-infective therapy. As a second-generation cephalosporin antibiotic, cefamandole exerts a bactericidal effect by inhibiting the biosynthesis of bacterial cell walls, and has good antibacterial activity against both Gram-positive bacteria and Gram-negative bacteria, especially high sensitivity to Haemophilus influenzae, Escherichia coli, Klebsiella pneumoniae, etc. It is clinically mainly used for respiratory tract infections, biliary tract infections, urinary tract infections, skin and soft tissue infections, sepsis and bone and joint infections caused by sensitive bacteria. The applicable population covers adult and pediatric patients with sensitive bacterial infections, and it is one of the commonly used options for clinical perioperative infection prevention.

The global market size of cephalosporin antibiotics maintains steady growth, among which the overall market size of second-generation cephalosporins is approximately USD 2.3 billion, with a compound annual growth rate maintained at around 2.8%. In terms of the domestic market, the annual sales of cefamandole preparations exceed RMB 1.5 billion, making it a mature and large-scale variety among second-generation cephalosporins. At present, domestic manufacturers are mainly generic pharmaceutical enterprises, with a relatively scattered competitive landscape, and the supply of APIs is dominated by local enterprises. With the advancement of national centralized procurement, the decline in preparation prices drives the continuous and stable demand for upstream APIs, and the requirements for the compliance and supply stability of suppliers are gradually increasing.

The original research enterprise of cefamandole is Eli Lilly and Company, and the original research brand name is Mandol®. Its core compound patent expired in 1987. The main dosage form approved for the original research product is cefamandole nafate for injection, with common specifications of 0.5g, 1.0g and 2.0g. The original research product has been included in the FDA Reference Listed Drug Catalog. In terms of the domestic market, more than 30 enterprises have obtained CDE registration numbers for cefamandole nafate APIs, among which more than 20 are in A status. There are more than 120 domestic approval documents for marketed cefamandole nafate for injection preparations, and preparations from multiple enterprises have passed the consistency evaluation of generic drugs. (Data as of November 2024, please refer to the official website of CDE for the latest data)

In response to the quality research and registration declaration requirements for this variety, CATO provides a full set of cefamandole impurity reference standards, covering more than 20 kinds of process impurities and degradation impurities of APIs and preparations. Most products are in stock, and spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can be provided with complete research data such as structure confirmation and purity calibration, fully meeting various compliance needs of pharmaceutical enterprises in quality control and registration declaration.