Ceftriaxone

In the clinical treatment of drug-resistant bacterial infections, third-generation cephalosporins have always been the core medication option, and ceftriaxone is one of the varieties with the highest clinical recognition among them. As a long-acting broad-spectrum β-lactam antibiotic, it exerts a bactericidal effect by inhibiting the synthesis of bacterial cell wall mucopeptides, and has strong antibacterial activity against both Gram-positive bacteria and Gram-negative bacteria. With a long half-life of 8 hours, it only needs to be administered once a day. It is widely used clinically for lower respiratory tract infections, urinary tract infections, biliary tract infections, abdominal infections, pelvic infections, skin and soft tissue infections, bone and joint infections, sepsis, meningitis, etc., and can also be used for perioperative infection prevention. It covers multiple applicable populations such as adults and children, and is a first-line recommended medication for diseases such as community-acquired pneumonia and gonorrhea.

At present, the global market size of ceftriaxone exceeds 2.5 billion US dollars. As the major consumer market, China has an annual sales volume of ceftriaxone stably above 4 billion yuan, with a compound annual growth rate maintained at 3.2% in the past three years. Due to its early launch time, the market of this variety has entered a mature stage, and the competitive landscape is dominated by generic drugs. There are more than 50 domestic manufacturers, and the price has dropped by more than 80% after the centralized procurement, which has greatly improved the accessibility for patients. From the perspective of the industrial chain, China is the world's largest producer and exporter of ceftriaxone active pharmaceutical ingredients (APIs), with production capacity accounting for more than 75% of the global total capacity, and its products are exported to Southeast Asia, Europe, Africa and other countries and regions.

The original research enterprise of ceftriaxone is Roche Pharma, with the original brand name "Rocephin", and its core compound patent expired globally in 2000. At present, the dosage form of the original research product approved in China is injection, with four specifications including 0.25g, 0.5g, 1.0g and 2.0g. It has been included in the National Reference Preparation Catalogue and is also listed in the FDA Reference Preparation Catalogue. In terms of domestic API registration, more than 30 enterprises have obtained CDE registration numbers for ceftriaxone APIs, among which nearly 20 have passed the approval and can supply domestic preparation manufacturers. There are more than 200 approvals for ceftriaxone injection varieties approved and marketed in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of ceftriaxone impurity reference standards. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different scenarios such as API R&D, quality research, and declaration and registration.