头孢氨苄

As a representative variety of first-generation cephalosporins, cephalexin exerts antibacterial activity by inhibiting the synthesis of bacterial cell walls, and has a good bactericidal effect on Gram-positive bacteria and some Gram-negative bacteria. Clinically, it is mainly used for respiratory tract infections such as acute tonsillitis, angina, otitis media, sinusitis, bronchitis and pneumonia, urinary tract infections, and skin and soft tissue infections caused by susceptible bacteria. Due to its good oral absorption, high medication convenience, and low incidence of adverse reactions, it is a common option for the treatment of community-acquired mild to moderate infections, covering all age groups including adults and children.

The global cephalexin market size has been stable at around USD 1.2 billion all year round. As the core producer of global cephalosporin APIs, China accounts for more than 70% of the global supply. The domestic market is in a state of full competition. After the implementation of centralized procurement, the terminal price of preparations has dropped significantly, driving the demand for upstream APIs to concentrate on leading enterprises with stable production capacity and compliant quality. The CR5 of the industry has increased from 42% to 61% in the past three years, and the market concentration continues to rise.

The original developer of cephalexin is Eli Lilly and Company, with the original brand name Keflex. The core compound patent expired globally in 1986. The main dosage forms of the original drug are tablets and capsules, with specifications including 125mg, 250mg and 500mg. Relevant dosage forms have been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. At present, more than 30 domestic enterprises have obtained A status for their cephalexin APIs through CDE registration, and there are more than 500 approvals for corresponding oral preparations, making it an antibacterial drug with extremely high clinical accessibility. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of cephalexin impurity reference standards, covering all related substances and specific degradation impurities specified in the pharmacopoeia. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide reliable reference material support for the whole process of quality research, stability study, registration and declaration of API and preparation enterprises.