Cefalotin

As the first cephalosporin antibiotic applied clinically worldwide, cephalothin exerts its bactericidal effect by inhibiting the biosynthesis of bacterial cell walls, and its antibacterial activity against Gram-positive bacteria is significantly superior to that of most second-generation and third-generation cephalosporins launched later. Clinically, it is mainly used to treat respiratory tract infections, urinary tract infections, skin and soft tissue infections, septicemia and other diseases caused by penicillin-resistant Staphylococcus aureus. It is a common option for surgical infection prophylaxis, and is especially suitable for adult and pediatric patients with infections who are allergic to penicillin but have no history of cephalosporin allergy.

The global market size of cephalothin preparations is stable at around USD 1.2 billion, with an annual compound growth rate of approximately 2.8%. The growth momentum mainly comes from the expansion of antibacterial drug use scenarios in primary medical institutions. The domestic market is dominated by the supply of generic drugs. At present, 12 enterprises have obtained the production approval documents for cephalothin preparations, and the production of APIs is concentrated in leading anti-infective pharmaceutical enterprises in North China and East China. Affected by the volume-based procurement policy, the terminal price of preparations has dropped by 67% compared with that in 2018, and the cost control of upstream APIs has become a core competitive factor for enterprises.

The original research enterprise of cephalothin is Eli Lilly and Company, with the original brand name Keflin. The core compound patent expired globally in 1981. The original dosage form is injection, with specifications of 0.5g and 1g, which has been included in the FDA Reference Listed Drug Catalogue, and the original preparation has not been imported into China. At present, there are 7 cephalothin API registration numbers in China, 5 of which are in status A and can be legally supplied to preparation manufacturers for use. All cephalothin preparations approved for marketing in China are cefalotin for injection, with a total of 27 approval numbers. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the impurity research needs in the process of generic drug development and quality control of cephalothin, CATO can provide a full set of impurity reference standards for this API. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can meet the full-process research needs of enterprises from methodological validation to release testing.