Cefoxitin

Cephalosporin antibacterial drugs are one of the core categories for clinical combat against bacterial infections. Among them, cefoxitin, as a representative of cephamycin antibiotics, exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls. It has good antibacterial activity against Gram-positive bacteria, Gram-negative bacteria and anaerobic bacteria, and is particularly highly stable to β-lactamases, which can cover anaerobic infections such as Bacteroides fragilis that are resistant to conventional cephalosporins. Clinically, it is mainly used to treat lower respiratory tract infections, urinary system infections, abdominal and pelvic infections, sepsis and skin and soft tissue infections caused by sensitive bacteria, and can also be used for perioperative infection prevention. The applicable population covers adults and children over 3 months old, and it is a common choice for moderate to severe mixed infections in clinical practice.

At present, the market size of domestic cefoxitin preparations is stably around 1.5 billion yuan, with an annual compound growth rate maintained at 3%~5%. The demand mainly comes from primary medical institutions and surgical perioperative prophylactic medication scenarios. In terms of the competitive landscape, the domestic preparation market is dominated by generic drugs. At present, nearly 20 enterprises have obtained the approval of cefoxitin injections through the generic drug consistency evaluation. After winning bids in multiple provincial centralized procurements, the price has dropped by more than 80%, which promotes the continuous release of upstream API demand. The localization rate of APIs has reached more than 90%, and the main manufacturers are concentrated in Jiangsu, Zhejiang and other regions.

The original research enterprise of cefoxitin is Merck Sharp & Dohme, with the original brand name Mefoxin. Its core compound patent in the United States expired in 1992, and all relevant patents in China have expired. The original dosage form is cefoxitin sodium for injection, with common specifications of 1g and 2g, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. According to the domestic API registration platform, more than 15 enterprises have obtained A-status registration numbers for their cefoxitin APIs, which can be used in association with preparation declarations. A number of domestic manufacturers have obtained the marketing approval of cefoxitin sodium for injection. (Data as of November 2024, please refer to the official website of CDE for the latest information)

In response to the impurity research needs in the R&D and quality control of generic cefoxitin drugs, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support enterprises' API quality research, preparation consistency evaluation and registration declaration work.