Flomoxef

In response to the clinical treatment needs of multidrug-resistant bacterial infections, oxacephem antibiotics, with their high stability to β-lactamases, have become an important option in the field of severe infection treatment. As a representative variety of oxacephems, flomoxef exerts a bactericidal effect by inhibiting the biosynthesis of bacterial cell walls, and has broad-spectrum antibacterial activity against both Gram-positive bacteria and Gram-negative bacteria. Its antibacterial effect is particularly prominent against methicillin-resistant Staphylococcus aureus (MRSA), Bacteroides fragilis and other anaerobic bacteria. Clinically, it is mainly used for the treatment of sepsis, pneumonia, peritonitis, biliary tract infections, as well as gynecological and surgical postoperative infections, etc. It is suitable for adult and pediatric patients with susceptible bacterial infections, and can also be used as an alternative treatment for patients with penicillin allergy.

The global flomoxef market size was approximately USD 320 million in 2023, with a compound annual growth rate maintained at around 4.8%. The Asia-Pacific market accounts for more than 60% of the global market, and China is the fastest-growing regional market. In 2023, the terminal sales of flomoxef in domestic public medical institutions exceeded RMB 1.2 billion. At present, the domestic market is dominated by generic drugs, and more than 7 enterprises have been approved for flomoxef for injection preparations. After the implementation of the centralized procurement policy, the product price has dropped by 58%, the clinical accessibility has been greatly improved, and the demand for API has continued to release accordingly.

The original developer of flomoxef is Shionogi Pharma Co., Ltd. of Japan, with the trade name "Flumarin". The core compound patents of flomoxef in major markets such as Japan and the United States expired in 2008. The main dosage form approved for the original drug is powder for injection, with specifications of 0.5g and 1.0g. The original preparation has been included in the China Listed Drug Catalogue as the reference listed drug. In terms of domestic API registration, at present, 4 enterprises have obtained A-status registration numbers for their flomoxef APIs after approval by the CDE, and the registration applications of another 6 enterprises are under the review process. In China, 8 generic flomoxef for injection products have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for flomoxef API. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standards use needs of pharmaceutical enterprises in various links such as API R&D, quality research, and consistency evaluation.