Fusidic acid /Sodium Fusidate

Infections caused by drug-resistant Gram-positive bacteria have always been a key and difficult point in clinical anti-infective treatment, and there are still unmet clinical needs especially in the medication options for methicillin-resistant *Staphylococcus aureus* (MRSA). Fusidate sodium is a type of steroidal antibiotic that exerts a bactericidal effect by inhibiting bacterial ribosomal translocation and blocking protein synthesis. It has high antibacterial activity against a variety of Gram-positive bacteria such as *Staphylococcus* (including MRSA), *Streptococcus*, and *Cutibacterium acnes*. Clinically, it is mainly used for skin and soft tissue infections, osteomyelitis, sepsis, pneumonia and other diseases caused by susceptible bacteria, and can also be used topically to treat superficial infections. It is an important component of the combination treatment regimen for drug-resistant Gram-positive bacterial infections, and is suitable for the treatment of corresponding infections in adults and children.

The global market size of fusidic acid preparations is approximately USD 1.6 billion, and the market size in China exceeds RMB 1.8 billion, with a compound annual growth rate of around 6% in the past three years. The growth momentum mainly comes from the increasing clinical demand for anti-infective treatment in dermatology and surgery. At present, the domestic preparation market is dominated by generic drugs, and more than 30 enterprises have been approved to produce fusidate sodium related preparations. Domestic enterprises dominate the API production side, and more than 70% of the global fusidate sodium API is supplied by Chinese manufacturers. With the advancement of the centralized procurement policy, the supply stability and quality compliance of APIs have become the core selection criteria for downstream preparation enterprises.

The original research enterprise of fusidate sodium is LEO Pharma from Denmark, and the original brand name is "Fucidin". Its core compound patent expired in the 1990s. The original dosage forms marketed in China include fusidate sodium for injection (specification: 0.5g), fusidic acid cream (specification: 2%: 15g), and fusidic acid eye drops (specification: 5g: 50mg). All relevant dosage forms have been included in the Catalogue of Marketed Drugs in China as reference preparations. As of July 2024, there are more than 20 registration entries of fusidate sodium on the CDE API Registration Platform, among which more than 10 have obtained A status (approved for use in marketed preparations). More than 30 fusidate sodium preparations have been approved for marketing in China, covering injection, cream, eye drops and other dosage forms. (Data as of July 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for fusidate sodium, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for the whole process of API R&D, quality research and preparation declaration.