Fosfomycin

As a classic broad-spectrum antibacterial agent, fosfomycin belongs to the phosphate derivative class of antibiotics. It exerts a bactericidal effect by inhibiting the early stage of bacterial cell wall synthesis, and has good antibacterial activity against both Gram-positive bacteria and Gram-negative bacteria, including some drug-resistant strains such as methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa. Clinically, it can be used to treat respiratory tract infections, urinary tract infections, skin and soft tissue infections, intestinal infections, etc. caused by susceptible bacteria. It can also be used in combination with other antibacterial agents to treat severe infections caused by susceptible bacteria, with an applicable population covering adults and children. Due to its high safety, it has unique clinical value in antibacterial therapy for special populations.

The global fosfomycin market size was approximately USD 1.28 billion in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain around 4.2%. The growth momentum mainly comes from the rising demand for the treatment of drug-resistant bacterial infections and the improvement of the standardization of antibacterial drug use at the primary level. In terms of the competitive landscape, China is the world's largest producer and exporter of fosfomycin API, with production capacity accounting for more than 85% of the global total. The product quality of domestic leading enterprises has reached the standards of mainstream international markets. After the implementation of centralized procurement, the demand on the preparation side continues to be released, further driving the expansion of the upstream API market.

The original developer of fosfomycin is the Spanish Zambon Group, and the original brand name is "Fosfomycin". Its core compound patent has expired worldwide. At present, the dosage forms of the original drug approved in China include fosfomycin trometamol powder (specification: 3g) and fosfomycin sodium for injection (specifications: 1g, 2g, 4g). All relevant dosage forms have been included in the China Listed Drugs Catalogue as reference listed drugs. As of now, there are more than 30 registration entries of fosfomycin API on the API registration platform of China CDE, most of which are in the A status, and a number of domestic enterprises have obtained marketing approval for fosfomycin preparations. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of fosfomycin impurity reference standards, covering all categories such as synthesis process impurities and degradation impurities. Most of the products are available from 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 the Chinese Pharmacopoeia and FDA, and can provide reliable reference material support for API and preparation enterprises in links such as quality research, stability study and registration declaration.