Florfenicol

In the field of livestock and poultry breeding, bacterial respiratory and digestive tract infections have long been common diseases that restrict breeding benefits. As a third-generation amphenicol broad-spectrum antibiotic, florfenicol binds to the 50S subunit of the bacterial 70S ribosome, inhibits peptidyl transferase activity, and blocks protein synthesis, exerting a strong killing effect on Gram-positive bacteria, Gram-negative bacteria and mycoplasma. Its safety is significantly better than that of chloramphenicol of the same category, with no potential risk of aplastic anemia. At present, it is the first-choice anti-infective drug for the prevention and treatment of colibacillosis, pasteurellosis and mycoplasmal pneumonia in the breeding of livestock, poultry and aquatic animals such as pigs, chickens and fish, and can also be used for the treatment of animal respiratory, digestive and genitourinary system infections caused by susceptible bacteria.

The global florfenicol market size was approximately USD 780 million in 2023. Driven by the large-scale expansion of livestock and poultry breeding and the growing demand for animal health, the compound annual growth rate is expected to reach 5.2% by 2028, and the market size will exceed USD 1 billion. China is the core producer of florfenicol in the world, with its production capacity accounting for more than 85% of the global total production capacity. The industry concentration is relatively high, and the combined production capacity of leading enterprises accounts for more than 60%. After the implementation of the domestic veterinary antibacterial drug centralized procurement policy, the cost advantage of compliant enterprises has been further highlighted, and the process of generic drug substitution continues to accelerate.

The original research enterprise of florfenicol is Schering-Plough Corporation of the United States, with the original brand name Nuflor. The core compound patent expired globally in 2003. The current mainstream dosage forms on the market include injection (300mg/ml), premix (10% and 20% content) and soluble powder (10% and 30% content). Its original preparation has been included in the FDA Reference Listed Drug Catalog for Veterinary Use. In China, as of September 2024, there are more than 150 valid registration numbers for florfenicol API on the CDE API registration platform, among which more than 80 are A-status registration numbers, and the corresponding veterinary injection approvals exceed 2,000, realizing the domestic supply of all dosage forms. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the needs of florfenicol R&D and quality control, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and fully meet the full-process testing needs of veterinary drug enterprises for impurity research, quality standard establishment and daily quality inspection.