Tulathromycin

For animal infectious diseases such as dairy cow mastitis caused by Gram-positive bacteria, the clinical application of macrolide antibiotics has long been a research focus in the veterinary field. Tulathromycin, as a second-generation macrolide antibiotic exclusively for animals, exerts its antibacterial activity by binding to the 50S subunit of bacterial ribosomes to inhibit protein synthesis. It has strong efficacy against common animal pathogenic bacteria such as *Mannheimia haemolytica*, *Pasteurella multocida*, *Actinobacillus pleuropneumoniae* and mycoplasma. It is mainly used for the treatment of respiratory diseases in beef cattle and non-lactating dairy cows, and can also be used for the prevention and control of related bacterial infections in livestock and poultry such as pigs and sheep. It is an important anti-infective veterinary API in livestock and poultry breeding.

At present, the global market size of veterinary macrolide antibiotics has exceeded 3 billion US dollars, with an annual compound growth rate maintained at around 6.8%. Among them, tulathromycin, due to its characteristics of long-acting effect and low residue, accounts for an increasing proportion year by year in the medication structure of respiratory veterinary drugs. In the domestic veterinary drug market, the clinical demand for tulathromycin continues to grow along with the increase in the proportion of large-scale breeding. At present, a number of domestic enterprises have deployed the generic R&D of APIs and preparations of this variety, and the overall market is in the competitive stage where original research and generic drug enterprises coexist. As the demand for high-efficiency and low-toxicity veterinary drugs from the breeding side is further released, the market size of tulathromycin still has a large room for growth.

The original research enterprise of tulathromycin is Zoetis, and the original research trade name is "Draxxin". The core compound patent of the original research product expires in 2021 in the United States, and the core patent in the European Union expires in 2022. The main dosage form approved for the original research product is injection, with the specification of 100ml:10g. This product has been included in the FDA Reference Listed Drug Catalog for Animal Drugs, and is also included in the *Imported Veterinary Drug Quality Standards* of China. Up to now, the tulathromycin APIs of a number of domestic enterprises have obtained A status after CDE registration, and a number of domestic tulathromycin injection preparations have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for tulathromycin API, most of which are available in stock. Orders for in-stock products 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 and reliable reference standard support for links such as API quality research and preparation stability study of veterinary drug enterprises.