Valnemulin

In the pig breeding industry, chronic respiratory diseases such as mycoplasmal pneumonia and pleuropneumonia have long restricted breeding benefits, and the problem of drug resistance of conventional antibacterial drugs has further aggravated the difficulty of prevention and control. Valnemulin is a pleuromutilin-class antibiotic exclusively for animals. It inhibits protein synthesis by selectively binding to the 50S subunit of bacterial ribosomes, and exhibits high antibacterial activity against Gram-positive bacteria, mycoplasma and some Gram-negative bacteria. It has no cross-resistance with other categories of antibacterial drugs, is mainly used for the prevention and treatment of porcine respiratory diseases, and is a key anti-infective drug in the livestock and poultry health prevention and control system.

At present, the global market size of veterinary antibacterial drugs has exceeded 40 billion US dollars, among which the annual compound growth rate of anti-mycoplasma drugs remains at around 6.8%. With the advantages of low drug resistance and high target specificity, the market size of valnemulin has exceeded 320 million US dollars, and its growth rate is far higher than that of similar veterinary antibiotics. At the domestic market level, as the scale rate of pig breeding exceeds 65%, farmers' demand for new antibacterial drugs with low residues continues to rise. At present, the domestic supply of this API is still dominated by imports and leading generic pharmaceutical enterprises, there is no overcapacity, and there is a clear market incremental space.

The original developer of valnemulin is Novartis Animal Health (now affiliated to Elanco Animal Health), and the original trade name is "Tiamulin". The core compound patent of valnemulin first expired in major markets such as the European Union and China in 2021. The main dosage form approved for the original product is premix, with specifications of 10% and 80%, which has been included in the FDA Reference Listed Drug Directory for Animal Drugs and the Chinese *Reference Preparation Directory for Veterinary Chemical Drugs*. At present, the valnemulin APIs of 3 domestic enterprises have obtained A status through CDE registration, and the corresponding approved preparation products are all 10% valnemulin premix. (Data as of June 2025, please refer to the official CDE website for the latest information)

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