Thiamphenicol

Respiratory tract, urinary tract and intestinal infections are common clinical bacterial infectious diseases, and the rising drug resistance of pathogenic bacteria has always been one of the core challenges in diagnosis and treatment. Thiamphenicol belongs to the amphenicol class of broad-spectrum antibiotics. It reversibly binds to the 50S subunit of bacterial ribosomes, inhibits the extension of peptide chains and thus blocks bacterial protein synthesis. It has good antibacterial activity against Gram-negative bacteria such as *Haemophilus influenzae*, *Escherichia coli* and *Salmonella* species, as well as Gram-positive bacteria such as *Streptococcus pneumoniae* and *Streptococcus pyogenes*. Clinically, it is mainly used for the treatment of respiratory tract, urinary tract, intestinal and other infections caused by sensitive bacteria, and can also be used for adult and pediatric patients with typhoid fever, paratyphoid fever and other *Salmonella* infections.

At present, the global market size of thiamphenicol is approximately USD 120 million, of which the veterinary field accounts for more than 65%, and the annual compound growth rate of the human market is maintained at around 3.2%. In the domestic market, the annual sales of human-use thiamphenicol preparations are approximately RMB 180 million, and the annual demand for veterinary API exceeds 800 tons. The competitive landscape is dominated by generic drugs, domestic manufacturers are concentrated in East China and South China, the top 3 enterprises account for more than 70% of the API supply share, and the oral preparation varieties covered by centralized procurement have further driven the growth in demand for compliant APIs.

The original research enterprise of thiamphenicol is Zambon S.p.A. of Italy, with the original trade name Thiophenicol, and the core compound patent expired globally in 1980. Currently, the main commercially available dosage forms include tablets (250 mg), capsules (250 mg) and granules (0.25 g/bag). The original research tablet has been included in the FDA Reference Listed Drug Catalog, the original research preparation has not been imported into China, and the domestic reference preparation has been included in the *List of Chemical Drugs*. Up to now, there are 12 thiamphenicol registration records in the domestic CDE API registration platform, among which 8 are in A status and eligible for associated review, and another 2 DMFs are filed with the FDA. Three dosage forms of thiamphenicol, namely tablets, capsules and granules, have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of thiamphenicol impurity reference standards. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support various testing needs in the processes of API R&D, quality research and consistency evaluation.