Taurolidine

In response to the gap in the prevention and control of nosocomial infections caused by multidrug-resistant bacteria, the clinical value of taurolidine as a broad-spectrum antibacterial API continues to be increasingly prominent. It is a synthetic taurine derivative with a mechanism of action different from that of traditional antibiotics. It exerts effects by destroying the integrity of bacterial cell membranes, inhibiting bacterial adhesion and biofilm formation, and is not easy to induce drug resistance. Meanwhile, it also has anti-inflammatory and anti-endotoxin activities. Clinically, it is mainly used for the prevention and treatment of abdominal infection, urinary catheter-related infection, and burn wound infection. It is also used as an irrigation fluid to prevent infection in surgical operations. The applicable population covers inpatients requiring prevention and control of drug-resistant bacterial infections, immunocompromised people with infections, and surgical patients.

The global taurolidine market size was approximately USD 120 million in 2023, and the compound annual growth rate from 2024 to 2029 is expected to remain at 6.8%. The core growth drivers come from the rising incidence of nosocomial drug-resistant bacterial infections, the increase in surgical volume, and the growing demand for non-antibiotic antibacterial drugs in the anti-infection field. In terms of the competitive landscape, the original research manufacturer of this product still occupies the main market share at present, and generic drug manufacturers are mostly concentrated in Europe and Asia. China is still in the early stage of generic drug development, and the product has not yet been included in the centralized procurement catalog.

The original research enterprise of taurolidine is Pharmaceutische Fabrik Promonta GmbH in Germany, with the original trade name Taurolin. Its core compound patent expired globally around 1990, and subsequent preparation-related patents have also expired successively. The main dosage forms approved by the original research include 2% injection solution, 10% oral suspension, and topical gel. Among them, the 2% 500ml injection solution has been included in the FDA Reference Listed Drug Catalog, and is not yet included in the *Collection of Chemical Drug Catalogs* in China. There is no A-state registration number for the API of this product in China, nor are there any domestic taurolidine preparations approved for marketing. Only a small amount of original research preparations are temporarily imported for application through the clinically urgently needed channel. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of taurolidine impurity reference standards, supporting the testing needs in various stages of generic drug research and development and quality research. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. Meanwhile, the products comply with the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of enterprises for declaring domestic and foreign markets.