Nalidixic Acid

Urinary tract infection is one of the most common bacterial infectious diseases in clinical practice, and the rising drug resistance of pathogenic bacteria has always been a core challenge for clinical medication. As the first quinolone synthetic antibacterial drug launched worldwide, nalidixic acid exerts its bactericidal effect by inhibiting bacterial DNA gyrase and blocking the bacterial DNA replication process. It mainly targets Gram-negative bacteria and is clinically used for the treatment of urinary tract infections and intestinal infections caused by susceptible bacteria. It is a landmark product in the development history of quinolone drugs, laying a mechanistic foundation for the subsequent research and development of fluoroquinolone drugs.

The global nalidixic acid market size is currently stable at around USD 120 million. In recent years, affected by the iteration of new quinolone drugs, the overall growth rate has maintained a low level of 1.3%. The competitive landscape is characterized by the dominance of generic drugs, and the original research product has withdrawn from the mainstream market. China and India are the world's major producers of nalidixic acid API. China's domestic production capacity accounts for about 62% of the global total production capacity, and the products are mainly exported to emerging markets such as Southeast Asia and Latin America. On the domestic preparation side, nalidixic acid has been included in the catalogue of commonly used antibacterial drugs for primary medical institutions, and the demand from primary medical institutions accounts for more than 70% of the total domestic demand.

The original research enterprise of nalidixic acid is Merck & Co., Inc. in the United States, with the original trade name NegGram, and the core compound patent expired worldwide in 1978. The main dosage form approved for the original product is tablet, with specifications of 0.25g and 0.5g. The original research product has been included in the FDA reference preparation catalogue, and there is no import of the original reference preparation in China for the time being. In terms of domestic API registration, there are currently 6 enterprises whose nalidixic acid APIs have obtained CDE registration numbers, among which 3 have been activated with A status and can be used for associated preparation declaration. A number of domestic enterprises have obtained approval for the marketing of nalidixic acid tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of nalidixic acid impurity reference standards, which can meet the needs of the whole process of API R&D, quality research and declaration. Most of the products are in stock. For in-stock products, orders placed 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, providing reliable support for enterprises to reduce R&D costs and accelerate the declaration progress.