Nitrofurantoin

Urinary tract infection is one of the most common types of bacterial infection in clinical practice, among which Gram-negative bacteria such as Escherichia coli are the main pathogenic bacteria. The increase in drug resistance rate has led to a continuous rise in clinical demand for antibacterial drugs with low drug resistance risk. Nitrofurantoin is a synthetic nitrofuran antibacterial agent. It exerts bacteriostatic or bactericidal effects by interfering with the bacterial oxidoreductase system and blocking its metabolic process. It has definite efficacy in acute uncomplicated lower urinary tract infections caused by sensitive bacteria, and can also be used for long-term prevention of urinary tract infections. It is a first-line drug recommended by domestic and foreign guidelines for the diagnosis and treatment of urinary tract infections, and the applicable population covers adults without contraindications and children over 3 months old.

At present, the global market size of nitrofurantoin is approximately USD 420 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at around 3.8%. The growth momentum mainly comes from the increase in the penetration rate of urinary tract infection diagnosis and treatment in primary medical institutions and the increase in demand for preventive medication. In terms of the domestic market, this variety has been included in the national centralized procurement catalog, the generic drug substitution rate exceeds 90%, the supply of API is dominated by local enterprises, the overall market pattern is stable, and cost control and compliance are the core competitive factors for suppliers.

The original research enterprise of nitrofurantoin is Procter & Gamble, with the original brand name Macrodantin, and its core compound patent expired worldwide in 1964. At present, the main marketed dosage forms include tablets, capsules and suppositories, with common specifications of 50mg and 100mg. The original research product has been included in the FDA Reference Listed Drug Catalog, and there is no imported original research preparation in China. As of the retrieval time point, there are 36 nitrofurantoin API registration records on the domestic CDE API registration platform, of which 24 are in the status of "A" (approved for use in marketed preparations), the number of domestic preparation approval documents exceeds 120, and the pass rate of relevant generic drug consistency evaluation has reached 62%. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of nitrofurantoin impurity reference standards, which can fully meet the needs of API manufacturers in the whole process of impurity research, quality control and declaration and registration. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, providing reliable support for the product compliance and quality stability of enterprises.