Furazolidone

For the clinical treatment of gastrointestinal infectious diseases such as Helicobacter pylori infection and bacillary dysentery, nitrofuran antibacterial drugs are an important basic medication option. As a broad-spectrum nitrofuran antibacterial drug, furazolidone blocks the normal metabolism of bacteria by interfering with the activity of bacterial oxidoreductases, and has an inhibitory effect on both Gram-positive and Gram-negative bacteria. Clinically, it is mainly used as a combined medication in Helicobacter pylori eradication regimens, and can also be used to treat gastrointestinal infections such as bacillary dysentery, enteritis and cholera. In some cases, it can also be used for the treatment of trichomoniasis. The applicable population covers adult infected patients, and the dosage for children should be strictly controlled in accordance with doctor's advice.

At present, the global market size of furazolidone is approximately US$230 million. Driven by the persistently high Helicobacter pylori infection rate and the increasing demand for diagnosis and treatment of gastrointestinal infections in developing countries, the compound annual growth rate is maintained at around 3.2%. The competition in the domestic market is dominated by generic drugs, and the manufacturing enterprises are concentrated in East China and North China. Due to the low cost and stable clinical demand of this drug, it is a standing variety in the infectious medication catalogue of primary medical institutions. After the centralized procurement, the winning bid price has dropped by approximately 47%, which further improves the accessibility at the primary level.

The original research enterprise of furazolidone is Abbott Laboratories of the United States, and the original research brand name is Furoxone. The core compound patent expired in 1967, and there is currently no core patent restriction under research. The main dosage form of the original research product is tablet, with a specification of 100mg, which has been included in the FDA Reference Listed Drug Catalogue. At present, 12 domestic enterprises have obtained CDE registration numbers (Status A) for furazolidone API, and another 3 enterprises have had their DMFs accepted by the US FDA. The domestically approved preparation varieties are mainly furazolidone tablets and compound preparations, all of which have passed the consistency evaluation. (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 furazolidone API. Most of the products are in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of API R&D, quality research and production.