Nifuratel

Gynecological infections are common diseases with high incidence among women of childbearing age, with mixed infections accounting for more than 40%. A single antibacterial drug is often difficult to cover multiple pathogens, and there is an urgent clinical demand for broad-spectrum and safe anti-infective drugs. Nifuratel is a broad-spectrum anti-infective drug of the nitrofuran class. It inhibits the growth and reproduction of pathogens by interfering with their enzyme system, and has a killing effect on various common gynecological pathogens such as bacteria, trichomonas and candida. Meanwhile, it has little impact on the normal flora in the vagina, and can be used for the treatment of bacterial vaginosis, trichomonas vaginitis, candidal vulvovaginitis and urinary system infections. The applicable population includes adult women and patients with urinary tract infections, and its safety in medication during pregnancy has also been clinically verified.

Nifuratel is one of the mainstream drugs in the field of gynecological anti-infection. In the past five years, the domestic market scale has maintained a compound annual growth rate of 8%~10%, and the overall market scale was nearly 2.5 billion yuan in 2023. At present, the domestic preparation market is dominated by generic drugs, and more than 30 enterprises have obtained the approval of relevant preparation approvals. The domestic supply of API accounts for more than 90%. With the expansion of the coverage of centralized procurement policies, the demand of downstream preparation enterprises for cost-effective and compliant APIs continues to rise.

The original research enterprise of nifuratel is Doppel Farmaceutici S.R.L. of Italy, with the original research brand name "Macmiror", and its core compound patent expired globally in 2008. The main dosage forms of the original research include oral tablets (200mg), vaginal tablets (250mg) and ointments, all of which have been included in the Catalogue of Marketed Drugs in China as reference preparations. At present, more than 15 domestic enterprises have obtained A status for their nifuratel APIs through CDE registration, and the approved and marketed preparations cover multiple dosage forms such as tablets, vaginal tablets, capsules and suppositories, which can fully meet the medication needs of different clinical scenarios. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of nifuratel impurity reference standards, which can meet the quality research needs of the whole process from R&D to declaration. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. Meanwhile, the products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, helping enterprises efficiently complete pharmaceutical research and declaration work.