Furacillin

As a classic variety of nitrofuran synthetic antibacterial drugs, nitrofurazone exerts broad-spectrum antibacterial activity by interfering with the bacterial oxidase system and inhibiting the metabolic process of acetyl coenzyme A. It has a significant inhibitory effect on both Gram-positive bacteria and Gram-negative bacteria, and also shows certain efficacy against anaerobic bacteria in some scenarios. Clinically, this drug is mainly used for the prevention and control of local infections of the skin and mucous membranes, covering the local disinfection treatment of burns, trauma, purulent dermatitis, acute and chronic rhinitis, otitis media and other diseases. It can also be used for irrigation and nursing of lumens such as the bladder and vagina. It is applicable to a wide range of people, but due to its high oral toxicity, it is only used as a topical drug for external use.

At present, the global market size of nitrofurazone is approximately USD 230 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at around 4.2%. The growth momentum mainly comes from the expansion of disinfection demand in the animal husbandry and breeding field and the market expansion of topical external preparations. The domestic market is highly concentrated, with more than 80% of the API production capacity concentrated in leading manufacturing enterprises in Jiangsu and Zhejiang provinces. There is no relevant centralized procurement implementation record so far. Export share accounts for more than 65% of the total domestic production, and the products are mainly supplied to emerging markets such as Southeast Asia and Latin America.

The original research enterprise of nitrofurazone is Bayer AG of Germany, with the original brand name Furacilin. The core compound patent expired before 1960, and there is no valid core patent restriction. At present, the mainstream dosage forms include 0.02% external solution and 0.2% ointment, and the reference listed drug has been included in the FDA Orange Book Reference Listed Drug Catalog. According to the domestic API registration platform, there are currently 7 enterprises whose nitrofurazone API registration applications have been approved with the status of A, and another 2 enterprises' registration applications are under review. A number of corresponding external solutions and ointment preparations have been approved for marketing in China. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for nitrofurazone API, and the vast majority of products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the requirements of pharmaceutical regulatory regulations of multiple countries such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process R&D and production needs of pharmaceutical enterprises in API quality research, consistency evaluation, impurity release, etc.