Fluocinolone Acetonide

Glucocorticoids, as core medications for clinically controlling inflammatory responses and suppressing immune responses, occupy an irreplaceable therapeutic position in the field of dermatology. Fluocinonide is a potent fluorine-containing topical glucocorticoid. By binding to intracellular glucocorticoid receptors, it can inhibit the synthesis and release of inflammatory mediators, reduce capillary permeability, and meanwhile decrease the proliferation of fibroblasts to alleviate scar hyperplasia. It is clinically indicated for a variety of chronic non-infectious inflammatory skin diseases such as contact dermatitis, seborrheic dermatitis, atopic dermatitis, neurodermatitis, psoriasis, eczema, etc. It is only for topical skin application, and is a common option for controlling symptoms in the acute phase of moderate to severe skin inflammation.

At present, the global market size of topical glucocorticoids has exceeded 12 billion US dollars, and the annual growth rate of the Chinese market maintains at around 6.8%, among which potent glucocorticoids account for approximately 18%. As a classic potent topical hormone, fluocinonide has a long clinical application history, definite efficacy and controllable safety, so it is a commonly used variety in the dermatology departments of primary medical institutions. Currently, the domestic market is dominated by generic drug supplies, there are more than 40 preparation enterprises approved for production, and the annual demand for active pharmaceutical ingredients is stable at around 12 tons.

The original research enterprise of fluocinonide is Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd., and the trade name of the original research product is "Fuqingsong" ointment. The core compound patent expired in 1983. At present, the main dosage forms approved in China include fluocinonide acetate ointment and cream, with the common specification of 10g:2.5mg (0.025%). Relevant preparations have been included in the National Essential Drug List, and are also included as reference preparations in the China Listed Drug Catalogue. In terms of API registration, 6 valid registration numbers of fluocinonide acetate APIs can be queried on the CDE platform at present, among which 3 are in A status, all produced by domestic enterprises, and dozens of corresponding generic preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for fluocinonide API. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most of the products are in stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the full-process needs of API research and development, quality research and release testing.