Clobetasol Propionate

In the clinical treatment of chronic inflammatory skin diseases such as psoriasis and atopic dermatitis, potent glucocorticoids are the core medications for rapid symptom control. Clobetasol propionate is a super-potent topical glucocorticoid. By binding to intracellular glucocorticoid receptors, it inhibits the release of inflammatory factors, reduces the infiltration of inflammatory cells, simultaneously constricts local blood vessels and lowers capillary permeability, exerting multiple effects including anti-inflammation, anti-allergy, antipruritus and anti-proliferation. Clinically, it is mainly used for the treatment of chronic hypertrophic skin diseases sensitive to glucocorticoids, including plaque psoriasis, chronic eczema, neurodermatitis, lichen planus, etc., and is applicable to adult and adolescent patients aged 12 years and above. Due to its high potency, long-term and large-area use is generally not recommended.

In 2023, the market size of topical glucocorticoid preparations in China was nearly RMB 4 billion, among which the super-potent glucocorticoid category recorded an annual compound growth rate of 7.2%, with a growth rate significantly higher than that of medium- and low-potency glucocorticoid categories. In terms of competitive landscape, the current domestic clobetasol propionate preparation market is dominated by generic drugs, with local enterprises accounting for more than 85% of the market share. For cream dosage form alone, there are nearly 70 approval numbers, while there are only more than 10 domestic manufacturers in the API segment, with production capacity concentrated in leading enterprises. With the continuous release of demand for primary dermatological medications in recent years, the supply and demand relationship in the API market has maintained a tight balance.

The original developer of clobetasol propionate is GlaxoSmithKline, with the original brand name Dermovate, and its core compound patent expired globally in 1997. At present, the main dosage forms approved for the original product include cream and ointment, with a conventional specification of 0.05%. The original preparation has been included in the FDA Reference Listed Drug Catalog, and the original preparation has not been imported into China yet. In terms of domestic API registration, as of now, a total of 8 A-status registration numbers for clobetasol propionate API have been published on the CDE platform, all of which are produced by local enterprises, and the corresponding approved preparations cover multiple dosage forms such as cream, ointment and liniment. (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 clobetasol propionate, which comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations. Most products are in sufficient stock. Spot orders placed before 16:00 can be shipped on the same day, which can fully meet the R&D and production needs of pharmaceutical enterprises in various links such as impurity research, quality standard establishment and stability study.