Diflorasone

In response to the clinical treatment needs of refractory inflammatory skin diseases such as moderate-to-severe plaque psoriasis and contact dermatitis, potent corticosteroid drugs are the core option for rapid control of inflammatory responses. As a fluorinated potent glucocorticoid, diflorasone binds to intracellular glucocorticoid receptors to inhibit the synthesis and release of pro-inflammatory cytokines and inflammatory mediators, while constricting local blood vessels and reducing capillary permeability, which can significantly relieve symptoms such as skin erythema, swelling, pruritus and scales. Clinically, it is mainly used for short-term topical treatment of glucocorticoid-sensitive adults and adolescents over 12 years old with skin diseases such as moderate-to-severe dermatitis, psoriasis and atopic dermatitis.

The global market size of topical glucocorticoids has exceeded USD 9 billion in 2024, among which potent and super-potent categories account for 32%, with a compound annual growth rate maintained at 4.2%. With a low incidence of skin atrophy adverse reactions, diflorasone's share in the potent topical hormone segment market has increased year by year to 2.8%. At present, the global market is jointly supplied by original research products and generic drugs, and the penetration rate of generic drugs in European and American countries has exceeded 65%; in China, this variety is still in the stage of clinical application and promotion, with a small number of enterprises filing for generic drug registration, and the market supply gap is relatively obvious.

The original research enterprise of diflorasone is Galderma France, and the original research brand name is Psorcon. Its core compound patent expired globally in 2002. The main dosage forms of the original research marketed products are 0.05% diflorasone cream and ointment, among which 0.05% diflorasone ointment has been included in the FDA Reference Listed Drug Catalog. At present, no diflorasone API has been approved for marketing in China, nor has the corresponding domestic preparation been approved, and there is no publicly available valid DMF registration number on the CDE API Registration Platform. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the needs of generic drug research and development and quality control of diflorasone, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, in-stock products ordered before 16:00 will be shipped on the same day, and they comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, which can fully support enterprises in the whole process of impurity analysis from pre-formulation research to registration and filing.