Dexamethasone

The number of patients suffering from chronic inflammation, autoimmune diseases and allergic diseases worldwide continues to rise, and there is a long-term urgent clinical demand for drugs with both potent anti-inflammatory and immunosuppressive effects. Dexamethasone is a synthetic long-acting glucocorticoid API. By binding to intracellular glucocorticoid receptors, it inhibits the transcription of inflammatory factors and reduces the activation of immune cells. Its anti-inflammatory efficacy is about 4-5 times that of prednisone, and the side effect of water and sodium retention is lower. It is widely used in the clinical treatment of rheumatoid arthritis, bronchial asthma, allergic dermatitis and severe infectious shock. It is also a conventional medication for anti-rejection after organ transplantation and adjuvant antiemesis during tumor radiotherapy and chemotherapy, covering emergency and chronic disease treatment scenarios for all age groups.

The global market size of dexamethasone API was approximately USD 320 million in 2023, and it is expected to grow steadily at a compound annual growth rate of 3.7% from 2024 to 2030. China is the core supplier of dexamethasone API in the world, with production capacity accounting for more than 80% of the total global supply. Leading manufacturers have mature processes and significant cost advantages, and their products are exported to more than 100 countries and regions such as Europe, America and Southeast Asia. In terms of centralized procurement, both oral regular-release dosage forms and injections of dexamethasone have been included in the national centralized procurement scope. The demand of winning bidders for preparation manufacturers for high-quality and stably supplied APIs continues to increase, driving the market share of compliant APIs to further concentrate on leading production capacity.

Dexamethasone was first developed by Merck & Co., Inc., with the original brand name Decadron, and the core compound patent expired in 1966. At present, commonly used clinical dosage forms include tablets (0.75mg), injections (1ml:5mg), creams (0.05%), etc. The original research related dosage forms have been included in the FDA Reference Listed Drug Catalog, and domestic dexamethasone related preparations have also been included in the *Collection of Chemical Drug Catalogs*. According to the domestic API registration platform, as of now, dexamethasone APIs from 15 enterprises have been registered with CDE, all with the status of A, which can be used for the marketing authorization and association of preparations in China, and more than 30 dexamethasone related preparation varieties have been approved for marketing in China. (Data as of May 2025, please refer to the official CDE website for the latest information)

In response to the demand for quality research and consistency evaluation of dexamethasone API, CATO can provide a full set of impurity reference standards for this API. Most 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 compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of pharmaceutical enterprises and R&D institutions in various scenarios such as impurity qualitative and quantitative research, stability investigation, etc.