Hydrocortisone

As a commonly used glucocorticoid drug in clinical practice, hydrocortisone inhibits the aggregation of inflammatory cells and reduces the release of inflammatory mediators, while exerting immunosuppressive, anti-toxin and anti-shock effects. It is the first-choice replacement therapy for adrenocortical insufficiency, and is also widely used in the treatment of allergic diseases, inflammatory diseases, severe infections and shock, covering patients of all ages in multiple departments such as endocrinology, dermatology, emergency department, rheumatology and immunology department.

At present, the global hydrocortisone market size is stably around 1.2 billion US dollars, with an annual compound growth rate of approximately 3.2%. The growth is mainly driven by the long-term medication demand of patients with chronic adrenocortical insufficiency and the market expansion of topical preparations in the fields of dermatology and respiratory department. In the domestic market, local enterprises occupy an absolute dominant position, the overall supply is sufficient, and the price of APIs has remained stable for a long time. In 2023, the total domestic output of hydrocortisone APIs exceeded 500 tons. In addition to meeting the demand of domestic preparation production, about 30% is exported to supply the global market.

The original research enterprise of hydrocortisone is Pfizer, and the original trade name is Cortef. The compound patent in the US market expired in 1996. The main dosage forms of the original marketed products include tablets (5mg, 10mg, 20mg), injections (50mg/2ml, 100mg/5ml) and topical creams (1%, 2.5%). Among them, the 5mg and 20mg tablets and the 100mg injection have been included in the FDA Reference Listed Drug Catalog, and the imported products of the above dosage forms of Pfizer have also been included in the *Catalog of Reference Listed Drugs for Chemical Drugs* in China. Up to now, more than 30 domestic enterprises have completed the registration of hydrocortisone APIs in CDE and obtained Grade A status. The domestically approved hydrocortisone preparations cover multiple dosage forms such as tablets, injections, creams and eye ointments. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for quality research and impurity control of this API, CATO provides a full set of hydrocortisone impurity reference standards. Relevant products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day, which can efficiently respond to the relevant needs of pharmaceutical enterprises in impurity research, quality standard formulation and generic drug consistency evaluation.