Hydrocortisone

As a classic glucocorticoid with more than 70 years of clinical application, hydrocortisone is the first-line drug for replacement therapy of adrenocortical hypofunction. Its mechanism of action is completely consistent with that of endogenous cortisol, and it exerts multiple effects of anti-inflammation, anti-shock and anti-allergy by inhibiting the release of inflammatory factors and regulating immune response. In addition to long-term replacement therapy for patients with primary/secondary adrenocortical insufficiency, it is also commonly used in the intervention of emergency conditions such as severe allergic reactions, acute asthma attacks and septic shock, and is a core first-aid and chronic disease management drug included in the World Health Organization Model List of Essential Medicines.

At present, the global market size of hydrocortisone API is approximately USD 230 million, with an average annual growth rate of 4.2% in the past three years. The demand growth mainly comes from the improved diagnostic rate of adrenal diseases and the improved accessibility of drugs for first-aid scenarios in developing countries. The domestic market accounts for 62% of the global production capacity. After the implementation of volume-based procurement, the demand of generic drug preparation enterprises for high-purity APIs that meet the standards of multiple pharmacopeias continues to rise, the market share is further concentrated among leading API suppliers, and the bargaining power of manufacturers with compliant supply capacity has been steadily increasing.

CATO can provide a full set of impurity reference standards for hydrocortisone API. All products meet the quality control requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Core specifications are in sufficient stock, which can directly match the full-process needs of API enterprises in process research and development, quality study and registration declaration, without additional waiting for customized cycles.