Betamethasone

Glucocorticoid drugs are one of the core categories for clinical anti-inflammatory and immunosuppressive therapy. As a representative of long-acting glucocorticoids, betamethasone binds to glucocorticoid receptors to inhibit the synthesis of inflammatory mediators and downregulate immune response pathways. Its anti-inflammatory activity is about 30 times that of hydrocortisone, and the adverse reaction of water and sodium retention is milder. It is widely used clinically in the treatment of autoimmune and inflammatory diseases such as rheumatoid arthritis, bronchial asthma, allergic dermatitis and lupus erythematosus, and can also be used for the intervention of hematological diseases and organ transplant rejection. It covers multiple indication populations of adults and children, and is a standing drug for primary medical institutions and specialized diagnosis and treatment around the world.

In recent years, the global betamethasone market size has been stable at around USD 500 million, with a compound annual growth rate maintained at approximately 2.8%. The growth momentum mainly comes from the rising prevalence of autoimmune diseases and the improvement of primary healthcare accessibility in emerging markets. At present, generic drugs have dominated the market, accounting for more than 85%. China and India are the main suppliers of betamethasone API in the world, with a combined production capacity accounting for more than 70% of the global total. In terms of the domestic market, betamethasone-related preparations have been included in multiple batches of national centralized procurement, with an average price reduction of over 60% for winning bids, which has driven the continuous expansion of API demand, and the cost advantage of local enterprises has further highlighted their competitiveness in the global supply chain.

The original research enterprise of betamethasone is Merck & Co., Inc., with the original brand name Celestone. The core compound patent expired worldwide in the 1980s. The main currently marketed dosage forms include tablets (0.5mg), injections (1ml:5mg) and creams (0.05%). Its original research preparation has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. According to the domestic API registration platform, 12 enterprises have obtained A-status registration numbers for their betamethasone APIs, which can support the production and declaration of domestic preparations, and more than 30 enterprises have obtained domestic marketing approval for betamethasone oral, injectable and topical preparations. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for betamethasone API, which comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations. Most products are available from stock. Stock orders placed before 16:00 can be shipped on the same day, which can efficiently meet the reference standard needs of each stage of API research and development, quality research, and declaration and registration.