Methylprednisolone

In the clinical treatment of autoimmune diseases and inflammatory responses, glucocorticoids have always been the core medications for anti-inflammation and immunosuppression. As a medium-acting synthetic glucocorticoid, methylprednisolone binds to glucocorticoid receptors to inhibit the release of inflammatory mediators and downregulate immune response pathways. Its anti-inflammatory activity is 5 times that of hydrocortisone, and it has milder side effects of water and sodium retention. It is widely used in clinical scenarios such as rheumatoid arthritis, systemic lupus erythematosus, acute asthma attack, anti-rejection reaction in organ transplantation, and adjuvant treatment of severe infections, covering both adult and pediatric patients, and is an essential drug in multiple departments including emergency, rheumatology and immunology, and respiratory medicine worldwide.

The global methylprednisolone market size was approximately USD 1.98 billion in 2023, and is expected to expand steadily at a compound annual growth rate of 3.2% from 2024 to 2030. The growth momentum mainly comes from the rising prevalence of autoimmune diseases and the increase in the number of transplantation surgeries. The domestic market size exceeds RMB 2.2 billion, of which generic drugs account for more than 85%. At present, methylprednisolone generic preparations from more than 30 enterprises have been approved for marketing. Methylprednisolone sodium succinate for injection has been included in multiple batches of national centralized drug procurement, and the winning bid price has dropped by more than 70% compared with the original research drug, greatly improving clinical accessibility.

The original research enterprise of methylprednisolone is Pfizer Inc., and the original research trade names are "Medrol" (oral tablet) and "Solu-Medrol" (injection). Its core compound patent expired globally in 1997, and the preparation patent in the US market also expired in 2008. The domestically approved original research dosage forms include 4mg and 16mg oral tablets, as well as 40mg and 500mg methylprednisolone sodium succinate for injection. Both dosage forms have been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the China NMPA. Up to now, methylprednisolone active pharmaceutical ingredients (APIs) from more than 20 domestic enterprises have obtained A status through CDE registration, which can be associated with preparation declarations. The domestically approved methylprednisolone preparation varieties cover two major categories: oral common-release dosage forms and injections. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for methylprednisolone APIs. The products meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most impurities are available from stock. For in-stock orders, payment before 16:00 can be shipped on the same day, fully meeting the reference standard requirements in the processes of API R&D, quality research and consistency evaluation.