Prednisone

In the clinical treatment of autoimmune diseases and inflammatory diseases, glucocorticoids have always been the core category of drugs for anti-inflammation and immunosuppression. As a representative medium-acting glucocorticoid, prednisone binds to intracellular glucocorticoid receptors to inhibit the transcription and release of inflammatory factors, while reducing the activation and proliferation of immune cells, and has multiple pharmacological activities of anti-inflammation, anti-allergy and immunosuppression. Its clinical application covers dozens of diseases such as connective tissue disease, systemic lupus erythematosus, severe bronchial asthma, acute leukemia, and nephrotic syndrome. It is one of the basic drugs for the long-term control of related diseases in adults and children, with stable and rigid clinical demand.

At present, the global market size of prednisone preparations is about 1.8 billion US dollars, with an annual compound growth rate maintained at around 2.3%, of which generic drugs account for more than 92%. In the domestic market, prednisone oral immediate-release dosage forms have been included in the national centralized procurement catalog, with the winning bid price reduced by more than 70%, driving the continuous increase of preparation penetration rate. The corresponding annual demand for API is about 180 tons. Domestic manufacturers are mainly characteristic steroid hormone pharmaceutical enterprises, with the production capacity of leading enterprises accounting for more than 60%. The industrial chain has high maturity and the competition pattern is relatively concentrated.

The original developer of prednisone is Pfizer, and the original brand name is Deltasone. The core compound patent has expired globally in 1983. The main dosage forms approved for the original drug are oral tablets, with specifications including 1mg, 5mg, 10mg, 20mg and 50mg, which have been included in the FDA Reference Listed Drug Catalog. Meanwhile, the domestic Catalog of Reference Preparations for Chemical Drugs also includes its 5mg specification tablet as the reference preparation. According to the domestic API registration platform, 12 enterprises have obtained A-status registration numbers for prednisone APIs, which can be legally supplied to preparation manufacturers. More than 30 domestic enterprises have obtained marketing approval for prednisone oral tablets. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for prednisone. Most of the products are available from stock. In-stock products ordered 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 quality research and impurity control in the R&D and production processes of APIs.