Daunorubicin

For the clinical treatment of hematological malignancies such as acute myeloid leukemia and lymphocytic leukemia, anthracyclines have always been the core component of combination chemotherapy regimens, and daunorubicin is a classic variety with a long application history and sufficient evidence-based evidence among them. It acts by embedding into the double-stranded DNA of tumor cells and inhibiting the activity of topoisomerase II, thereby blocking nucleic acid synthesis and cell replication. In addition to various types of leukemia in adults and children, it can also be used in the combination treatment of solid tumors such as neuroblastoma and Ewing sarcoma, and is an indispensable basic drug in the field of hematological tumors.

At present, the global market size of daunorubicin API is approximately USD 180 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at around 4.2%. The growth momentum mainly comes from the improvement of the diagnosis and treatment rate of hematological tumors in developing countries and the expansion of drug demand for pediatric tumor indications. Since this drug has been on the market for more than 50 years and its patents have long expired, the current market is dominated by generic drug supplies. China and India are the major API exporters, and the production capacity of domestic pharmaceutical enterprises accounts for more than 60% of the total global supply. After the implementation of centralized procurement, the clinical dosage has further increased, and the demand for upstream APIs and supporting quality control materials continues to expand.

CATO can provide a full set of impurity reference standards for daunorubicin API. All products meet the quality control requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Core categories are kept in stock regularly, which can quickly match the full-process needs of API manufacturers and R&D institutions in impurity qualitative and quantitative research, quality standard establishment and release testing, helping customers reduce R&D and quality control costs and accelerate the compliance process.