Doxorubicin

In the clinical chemotherapy of malignant tumors, anthracyclines are the cornerstone medication options, and doxorubicin is one of the most widely used varieties among them. It intercalates into the DNA base pairs of tumor cells, inhibits the activity of topoisomerase II, blocks nucleic acid synthesis and cell division, and at the same time can induce the generation of oxygen free radicals to destroy the structure of tumor cells, with broad-spectrum anti-tumor activity. It is clinically used for the treatment of a variety of malignant tumors such as acute leukemia, lymphoma, breast cancer, lung cancer, ovarian cancer, osteosarcoma, etc. It can be used as a single agent, or combined with other chemotherapeutic drugs to form standard chemotherapy regimens, covering both adult and pediatric tumor patient populations.

The global market size of doxorubicin preparations has maintained steady growth in recent years. In 2023, the market size was approximately USD 1.68 billion, with a compound annual growth rate maintained at around 3.7%. As the core patents have long expired, the global market is dominated by generic drug supplies, among which China and India are the major production and export regions of doxorubicin active pharmaceutical ingredients (APIs). In terms of the domestic market, ordinary doxorubicin preparations have been included in the national centralized drug procurement. The winning bid price has dropped by more than 80% compared with that before the centralized procurement, and clinical accessibility has been greatly improved. Special dosage forms such as liposomes still maintain a relatively high market growth rate, driving the stable rise in demand for upstream APIs.

The original developer of doxorubicin is Pfizer, with the original brand name Adriamycin. The core compound patent expired globally in 1988. The main dosage form of the original marketed product is powder for injection, with specifications of 10 mg and 50 mg, which has been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, at present, doxorubicin APIs from more than 20 enterprises have obtained A status through registration with the Center for Drug Evaluation (CDE), which can meet the domestic preparation production demand; at the preparation level, dozens of domestic approval numbers for ordinary doxorubicin for injection have been marketed, and the original product has not been marketed in China. (Data as of May 2025, please refer to the official website of CDE for the latest information)

A variety of specific impurities will be generated during the synthesis process of doxorubicin and the production process of its preparations, which directly affect the drug quality and medication safety. CATO can provide a full set of impurity reference standards for this API, with most products in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises and preparation manufacturers for quality research, registration and declaration, as well as daily inspection.