Cyclophosphamide

There has been a long-standing clinical demand for broad-spectrum immunosuppressants in the treatment of malignant tumors and autoimmune diseases. As an alkylating agent immunosuppressant, cyclophosphamide forms cross-links by embedding into DNA double strands, inhibits cell proliferation and activation, and can down-regulate the abnormal immune response of the body. Clinically, it is used not only in the combination chemotherapy of various solid tumors such as malignant lymphoma, multiple myeloma and small cell lung cancer, but also as a second-line drug for the treatment of refractory autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis and nephrotic syndrome, covering a variety of adult and pediatric patient groups, and is one of the basic drugs for clinical immunomodulation and anti-tumor treatment.

The annual sales of cyclophosphamide at the terminals of public medical institutions have remained above 1.5 billion yuan for many years. In recent years, driven by the improvement of the diagnosis and treatment rate of autoimmune diseases and the popularization of anti-tumor combination regimens, the annual compound growth rate has maintained at about 6%. The domestic market is composed of both original research and generic products, and more than 10 enterprises have passed the consistency evaluation of the quality and efficacy of generic drugs. After the implementation of volume-based procurement, the price of preparations has dropped by more than 70%, which directly drives the continuous expansion of the demand for upstream API, and the localization rate of API has exceeded 90%, with only a small amount of API for high-end preparations still dependent on imports.

The original research enterprise of cyclophosphamide is Baxter Oncology GmbH, and the original brand name is "Endoxan". The core compound patent expired worldwide in 1993. At present, the original research dosage forms approved in China include cyclophosphamide for injection, with three specifications of 0.1g, 0.2g and 0.5g, which have been included in the *Reference Preparations Catalogue of Chemical Drugs* issued by the National Medical Products Administration. According to the domestic API registration platform, 8 enterprises have obtained approval for the marketing of cyclophosphamide API with activated A status, and the corresponding approved preparation numbers exceed 70, covering injections and oral dosage forms. (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 cyclophosphamide API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process testing needs in the process of API R&D, quality research and production.