Fluorouracil

As a classic antimetabolite antineoplastic drug, fluorouracil inhibits thymidylate synthetase, blocks the conversion of deoxyuridine monophosphate to deoxythymidine monophosphate, and then interferes with the DNA synthesis of tumor cells. Meanwhile, it can be incorporated into RNA to inhibit its function, and ultimately arrests the proliferation of tumor cells. It is commonly used in clinical practice for the treatment of various malignant tumors such as digestive tract tumors (gastric cancer, colorectal cancer, liver cancer), breast cancer, ovarian cancer, lung cancer, etc. It is a basic medication in chemotherapy regimens for solid tumors, covering the whole disease course population from postoperative adjuvant therapy to advanced palliative therapy. It has a clinical application history of more than 60 years, and is still a first-line medication component recommended by many guidelines up to now.

At present, the global market size of fluorouracil drugs exceeds 12 billion US dollars, among which the market size of API is about 480 million US dollars, with a compound annual growth rate of around 3.2% in the recent five years. Due to its early launch and long-expired patents, the global fluorouracil API market is mainly supplied by generic pharmaceutical enterprises, with China as the core production area, accounting for more than 65% of the global total production capacity. There are more than 20 domestic manufacturers, with sufficient market competition and long-term stable price. It is a highly accessible basic antineoplastic drug covered by medical insurance, and there is no obvious supply shortage or price fluctuation.

The original research enterprise of fluorouracil is Roche, with the original brand name 5-FU, and the core compound patent expired in the 1960s. At present, the mainstream dosage forms include injection (10ml:0.25g), tablet (50mg) and cream (0.5%/2.5%). Relevant dosage forms of the original drug and multiple generic manufacturers have been included in the China Listed Medicines Catalogue as reference preparations, and also included in the FDA Reference Preparations List. Up to now, there are 32 registration records of fluorouracil API on the API registration platform of China CDE, among which 24 have been activated with A status and can be associated with preparation declaration. More than 50 fluorouracil-related preparation varieties have been approved for marketing in China, covering all mainstream 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 fluorouracil API, covering all categories required for research such as synthesis process impurities and degradation impurities. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different scenarios such as API quality research, preparation stability investigation, and registration declaration.