Colchicine

Gout is a common inflammatory arthropathy, and the severe pain during acute attacks seriously affects the quality of life of patients. Colchicine is one of the few alkaloid drugs that exert specific therapeutic effects on acute gout attacks. It binds to tubulin to inhibit microtubule polymerization, blocks the chemotaxis, adhesion and phagocytosis of neutrophils, reduces the release of inflammatory mediators, and rapidly relieves the symptoms of redness, swelling, heat and pain in joints. In addition to being used as the first-line treatment for acute gout attacks in clinical practice, it can also be used for symptom control of autoinflammatory diseases such as familial Mediterranean fever and Behçet's disease, and is an indispensable basic variety in the clinical medication system of the rheumatology and immunology field.

At present, the global colchicine market size is stable at around US$200 million. Driven by the rising prevalence of gout, the compound annual growth rate in the past five years has maintained at 4.2%. In terms of the domestic market, the annual sales at the terminal of public medical institutions have exceeded RMB 300 million, and generic drugs occupy more than 90% of the market share. At this stage, 12 enterprises that produce oral preparations have passed the consistency evaluation. In the local centralized procurement in 2022, the average price reduction of this variety exceeded 60%, and the stability of API supply directly affects the cost control ability of downstream preparation enterprises.

The original developer of colchicine is Takeda Pharmaceutical Company Limited, Japan, with the original brand name Colcrys. The compound patent in the US market expired in 2015, and the core preparation patent in China will expire in 2027. The main dosage form of the original product is oral tablet with a specification of 0.6 mg per tablet, which has been included in the FDA Reference Listed Drug Catalog, while it has not been included in the domestic Reference Listed Drug Catalog for the time being. In terms of domestic API registration, a total of 10 colchicine API registration numbers have been published on the CDE platform so far, among which 8 are in status A and can be supplied for associated review. 17 domestic enterprises have obtained approval for the marketing of colchicine tablets, covering the two specifications of 0.5 mg and 1 mg. (Data as of November 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of colchicine impurity reference standards, supporting the API quality research needs under multiple domestic and foreign regulatory systems. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards comply with the relevant compliance requirements of the Chinese Pharmacopoeia and the FDA, and can assist pharmaceutical enterprises to efficiently complete quality research and registration and declaration work.