Sulindac

Chronic inflammation and pain are long-standing clinical burdens in the fields of rheumatology and immunology, and orthopedics. As first-line medications, non-steroidal anti-inflammatory drugs (NSAIDs) have always faced the trade-off issue of gastrointestinal adverse reactions. Sulindac is a prodrug-type NSAID that has no pharmacological activity itself. After entering the body, it is metabolized and converted into sulfide in the liver, then exerts the effects of inhibiting cyclooxygenase and reducing prostaglandin synthesis. Compared with traditional non-selective NSAIDs, it can significantly reduce the risk of gastrointestinal irritation. Clinically, it is mainly used to improve joint symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, and can also relieve various mild to moderate pain such as acute gout, scapulohumeral periarthritis and low back pain. The applicable population covers adult patients with chronic joint diseases and people with acute pain attacks, especially suitable for patients who require long-term anti-inflammatory treatment and have poor gastrointestinal tolerance.

The global sulindac market size has maintained steady growth in recent years, with the overall market size reaching approximately USD 120 million in 2023, of which generic drugs account for more than 92%. In terms of the domestic market, the sales of sulindac at public medical institution terminals increased by 7.3% year-on-year in the first half of 2024. After the centralized procurement, the price dropped by 68%, and clinical accessibility has been greatly improved. At present, domestic generic drug enterprises are the main body of market supply, and the supply of API is mainly from domestic manufacturers. The overall competitive landscape is stable, and there are no new entrants to break the existing supply structure.

The original developer of sulindac is Merck, with the original brand name Clinoril®. Its core compound patent in the United States expired in 1994. The main dosage forms approved for the original product are tablets, with specifications including 100mg and 200mg. The 200mg tablet has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs*. There is no imported original formulation marketed in China. As of October 2025, there are a total of 7 sulindac API registration records on the CDE API registration platform, of which 5 are in the "A" status and can be used for associated review. At the formulation level, 9 generic varieties of sulindac tablets have been approved for marketing, of which 7 have passed the consistency evaluation. (Data as of October 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for sulindac API, which meet the qualitative and quantitative requirements of different R&D stages. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable and reliable reference standard support for API and formulation enterprises in quality research, consistency evaluation and registration declaration.