Nimesulide

Chronic pain and inflammatory responses are common pathological manifestations that affect the quality of life of billions of people worldwide. As core clinically used drugs for alleviating such symptoms, non-steroidal anti-inflammatory drugs (NSAIDs) have long had the application limitation of gastrointestinal adverse reactions. Nimesulide is a selective cyclooxygenase-2 (COX-2) inhibitor class of NSAIDs. It reduces the synthesis of prostaglandins by preferentially inhibiting the activity of COX-2, which greatly lowers the risk of irritation to the gastrointestinal mucosa while exerting anti-inflammatory, analgesic and antipyretic effects. Clinically, it is mainly used for the symptomatic treatment of pain from chronic arthritis (such as osteoarthritis, etc.), pain after surgery and acute trauma, and primary dysmenorrhea. Its applicable population covers adult patients and children over 1 year old for symptomatic treatment of fever, making it an important clinical option in the field of anti-inflammation and analgesia.

The global market size of nimesulide preparations has exceeded USD 1.2 billion. Driven by factors such as the rising demand for pain management and the improved accessibility of drugs in emerging markets in recent years, its compound annual growth rate has remained at around 3.2%. In terms of the domestic market, nimesulide is a winning variety in centralized drug procurement. There are currently more than 130 approved preparation approval documents, local pharmaceutical companies are the main force in market supply, the localization rate of active pharmaceutical ingredients (APIs) has reached more than 90%, and the price has dropped by more than 60% compared with that before centralized procurement, which significantly reduces the burden of clinical medication. At present, there is no publicly available statistical data on the细分 market size of nimesulide API in China.

The original research enterprise of nimesulide is Helsinn Healthcare SA of Switzerland, and the original research brand name is "普威 (Puwei)". The core compound patent expired globally in 2010. The original research dosage form is mainly tablet with a specification of 0.1g, which has been included in the China Listed Drug Catalogue as a reference listed drug. Up to now, there are 31 pieces of nimesulide API registration information on the API registration platform of China Center for Drug Evaluation (CDE), among which 25 are in the status of "A" (approved for use in marketed preparations). The domestically approved nimesulide preparations cover multiple dosage forms such as tablets, capsules, granules and suppositories, which can meet the medication needs of different clinical scenarios. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for nimesulide API. Most of the products are in regular stock, and spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in the whole process of API R&D, quality research and production.