Niflumic acid

Non-steroidal anti-inflammatory drugs in the field of rheumatism, immunology and pain have always been the core choice for clinical symptomatic treatment. As a non-steroidal anti-inflammatory drug of the anthranilic acid class, niflumic acid reduces the synthesis of prostaglandins by inhibiting the activity of cyclooxygenase, and has the triple effects of anti-inflammation, analgesia and antipyresis. Compared with some traditional NSAIDs, it has relatively mild gastrointestinal adverse reactions, and is clinically commonly used in the treatment of rheumatoid arthritis, osteoarthritis, acute gout attack, postoperative pain, soft tissue injury and other conditions. The applicable population covers adult patients with chronic arthropathy, postoperative population requiring symptomatic intervention for acute pain, etc., and it can also be used as an alternative for patients who cannot tolerate the gastrointestinal irritation of other NSAIDs.

The global market size of niflumic acid is approximately USD 230 million. Driven by the rising prevalence of chronic osteoarthropathy and the growing demand for analgesia in emerging markets, the compound annual growth rate in the past three years has maintained at 4.1%. Generic drugs dominate the market supply side, and Europe, India and China are the core production regions of API. At present, this variety has not been included in the national centralized procurement scope in China, and the stable release of downstream preparation demand drives the upstream API supply side to maintain a steady and rising competitive trend.

The original research enterprise of niflumic acid is Pfizer, with the original research trade name Niflam. The core compound patent expired globally in 1983. The main marketed dosage forms include 250mg tablets, 250mg capsules and 3% topical gel. The original research tablets have been included in the FDA Reference Listed Drug Catalog. Up to now, there are no approved niflumic acid preparation products marketed in China, and there is no registered niflumic acid API in A status available for use on the CDE API registration platform. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full series of niflumic acid impurity reference standards, supporting the full process requirements from R&D to quality research. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, which can help customers greatly shorten the impurity research cycle and effectively reduce R&D compliance risks.