Mefenamic Acid

As a common health problem affecting more than 20% of the global population, chronic pain is clinically managed with non-steroidal anti-inflammatory drugs (NSAIDs) as one of the core options for analgesic regimens. Mefenamic acid is an anthranilic acid-class non-steroidal anti-inflammatory drug, which reduces the synthesis of prostaglandins by inhibiting the activity of cyclooxygenase, and has analgesic, anti-inflammatory and antipyretic effects. It is mainly used clinically for the relief of mild to moderate pain, including post-dental surgery pain, dysmenorrhea, headache, as well as joint swelling and pain caused by rheumatoid arthritis and osteoarthritis. Its applicable population covers adult patients, and it can also be used for pain scenarios in specific children under the evaluation of a physician. Its gastrointestinal tolerance is better than that of some traditional non-steroidal anti-inflammatory drugs, and it is suitable for outpatients who need short-term analgesia.

The global mefenamic acid market size was approximately USD 320 million in 2023, and it is expected to maintain a steady growth at a compound annual growth rate of 2.1% from 2024 to 2030. The growth drivers mainly come from the expansion of analgesic demand in primary care and the improvement of generic drug accessibility. At present, the market is dominated by generic drug supply, and India and China are the world's major producers and exporters of API, collectively supplying more than 70% of the global mefenamic acid raw materials. In terms of the domestic market, this variety has been included in the National Essential Medicines List, the price of preparations has dropped by more than 60% after volume-based procurement, and the demand for upstream API has continued to increase with the implementation of volume-based procurement.

The original developer of mefenamic acid is Pfizer Inc. of the United States, with the original brand name Ponstel, and the core compound patent expired globally in 1987. The main dosage forms approved for the original product are tablets, with specifications including 250mg and 500mg. Among them, the 250mg tablet has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (29th Batch)* of China. In terms of domestic API registration, at present, 10 enterprises have obtained A status for their mefenamic acid API through CDE registration, which can be legally supplied to preparation manufacturers. Domestic mefenamic acid tablets and capsules have been approved for marketing with multiple approval numbers, and complete import substitution has been achieved. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of mefenamic acid impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day, which can meet the needs of impurity qualitative and quantitative analysis and quality research in R&D and production links. The products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference material support for the API and preparation declaration and quality control of relevant enterprises.