Flufenamic acid

In the clinical medication for chronic non-specific pain and inflammatory diseases, non-steroidal anti-inflammatory drugs have always been the basic treatment option. As a representative variety of anthranilic acid NSAIDs, flufenamic acid reduces the synthesis of prostaglandins by inhibiting the activity of cyclooxygenase, and has the triple effects of anti-inflammation, analgesia and antipyresis. In clinical practice, it is mainly used to relieve joint swelling and pain in rheumatoid arthritis and rheumatoid arthritis, can also be used for symptomatic treatment of mild to moderate pain such as dysmenorrhea, toothache and postoperative pain, and can also assist in improving fever symptoms caused by inflammation. The applicable population covers adult patients under chronic disease management and people with acute pain attacks. On the premise that the risk of gastrointestinal adverse reactions is controllable, it is a commonly used anti-inflammatory and analgesic option in primary medical scenarios.

The global market size of flufenamic acid related preparations is about USD 210 million. Driven by the rising prevalence of senile osteoarthropathy and the expansion of primary medical care in developing countries, the compound annual growth rate remains at 3.2%. At present, generic drugs account for more than 90% of the market share. China and India are the core suppliers of flufenamic acid API in the world. The domestic preparation market has completed domestic substitution, the overall price level has dropped by 68% compared with the initial stage of the original drug's launch, and the primary accessibility has been significantly improved.

The original research enterprise of flufenamic acid is Pfizer, and the original brand name is Ponstel. The core compound patent in the United States expired in 1985, and the compound patent in China has expired due to its early launch time. The main dosage form approved for the original drug is oral capsule with a specification of 250mg, which has been included in the FDA Orange Book Reference Listed Drug Catalog. The original drug has not been listed as a reference preparation in China for the time being. At present, 3 valid A-status registration numbers have been publicized on the domestic API registration platform, and more than 10 domestic enterprises have obtained approval for the marketing of flufenamic acid capsules and tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the demand for quality research and compliance declaration of flufenamic acid, CATO provides a full set of impurity reference standards for this API. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. Meanwhile, all reference standards meet the requirements of multiple regulatory systems including Chinese Pharmacopoeia and FDA, and can directly support the whole process of API and preparation quality research, stability study, registration declaration, etc., helping customers shorten the R&D cycle and reduce compliance risks.