Etofenamate

Chronic pain of the musculoskeletal system is a highly prevalent clinical disease, and non-steroidal anti-inflammatory drugs (NSAIDs) are the core treatment category in this field. As a representative variety of topical NSAIDs, etofenamate reduces the synthesis of prostaglandins by inhibiting cyclooxygenase, and has dual effects of anti-inflammation and analgesia. In addition, the topical dosage form can directly act on the lesion site, reducing the risk of systemic adverse reactions. It is clinically mainly used to treat local pain and swelling caused by osteoarthritis, rheumatoid arthritis, acute and chronic soft tissue injury, scapulohumeral periarthritis, etc., and is suitable for adult patients who need long-term control of local inflammatory response and have poor tolerance to oral NSAIDs.

The global market size of topical anti-inflammatory and analgesic drugs has continued to expand in recent years, exceeding USD 12 billion in 2023. With higher local bioavailability, etofenamate accounts for about 8% of the topical NSAID market share in the European Union, Southeast Asia and other markets. In the domestic market, the existing preparation approvals are mainly generic drugs. Driven by factors such as the expansion of medical insurance coverage for topical analgesic drugs and the rising incidence of sports injuries among residents, the compound annual growth rate of the domestic etofenamate preparation market from 2020 to 2023 reached 11.2%. At present, the supply of API is still dominated by imports, and the registration progress of local enterprises is relatively lagging behind.

The original research enterprise of etofenamate is Bayer, and the original research trade name is "Rheumon". Its core compound patent expired in 2000, the main dosage form is cream, with the specification of 20g:1g. The original research cream has been included in the China Listed Drug Catalogue as a reference preparation. In terms of domestic API registration, as of now, there is no approved A-status registration number, and 6 etofenamate creams produced by domestic enterprises have been approved for marketing. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for etofenamate API, covering impurities in the whole process of the synthetic route and degradation impurities, all of which meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard supply needs of pharmaceutical enterprises in API R&D, quality research and production links.