Felbinac

Non-steroidal anti-inflammatory drugs are core medications clinically used to relieve pain and inflammation in diseases such as osteoarthritis and acute soft tissue injury. As a representative topical active ingredient among them, felbinac reduces prostaglandin synthesis by inhibiting the cyclooxygenase (COX) pathway, and has the advantages of strong anti-inflammatory and analgesic effects, high transdermal absorption efficiency, and low systemic adverse reactions. Its topical preparations can directly target the lesion site, and are suitable for relieving joint swelling and pain in patients with various types of osteoarthritis, as well as for symptomatic treatment of patients with acute or chronic soft tissue injuries such as sports strains, sprains, frozen shoulder, and tenosynovitis. They can effectively avoid the risk of gastrointestinal irritation common with oral non-steroidal anti-inflammatory drugs, and are a common choice for clinical topical analgesia.

At present, the global market size of felbinac-related preparations is growing steadily. In 2023, the overall size exceeded USD 420 million, with a compound annual growth rate maintained at around 4.6%. The growth rate of the Chinese market is higher than the global average, with a compound annual growth rate of 7.2% in the past three years, and the domestic preparation market size exceeded RMB 800 million in 2023. The competitive landscape is dominated by generic drugs, with the market share of original research products being less than 15%. Domestic API manufacturers are concentrated in Jiangsu, Zhejiang, Shandong and other regions, and more than 10 enterprises have obtained CDE registration for felbinac APIs. Against the background of centralized procurement, the demand of downstream preparation enterprises for cost-effective and compliant APIs continues to rise.

The original research enterprise of felbinac is Hisamitsu Pharmaceutical Co., Ltd. of Japan, with the original brand name "Napageln". The core compound patent expired globally in 1999. The main dosage form promoted by the original research is gel plaster, with the common specification of 100 mg felbinac per plaster. This original research product has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. As of the date of retrieval, there are 23 felbinac API registration entries in China, of which 15 are in status A (approved for use in marketed preparations). A number of domestic enterprises have obtained marketing approval for felbinac gels and plasters. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the impurity research needs of felbinac throughout the whole process from R&D to mass production, CATO provides a full set of impurity reference standards for this API, covering all categories such as synthetic starting materials, intermediates, and degradation impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of various scenarios of pharmaceutical enterprises in registration and declaration, as well as quality research.