Pelubiprofen

Osteoarthritis is a chronic degenerative disease with a high incidence among the middle-aged and elderly population, and non-steroidal anti-inflammatory drugs commonly used in clinical treatment have long had the pain point of high risk of gastrointestinal adverse reactions. Pirprofen belongs to propionic acid class selective cyclooxygenase-2 inhibitors, which exerts anti-inflammatory and analgesic effects by targeted inhibition of prostaglandin synthesis, with significantly lower gastrointestinal irritation than traditional non-steroidal anti-inflammatory drugs. It is suitable not only for long-term symptom control of chronic inflammatory arthropathies such as osteoarthritis and rheumatoid arthritis, but also for short-term analgesia of postoperative pain and acute gout attack, providing a safer medication option for patients intolerant to traditional NSAIDs.

The global patient base of osteoarthritis exceeds 500 million, driving the continuous and stable growth of market demand for pirprofen. In 2023, the global market size of pirprofen related preparations was approximately USD 1.27 billion, with a compound annual growth rate maintained at 4.2%. In the current market pattern, the original research products account for more than 60% of the share in major mature markets such as Japan and Europe, while the domestic market is still in the generic drug layout stage. Three enterprises have submitted generic drug marketing applications, there is no relevant centralized procurement implementation policy yet, and there is still a large market gap in the API supply side.

The original research enterprise of pirprofen is Kaken Pharmaceutical Co., Ltd. of Japan, with the original brand name of Pirprofen, and the core compound patent expired worldwide in 1999. At present, the original research formulations approved for marketing are mainly tablets, with conventional specifications including 100mg and 200mg, which have been included in the PMDA reference preparation catalog of Japan, but have not been included in the *Catalogue of Chemical Pharmaceuticals* of China. There is no pirprofen preparation variety approved for marketing in China. No valid A status registration number has been found on the CDE API registration platform for the time being, and only 2 enterprises have submitted API DMF filing applications, which are currently in the review stage. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for pirprofen, most of which support spot supply. Spot products ordered before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the impurity reference needs in the process of generic drug research and development, quality research and production.