Ketoprofen

As chronic pain is a public health problem affecting more than 1.5 billion people worldwide, non-steroidal anti-inflammatory drugs are the first-line choice for clinical analgesia and anti-inflammation, and ketoprofen is a representative variety among them with both good tolerance and potent effect. As an arylpropionic acid class of non-steroidal anti-inflammatory drug, it reduces prostaglandin synthesis by inhibiting cyclooxygenase activity, and meanwhile can inhibit the lipoxygenase pathway and reduce bradykinin production, thus exerting triple effects of anti-inflammation, analgesia and antipyresis. Clinically, it can be used to improve joint symptoms of rheumatic immune diseases such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, and can also relieve acute mild to moderate pain such as postoperative pain, toothache and dysmenorrhea. The applicable population covers adult patients and adolescents over 12 years old who need analgesia.

The global ketoprofen market size has maintained a steady growth trend in recent years. In 2023, the market size was approximately USD 420 million, with a compound annual growth rate maintained at around 3.1%. As the compound patents have long expired, the global market is dominated by generic drug supplies. Europe, India and China are the three major production regions of ketoprofen API globally, among which the API supplied by Chinese enterprises accounts for more than 40% of the raw material share of the global generic drug market. In terms of the domestic market, ketoprofen oral preparations have been included in the provincial centralized procurement of multiple provinces, with the price of winning products dropping by more than 60%, and the demand of downstream preparation enterprises for cost-effective and compliant APIs continues to rise.

The original research enterprise of ketoprofen is Sanofi, with the original brand name Profène, which was first approved for marketing in France in 1973, and the core compound patents in major global markets all expired before 1986. The main dosage forms approved by the original research include oral tablets, capsules and topical gels. Among them, the specifications of oral dosage forms are mostly 50mg and 100mg, and the topical gels are mainly of 2.5% concentration. The original oral preparations have been included in the FDA Reference Listed Drug Catalogue. In China, currently more than 20 enterprises have obtained CDE registration numbers (status A) for ketoprofen APIs, and a variety of preparations including sustained-release tablets, enteric capsules and gel patches have been approved for marketing, and the relevant reference listed drugs have also been included in the *Catalogue of Reference Listed Drugs for Generic Chemical Drugs*. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the impurity research requirements in the process of ketoprofen generic drug research and development and quality control, CATO provides a full set of impurity reference standards for this API, covering the requirements of the whole research path such as synthetic impurities 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, which can effectively shorten the R&D path and reduce compliance risks.