Celecoxib

As the world's first selective COX-2 inhibitor, celecoxib breaks through the limitation of gastrointestinal adverse reactions of traditional non-steroidal anti-inflammatory drugs. By specifically blocking the prostaglandin synthesis mediated by cyclooxygenase-2, it exerts potent anti-inflammatory, analgesic and antipyretic effects while greatly reducing the risks of gastrointestinal ulcer, bleeding and other conditions. Clinically, it is mainly used to relieve the symptoms and signs of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, and can also be used for the treatment of acute pain in adults, covering the two types of needs of long-term chronic disease management and acute symptom control, and the applicable population includes middle-aged and elderly patients with degenerative joint disease, patients with autoimmune diseases, and people with post-surgical and post-traumatic pain.

The global celecoxib market size has long maintained above USD 1.5 billion. With the逐年 rise in the prevalence of osteoarthritis, the market growth rate reached 4.2% in 2023. In terms of the domestic market, the sales of celecoxib at public medical institution terminals exceeded RMB 2.2 billion in 2024, with a compound annual growth rate of 11.7% in the past 3 years. In terms of the competitive landscape, the original research product still accounts for about 42% of the market share, and more than 30 domestic generic preparations have been approved. After the volume-based procurement, the terminal price has dropped by more than 80%, driving the continuous rise in the demand for APIs. At present, there are 13 domestic celecoxib API enterprises that have been registered, with sufficient supply but continuously improving requirements for impurity compliance.

The original research enterprise of celecoxib is Pfizer, with the trade name "Celebrex". Its core compound patent in the United States expired in 2013, and the compound patent in China expired in 2014. The main dosage form approved by the original research is capsules, with specifications of 0.1g and 0.2g, which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also reference preparations listed by the FDA. At present in China, 13 enterprises have obtained CDE registration numbers (status A) for celecoxib APIs, and more than 30 enterprises have obtained approval for the marketing of celecoxib capsules, among which 28 have passed the quality and efficacy consistency evaluation of generic drugs. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full range of celecoxib impurity reference standards, covering dozens of细分 types such as synthesis process impurities and degradation impurities. Most products are in sufficient stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of different scenarios such as API R&D, quality research and consistency evaluation.