Parecoxib

Postoperative pain is one of the core clinical issues affecting the quality of patients' postoperative rehabilitation. Non-steroidal anti-inflammatory drugs, as the core medications for multimodal analgesia, can effectively reduce the dosage of opioids and related adverse reactions. Parecoxib is the world's first injectable selective cyclooxygenase-2 (COX-2) inhibitor. After entering the body, it is rapidly converted into the active metabolite valdecoxib. By selectively inhibiting the COX-2 pathway to reduce the synthesis of prostaglandins, it exerts anti-inflammatory and analgesic effects with little impact on gastrointestinal tract and platelet function. Clinically, it is mainly used for the short-term treatment of moderate to severe acute postoperative pain, covering adult patients in multiple surgical departments such as general surgery, orthopedics, gynecology and stomatology. It can also be combined with opioids for synergistic analgesia of severe pain.

In recent years, the global market size of parecoxib has been stable at around USD 2 billion, and the sales volume at the terminals of Chinese public medical institutions has exceeded RMB 3 billion, with a compound annual growth rate remaining above 6%. The domestic competitive landscape is dominated by generic enterprises. At present, more than 30 enterprises have obtained approval for the marketing of parecoxib sodium for injection. After being included in the fifth batch of national centralized procurement in 2021, its price has dropped by more than 90%, and its clinical accessibility has been greatly improved, driving the continuous rise in the demand for API. At present, nearly 20 domestic enterprises have obtained CDE approval for their parecoxib APIs.

The original research enterprise of parecoxib is Pfizer, and the original brand name is "Dynastat". The core compound patent of the original product expired in 2022 in the United States, and expired in 2021 in China. The original dosage form is injection with a specification of 40mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also included in the FDA Reference Preparation Catalogue. Up to now, there are 19 A-status registration numbers for parecoxib APIs in China, and all the domestically approved preparation products are parecoxib sodium for injection. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

In response to the needs of parecoxib quality research and generic drug declaration, CATO can provide a full set of impurity reference standards for this API. Most of the products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can meet the full-process R&D needs such as impurity qualitative and quantitative research, stability investigation and quality standard establishment.