Tolmetin

In response to clinical pain points such as joint swelling and pain, and limited mobility caused by chronic inflammation, tolmetin, as a representative variety of non-steroidal anti-inflammatory drugs, reduces prostaglandin synthesis through reversible inhibition of cyclooxygenase activity, and has anti-inflammatory, analgesic and antipyretic effects. It is commonly used clinically for long-term symptom control of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis, and can also be used for short-term relief of trauma, postoperative pain and dysmenorrhea. The applicable population covers adult patients with chronic bone diseases and groups with acute pain attacks. Compared with traditional non-steroidal anti-inflammatory drugs, it has a lower risk of gastrointestinal adverse reactions and better tolerance.

At present, the global market size of tolmetin-related preparations is approximately USD 230 million. Driven by the increasing prevalence of chronic bone diseases year by year, the compound growth rate in the past 3 years has maintained at 4.2%. The domestic market is currently dominated by generic drug supply, and the original research products have basically withdrawn from the circulation market. As of 2024, there are 7 tolmetin preparation approvals in China, and only 3 API registration enterprises, resulting in a tight supply and demand pattern. With the release of demand for chronic bone disease drugs in primary medical institutions, the market gap of tolmetin API is expected to further expand in the future.

The original research enterprise of tolmetin is Johnson & Johnson, with the original trade name Tolectin. The US compound patent expired in 1986, and the core dosage form patents fully expired in 1993. The main dosage forms approved by the original research are tablets and capsules, with specifications covering 200mg and 400mg, which have been included in the FDA Reference Listed Drug Catalog. At present, there is no import approval record of original research preparations in China. At the API level, the CDE registration numbers of 2 enterprises are in active status, and another 6 domestic tolmetin sodium capsule and tablet varieties have been approved for marketing, which can meet the reference requirements for consistency evaluation. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for tolmetin API, which can meet the impurity research needs of different process routes. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All impurities meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for enterprises' API registration and preparation consistency evaluation work.