Indometacin

As a classic variety of non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin reduces prostaglandin synthesis by inhibiting cyclooxygenase (COX), and has potent anti-inflammatory, antipyretic and analgesic effects. It is clinically commonly used to relieve the swelling and pain symptoms of chronic inflammatory arthropathies such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, etc. It can also be used for the symptomatic treatment of acute gout attacks, postoperative pain, and migraine. The applicable population covers adult patients with chronic pain and inflammatory diseases. Due to its strong antipyretic effect, it is only used for symptomatic treatment of high fever in pediatrics under the advice of a physician.

In recent years, the global indomethacin market size has been stable at around USD 320 million, with a compound annual growth rate of approximately 2.1%. The growth momentum mainly comes from the continuous release of demand for drugs for chronic arthropathies in the primary medical market. As a core producer of indomethacin API, China has an annual output of more than 2,000 tons, supplying more than 70% of the global market share; the preparation segment has been included in the National Essential Medicine List and the Class A Medical Insurance List. After centralized procurement, the price of oral dosage forms has dropped to about RMB 0.05 per tablet, and the annual usage in public medical institutions exceeds 1 billion tablets. The market pattern is dominated by generic drugs with sufficient competition.

The original research enterprise of indomethacin is Merck Sharp & Dohme, with the original brand name Indocin, and the core compound patent expired globally in 1971. The current mainstream clinical dosage forms include 25mg oral conventional-release tablets, 50mg sustained-release capsules, 1% external suppositories and creams. Among them, the original 25mg tablets have been included in the FDA Reference Listed Drug Catalog, and the original preparation is not imported into China. The reference listed drug for domestic preparations is the selected generic drug of domestic enterprises. According to the domestic API registration platform, at present, 32 enterprises have obtained approval for registration of indomethacin API, all of which are in status A and can be legally supplied for preparation production. There are more than 600 approvals for domestic oral and external preparations in total. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of indomethacin impurity reference standards, covering dozens of types such as synthesis process impurities, degradation impurities, etc. Most products are in stock. Stock orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet various needs of API R&D, quality research and routine release testing.