Acemetacin

In the treatment of chronic inflammation-related diseases such as rheumatoid arthritis and osteoarthritis, non-steroidal anti-inflammatory drugs (NSAIDs) have always been the first-line medication option. As an indoleacetic acid class of NSAIDs, acemetacin reduces prostaglandin synthesis by inhibiting cyclooxygenase, and exerts combined anti-inflammatory, analgesic and antipyretic effects. Compared with traditional indomethacin, it has a lower incidence of gastrointestinal adverse reactions. Clinically, it is mainly used to improve the symptoms of rheumatic immune diseases such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, and can also be used for the symptomatic treatment of postoperative pain, acute gout attack and soft tissue inflammation. The applicable population covers adult patients with chronic inflammatory diseases and people with acute pain attacks.

At present, the global market size of NSAIDs APIs maintains a steady growth. As a differentiated variety among them, acemetacin had a global market size of approximately USD 120 million in 2023, with a compound annual growth rate of around 3.7%. In terms of the domestic market, with the improvement of the diagnosis rate of rheumatic immune diseases and the accessibility of primary medical medication, the average annual growth rate of the sales volume of acemetacin preparations in the past three years has reached 8.2%, and the demand for APIs has increased simultaneously. In terms of the competitive landscape, the concentration of domestic API manufacturers is relatively high, with the top 3 enterprises accounting for nearly 75% of the domestic market supply share. There is no centralized procurement winning record yet, and the overall market supply pattern is relatively stable.

The original research enterprise of acemetacin is Bayer, with the original research brand name "Rantudil". The core compound patent expired in 2001. The mainstream dosage form of the original research product is sustained-release capsules, with two specifications of 30mg and 90mg. Among them, the 90mg sustained-release capsule has been included in the China Listed Medicines Catalogue, and is recognized as the reference listed drug (RLD). Up to now, 6 domestic enterprises have obtained Grade A status for their acemetacin APIs through CDE registration, and another 3 enterprises are under the review process. In terms of preparations, dosage forms such as acemetacin sustained-release capsules and enteric-coated tablets have been approved for marketing by domestic enterprises, and the supply channels cover hospitals and retail terminals. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for acemetacin API. Most products support spot supply, and spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of pharmaceutical research and development, quality research and production of pharmaceutical enterprises.