Aceclofenac

As an upgraded version of highly selective COX-2 inhibitors in the field of non-steroidal anti-inflammatory drugs (NSAIDs), aceclofenac reduces prostaglandin synthesis by inhibiting the activity of cyclooxygenase, which has both anti-inflammatory and analgesic effects, and the incidence of gastrointestinal adverse reactions is significantly lower than that of traditional NSAIDs. It is clinically mainly used to treat pain and dysfunction caused by chronic inflammatory joint diseases such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, and can also relieve acute pain after surgery and trauma. Its applicable population covers middle-aged and elderly patients with chronic osteoarthropathy and people recovering from surgical operations, and it is a commonly used first-line drug in the pain ladder treatment scheme.

At present, the global market size of aceclofenac is approximately USD 1.28 billion, and the compound annual growth rate in the past three years has remained at 4.2%. The growth momentum mainly comes from the rising prevalence of osteoarthropathy among the middle-aged and elderly and the release of primary-level pain management demands. In terms of the domestic market, aceclofenac has been included in the national Class B medical insurance catalogue. In 2023, the terminal sales in public hospitals exceeded RMB 1.8 billion, of which generic drugs accounted for more than 92%, and the main suppliers of raw materials are pharmaceutical enterprises in China and India. With the advancement of the volume-based procurement policy, the demand of winning bid preparation enterprises for high-quality and compliant active pharmaceutical ingredients continues to rise.

The original research enterprise of aceclofenac is Almirall, a Spanish company, with the original brand name "Apronal", and the core compound patent expired globally in 2009. The main dosage forms of the original research drug include enteric-coated tablets, sustained-release tablets and capsules, with common specifications of 100 mg/tablet and 200 mg/sustained-release tablet, which have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the reference preparation catalogue of the FDA Orange Book. At present, more than 30 domestic enterprises have obtained Class A status for their aceclofenac active pharmaceutical ingredients through CDE registration, and the approved and marketed preparation varieties cover all mainstream dosage forms such as enteric-coated tablets, sustained-release tablets and capsules. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of aceclofenac impurity reference standards, which meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day, which can fully meet the full-process needs of active pharmaceutical ingredient enterprises and preparation manufacturers in impurity research, quality control and registration declaration.