Fenbufen

Among the clinical medications used in the fields of rheumatology, immunology and pain management, non-steroidal anti-inflammatory drugs (NSAIDs) have always been one of the core categories for controlling inflammatory responses and relieving mild to moderate pain. As a representative variety of long-acting arylpropionic acid NSAIDs, fenbufen reduces prostaglandin synthesis by reversibly inhibiting the activity of cyclooxygenase (COX), and has the triple effects of anti-inflammation, analgesia and antipyresis. It is clinically mainly used for symptom control of rheumatoid arthritis, rheumatic arthritis, osteoarthritis and ankylosing spondylitis, and can also be used for the relief of acute pain such as toothache, post-surgical pain and traumatic pain. Its applicable population covers adult patients with chronic bone diseases and patients requiring short-term analgesia after surgery or trauma. Due to its long duration of action and relatively mild gastrointestinal adverse reactions, it is widely used in primary medical scenarios.

The domestic market size of fenbufen preparations has been maintained in the range of 300 to 400 million yuan for years. Driven by the increasing penetration rate of diagnosis and treatment of primary rheumatic bone diseases in recent years, its annual compound growth rate has remained at around 4%. The competitive landscape is dominated by generic drugs. Currently, there are 127 approved marketing authorizations for fenbufen preparations and 19 marketing authorizations for fenbufen API in China. The manufacturers are concentrated in East China and North China, the overall market concentration is relatively low, and no leading enterprise with absolute advantages has emerged. Affected by the centralized drug procurement policy, fenbufen tablets and capsules have been included in the provincial centralized procurement scope by multiple provinces, with an average price reduction of 58% for winning bids. The stable supply of upstream API has become the core demand of generic drug manufacturers to maintain cost advantages.

The original research enterprise of fenbufen is Pfizer, with the original brand name Lederfen, and the core compound patent expired globally in 1986. The main dosage forms approved for the original drug include tablets (150mg, 300mg) and capsules (300mg). The original reference listed drug has been included in the FDA Orange Book, and the original drug is not imported into China. At present, the same variety marketed in the European Union can be selected as the domestic reference listed drug. According to the domestic API registration platform, there are currently 19 fenbufen API registration numbers, of which 11 are in A status and can be used for associated review. The domestically approved fenbufen preparations cover three dosage forms: tablets, capsules and suppositories, all of which are domestic generic drugs. (Data as of April 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for fenbufen API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in API production, quality research and associated review.