Naproxen

For long-term analgesic and anti-inflammatory treatment of chronic inflammatory diseases such as rheumatoid arthritis and osteoarthritis, there is always a clinical demand for non-steroidal anti-inflammatory drugs with good tolerance and controllable side effects. Naproxen is an arylpropionic acid NSAID, which exerts anti-inflammatory, analgesic and antipyretic effects by inhibiting cyclooxygenase to reduce the synthesis of prostaglandins. Compared with similar drugs, it has a lower incidence of gastrointestinal adverse reactions and a longer duration of action. It is suitable for a variety of pain and inflammation scenarios in adults and adolescents, such as rheumatoid arthritis, ankylosing spondylitis, gout and dysmenorrhea, and is a common choice for long-term management of clinical chronic pain.

The global naproxen market size has maintained a steady growth trend in recent years. The market size was approximately USD 1.28 billion in 2023, and is expected to increase to USD 1.63 billion by 2028, with a compound annual growth rate of approximately 4.9%. The domestic market is currently dominated by generic drugs, and the preparation segment has been included in the third batch of national centralized procurement. The price of winning bids has dropped by more than 70%, and the accessibility at the primary level has been greatly improved, driving the continuous rise in demand for upstream API. At present, there are fewer than 10 domestic naproxen API manufacturers, and the production capacity of leading enterprises accounts for more than 60%. The market concentration is relatively high, and the supply-side pattern is relatively stable.

The original developer of naproxen is Roche, and the original brand name is Naprosyn. The core compound patent in the United States expired in 1993, and all relevant patents in China have also expired. The main dosage forms approved for the original product include tablets, sustained-release tablets and suspensions, with common specifications of 250mg, 375mg and 500mg. The original product has been included in the FDA Reference Listed Drug Directory and the Chinese Catalogue of Reference Preparations for Chemical Drugs. According to the domestic API registration platform, there are currently 12 naproxen API registration numbers, 8 of which are in A status and can be legally supplied for preparation production. More than 50 naproxen preparation varieties have been approved for marketing in China, covering various dosage forms such as conventional tablets, sustained-release capsules and suppositories. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of naproxen impurity reference standards, most of which are in stock. Orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of API R&D, quality research and production.