氟比洛芬

As a classic product in the field of non-steroidal anti-inflammatory drugs, flurbiprofen reduces prostaglandin synthesis by inhibiting the activity of cyclooxygenase, and has potent analgesic, anti-inflammatory and antipyretic effects. Its analgesic effect is superior to that of traditional NSAIDs such as aspirin, and it has a lower incidence of gastrointestinal adverse reactions. It is mostly used clinically for symptom control of chronic joint diseases such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, and can also relieve moderate to severe pain caused by postoperative pain, toothache and acute gout. It covers the medication population in multiple departments such as adult rheumatology and immunology, orthopedics and surgery, and is a common choice for perioperative analgesia and long-term management of chronic osteoarthropathy.

At present, the global flurbiprofen market size is about USD 1.2 billion, with a compound annual growth rate of 4.2% in the past 3 years, among which the Asia-Pacific region is the fastest growing region with an annual growth rate of 6.8%. Affected by the increase in orthopedic visits and the structural adjustment of analgesic drugs in the domestic market, the annual growth rate of terminal sales in public medical institutions has exceeded 7% in the past 2 years. There are more than 90 existing preparation approvals, among which dosage forms such as patches and injections are in relatively sufficient competition and have been included in multiple batches of national centralized procurement, with an average reduction of more than 60% in the winning bid price. The demand of downstream preparation enterprises for high-cost-effective and compliant API continues to rise.

The original research enterprise of flurbiprofen is Kaken Pharmaceutical Co., Ltd. of Japan, with the original research trade name "Froben", and its core compound patent expired in major global markets in the 1990s. The domestically approved original research dosage forms are mainly tablets, with specifications including 50mg and 100mg, which have been included in the *Reference Listed Drug Catalogue of Chemical Drugs* issued by the National Medical Products Administration. As of now, more than 30 domestic enterprises have obtained Class A status for their flurbiprofen API through CDE registration, which can be directly associated with preparation applications. Meanwhile, more than 20 dosage forms of domestic generic drugs have been approved for marketing, and the supply system is relatively mature. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of flurbiprofen impurity reference standards. All products meet the quality requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most impurities are in regular stock. Spot orders submitted before 16:00 can be shipped on the same day, which can quickly respond to sample needs in different scenarios such as API R&D, quality research and routine quality control.

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