Diclofenac

As one of the most widely used non-steroidal anti-inflammatory drugs (NSAIDs) in clinical practice, diclofenac reduces prostaglandin synthesis by inhibiting the activity of cyclooxygenase (COX), and exerts potent anti-inflammatory, analgesic and antipyretic effects. Its indications cover acute and chronic rheumatoid arthritis, osteoarthritis, gouty arthritis, acute mild to moderate pain (postoperative traumatic pain, dysmenorrhea, toothache, etc.). The applicable population ranges from adult patients to elderly groups with osteoarthropathy in need of anti-inflammatory and analgesic treatment, making it one of the basic drugs in the global pain management treatment pathway.

In recent years, the global market size of diclofenac API has stabilized at around USD 1.2 billion, with a compound annual growth rate of approximately 3.2%, showing a significant characteristic of rigid demand. In terms of the domestic market, this variety has been included in multiple batches of the national centralized procurement catalog, with a generic drug substitution rate of over 90%. Its main production areas are concentrated in Shandong, Jiangsu and other regions, and the annual production capacity of leading manufacturers all exceeds the kiloton level. With the increase in the clinical application proportion of topical formulations and sustained-release formulations, the market demand for high-purity API is growing at a rate of 5% per year, and there is no publicly disclosed restriction related to the expiration of core patents.

CATO provides a full set of impurity reference standards for diclofenac API. All products of the full series meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. With sufficient in-stock reserve, same-day delivery can be realized, which can directly meet the full-process needs of pharmaceutical enterprises in quality research, consistency evaluation and routine production quality control.