Diclofenac sodium

As one of the most widely used non-steroidal anti-inflammatory analgesics (NSAIDs) in the world, diclofenac sodium reduces prostaglandin synthesis by inhibiting the activity of cyclooxygenase, and meanwhile inhibits the lipoxygenase pathway to reduce the production of inflammatory mediators such as leukotrienes and bradykinin, which has triple effects of anti-inflammation, analgesia and antipyresis. In clinical practice, it is mainly used for the relief of rheumatoid arthritis, osteoarthritis, acute gout attack, postoperative pain and various soft tissue rheumatic pain, covering adults and adolescents over 12 years old. Due to its rapid onset of action, high analgesic intensity and relatively controllable gastrointestinal adverse reactions, it is a commonly used anti-inflammatory and analgesic drug in primary medical institutions and specialized diagnosis and treatment.

The overall global market size of diclofenac sodium has exceeded RMB 12 billion, among which the generic drug market accounts for more than 95%, with a stable compound annual growth rate of about 3.2%. In terms of the domestic market, the annual sales at the terminal of public medical institutions are nearly RMB 3 billion, and the growth rate of topical preparations reaches 8.7%, which is significantly higher than that of oral dosage forms. At present, there are more than 300 approved marketing authorization numbers for diclofenac sodium preparations in China, and 28 API manufacturers, with production capacity concentrated in Shandong, Jiangsu and other regions. As the core patents have long expired, the price of preparations has dropped by more than 70% after centralized procurement, and the compliance and supply stability of upstream APIs have become the core element of competition for downstream enterprises.

The original research enterprise of diclofenac sodium is Novartis, with the original brand name "Voltaren". The core compound patent was published as early as 1970, and the patents in major global markets have all expired. The marketed dosage forms of the original product include oral sustained-release tablets, topical gels, suppositories, injections, etc. Among them, 75mg sustained-release tablets and 1% topical gel are the mainstream clinical specifications, which have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA Reference Preparation Catalogue. Up to now, there have been 63 domestic registration numbers of diclofenac sodium APIs, among which 41 are in Status A (available for use in marketed preparations), and domestic preparations of all dosage forms such as oral, topical and injection have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the relevant R&D and quality control needs of diclofenac sodium, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of the whole process of drug R&D, quality research, marketing application, etc.