Diclofenac

Chronic pain is a type of chronic disease with high incidence worldwide, and anti-inflammatory and analgesic drugs have long been a category with rigid demand in the field of clinical medication. Diclofenac is a non-steroidal anti-inflammatory drug, which reduces the synthesis of prostaglandins by inhibiting the activity of cyclooxygenase, and meanwhile reduces the production of inflammatory mediators such as leukotrienes by inhibiting the lipoxygenase pathway. It has triple effects of anti-inflammation, analgesia and antipyresis, and is widely used clinically to relieve various acute and chronic inflammation and pain symptoms such as rheumatoid arthritis, osteoarthritis, acute attack of gout, postoperative pain, toothache, etc., covering adult and pediatric populations for symptomatic treatment. It is one of the basic drugs in the field of anti-inflammation and analgesia worldwide.

As a classic and mature drug that has been on the market for more than half a century, diclofenac has an annual global market size of more than 2 billion US dollars, and its annual sales at the terminal of public medical institutions in China exceed 3 billion yuan. In recent years, affected by the accelerating aging process and the increasing demand for pain management, its compound annual growth rate has remained at around 4%. The current market is dominated by generic drugs, with more than 200 domestic manufacturers. It is one of the winning varieties in the national centralized drug procurement, with the winning price dropping by more than 80% compared with the price of the original research drug. The main production areas of API are concentrated in China and India, and China's export volume accounts for more than 60% of the total global trade volume.

The original research enterprise of diclofenac is Novartis, and the original research trade name is "Voltaren". The core compound patent expired in 1985. At present, the main dosage forms include enteric-coated tablets, sustained-release tablets, creams, suppositories and injections, covering various specifications such as 25mg, 50mg and 75mg. The original research preparations have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA reference preparation catalogue. At present, more than 60 domestic enterprises have obtained CDE registration numbers for diclofenac APIs, all of which are in status A, and there are more than 600 approval numbers for domestic preparations, realizing the domestic supply of all dosage forms. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for diclofenac API, which can meet the impurity research requirements of different process routes. All products comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in stock, and orders placed before 16:00 can be shipped on the same day, helping API enterprises and preparation manufacturers quickly complete quality research and compliance declaration work.