Metamizole

Fever is one of the most common clinical symptoms worldwide. In emergency scenarios of acute and severe hyperthermia and severe pain, rapid antipyretic and analgesic drugs have always been a clinical rigid demand. Metamizole sodium is a pyrazolone non-steroidal anti-inflammatory drug, which reduces the synthesis and release of prostaglandins by inhibiting cyclooxygenase, and has strong antipyretic, analgesic and anti-inflammatory effects. It was once widely used for emergency antipyresis of acute hyperthermia, as well as the relief of moderate to severe pain such as migraine, acute arthritis, rheumatic pain and toothache. The applicable population must be strictly limited to patients with no history of pyrazolone drug allergy and no response to other antipyretic and analgesic drugs.

As a classic drug that has been on the market for more than 100 years, metamizole sodium has been strictly restricted in its scope of use in most countries around the world due to the risk of adverse reactions. At present, only specific dosage forms such as oral preparations and injections are retained in the domestic market for clinical emergency scenarios. In 2023, the sales volume of metamizole sodium related preparations at the terminal of domestic public medical institutions was approximately 120 million yuan, a year-on-year decrease of 8.7%, and the market scale continues to narrow with the standardization of clinical medication. The competitive landscape is dominated by local generic drug enterprises, and no original research products are in circulation in China. The production of APIs is concentrated in a small number of compliant pharmaceutical enterprises in North China and East China, and the overall supply is stable.

The original research enterprise of metamizole sodium is Merck Germany, and the original trade name is Novalgin. It was first launched in Germany in 1922, and the core compound patent has expired worldwide for many years. The main dosage forms of the original research include tablets, injections and suppositories, among which the 250mg tablets and 500mg/2ml injections were once included in the FDA Reference Listed Drug Catalog, and the US market stopped marketing in 1977 due to safety issues. At present, more than 20 domestic enterprises have obtained approval for the registration of metamizole sodium APIs, among which 11 have A-status effective registration numbers. The approved marketed metamizole sodium preparations cover three categories: tablets, injections and nasal drops, all of which are generic varieties of local enterprises. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for metamizole sodium API. Most of the products support spot supply. Spot orders paid before 16:00 can be delivered on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Parameters such as impurity structure and purity have been strictly verified, which can meet the use needs of the whole process scenarios such as API R&D, quality research and registration declaration.