Glimepiride

The continuous rise in the global prevalence of type 2 diabetes has driven the clinical iteration of sulfonylurea hypoglycemic drugs. As a third-generation sulfonylurea insulin secretagogue, glimepiride has a dual mechanism of insulin sensitization and secretion promotion: on the one hand, it can stimulate islet β cells to secrete insulin; on the other hand, it can improve the sensitivity of peripheral tissues to insulin and reduce insulin resistance. Its indications cover adult patients with type 2 diabetes whose blood glucose cannot be adequately controlled by diet control and exercise therapy. Due to lower risk of hypoglycemia and less frequent administration, it is especially suitable for elderly diabetic patients and patients with mild renal insufficiency. It is a first-line and second-line alternative drug recommended by domestic and foreign diabetes guidelines at present.

Data show that in 2023, the market size of glimepiride at the terminal of domestic public medical institutions was about 1.8 billion yuan. With the expansion of the diabetic patient base and the increase in the penetration rate of primary-level medication, the compound annual growth rate is expected to remain at around 3.2% from 2025 to 2030. At present, the domestic market is dominated by generic drugs. Enterprises winning the bid for centralized procurement occupy more than 80% of the public medical market share, while the original research product only retains a small share in the high-end self-paid market. On the raw material side, domestic enterprises have achieved large-scale independent production, and China is one of the world's core exporters of glimepiride API, with its export volume accounting for 62% of the global trade volume in 2024.

The original research enterprise of glimepiride is Sanofi, and the original trade name is "Amaryl". The core compound patents have expired in major markets such as the European Union and the United States from 2003 to 2004, and the Chinese compound patent also expired in 2004. The main dosage form approved for the original research product is tablet, with specifications of 1mg and 2mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* in China, and is also a reference preparation recognized by the FDA. As of November 2024, there have been 38 glimepiride API registration entries on the API registration platform of China's CDE, of which 29 are in the status of "A" (can be used in marketed preparations). More than 40 domestic enterprises have obtained marketing approval for glimepiride preparations. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of glimepiride impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference substance support for API R&D, quality research and consistency evaluation.