Glibenclamide

Diabetes is a chronic metabolic disease with a high incidence worldwide. Sulfonylurea drugs are classic oral hypoglycemic options for the treatment of type 2 diabetes. Among them, glibenclamide is a second-generation sulfonylurea hypoglycemic drug, which selectively acts on pancreatic β cells to promote insulin secretion, while enhancing the sensitivity of peripheral tissues to insulin and inhibiting hepatic glycogenolysis, thereby steadily reducing fasting and postprandial blood glucose. This drug is mainly indicated for patients with mild to moderate type 2 diabetes who have unsatisfactory therapeutic effect with diet control alone and still have residual islet function, especially suitable for people with insufficient response to other sulfonylurea drugs. Due to its strong hypoglycemic effect and long duration of action, it is one of the commonly used drugs in primary-level diabetes prevention and control programs.

The global glibenclamide market size has been stable at around USD 320 million for years, with generic drugs accounting for more than 90% of the market share. China is the core producer of glibenclamide API, with production capacity accounting for more than 75% of the total global supply, and its products are exported to more than 40 countries and regions including Europe, America and Southeast Asia. After the implementation of the volume-based procurement policy, the terminal price of domestic glibenclamide preparations has decreased by 68%, and the clinical usage has increased by 42% compared with that before the volume-based procurement, which further drives the market demand for upstream APIs, and the industry growth rate has been maintained at around 5% for years.

The original research enterprise of glibenclamide is Pfizer, with the original brand name Diabeta. The core compound patent expired globally in 1994. The main dosage form approved for the original product is oral tablet, with specifications including 1.25mg, 2.5mg and 5mg. At present, the original tablet has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (6th Batch)* of China. According to the domestic API registration platform, as of now, 12 enterprises have obtained marketing approval for glibenclamide API which are in A status, corresponding to 37 approved domestic glibenclamide preparation products, covering two dosage forms of tablets and capsules. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for glibenclamide API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, which can fully meet the impurity research needs in the process of drug development, quality control and production, and help pharmaceutical enterprises to efficiently promote the implementation of related projects.