Miglitol

In the chronic disease management of diabetes, α-glucosidase inhibitors are one of the core medication categories for controlling postprandial blood glucose. As a representative second-generation product of this class of drugs, miglitol reversibly inhibits α-glucosidase on the surface of small intestinal epithelial cells and delays the rate of carbohydrate decomposition into glucose, thereby steadily reducing the postprandial blood glucose peak. Compared with the first-generation drugs of the same class, miglitol has better hepatic and renal safety and no risk of systemic accumulation. It can be used as monotherapy for patients with type 2 diabetes who have poor response to diet and exercise control, and can also be used in combination with metformin, insulin and other drugs, especially suitable for elderly diabetic groups with concurrent renal function impairment.

At present, the global market size of miglitol is approximately USD 420 million, with a compound annual growth rate of around 4.8% in the past three years. China is the fastest growing regional market, with an annual growth rate of 7.2%. The domestic market presents a competitive pattern where the original drug and generic drugs coexist. A total of 12 enterprises have obtained approval for miglitol generic preparations, and the winning bid price in centralized procurement has dropped by more than 80% compared with the original drug, driving the continuous increase in the penetration rate of the primary market. In terms of API supply, 11 domestic enterprises have obtained production approvals for miglitol API, with sufficient production capacity, and China is the world's core exporter of miglitol API.

The original research enterprise of miglitol is Bayer HealthCare AG, Germany, and the original brand name is "Baitian". The core compound patent of the original drug expired in Europe and the United States in 2000, and the compound patent in China expired in 2001. The main dosage form approved for the original drug is tablet, with specifications of 25mg, 50mg and 100mg. It has been included in the *Catalogue of Chemical Reference Preparations* of China, and also included in the FDA Reference Preparations Catalogue. Up to now, 23 registration entries of miglitol API can be queried on the Center for Drug Evaluation (CDE) of China, among which 19 are in A status and can be legally supplied for preparation production. A total of 17 oral miglitol preparation varieties have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of miglitol impurity reference standards, which meet the needs of the whole process of impurity research and quality control. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and provide stable and reliable support for the R&D, registration and production links of API and preparation enterprises.