Voglibose

In the chronic disease management of diabetes, postprandial blood glucose control is a key link to reduce long-term vascular complications. As one of the core varieties of α-glucosidase inhibitor hypoglycemic drugs, voglibose reversibly inhibits α-glucosidase on the surface of small intestinal mucosa to delay the decomposition and absorption of carbohydrates, thereby steadily reducing the postprandial blood glucose peak. Compared with similar drugs, it has lower gastrointestinal irritation and better tolerance. It is clinically mainly used for postprandial blood glucose control in patients with type 2 diabetes, and can also be combined with insulin or other oral hypoglycemic drugs for adult diabetic patients with poor blood glucose control with diet and exercise therapy alone, especially suitable for East Asian populations with carbohydrates as the main dietary structure.

At present, the global voglibose market size is stable at around US$1.6 billion, of which the Chinese market accounts for more than 35%, and the compound growth rate in the past three years has remained at 4.2%. As the oral immediate-release dosage form of voglibose has been included in the national centralized procurement catalog, the price of generic drugs of selected enterprises has dropped by more than 90%, the market share has gradually concentrated on leading generic enterprises, and the market share of original research products has dropped from 68% in 2018 to 22% in 2023. The supply side of domestic API has basically achieved independent and controllable, and the API production capacity of domestic enterprises accounts for more than 60% of the global total production capacity. In addition to meeting the domestic preparation production demand, it is also exported in large quantities to Southeast Asia, South America and other regions.

The original research enterprise of voglibose is Takeda Pharmaceutical Company Limited of Japan, and the original research trade name is "Basen". The expiration time of its core compound patent in major markets such as Japan and the United States is 2001, and the expiration time of the core compound patent in China is 1999. The main dosage form approved by the original research is oral tablet, with a specification of 0.2mg/tablet. It has been included in the China Listed Drug Catalog as a reference preparation, and is also included in the FDA Reference Preparation Catalog. Up to now, there are more than 30 registrations of voglibose API registered by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, among which there are 19 registration numbers with the status of A (already used in marketed preparations), and more than 20 domestic enterprises have obtained approval for the marketing of voglibose oral preparations. (Data as of November 2024, please refer to the official CDE website for the latest information)

In response to the quality research and compliance declaration needs of voglibose, CATO provides a full set of impurity reference standards for this 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 requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully support the quality research, stability investigation and registration declaration of APIs and preparations.