Acarbose

Diabetes is one of the chronic metabolic diseases with the highest prevalence in the world, among which patients with type 2 diabetes account for more than 90%. Postprandial blood glucose control is the core link to delay disease progression and reduce the risk of complications. Acarbose is an oral hypoglycemic drug belonging to the α-glucosidase inhibitor class. It reversibly inhibits the activity of α-glucosidase at the brush border of the small intestinal mucosa to slow down the rate of carbohydrate decomposition into glucose, thereby smoothly reducing the postprandial blood glucose peak. It is especially suitable for East Asian patients with type 2 diabetes whose main dietary structure is carbohydrates, and can also be used in combination with other hypoglycemic drugs such as metformin and insulin to optimize the overall blood glucose control effect.

At present, the global market size of acarbose exceeds 7 billion yuan, and the Chinese market accounts for more than 60%, making it the largest consumption region in the world. Driven by the continuous rise in the prevalence of diabetes and the improvement of primary diagnosis and treatment coverage, the compound growth rate of the domestic acarbose market in the past three years has remained at 4.2%. In terms of the competitive landscape, the market share of the original research enterprise Bayer has dropped from nearly 70% before the centralized drug procurement to about 30%, and domestic generic drug enterprises such as Huadong Medicine and Luye Pharma have occupied more than 60% of the market share by virtue of their cost advantages. With the continuous optimization of the API process, the demand of downstream preparation enterprises for high-quality compliant APIs and supporting impurity reference products continues to rise.

CATO can provide a full set of impurity reference standards for acarbose API. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Relevant reference products have sufficient stock reserves, which can directly meet the full-scenario needs of pharmaceutical enterprises in R&D, quality research and routine release testing, without additional waiting period.