Metformin

As one of the most widely used oral hypoglycemic drugs in the world, metformin is a biguanide antihyperglycemic drug. Its unique advantage in the mechanism of action lies in that it does not stimulate insulin secretion, but achieves stable glucose control by reducing hepatic glucose output, improving peripheral insulin sensitivity, and increasing glucose uptake and utilization in muscles. It is the first-line preferred drug for patients with type 2 diabetes, especially suitable for overweight or obese patients. Long-term use of metformin can not only reduce the level of glycosylated hemoglobin, but also lower the risk of cardiovascular events. Some guidelines also recommend it for the intervention and management of prediabetes.

The global market size of metformin preparations has consistently remained above USD 4 billion for many years, while the annual sales in the domestic market exceed RMB 5 billion, with the demand for primary-level medication accounting for more than 60%. As a classic drug that has been on the market for more than 60 years, it has a low threshold for generic development. There are more than 160 domestic preparation manufacturers. After the centralized drug procurement, the minimum price of a single tablet has dropped to RMB 0.05, and the overall market pattern is fragmented. In terms of the API segment, domestic production capacity accounts for more than 80% of the total global supply, making China the largest exporter of metformin API in the world.

The original developer of metformin is Bristol-Myers Squibb, and the original brand name is Glucophage. Its core compound patent expired as early as 1957, and the core preparation patent in the Chinese market expired in 2019. Currently, the dosage forms of the original drug marketed in China include immediate-release tablets (0.25g, 0.5g, 0.85g) and sustained-release tablets (0.5g), all of which have been included in the Chinese Reference Listed Drug Catalogue. According to the domestic API registration platform, metformin APIs from more than 80 enterprises have been registered with the Center for Drug Evaluation (CDE), among which there are more than 60 registration numbers with A status, and the cumulative number of approved domestic metformin preparations has exceeded 300 product specifications. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of metformin impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of API enterprises in different scenarios such as quality research, consistency evaluation, and registration declaration.