Gliclazide

As a classic variety of sulfonylurea oral hypoglycemic drugs, gliclazide selectively acts on pancreatic β cells to promote insulin secretion while improving the sensitivity of peripheral tissues to insulin, and also has additional pharmacological effects of reducing platelet aggregation and improving microcirculation. It is clinically mainly used for adult patients with type 2 diabetes whose blood glucose level cannot be sufficiently controlled by diet control, exercise therapy and weight reduction alone, especially for elderly diabetic patients with microvascular complications, and is an important oral drug option in the stepwise treatment of diabetes.

In the current global hypoglycemic drug market, although sulfonylurea drugs are facing market diversion by new preparations such as GLP-1 receptor agonists, they still maintain stable demand in primary medical care and low- and middle-income countries due to their affordable price and definite hypoglycemic effect. In 2023, the global market size of gliclazide-related preparations was approximately US$1.28 billion, with a compound annual growth rate maintained at 2.1%. For the domestic market, this variety has been included in the national centralized procurement. The price of winning preparations has dropped by more than 80%, the market share is concentrated in leading generic drug enterprises, and the demand for APIs shows a trend of concentrating in manufacturers with strong cost control capabilities along with the implementation of centralized procurement.

The original research enterprise of gliclazide is Servier from France, and the original research brand name is "Diamicron". Its core compound patent expired around 2005 in major global markets. The main dosage forms of the original marketed products include sustained-release tablets (30mg, 60mg) and conventional tablets (80mg). Both dosage forms have been included in the China Listed Drug Catalogue as reference preparations, and are also included in the FDA Reference Preparation Catalogue. According to the domestic API registration platform, as of now, gliclazide APIs from more than 20 enterprises have passed the review of CDE and obtained A status registration numbers. Both the original research and domestic generic gliclazide conventional tablets and sustained-release tablets have been approved for marketing in China. (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 gliclazide API. Most products are available from stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs in the whole process of API R&D, quality research and registration declaration.