Glipizide

In response to the clinical pain points of β-cell function decline and large postprandial blood glucose fluctuations in patients with type 2 diabetes as the disease progresses, sulfonylurea insulin secretagogues have always been a first-line combined medication option recommended by guidelines. As a representative variety of the second-generation sulfonylurea oral hypoglycemic drugs, glipizide selectively blocks ATP-sensitive potassium channels on pancreatic β-cells to promote rapid insulin secretion, while inhibiting glycogenolysis and reducing hepatic glucose output. It can meet the needs of both fasting and postprandial blood glucose control, and is especially suitable for adult patients with type 2 diabetes whose blood glucose fails to reach the target with metformin monotherapy. Its risk of hypoglycemia is significantly lower than that of the first-generation sulfonylurea drugs, and its long-term medication safety has been validated by decades of clinical practice.

Currently, the global market size of oral hypoglycemic drugs exceeds 50 billion US dollars. Among them, sulfonylurea drugs still account for about 12% of the market share by virtue of their definite efficacy and high cost-effectiveness. The annual sales of glipizide preparations at the terminals of Chinese public medical institutions are stable at more than 1.2 billion yuan, with a compound annual growth rate of 3.2% in the past 3 years. The domestic glipizide preparation market is dominated by generic drugs, and more than 30 enterprises have had their oral preparations pass the consistency evaluation. After the implementation of volume-based procurement, the terminal price has dropped by more than 70%, and the winning enterprises have a continuously rising demand for high-quality and compliant API supplies. Meanwhile, the production concentration of upstream APIs is relatively high, with local enterprises accounting for more than 90% of the supply.

The original research enterprise of glipizide is Pfizer, and the original research brand name is Glucotrol®. Its core compound patent expired globally in 1994. The main dosage forms currently on the market include 5mg and 10mg conventional tablets and 5mg sustained-release tablets. The original research preparation has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA reference preparation catalogue. Up to now, there are 21 glipizide API registration records on the API registration platform of China CDE, among which 12 have been activated in status A and can be directly associated with preparation declaration. A number of glipizide preparations of different dosage forms, including conventional tablets, sustained-release tablets and capsules, have been approved for marketing in China. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of glipizide impurity reference standards, covering all categories such as process impurities and degradation impurities. Most of the products are available in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API enterprises in R&D, quality research and routine quality control.