Dapagliflozin

In the field of chronic metabolic diseases, the emergence of sodium-glucose cotransporter 2 (SGLT2) inhibitors has broken the limitation of traditional hypoglycemic drugs that rely on the insulin pathway. Dapagliflozin is a representative variety of this class of drugs. By inhibiting the SGLT2 receptor in the proximal renal tubule, it reduces glucose reabsorption and promotes urinary glucose excretion. It can not only be used for blood glucose control in patients with type 2 diabetes, but is also recommended by guidelines for patients with heart failure with reduced or preserved ejection fraction and chronic kidney disease. The population covered by its indications extends from patients who only need hypoglycemic treatment to the population with cardiorenal comorbidities, and its clinical value has expanded from the metabolic field to full-cycle cardiorenal management.

The global market size of dapagliflozin exceeded 7.5 billion US dollars in 2023, with a compound annual growth rate of 11.2% from 2019 to 2023. The sales in sample hospitals in the domestic market exceeded 3.5 billion yuan in 2023. In terms of the competitive landscape, 13 domestic enterprises have obtained approval for generic dapagliflozin preparations at present. The winning bid price of this variety in the seventh batch of national centralized drug procurement decreased by more than 80% compared with the original research price. With the accelerated penetration of the primary market, the demand for high-quality active pharmaceutical ingredients (APIs) continues to rise, and the API supply chain layout of leading generic pharmaceutical enterprises has become a core competitive barrier.

The original research enterprise of dapagliflozin is AstraZeneca, with the trade name Forxiga. The core compound patents expire in 2023 in the United States and in 2024 in China respectively. At present, the domestically approved original research dosage form is tablet, with specifications of 5mg and 10mg. The 10mg specification has been included in the Reference Listed Drug Catalog of the China Listed Medicines Collection, and is also included in the FDA Reference Listed Drug Catalog. As of now, there are more than 30 domestic registration numbers of dapagliflozin APIs, among which more than 20 are in status A and can be used for associated preparation declaration. A number of domestic enterprises have obtained approval for the marketing of oral regular-release dosage forms of dapagliflozin. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full range of dapagliflozin impurity reference standards. The products meet the regulatory requirements of multiple countries including the Chinese Pharmacopoeia and FDA. Most products are in stock. In-stock products with orders submitted before 16:00 can be shipped on the same day, fully meeting the diverse needs in the stages of API R&D and quality research.