Empagliflozin

As a chronic metabolic disease with high global incidence, traditional hypoglycemic regimens have long faced the clinical pain point of insufficient cardiovascular benefits, and the emergence of SGLT-2 inhibitors has broken this dilemma. Empagliflozin is a highly selective sodium-glucose co-transporter 2 (SGLT-2) inhibitor. Its mechanism of action does not depend on insulin function. By inhibiting the reabsorption of glucose by the renal proximal tubule, excess glucose is excreted from the body with urine. It can be used alone or in combination with other hypoglycemic drugs to improve glycemic control in patients with type 2 diabetes mellitus, and is also recommended by guidelines for adult patients with concomitant cardiovascular diseases and chronic kidney diseases. It can significantly reduce the risk of major adverse cardiovascular events and renal endpoint events, covering more than 10 million applicable populations.

The global market size of empagliflozin has continued to rise in recent years, exceeding US$8 billion in 2023, with a compound annual growth rate of around 12% in the past three years. In the Chinese market, as the indications are included in medical insurance and clinical awareness improves, the terminal sales of public medical institutions exceeded RMB 4 billion in 2023, with an annual growth rate of more than 35%. In terms of the competitive landscape, the original research product still accounts for nearly 60% of the market share. More than 20 domestic enterprises have had their generic drugs approved for marketing. In the seventh batch of national centralized drug procurement, the average price reduction of this variety exceeded 60%, further promoting the improvement of clinical accessibility, and the demand for upstream APIs continues to be released.

The original research enterprise of empagliflozin is Boehringer Ingelheim, and the original research trade name is "Jardiance". The expiration date of its core compound patent in China is 2025. The main dosage form approved by the original research is tablet, with specifications including 10mg and 25mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation included in the FDA. Up to now, more than 30 domestic empagliflozin API registration numbers have been approved, among which more than 20 are A-status registration numbers, and the corresponding approved preparation varieties cover multiple dosage forms such as tablets and compound preparations. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of empagliflozin impurity reference standards, which can fully meet the qualitative and quantitative requirements of impurities in the process of API R&D, quality research and production. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, providing stable and reliable support for the quality compliance of pharmaceutical enterprises.