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东北制药(000597.SZ):恩格列净原料药上市申请获得批准

Northeast Pharmaceutical Group (000597.SZ): The application for the marketing of the Active Pharmaceutical Ingredient empagliflozin has been approved.

Zhitong Finance ·  Dec 18 19:19

Northeast Pharmaceutical Group (000597.SZ) has announced that the company recently received approval from the National Medical Products Administration...

According to Zhito Finance APP, Northeast Pharmaceutical Group (000597.SZ) announced that the company recently received the "Chemical Raw Materials Active Pharmaceutical Ingredient Listing Application Approval Notice" for empagliflozin issued by the National Medical Products Administration (Registration Number: Y20230000623, Acceptance Number: CYHS2360562, Notice Number: 2024YS01308).

Empagliflozin is a sodium-glucose co-transporter 2 (SGLT-2) inhibitor that reduces glucose reabsorption in the kidneys, lowers renal glucose threshold, and promotes the excretion of glucose in urine. Empagliflozin also reduces sodium reabsorption and increases sodium transport to the distal tubule. Its formulation is clinically used to treat type 2 diabetes, heart failure, and chronic kidney disease. The approval of the company's empagliflozin Active Pharmaceutical Ingredient listing application indicates that the production process stability and quality controllability of the company's products meet the relevant technical requirements of pharmaceutical products in China, and the product can be used in domestic marketed formulations, which helps further enrich the company's product pipeline and enhance the company's market competitiveness.

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