马来酸依那普利片(10mg)
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国药现代:马来酸依那普利片(5mg)通过仿制药一致性评价
Guo Ji Jin Rong Bao· 2025-09-17 08:29
Core Viewpoint - The company has received approval from the National Medical Products Administration for the supplementary application of Maleate Enalapril Tablets (5mg), which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval and Market Potential - The approval allows for the expansion of the product's market and sales potential, with projected sales in 2024 for the drug estimated at RMB 164 million in public medical institutions and urban pharmacies [1] - The company has invested approximately RMB 15.3657 million in the research and development of this project [1] Group 2: Product Information - Maleate Enalapril Tablets are an angiotensin-converting enzyme inhibitor primarily used for treating primary hypertension, renovascular hypertension, and symptomatic heart failure [1] - The company’s Maleate Enalapril Tablets (10mg) had already passed the consistency evaluation in January 2022, indicating a strong foundation for the new 5mg formulation [1]