Good news! Chang Le Pharmaceutical’s Bumetanide Injection has received approval for its Supplemental Drug Application

April 8, 2026  Source: drugdu 32

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Recently, Chang Le Pharmaceutical, a subsidiary of Lianhuan Pharmaceutical, received the "Approval Notice for Supplementary Drug Application" issued by the National Medical Products Administration. Bumetanide injection was successfully approved, marking a new stage in the company's production and supply capacity and quality management level in the field of diuretics, and injecting strong momentum into the company's high-quality development.

Bumetanide injection is a commonly used, potent diuretic in clinical practice, widely applied in the treatment of edematous diseases, hypertension, prevention of acute renal failure, and hyperkalemia, demonstrating significant clinical value. This approval includes a new 1ml:0.5mg product specification, along with simultaneous changes to the manufacturing process, production volume, and packaging materials and containers. Since the project's inception, Chang Le Pharmaceutical has assembled a professional R&D and production team, conducting systematic pharmaceutical research over several months. Adhering strictly to national drug development principles, the team has carried out comprehensive and in-depth experimental verification of the new specification's formulation process, quality standards, and stability studies to ensure the quality, safety, and efficacy of the modified product.
The approval of this new specification for bumetanide injection not only enriches the company's diuretic product line and enhances its market adaptability and production capacity, but also further meets diverse clinical needs. Moving forward, Changle Pharmaceutical will continue to uphold its commitment to drug quality and safety, focus on R&D innovation and quality improvement, continuously optimize its industrial layout, and contribute to the development of the pharmaceutical and healthcare industry with higher-quality products and services.

https://mp.weixin.qq.com/s/aKWwgbO-mrc008wgcZN6ng

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