Lupin Receives FDA Approval for Generic Bumetanide Injection to Treat Edema

Lupin Limited, a leading global pharmaceutical company, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bumetanide Injection USP. The approved dosages include 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multiple-Dose Vials. This generic version is equivalent to Bumex® Injection (0.25 mg/mL) by Validus Pharmaceuticals, LLC, and will be produced at Lupin's manufacturing facility in Nagpur, India.

Bumetanide Injection is primarily used to treat edema associated with congestive heart failure, liver and kidney diseases, including nephrotic syndrome. The generic version of Bumex® Injection had annual sales of approximately USD 20 million in the U.S. as of July 2024, according to IQVIA data.

Lupin, headquartered in Mumbai, India, is a pharmaceutical giant with a broad presence in over 100 countries. The company specializes in both generic and branded formulations, biotechnology products, and active pharmaceutical ingredients. With a strong focus on innovation and quality, Lupin operates 15 cutting-edge manufacturing facilities and 7 research centers worldwide, driven by a team of over 22,000 professionals. Lupin is committed to enhancing patient outcomes through its wide-ranging healthcare solutions, including Lupin Diagnostics and Lupin Digital Health.