Mumbai, Naples, September 18, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Bumetanide Injection USP, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multiple-Dose Vials to market a generic equivalent of Bumex® Injection, 0.25 mg/mL of Validus Pharmaceuticals, LLC. The product will be manufactured at Lupin’s Nagpur facility in India.

Bumetanide Injection USP, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multiple-Dose Vials are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.

Bumetanide Injection USP (RLD Bumex®) had estimated annual sales of USD 20 million in the U.S. (IQVIA MAT July 2024).

About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

For further information or queries please contact –

Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com

*Safe Harbor Statement
Bumex® is a registered trademark of Validus Pharmaceuticals, LLC.