Lupin Receives Tentative FDA Approval for Revefenacin Inhalation Solution
Mumbai, India, Naples, Fla, May 18, 2026: Global pharmaceutical major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA). The approval pertains to its Abbreviated New Drug Application (ANDA) for Revefenacin Inhalation Solution, available in 175 mcg/3 mL Unit-Dose Vials.The newly approved Revefenacin Inhalation Solution (175 mcg/3 mL) is bioequivalent to Mylan's Yupelri® Inhalation Solution and is indicated for the maintenance treatment of patients suffering from Chronic Obstructive Pulmonary Disease (COPD).
The pharmaceutical market for this product segment is significant, with Revefenacin Inhalation Solution (RLD Yupelri®) having estimated annual sales of USD 260.7 million in the U.S., according to IQVIA MAT March 2026.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India. The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. With a strong operational presence, Lupin serves over 100 markets and maintains a position across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, and central nervous system segments. The company operates 15 state-of-the-art manufacturing sites and 7 research centers worldwide.
LUPIN Stock Price Movement
Lupin Limited shed 0.98% of its value today, closing at ₹2252.4. The stock saw significant activity throughout the session, with 907,343 shares trading in the equity.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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