Lupin Limited Gains FDA Approval for Diazepam Injection, USGing Health Outcomes
Global pharmaceutical major Lupin Limited has announced receiving regulatory approval from the U.S. Food and Drug Administration (FDA) for its Diazepam Injection USP, securing a key market access point in the United States.The approval pertains to the Abbreviated New Drug Application for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes. The FDA granted the approval under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Lupin's product has been certified as bioequivalent to the reference listed drug (RLD) Valium® Injection 10 mg/2 mL (5 mg/mL), manufactured by Hoffman-LaRoche, Inc. The injection is indicated for both the management of anxiety disorders and for providing short-term relief of anxiety symptoms.
The market potential for the Diazepam Injection USP in the U.S. was estimated at USD 77.9 million annually, according to IQVIA MAT data from May 2026.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, distributing products across over 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin serves various therapy areas, including central nervous system disorders, cardiovascular health, respiratory care, anti-diabetic treatments, gastrointestinal conditions, and women's health.
The company maintains a robust global presence with 15 state-of-the-art manufacturing sites and 7 research centers worldwide, supported by over 24,000 professionals. Lupin is committed to improving patient health outcomes through its various subsidiaries.
LUPIN Stock Price Movement
Lupin Limited shares shed 0.30% in the market, settling at ₹2415 after trading closed today. A total of 1.01 million shares were traded during the session.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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