Lupin has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for diazepam injection USP, 10 mg/2 mL (5 mg/mL), single-dose prefilled syringes, strengthening the company's injectable product portfolio in the United States.

The approved product is a bioequivalent version of Valium (diazepam) injection developed by Hoffmann-La Roche Inc. and is indicated for the management of anxiety disorders and the short-term relief of anxiety symptoms.

The approval enables Lupin to expand its presence in the US generic injectables market while providing healthcare providers and patients with an additional treatment option in a convenient prefilled syringe format.

According to IQVIA MAT May 2026 data, the reference product recorded estimated annual sales of USD 77.9 million in the US, representing a significant market opportunity for the company.

The latest approval underscores Lupin's continued focus on expanding its complex generic and injectable medicines portfolio for regulated markets. It also reinforces the company's aim to improving patient access to high-quality, affordable medicines while strengthening its footprint in the United States, one of its key global markets.

With this approval, Lupin continues to build momentum in the US pharmaceutical market by leveraging its manufacturing capabilities and robust pipeline of differentiated generic products.