Gland Pharma Limited — Updates, 12-08-2025: Press Release

Gland Pharma has secured USFDA approval for its Norepinephrine Bitartrate in 5% Dextrose Injection, available in 4mg/250mL and 8mg/250mL single-dose bags. This generic injectable is bioequivalent to Baxter's reference product, used for raising blood pressure in severe hypotension. Gland is the exclusive First-to-File, granting them 180 days of generic drug exclusivity. The reference product's US sales were approximately USD 55 million for the past year, indicating a significant market opportunity. This approval strengthens Gland's injectables portfolio.