Gland Pharma Ltd., a generic injectable and ophthalmic-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed through its partner for Norepinephrine Bitartrate in 5 percent Dextrose Injection, 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL) Single-Dose Bags.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartrate in 5 percent Dextrose of Baxter Healthcare Corp, the company said in a statement.

It further added that this product is indicated to raise blood pressure in adult patients with severe, acute hypotension. “We are the exclusive First-to-File and are eligible for 180 days of generic drug exclusivity,” it said.

According to IQVIA, the product had US sales of approximately USD 55 million for the twelve months ending June 2025.