Gland Pharma gets USFDA nod for generic sugammadex injection

New Delhi: Gland Pharma Ltd on Wednesday stated it has acquired approval from the US well being regulator for its generic model of sugammadex injection indicated to reverse the consequences of the muscle relaxants given throughout surgical procedure.

The approval from the US Meals and Drug Administration (USFDA) is for the abbreviated new drug software (ANDA) filed for Sugammadex Injection in strengths of 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vials, Gland Pharma stated in a regulatory submitting.

Additionally Learn: Alembic Pharma will get USFDA approval for generic persistent constipation therapy tablets

The product is bioequivalent and therapeutically equal to the reference listed drug, BRIDION injection of Merck Sharp & Dohme LLC ZZ it added.

It’s indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in grownup and pediatric sufferers present process surgical procedure, Gland Pharma stated.

Citing IQVIA, the corporate stated the product had US gross sales of roughly USD 1.6 billion for the 12 months ended April 2026.