Gland Pharma Gets USFDA Nod for Generic Sugammadex Injection

New Delhi: Gland Pharma Ltd on Wednesday said it has received approval from the US health regulator for its generic version of sugammadex injection indicated to reverse the effects of the muscle relaxants given during surgery.

The approval from the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (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 said in a regulatory filing.

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

It is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery, Gland Pharma said.

Citing IQVIA, the company said the product had US sales of approximately USD 1.6 billion for the 12 months ended April 2026.

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