Drug Approval

Lupin gets FDA nod for launch of Generic Sugammadex injection in US market

Bioequivalent version of Merck's Bridion targets the reversal of neuromuscular blockade in adult and pediatric surgical patients

  • By IPP Bureau | August 01, 2026

Global pharmaceutical major Lupin Limited has launched Sugammadex Injection in the United States after receiving approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA).

The company has introduced the product in 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial presentations.

Lupin's Sugammadex Injection is the bioequivalent of Merck's Bridion Injection and is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged two years and older undergoing surgery.

The launch further strengthens Lupin's injectable portfolio in the U.S., one of its key global markets, and expands its offerings in the hospital and acute care segment. 

Sugammadex is widely used by anesthesiologists to rapidly reverse the effects of neuromuscular blocking agents administered during surgical procedures, helping patients regain muscle function after anesthesia.

The commercial launch follows Lupin's recent USFDA approval for the product and underscores the company's continued focus on expanding its portfolio of complex generic and specialty injectable medicines in regulated markets.

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