Mumbai, March 31 -- The approval covers strengths of 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) in single-dose vials, the company said in a statement.

The product has been deemed bioequivalent to Merck & Co.'s Bridion Injection. It is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged two years and above undergoing surgery.

Tentative approval indicates that the drug meets all regulatory requirements but cannot be marketed in the United States until the expiry of applicable exclusivities or patents.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in ph...