Lupin partner Caplin Steriles gets FDA nod for Zemuron Bromide generic

Lupin Limited said that its alliance partner Caplin Steriles has won final approval for Rocuronium Bromide Injection, 10mg/mL in 5 mL and 10 mL multi-dose vials from the US Food and Drug Administration (FDA).

The approved abbreviated new drug application (ANDA) of the Indian pharma company is for marketing a generic version of Organon USA‘s Zemuron Bromide Injection, 50 mg/5 mL and 100 mg/10 mL.

As per IQVIA MAT December 2022, the annual sales of Rocuronium Bromide Injection in the US are around $53 million.