Lupin's alliance partner gets USFDA nod for generic rocuronium bromide injection

Pharmaceuticals firm Lupin Ltd on Monday said its alliance partner Caplin Steriles Ltd has received final approval from the US health regulator for generic rocuronium bromide injection used as an adjunct to general anesthesia.

The approval granted by the US Food and Drug Administration (USFDA) to Caplin Steriles is for its abbreviated new drug application (ANDA) rocuronium bromide injection of strengths 10mg/ml in 5 ml and 10 ml multi-dose vials, Lupin said in a regulatory filing.

These are the generic equivalent of Zemuron bromide Injection, 50 mg/5 mL and 100 mg/10 mL of Organon USA Inc, it added.

The rocuronium bromide injection had an annual sale of approximately USD 53 million in the US, Lupin said citing IQVIA MAT December 2022 data.

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