USFDA gives approval for generic Rocuronium Bromide Injection

The injections are the generic version of Zemuron Bromide Injection of Organon USA Inc and will be used as an adjunct to general anaesthesia.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

Mumbai: Lupin Limited has announced that its alliance partner Caplin Steriles Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rocuronium Bromide Injection, 10 mg/mL in 5 mL and 10 mL multi-dose vials.

The injections are the generic version of Zemuron Bromide Injection of Organon USA Inc and will be used as an adjunct to general anaesthesia.

As per the IQVIA MAT December 2022, Rocuronium Bromide Injection had an annual sale of approximately $53 million in the US.

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