Express Pharma

Lupin receives US FDA approval for Rufinamide tablets 

The product will be manufactured at Lupin’s facility in Goa

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Lupin today received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Rufinamide Tablets USP, 100 mg, 200 mg, and 400 mg, to market a generic equivalent of Banzel Tablets, 100 mg, 200 mg, and 400 mg, of Eisai Inc.

The product will be manufactured at Lupin’s facility in Goa, the statement added.

 

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