Strides receives US FDA approval for generic of CellCept
Indian generic drugmaker Strides Pharma Science (BSE: 532531) announced that its stepdown wholly-owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for mycophenolate mofetil for oral suspension USP, 200mg/mL, from the US Food and Drug Administration (FDA).
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), CellCept for oral suspension, 20mg/mL from Swiss pharma giant Roche (ROG: SIX). The approval bolsters Strides' mycophenolate mofetil portfolio, which already includes numerous products in which the Company is a market leader.
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