Strides Pharma Science Ltd. on Wednesday said its wholly-owned arm, Strides Pharma Global Pte. Ltd., Singapore, has received approval from the U.S. health regulator for generic Mycophenolate Mofetil for oral suspension indicated in organ transplant patients to avoid rejection.
The approval granted by the U.S. Food & Drug Administration is for Mycophenolate Mofetil for oral suspension of strength 200 mg/ml, Strides Pharma Science said in a regulatory filing.
The product is bioequivalent and therapeutically equivalent to the reference listed drug, CellCept for oral suspension, 200 mg/m; of Roche Palo Alto, LLC, it added.
The approval bolsters the company's Mycophenolate Mofetil portfolio, which already includes numerous products, it added.
The product will be manufactured at the company's facility in Bengaluru, Strides said.
Mycophenolate Mofetil for oral suspension has a market size of $41 million, the company said citing IQVIA data.
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