Strides Pharma's Singapore Arm Receives USFDA Nod for Generic Mycophenolate Mofetil

30 Aug 2023 , 03:27 PM

Strides Pharma Science Ltd’s Singapore subsidiary, Strides Pharma Global Pte. Ltd, secures approval from USFDA for generic Mycophenolate Mofetil. The medication is intended for oral suspension and serves organ transplant patients to prevent rejection.

The approval covers Mycophenolate Mofetil of strength 200 mg/ml, as stated in Strides Pharma Science’s regulatory filing. This generic product is both bioequivalent and therapeutically equivalent to the reference listed drug (RLD) CellCept for oral suspension, with a strength of 200 mg/ml from Roche Palo Alto, LLC.

The approval reinforces Strides’ existing Mycophenolate Mofetil portfolio, which already encompasses several products. Manufacture of the approved product will occur at the company’s Bengaluru facility, according to Strides.

The market size for Mycophenolate Mofetil for oral suspension stands at USD 41 million, based on IQVIA data as noted by the company.

 

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