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Strides Pharma Science Limited’s subsidiary, Strides Pharma Global Pte. Limited, Singapore, secured an approval from the United States Food & Drug Administration (USFDA) for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL. This approval marks the first product clearance from Strides’ flagship Bengaluru facility, which underwent USFDA inspection closure in February 2023.
Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, is a newly approved product that is bioequivalent and therapeutically equivalent to Roche Palo Alto, LLC’s (Roche) CellCept for Oral Suspension, 200 mg/mL. With a market size estimated at approximately US$41 million, according to IQVIA, mycophenolate mofetil for Oral Suspension holds substantial market potential.
The shares were up by 0.61 per cent to Rs. 438 at 11.34 a.m. on the BSE.
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