Strides Singapore arm bags USFDA nod for Mycophenolate Mofetil for Oral Suspension

Bangalore: Strides Pharma Science Limited has announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), CellCept for Oral Suspension, 200 mg/mL of Roche Palo Alto, LLC. (Roche).

Mycophenolate Mofetil for Oral Suspension belongs to a group of medicines called immunosuppressants. After a transplant, it is used with other medicines to prevent the body from rejecting an organ (such as a kidney, heart, or liver). It works by suppressing the body’s immune system so that it does not attack the new organ.

"The approval bolsters the Company's Mycophenolate Mofetil portfolio, which already includes numerous products in which the Company is a market leader," Strides stated.

The Mycophenolate Mofetil for Oral Suspension has a market size of ~US$41 Mn per IQVIA. The entire Mycophenolate Mofetil range of products for the company has a cumulative market opportunity of ~US$145 Mn per IQVIA.

The products will be manufactured at the company’s facility in Bengaluru.

The company has 280 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 260+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US. 

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