Strides Receives USFDA Approval For Mycophenolate Mofetil For Oral Suspension

Strides Pharma Science Limited (Strides) on Wednesday 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 company announced through an exchange filing.

About the product

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

The Mycophenolate Mofetil for Oral Suspension has a market size of approximately US$41 Million per IQVIA.

The entire Mycophenolate Mofetil range of products for the company has a cumulative market opportunity of approximately US$145 Million 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 approximately 60 new products over three years in the US.

Strides Pharma Science Limited shares

The shares of Strides Pharma Science Limited on Wednesday at 3:02 pm IST were at Rs 439, up by 0.69 percent.