Strides Pharma Science’s step-down wholly owned subsidiary -- Strides Pharma Global, 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). 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 $41 million per IQVIA. The entire Mycophenolate Mofetil range of products for the company has a cumulative market opportunity of $145 million per IQVIA. The products will be manufactured at the company’s facility in Bengaluru.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
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