Strides Pharma gets USFDA approval for Mycophenolate Mofetil oral suspension

Pharmaceutical company Strides Pharma on Wednesday announced that its subsidiary, Strides Pharma Global, Singapore, received approval for Mycophenolate Mofetil for Oral Suspension from the United States Food & Drug Administration (USFDA).

The company, in its official communication, informed that Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, is the first product approval from the Bengaluru facility, which achieved USFDA inspection closure in February 2023. The product, which is used to lower natural immunity in organ transplant patients, will be introduced into the market immediately.

According to the pharma company, 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 is expected to boost Strides’ Mycophenolate Mofetil portfolio, which the company is a market leader.