The generic drug Mycophenolate Mofetil for oral suspension, which is used in organ transplant patients to prevent rejection, has been approved by the US health agency, Strides Pharma Science Ltd. on Wednesday said.
The approval granted by the US Food & Drug Administration (USFDA) is for Mycophenolate Mofetil for oral suspension of strength 200 mg/ml, Strides Pharma Science said in a regulatory filing.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), CellCept for oral suspension, 200 mg/m; of Roche Palo Alto, LLC, it added.
The approval bolsters the company’s Mycophenolate Mofetil portfolio, which already includes numerous products, it added.
The product will be manufactured at the company’s facility in Bengaluru, Strides said.
Mycophenolate Mofetil for oral suspension has a market size of USD 41 million, the company said citing IQVIA data.
According to the company filing, total consolidated revenue declined by 1.5% from Rs. 953.6 Cr in Q1 FY23 to Rs. 938.6 Cr in Q1 FY24. The company reported a net profit of Rs. 0.30 cr in Q1 FY24 against a loss of Rs. 163.4 Cr in Q1 FY23.
Currently, company shares trading at 0.60% up at 438.60, as per the latest shareholding information, Promoters hold 28.07%, Public holds 35.12%, FIIs hold 16.67% and DIIs hold 20.05% stake in this company.
The development and production of finished dosage formulations and generic pharmaceutical products are performed by Strides Pharma Science Ltd (Strides Pharma), formerly known as Strides Shasun Ltd. The business produces pills, topicals, oral liquids, powders, and capsules made of soft and firm gelatin.
