Strides Pharma gets US FDA approval for generic Ibuprofen oral suspension
The product will be manufactured at the company’s facility in Bengaluru and will be marketed by Strides Pharma Inc in the US market
Strides Pharma yesterday said its Singapore-based arm has received approval from the US health regulator for generic Ibuprofen oral suspension, which is used to relieve pain from various conditions.
The approval granted to the company’s step-down wholly-owned subsidiary Strides Pharma Global, Singapore, by the US Food and Drug Administration (FDA) is for Ibuprofen oral suspension of the strength of 100 mg/5 ml, the company said in a statement.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Motrin oral suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil), it added.
The product will be manufactured at the company’s facility in Bengaluru and will be marketed by Strides Pharma Inc in the US market.
Citing IQVIA MAT March 2022 data, the company said the US market for Ibuprofen oral suspension 100 mg/5 ml is approximately $66 million.
Edits by EP News Bureau
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