On Wednesday, USFDA approved Drug firm Strides Pharma Science to launch Ibuprofen Oral Suspension USP, 100 mg/5 mL.
It confirmed about receiving the approval from United States Food and Drug Administration in a regulatory filing.
Strides Pharma Global Pte Ltd is a step-down wholly owned subsidiary of Strides Pharma Science.
The approved product is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions.
This includes headache, dental pain, muscle aches besides relieving minor aches and pain due to the common cold or flu.
It is a generic version and therapeutically equal to the reference listed drug (RLD), Children’s Motrin Oral Suspension, 100 mg/mL.
Moreover, Strides aims to specialize in constructing a non-public label enterprise within the US.
This is via leveraging its portfolio of merchandise throughout delicate gels, tablets, capsules, topicals, powders and oral options.
Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC) plans to boost the company’s private label portfolio for the US market.
Currently, the company has 127 new drug applications out of which 99 have received approval.
However, 28 ANDAs are still pending for approval.
US market for Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC) is estimated to be around USD 133 million.
The corporate will manufacture the product at the firm’s facility in Bengaluru.
BSE recorded the shares of Strides Pharma Science trading 0.32 per cent higher at Rs 856.50 a piece
Strides can launch the product earliest by September 2022 based on terms of settlement.
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