Strides receives USFDA approval for Ibuprofen Oral Suspension

Strides Pharma Science (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Ibuprofen Oral Suspension USP, 100 mg/5 mL from the United States Food & Drug Administration (USFDA). 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).

According to IQVIA MAT March 2022 data, the US market for Ibuprofen Oral Suspension USP, 100 mg/5 mL is approximately ~US$ 66 Mn. The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

The company has 274 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 250 ANDAs have been approved and 24 are pending approval. The company currently has ~60 commercialized products in the US and has set a target to launch ~ 20 new products every year from the combined portfolio

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