Strides Pharma bags USFDA nod for pain relief drug

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

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu.

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare.

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The medicine will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

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 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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