Strides Shasun gets US regulator nod for Ibuprofen capsules

Pharma-major Strides Shasun on Monday said it has received United States Food & Drug Administration (USFDA) approval for generic pain reliever Ibuprofen capsules.

The firm's wholly-owned subsidiary Strides Pharma Global has received nod for 200-mg Ibuprofen capsules from the US health regulator, Strides Shasun said. The nod comes after an approval cycle of almost six years.

The US over-the -counter market for the painkiller is $300 million, including a private label market of $60 million. The Bengaluru-based company looks garner at least 20 per cent of this private label market share. The product will be commercialised in fourth quarter of the current financial year and will be manufactured at the company's oral dosage unit in Bengaluru.

The company has 74 cumulative abbreviated new drug application filings with USFDA of which 45 have been approved and 29 are pending approval.