Strides Shasun receives USFDA approval for Ibuprofen OTC Tablets

Product further strengthens Strides Ibuprofen franchise for the US markets 

Bangalore, July 04, 2018: Strides Shasun Limited today announced that its wholly owned subsidiary Strides Pharma Global Pte. Ltd. has received final approval for Ibuprofen Tablets USP, 200 mg (OTC) from the United States Food & Drug Administration (US FDA). Ibuprofen Tablets 200 mg (OTC) is a generic version of Motrin® IB Tablets, 200 mg, of Johnson & Johnson Consumer, Inc.

The approval further strengthens Strides Ibuprofen franchise for the US markets that now comprises of 7 approved products addressing a combined Rx and OTC opportunity of US$ 900 Mn as per IMS and IRi data. The product will be manufactured at the Company’s Oral dosage facility at Puducherry and will be marketed by Strides Pharma Inc. in the US Market.

The company has 75 cumulative ANDA filings with US FDA of which 51 ANDAs have been approved as of date and 24 are pending approval.

Corporate Comm India(CCI Newswire)