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02-Apr2018

Strides Shasun receives USFDA's approval for Ibuprofen Softgel OTC capsules

Strides Shasun's wholly owned subsidiary - Strides Pharma Global has received approval for Ibuprofen Capsules, 200 mg OTC from the United States Food & Drug Administration (USFDA). This is a pre- GDUFA file for the company and the approval has come through after a long approval cycle of almost 6 years. The approval further strengthens Strides global ibuprofen portfolio that now includes multiple products in oral dosage format.

Ibuprofen Capsules is generic version of Advil Liqui-Gels, 200 mg, of Pfizer Inc. According to IRi data, the US OTC market for Ibuprofen Capsules is around $300 million including an attractive private label market of $60 million.

Strides Shasun is a vertically integrated global pharmaceutical Company headquartered in Bangalore. The company has 74 cumulative ANDA filings with USFDA of which 45 ANDAs have been approved as of date and 29 are pending approval.


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