Strides Shasun receives USFDA approval for Ranitidine tablets

First integrated product approval post-merger

Strides Shasun has received approval from the United States Food & Drug Administration (US FDA) for Ranitidine tablets USP, 150 mg and 300 mg.

Ranitidine tablet has received integrated product approval by which the API and formulations will be manufactured at erstwhile Shasun Pharmaceutical’s Cuddalore and Pondicherry facilities respectively. According to IMS data (MAT June 2016), the US market for Ranitidine tablets USP, 150 mg and 300 mg is approximately $125 million.

The product, to be launched immediately, will be marketed by Strides Pharma in the US market.