In a BSE filing, Strides Shasun said "it has received approval from the US Food and Drug Administration (USFDA) for Ranitidine tablets USP, 150 mg and 300 mg".
The company will manufacture the product at its Cuddalore and Pondicherry facilities.
According to IMS sales data, the US market for Ranitidine tablets USP, 150 mg and 300 mg is around USD 125 million.
Strides Shasun's shares were trading 1.35 per cent higher at Rs 970.50 apiece on BSE.