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Strides Shasun Limited has received approval from the United States Food & Drug Administration (FDA) for ranitidine tablets USP, 150 mg and 300 mg. The product to be launched immediately and will be marketed by Strides Pharma Inc in the US market.
Ranitidine tablet is the first integrated product approval where the API and formulations will be manufactured at erstwhile Shasun Pharmaceutical’s Cuddalore and Pondicherry facilities respectively.
The drug is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat problems. Ranitidine belongs to a class of drugs known as H2 blockers.
According to IMS data (MAT June 2016), the US market for ranitidine tablets USP, 150 mg and 300 mg. is approximately US$ 125 million.
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