Granules India gets USFDA approval for Ranitidine Tablets USP

The US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India for Ranitidine Tablets USP, 150 mg and 150 mg Cool Mint (OTC). The approved ANDA is the bioequivalent to Reference Listed Drug (RLD) of Maximum Strength Zantac Tablets, 150 mg, of Sanofi-aventis US. LLC. Granules India intends to commercialise this product shortly.

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