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Granules India foreign subsidiary gets USFDA approval

Jul 14, 2023

By: BlinkX Research Team

The US Food & Drug Administration (US FDA) has authorised Granules Pharmaceuticals, Inc. (GPI), a fully-owned foreign subsidiary of the company, to market Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC). This information was released by Granules India Limited today. 

It is bioequivalent to GlaxoSmithKline Consumer Healthcare Holdings (US) LLC's Advil Dual Action with Acetaminophen Tablets, 250mg/125 mg (OTC), a reference listed drug (RLD). Through the Granules Consumer Health (GCH) division, this product will be introduced, the company said in the filing. 

Ibuprofen and Acetaminophen tablets are used to provide short-term relief for a variety of minor aches and pains, including those caused by headache, toothache, backache, menstrual cramps, muscular aches and mild arthritis pain, Granules India said in the release. The US FDA has currently approved 59 ANDAs for granules (57 Final approvals and 2 TBD approvals). 

According to IRI multi-outlet market data, the total U.S. sales for the Advil Dual Action with Acetaminophen Tablets (OTC) brand and store brands for the most recent twelve months were around $70 million. 

Advil is a registered trademark of GlaxoSmithKline Consumer Healthcare Holdings (US). 

Founded in 1991 and with its headquarters in Hyderabad, Granules India Limited is a vertically integrated, rapidly expanding Indian pharmaceutical firm dedicated to operational excellence, product quality, and customer service.

Source: Media Reports