Granules India gets USFDA nod for generic Ibuprofen tablets

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26 Aug, 2025 12:21

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Drug maker Granules India has received approval from the US health regulator to market generic Ibuprofen tablets - used to treat fever, pain or inflammation - in the American market. The Hyderabad-based company said US Food and Drug Administration (USFDA) has approved its abbreviated new drug applications (ANDA) for Ibuprofen tablets in strengths of 400 mg, 600 mg, and 800 mg. "It's my pleasure to state that USFDA completed the review of Ibuprofen ANDA filed by us and has given its final approval," Granules India Chairman & Managing Director, C Krishna Prasad said in a statement.

The approval will further strengthen the company's base business and enable it to increase its product offering to customers in the US, he added. Granules India produces finished dosages, pharmaceutical formulation intermediates and active pharmaceutical ingredients (APIs).