The tablets are used to treat fever, pain or inflammation in the US market
Drug maker Granules India has received approval from the US Food and Drug Administration (US FDA) to market generic Ibuprofen tablets. It is used to treat fever, pain or inflammation in the US market.
The Hyderabad-based company said US FDA 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 US FDA completed the review of Ibuprofen ANDA filed by us and has given its final approval,” said C Krishna Prasad, Chairman and Managing Director, Granules India.
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).