Granules gets USFDA nod for anti-inflammatory drug

Pharma firm Granules on Thursday said it has received approval from the US health regulator for anti-inflammatory drug Ibuprofen tablets, in the US market.

"US FDA has approved Abbreviated New Drug Application (ANDA) for Ibuprofen tablets USP, 200 mg (OTC) filed by Granules India Ltd," the company said in a BSE filing.

The approved ANDA is bioequivalent to the reference listed drug product (RLD), Motrin IB Tablets, 200 mg, of Johnson & Johnson Consumer, Inc, it added.

Shares of Granules India Ltd were trading 0.62 per cent higher at Rs 121 on BSE.