Strides Pharma Gets USFDA Nod for Generic Pain Relief Drug

New Delhi, Jan 20 (PTI) Strides Pharma Science Ltd on Monday said its wholly-owned arm Strides Pharma Global Pte. Limited, Singapore, has received approval from the US health regulator for its generic pain-relieving Acetaminophen and Ibuprofen tablets.

The approval by the US Food & Drug Administration (USFDA) is for generic over-the-counter (OTC) Acetaminophen and Ibuprofen tablets of strength 125 mg /250 mg, Strides Pharma Science said in a statement.


The product is bioequivalent to the reference listed drug (RLD), Advil Dual Action with Acetaminophen, 125 mg /250 mg (OTC), of Haleon US Holdings LLC, it added.

"The addition of the Acetaminophen and Ibuprofen tablets, 125 mg /250 mg (OTC) will significantly enhance our existing portfolio of OTC products. By offering a dual-action pain relief option, we aim to cater to a broader patient base, providing effective and accessible solutions for pain management," the company said.

Acetaminophen and Ibuprofen tablets will be manufactured at the company's flagship facility in KRSG, Bengaluru, it added.