Granules India Limited announced on July 14 that the US Food & Drug Administration (USFDA) had approved its drug application filed by Granules Pharmaceuticals, Inc, a wholly-owned foreign subsidiary of the company, for Acetaminophen and Ibuprofen Tablets.

This product will be launched via the Granules Consumer Health division.

Acetaminophen and Ibuprofen Tablets temporarily relieve minor aches and pains caused due to headaches, toothaches, menstrual cramps, backaches, muscular aches, and minor pain of arthritis.

Granules now have 59 drug applications, out of which 57 have final approval from the USFDA, and 2 have tentative approval.

The Advil Dual Action with Acetaminophen Tablets (OTC) brand and store brands had combined US sales of approximately $70 million for the most recent twelve months based on the IRI multi-outlet market.

Advil is a registered trademark of GlaxoSmithKline Consumer Healthcare Holdings.

On July 13, USFDA issued an Establishment Inspection Report for the Gagillapur facility of the Company in India.

This facility, which manufactures finished dosages and Pharmaceutical Formulation Intermediates, was inspected by the USFDA as a part of a PAI in January 2023.

At 9:40 am, Granules India quoted Rs 302.95, up Rs 0.60, or 0.2%.