Shares of Granules India erased their opening gains and traded lower in the first hours of trading on Monday despite the US Food and Drug Administration’s approval of its losartan potassium tablets.

At 9:34 am, Granules India was trading at Rs 283.65 on the BSE, down Rs 1.65 or 0.58%.

The United States Food and Drug Administration (USFDA) has approved Granules India’s Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25mg, 50mg and 100mg, the company said in its press release. The drug is bioequivalent to Cozaar tablets from the Reference Listed Drug (RLD), Organon LLC.

The company added that the company now has 54 ANDA approvals from US drug regulators, including 52 final approvals and two tentative approvals.

Losartan Potassium is indicated for treating hypertension in adults and paediatric patients six years and older to lower blood pressure.

According to MAT Dec 2022, IQVIA/IMS Health, the current annual market for losartan potassium tablets in the US is approximately $336 million.