Granules India secures FDA nod to hypertension drug but share price falls

The company now has a total of 54 ANDA approvals from USFDA, including 52 final approvals and 2 tentative approvals.

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Granules India share price erased the opening gains and traded lower in the first hours of trading on Monday despite the USFDA approval for its Losartan Potassium tablets.

At 9:34am, Granules India traded at Rs 283.65, down Rs 1.65, or 0.58 percent, on the BSE.

The US Food & Drug Administration (USFDA) has approved Granules India‘s abbreviated new drug application (ANDA) for Losartan Potassium tablets USP, 25 mg, 50 mg, and 100 mg, company said in its release. The drug is a bioequivalent to the reference listed drug product (RLD), Cozaar tablets of Organon LLC.

The company now has a total of 54 ANDA approvals from the US drug regulator, including 52 final approvals and two tentative approvals, it added.

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Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients six years of age and older, to lower blood pressure.

The current annual US market for Losartan potassium Tablets is approximately USD 336 million, according to MAT Dec 2022, IQVIA/IMS Health.