Granules India gets USFDA nod for Losartan Potassium tablets

The pharmaceutical company announced that it has received approval from US Food and Drug Administration (USFDA) for its abbreviated new drug and application (ANDA) for Losartan Potassium tablets.

The said drug is bioequivalent to the reference listed drug product (RLD), Cozaar Tablets of Organon LLC. Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.

The current annual U.S. market for Losartan Potassium tablets is approximately $336 million, according to MAT Dec 2022, IQVIA/IMS Health.

The Granules now has a total of 54 ANDA approvals from USFDA (52 final approvals and 2 tentative approvals).

Granules India is a vertically integrated fast growing Indian pharmaceutical company. It is present across the entire manufacturing value chain - from active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).

Granules India reported 23.24% jump in net profit to Rs 124.32 crore on a 15% increase in revenue from operations to Rs 1,146.12 crore in Q3 FY23 over Q3 FY22.

The scrip shed 0.09% to Rs 285.05 on the BSE.

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