Alembic Pharmaceuticals gets USFDA nod for hypertension drug

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Chlorthalidone Tablets USP.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets of Sanofi Aventis US. LLC (Sanofi).

Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or; to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

According to IQVIA, Chlorthalidone Tablets USP have an estimated market size of $37 million for twelve months ending June 2022.

Alembic has a cumulative total of 171 ANDA approvals (147 final approvals and 24 tentative approvals) from USFDA.

Meanwhile, the pharmaceutical company also announced that it has completed the USFDA Remote Regulatory Assessment (RRA) for its bioequivalence facility, bio-analytical division, located at Vadodara, without any observations. The RRA was conducted from 22 August 2022 to 26 August 2022.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

The drug maker reported consolidated net loss of Rs 65.88 crore in Q1 FY23 as against a net profit of Rs 164.52 crore posted in Q1 FY22. Net sales fell 4.8% year on year to Rs 1,262.14 crore in the quarter ended 30 June 2022.

Shares of Alembic Pharmaceuticals were up 0.75% to Rs 655.30 on the BSE.

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