Alembic Pharma gets USFDA nod for antidepressant drug

The drug maker said that it has received final approval from the US Food & Drug Administration (USFDA) for its ANDA for desipramine hydrochloride tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.

The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Norpramin tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, of Validus Pharmaceuticals.

The drug is indicated for the treatment of depression. The tablets have an estimated market size of $7 million for twelve months ending March 2021 according to IQVIA.

Alembic has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA.

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

On a consolidated basis, the company's net profit jumped 16.7% to Rs 237.41 crore on 6.1% increase in net sales to Rs 1,280.39 crore in Q4 FY21 over Q4 FY20.

The scrip rose 0.32% to currently trade at Rs 988.70 on the BSE.

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