Alembic Pharma gets USFDA final approval for Prazosin Hydrochloride capsules

The drug maker announced that it has received final approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Prazosin Hydrochloride capsules.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Minipress capsules of Pfizer Inc. Prazosin Hydrochloride capsule is indicated for the treatment of hypertension, to lower blood pressure.

Prazosin Hydrochloride capsules has an estimated market size of $50 million for twelve months ending December 2022 according to IQVIA.

Alembic has a cumulative total of 183 ANDA approvals (160 final approvals and 23 tentative approvals) from USFDA.

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

The drug maker reported 29% drop in consolidated net profit to Rs 121.92 crore despite a 18.7% rise in net sales to Rs 1,509.02 crore in Q3 FY23 over Q3 FY22.

The scrip was down 0.88% to Rs 521 on the BSE.

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