Alembic Pharma gets USFDA nod for Nifedipine tablets

The drug maker has received US Food & Drug Administration (USFDA) final approval for Nifedipine extended-release tablets USP, 30 mg, 60 mg and 90 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Procardia XL extended-release tablets, 30 mg, 60 mg and 90 mg, of Pfizer Inc.

The drug is indicated for the management of vasospastic angina, chronic stable angina (classical effort-associated angina) and hypertension.

Nifedipine extended-release tablets USP, 30 mg, 60 mg and 90 mg, have an estimated market size of $56 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has a cumulative total of 177 ANDA approvals (153 final approvals and 24 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 consolidated basis, net profit declined 18.7% to Rs 133.35 crore despite of 14.1% jump in revenue from operations to Rs 1,475.01 crore in Q2 FY23 over Q2 FY22.

The scrip advanced 0.69% at Rs 629.65 on the BSE.

Powered by Capital Market - Live News