Alembic Pharma gets USFDA nod for Entacapone tablets

The drug is indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease.

Alembic Pharmaceuticals said it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Entacapone tablets USP, 200 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Comtan tablets (200 mg) of Orion Corporation.

Entacapone tablets USP, 200 mg have an estimated market size of $10.5 million for twelve months ending September 2021 according to IQVIA.

Year to date, Alembic Pharmaceuticals has received 17 approvals (13 final approvals and 4 tentative approvals) and a cumulative total of 156 ANDA approvals (136 final approvals and 20 tentative approvals) from USFDA.

On a consolidated basis, the drug maker's net profit dropped 49.22% to Rs 169.29 crore on 11.31% decline in sales to Rs 1,292.32 crore in Q2 FY22 over Q2 FY21.

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

Shares of Alembic Pharma were up 0.28% at Rs 818.50.

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