Alembic Pharmaceuticals rose 1.03 per cent to Rs 768.20 after the company announced that it’s Abbreviated New Drug Application (ANDA) for pirfenidone tablets had received final approval from the United States Food and Drug Administration (USFDA).

The approved ANDA is therapeutically equivalent to Genentech’s Reference Linked Drug (RLD) Esbriet tablet. Pirfenidone is used to treat a certain lung disease called Idiopathic Pulmonary Fibrosis (IPF). The disease causes the lungs to become scarred and stiff, making it difficult to breathe.

According to IQVIA, the market size for pirfenidone tablets is estimated at $548 million in the twelve months to December 2021. The company has settled with Genetech and will launch under the settlement terms.
Alembic has cumulatively received 167 ANDA approvals from the USFDA, out of which 144 are waiting for final approvals, and 23 are waiting for tentative approvals.

Alembic Pharmaceuticals is a vertically integrated R&D pharmaceutical company. It manufactures and sells generic drugs around the world. On a consolidated basis, the company reported a 3.2 per cent drop in net sales to Rs 1,271.7 crore and a 39.7 per cent drop in net profit to Rs 1,764.2 crore in the fourth quarter of fiscal 2022 compared to the fourth quarter of fiscal 2021.