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Alembic Pharma gets USFDA nod for Ticagrelor 60 mg tablets

29-Oct-25 13:05 Hrs IST

The approved ANDA is therapeutically equivalent to the reference listed drug Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP. Ticagrelor is indicated to reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of MI, and to reduce the risk of stent thrombosis in patients treated for ACS. It is also used to lower the risk of a first MI or stroke in high-risk coronary artery disease (CAD) patients and to reduce stroke risk in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA).

The Ticagrelor 60 mg market in the US is estimated at US$236 million for the 12 months ending June 2025, according to IQVIA. Alembic had earlier received final approval for Ticagrelor 90 mg tablets.

With this approval, Alembic now holds a cumulative total of 227 ANDA approvals from the USFDA, including 206 final approvals and 21 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research-driven company that manufactures and markets generic medicines globally.

The company's consolidated net profit jumped 14.6% to Rs 154.38 crore while revenue from operations grew 9.54% to Rs 1,710.72 crore in Q1 June 2025 over Q1 June 2024.

Shares of Alembic Pharmaceuticals shed 0.29% to Rs 902.70 on the BSE.

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