Alembic Pharma wins USFDA nod for heart disease drug
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-10-29 07:00 GMT | Update On 2025-10-29 07:00 GMT
Advertisement
Vadodara: Alembic Pharmaceuticals Limited has announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, 60 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP.
Ticagrelor tablets are indicated for:
Ticagrelor Tablets, 60 mg, have an estimated market size of US$ 236 million for twelve months ending June 2025 according to IQVIA.
Alembic had previously received final approval for Ticagrelor Tablets, 90 mg.
Alembic has a cumulative total of 227 ANDA approvals (206 final approvals and 21 tentative approvals) from USFDA.
Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.