USFDA approves Alembic Pharma Dabigatran Etexilate Capsules
Mumbai: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA Dabigatran Etexilate...
Mumbai: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd