Which pharmaceutical company received USFDA approval for Albendazole Tablets USP (200 mg), a generic equivalent to Impax Laboratories' Albenza?

A)
Ajanta Pharma
B)
Aurobindo Pharma
C)
Alembic Pharmaceuticals
D)
Glenmark Pharmaceuticals

Correct Answer :   Alembic Pharmaceuticals


Alembic Pharmaceuticals received approval from the US Food and Drug Administration (USFDA) for its Albendazole Tablets USP (200 mg), a generic version of Impax Laboratories' Albenza.

This approval allows Alembic Pharma to market its generic tablets, which are used to treat infections such as parenchymal neurocysticercosis and cystic hydatid disease caused by worm larvae.

The approved ANDA (Abbreviated New Drug Application) is therapeutically equivalent to Impax Laboratories' Albenza tablets.

Published On : September 6, 2024