United States Food and Drug Administration (USFDA) has concluded an inspection at Alembic Pharmaceuticals’ Bioequivalence facility located at Vadodara. The inspection was conducted from March 03, 2025 to March 07, 2025. This was a scheduled inspection. The USFDA issued a form 483 with one procedural observation.
The Company will provide comprehensive response to USFDA for the observations within the stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
