United States Food and Drug Administration (USFDA) has concluded an inspection at Alembic Pharmaceuticals’ API-I & II facility located at Panelav, Gujarat. The inspection was conducted from May 26, 2025 to May 31, 2025. This was an un-announced and routine cGMP inspection. The USFDA issued a Form 483 with four observations. None of the observations are related to data integrity and management believes that they are addressable.
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 is principally engaged in the manufacturing and selling of pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.
