The United States Food and Drug Administration (US FDA) has conducted an inspection at Alembic Pharmaceuticals Limited's oncology (Injectable and Oral Solid) formulation facility (F-2) at Panelav from 28th February, 2024 to 8th March, 2024. The US FDA issued a Form 483 with four procedural observations.

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.