United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals’ Oncology (Injectable and Oral Solid) Formulation Facility (F-2) at Panelav from February 28, 2024 to March 8, 2024. The USFDA issued a Form 483 with four procedural observations. The company will provide comprehensive response to USFDA for the observations within the stipulated period.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.