United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals’ Oncology Injectable Formulation Facility located at Panelav. The inspection was conducted from October 4, 2022 to October 14, 2022. The USFDA issued a Form 483 with 4 procedural observations. None of the observations are related to data integrity and management believes that they are addressable. The Company is preparing the response to the observations, which will be submitted to the USFDA within 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.
