Alembic Pharmaceuticals announced that the United States Food and Drug Administration (US FDA) has conducted an inspection at its Oncology (Injectable and Oral Solid) Formulation Facility (F-2) at Panelav from 28 February 2024 to 8 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.
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