United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals’ oncology injectable formulation facility at Panelav from October 4-14, 2022. The USFDA issued a Form 483 with four procedural observations.
These observations and subsequent delays in approvals could further elongate payback of Alembic's massive US focused capex. However, none of the observations were related to data integrity.
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