Alembic Pharma gets USFDA EIR for Panelav Oncology formulation facility
Vadodara: Alembic Pharma has announced that the Company has received an
Establishment Inspection Report (EIR) from the US Food and Drug Administration (US
FDA) for the inspection carried out at the Oncology (Injectable and Oral Solid)
Formulation Facility (F-2) at Panelav.
The USFDA had inspected the facility from 28th February, 2024 to 8th March, 2024 and issued a Form 483 with four procedural observations.
“With this, for all our USFDA facilities, EIRs are in place,” the Company stated in a BSE filing.
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Headquartered in Vadodara, Gujarat, Alembic Pharmaceuticals Limited is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. The company was founded in 1907. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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