USFDA inspection: Gland Pharma gets EIR for Dundigal Facility
Hyderabad: Gland Pharma has announced that the Company has received Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) indicating closure of the inspection at its Dundigal Facility at Hyderabad.
This follows an inspection for Good Manufacturing Practices (GMP) conducted between 22nd July, 2024 and 25th July. In July, the facility received two 483 Observations from the USFDA.
"In continuation to our intimation dated July 25, 2024; this is to inform you that following the Inspection for Good Manufacturing Practices (GMP) by US FDA at the Company’s Dundigal Facility at Hyderabad between 22nd July, 2024 and 25th July, 2024; the Company has received Establishment Inspection Report (EIR) from the US FDA indicating closure of the inspection," the Company stated in a BSE filing.
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