Gland Pharma gets USFDA EIR for Pashamylaram Facility
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Hyderabad: Gland Pharma has announced that the Company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) indicating the inspection closure at its Pashamylaram Facility in Hyderabad.
The US regulator had conducted the Pre-Approval Inspection (PAI) for Seven (7) products and Good Manufacturing Practice (GMP) Inspection at the facility between 15th June, 2023 and 27th June, 2023 and issued one 483 observation.
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