Alembic Pharma Karkhadi facility gets EIR from USFDA
Vadodara: Alembic Pharma has announced that the Company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the inspection carried out at the company's Injectable Facility (F-3) at Karkhadi from 18th August, 2022 to 30th August, 2022.
This was a pre-approval inspection for ANDAs filed with the USFDA.
"The Company has already started receiving ANDA approvals manufactured at this facility," Alembic informed in a BSE filing.
Medical Dialogues team had earlier reported that the USFDA had issued a Form 483 with 2 observations after the inspection at the company's Injectable Facility (F-3) located at Karkhadi.
Read also: USFDA issues 2 observations for Alembic Pharma Karkhadi facility
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. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. The company was founded in 1907.
Read also: Alembic Pharma bags USFDA nod for mantle cell lymphoma drug Acalabrutinib
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