Alembic Pharma gets USFDA EIR for Oncology Injectable Formulation Facility at Panelav
Vadodara: Drugmaker Alembic Pharma has recently announced that the Company has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for its Oncology Injectable Formulation Facility at Panelav.
The facility was inspected from 4 th October, 2022 to 14th October, 2022.
"This is to inform the exchange that the Company has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out by them at our Oncology Injectable Formulation Facility at Panelav during the period from 4th October, 2022 to 14th October, 2022," Alembic Pharma stated in a BSE filing.
Read also: Alembic Pharma osteoarthritis drug gets USFDA okay
Medical Dialogues had earlier reported that the United States Food and Drug Administration (USFDA) had issued a Form 483 with 4 procedural observations after an inspection of the Panelav facility. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Read also: Alembic Pharma Panelav facility gets 4 USFDA observations
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. It is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. Products under International Generics are manufactured across our world-class facilities in Panelav, Karkhadi, and Jarod in Gujarat. Under this vertical, the company also has R&D facilities in Vadodara (Gujarat), Hyderabad (Telangana), and New Jersey (USA).
Read also: Alembic Pharma bags USFDA nod for Hypertension drug Nifedipine Extended Release
