Alembic Pharma gets four USFDA observations for Panelav facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-06-02 09:33 GMT | Update On 2025-06-02 09:33 GMT
Vadodara: Alembic Pharma has announced that the United States Food and Drug Administration (US FDA) has issued four observations after an inspection at the company's API-I & II Facility located at Panelav.
The facility was inspected from 26th May, 2025 to 31st May, 2025.
This was an un-announced and routine cGMP inspection.
The USFDA issued a Form 483 with four observations. 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.
"None of the observations are related to data integrity and management believes that they are addressable. The Company will provide comprehensive response to USFDA for the observations within the stipulated period," Alembic stated in a BSE filing.
Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
Read also: Alembic Pharma bags USFDA nod for cardiovascular disease drug Ticagrelor in two strengths
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