Alembic Pharma gets 4 USFDA observations for Panelav facility

Vadodara: Alembic Pharma has announced that the Company has received a Form 483 with four procedural observations from the United States Food and Drug Administration (US FDA) after the inspection at the Company's Oncology (Injectable and Oral Solid) Formulation Facility (F-2) at Panelav.

The inspection was held from 28th February, 2024 to 8th March, 2024.

"The Company will provide comprehensive response to USFDA for the observations within the stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times," Alembic Pharma stated in a BSE filing.

The US FDA issued a Form 483 with four procedural 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. 

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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. The company was founded in 1907. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

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