Alembic Pharma gets 4 observations from USFDA for Panelav facility
Gujarat: Alembic Pharmaceuticals has announced that the US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals General Oral Solid Formulation Facility located at Panelav from 9 th March 2020 to 13th March 2020. This was a scheduled inspection and at the end of the inspection, the USFDA issued a Form 483 with four procedural observations.
None of the observations is related to data integrity or repetitive in nature.
"The Company will provide comprehensive corrective action report to address each observation. The Company is committed to maintaining the highest quality standards that meet USFDA standards" Alembic stated
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic 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. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.