Alembic Pharma clears USFDA inspection at oncology unit in Panelav
This was a first scheduled inspection and Alembic Pharma passed the inspection without any Form 483 Observation.
New Delhi: Alembic Pharmaceuticals (Alembic Pharma) recently announced that the United States Food and Drug Administration (US FDA) has conducted an inspection at Company's Solid Oral Oncology facility located at Panelav.
Alembic Pharma's Panelav plant houses active pharmaceutical ingredients (APIs) and formulation manufacturing.
The inspection for the facility was conducted from 24 June 2019 to 28 June 2019.
"The United States Food and Drug Administration (US FDA) has conducted an inspection at Company's Solid Oral Oncology facility located at Panelav from 24 June 2019 to 28 June 2019," the company said in a BSE filing.
"This was a first scheduled inspection and Company passed the inspection without any Form 483 Observation, " the company added.
Form 483 is issued by the USFDA to notify a company's management of any objectionable condition at its manufacturing facility. The form is issued after completing the inspection.
Headquartered in Gujarat, the company is involved in manufacture of pharmaceutical products, pharmaceutical substances and intermediates.
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