Alembic Scores FDA Nod for Oncology Unit In Panelav, Accelerating Drug Innovation

Alembic Pharmaceuticals Limited, a leading Indian pharmaceutical company, revealed on Monday that its oncology facility in Gujarat has secured an Establishment Inspection Report (EIR) from the US Food and Drug Administration. Situated at Panelav in Gujarat's Panchmahal district, this facility specializes in oncology formulations, both injectable and oral solid, marking a significant regulatory milestone for Alembic.

The company stated in its stock exchange filing, “The company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the inspection carried out by them at our Oncology (Injectable and Oral Solid) Formulation Facility (F-2) at Panelav.”

The pharmaceutical company’s formulation facility underwent inspection from February 28 to March 8. With this milestone, Alembic Pharmaceuticals Limited now holds Establishment Inspection Reports (EIRs) for all its US FDA regulated facilities. The company has notified exchanges that it will unveil its fourth-quarter and FY 2024 results later this week.