Alembic Pharma slips as US FDA issues Form 483 to Panelav facility

Alembic Pharmaceuticals declined 1.26% to Rs 562.35 after the firm received a Form 483 with four procedural observations for an inspection conducted by USFDA at its Panelav formulation facility.

The company said that the oncology injectable formulation facility at Panelav was inspected by United States Food and Drug Administration (US FDA) from 4 October 2022 to 14 October 2022.

At the end of the inspection, the pharmaceutical company was issued with four procedural observations by the US drug regulator. None of the observations are related to data integrity and management believes that they are addressable, the drug maker stated.

The pharma major also added that it is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The company stated that it is committed to maintain the highest quality standards and compliance at all times.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

The company reported a cconsolidated net loss of Rs 65.88 crore in Q1 FY23 as against a net profit of Rs 164.52 crore posted in Q1 FY22. Net sales fell 4.8% year on year to Rs 1,262.14 crore in the quarter ended 30 June 2022.

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