Alembic Pharma Slips 2% as US FDA Issues Observations for Gujarat Plant

11 Mar 2024 , 12:20 PM

Alembic Pharmaceuticals witnessed a 2% decline in early trade on March 11 following the issuance of a Form 483 by the US Food and Drug Administration (US FDA) for its Gujarat plant.

The FDA inspection focused on the oncology formulations unit at Panelav, conducted from February 28 to March 8, resulting in four procedural observations.

Alembic Pharma assured that it would provide a comprehensive response to the FDA within the stipulated period.

As of the latest update, Alembic Pharma’s shares were trading at ₹989.65 on the NSE, having delivered a return of approximately 29% in the past three months, driven by a strong Q3 performance.

In the December quarter, the company reported a net profit of ₹180.45 Crore, marking a 48% increase from the year-ago period. Revenue also rose by around 8% YoY to ₹1,630.57 Crore during the same quarter.

The robust quarterly performance was attributed to strong showings in the India and US markets, supported by factors such as reduced price erosion, new product launches, and the diminishing impact of high-cost inventories in the US, which contributed 29% to total sales.

Alembic Pharmaceuticals MD Shaunak Amin highlighted the incremental improvement in core operations, with the India branded business, speciality, and animal health segments showing strong performances despite challenging market conditions.

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