Shares of Alembic Pharmaceuticals Ltd slumped 2% on 11 March after the USFDA issued a Form 483 with 4 observations from its Gujarat plant.

In its regulatory filing, the company said that the US Food and Drug Administration (USFDA) has issued 4 observations from its oncology formulation facility at Panvel, Gujarat. The US regulator had inspected its Gujarat plant from 28 February to 8 March.

The company said that it would provide a comprehensive response to the US regulator within the stipulated period.

In its quarterly report for October-December, the company reported a 48% year-on-year increase to Rs 180.45 crore for the quarter from Rs 121.92 crore reported in the same quarter last year.

The revenue stood at Rs 1,630.57 crore, marking a 8% YoY increase from the same quarter of the previous fiscal year.

Shaunak Amin, MD of Alembic Pharmaceuticals, said, “The India branded business was underpinned by a continued incremental improvement in core operations. The speciality and animal health segments continued its strong performance; whereas the acute performance was relatively satisfactory despite challenging market conditions.”

At 12:57 pm, the shares of Alembic Pharma were trading 2.33% lower at Rs 975.95 on NSE.