Alembic Pharma drops 2% on USFDA 4 observations for Gujarat facility

The four observations issued are procedural in nature.

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26 Aug, 2025 12:21

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Shares of Alembic Pharmaceuticals fell 2 percent in the early trade on March 11 after the US Food and Drug Administration (US FDA) issued a Form 483 with four observations for the drugmaker's Gujarat plant.

The four observations issued are procedural in nature. The US drug regulator inspected the oncology formulations (injectable and oral solid) unit at Panelav from February 28 to March 8.

The drugmaker said that it would provide a comprehensive response to the FDA within the stipulated period.

At 9.31 am, Alembic Pharma was trading at Rs 988 on the NSE. Over the past three months, shares of the drugmaker have delivered returns of around 29 percent, buoyed by the company's strong performance in Q3.

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The drugmaker reported a net profit of Rs 180.45 crore in the December quarter, up 48 percent from Rs 121.92 crore clocked in the year-ago period. Moreover, its revenue rose around 8 percent on year to Rs 1,630.57 crore during the same quarter.

The strong quarterly performance was aided by the company's robust performance in the India and US market. Easing price erosion, new product launches and waning impact of high-cost inventories helped the company's US revenues which contributed 29 percent of its total sales.

"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," said Alembic Pharmaceuticals MD Shaunak Amin.

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