Aurobindo Pharma trades down after 7 observations on Telangana unit from USFDA

Aurobindo Pharma: The United States Food and Drug Administration (US FDA) inspected the injectable facility of Eugia SEZ, a step-down subsidiary of the pharma company at Mahaboobnagar, Telangana, during February 19–29. The health regulator closed the inspection with seven observations that were procedural in nature. Meanwhile, Eugia Pharma Specialties has restarted production in its terminally sterilized product lines at its Unit-III, which was temporarily stopped to address some of the observations of the USFDA in their recent inspection concluded on February 2, 2024. Aurobindo expects to start the production in the aseptic lines of the facility in March 2024.

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26 Aug, 2025 12:21

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Shares of Aurobindo Pharma were down marginally in the opening trade on March 1 after the company received seven observations from the United States Food and Drug Administration (USFDA).

At 9:17am, Aurobindo Pharma was quoting Rs 1,026.45, down Rs 1.00, or 0.10 percent, on the BSE.

The USFDA inspected the injectable facility of Eugia SEZ Pvt Ltd, a 100 percent step-down subsidiary of Aurobindo Pharma Ltd, at Polepally Village in Mahaboobnagar district of Telangana, from February 19 to 29.

The inspection closed with seven observations, which are procedural in nature and need be clarified within the stipulated time, the company said.

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Eugia Pharma Specialities Limited has restarted production in its terminally sterilised product lines at its Unit-III, that was temporarily stopped to address some of the observations of the USFDA in their recent inspection concluded on February 2.

"We expect to start the production in the aseptic lines of the facility in the March 2024," said Aurobindo Pharma.

Broking house Sharekhan in its report dated February 20, has downgraded the stock to 'hold' with a revised price target of Rs 1,133 per share.

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