Aurobindo Pharma shares trade lower after US FDA slaps 10 observations

The observations are procedural in nature and will be responded to within the stipulated time, while the plant is yet to start commercial operations, company said.

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The share price of Aurobindo Pharma took a hit in the opening trade on December 26 after the company’s arm received 10 observations from the United States Food and Drug Administration (USFDA).

At 9:31pm, Aurobindo Pharma was quoting at Rs 1,060.00, down Rs 6.15, or 0.58 percent, on the BSE.

The USFDA conducted a pre-approval inspection (PAI) at its new injectable facility of Eugia US Manufacturing LLC, a step-down wholly owned subsidiary of Aurobindo Pharma Ltd, situated at East Windsor, New Jersey, USA.

The inspection was conducted from December 11 to 22, 2023 and closed with 10 observations. The observations are procedural in nature and will be responded to within the stipulated time, while the plant is yet to start commercial operations, it added.

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Last week, the USFDA had classified a plant operated by its subsidiary APL Healthcare in Tirupati, Andhra Pradesh as “Voluntary Action Indicated” (VAI), on identifying deficiencies during its inspection that, while noteworthy, do not warrant official regulatory action.

The inspection was conducted at Unit IV of APL Healthcare Limited, a wholly owned subsidiary of the company, situated at Menakuru Village, under the Naidupeta Mandal, in Tirupati District of Andhra Pradesh.

The company had reported an 85 percent year-on-year rise in consolidated net profit to Rs 757 crore for the July-September quarter of the current financial year.