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EquityWireUS FDA issues 8 observations to Aurobindo Pharma's mfg unit in Telangana

US FDA issues 8 observations to Aurobindo Pharma's mfg unit in Telangana

This story was originally published at 20:06 IST on 5 September 2025
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Informist, Friday, Sept. 5, 2025

 

--US FDA issues 8 observations to Aurobindo Pharma's unit in Telangana

 

MUMBAI – Aurobindo Pharma Ltd. Friday said the US Food and Drug Administration has issued eight observations to the company's oral solid and injectable manufacturing unit at Bachupally in Telangana. The drug regulator has inspected the unit from Aug. 25 to Friday, the pharmaceutical company said in an exchange filing. "We will respond to the US FDA within the stipulated timelines," it said. 

 

For the quarter ended June, the company had reported a consolidated net profit of INR 8.25 billion on revenue of INR 78.68 billion. Its shares closed at INR 1,044.10 Friday on the National Stock Exchange, up 0.8%.  End

 

Reported by Anjana Therese Antony

Edited by Akul Nishant Akhoury

 

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