US FDA completed inspection of Aurobindo Pharma’s Unit-XII at Bachupally, Telangana, issuing eight procedural observations. The company said there is no financial or operational impact and will respond within timelines.
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Aurobindo Pharma Ltd said on Friday that the United States Food and Drug Administration (US FDA) has concluded an inspection of its Unit-XII manufacturing facility at Bachupally, Telangana.
The inspection, covering both oral solids and injectable units, was conducted between August 25 and September 5, 2025.
At the end of the inspection, the regulator issued a Form 483 with eight procedural observations. The company clarified that these are procedural in nature and do not impact its financials or operations. Aurobindo added it will submit a detailed response to the US FDA within the stipulated timelines.
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“The company remains committed to maintaining the highest quality manufacturing standards across all its facilities worldwide,” Aurobindo said in its filing to stock exchanges.
Ahead of the announcement, shares of Aurobindo Pharma closed at ₹1,048 on the NSE, up 1.16% or ₹12.
First Published: Sept 5, 2025 7:06 PM IST
