U.S. Food and Drug Administration (U.S. FDA). File
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A formulation manufacturing facility of Aurobindo Pharma subsidiary near Hyderabad has been issued a warning letter by the U.S. Food and Drug Administration (U.S. FDA).
The action on the facility of Eugia Pharma Specialities, the subsidiary, follows the four observations the regulator had issued in February after an inspection and in May, an Official Action Indicated (OAI) status.
Subsequent to OAI, the unit has received a warning letter, Aurobindo Pharma said on Firday (August 14, 2026) even as the parent company shares were in the spotlight. Around noon, the shares on BSE were around 1.25% down at ₹1,636.20 each recovering from a sharper decline when the market opened.
Aurobindo Pharma, in a filing, said it did not anticipate any impact on the existing supplies to the U.S. markets. The said facility, Unit I of Eugia Pharma Specialities, is contributing to around 2% to the company’s overall group revenue, it said.
For the quarter ended on June, this fiscal, the parent company had reported ₹9,150 crore revenue from operations, while for FY26 it had logged ₹33,653 crore revenue from operations.
The company remains committed to working closely with the U.S. FDA and continues to enhance its compliance on an ongoing basis, Aurobindo Pharma said.
Post-inspection, the U.S. FDA classifies facilities into three categories:Official Action Indicated (OAI) means regulatory and/or administrative actions are recommended; No Action Indicated (NAI) meaning no objectionable conditions or practices were found during inspection; and Voluntary Action Indicated (VAI) which means objectionable conditions or practices were found, but it is not for any administrative or regulatory action as the other two categorisations issued by the U.S. FDA.
Aurobindo forms new arm
On August 13, Aurobindo Pharma announced the incorporation of a new wholly owned subsidiary company Auropharm Overseas in India. The new entity had been set up with the objective of undertaking manufacturing and marketing operations in India and foreign countries, it said in a filing.
Published – August 14, 2026 12:57 pm IST
