The facility is located at Phase-III, TSIIC, EPIP, IDA, Pashamylaram, Patancheru Revenue Mandal, Sangareddy District, Telangana, and is operated by Eugia Pharma Specialities Ltd, a wholly owned subsidiary of Aurobindo Pharma. The inspection was conducted from January 27 to February 6, 2026, and concluded with 11 observations.
“The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe. We will keep the stock exchanges informed if there is any further information relating to the above in the future,” it said.
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The US FDA communicated the “Official Action Indicated” classification on June 12, 2026. Aurobindo Pharma said there is no impact on its financials or operations due to the development.
What is Official Action Indicated (OAI)?
If violations are found on-site, require further administrative sanctions and mandatory corrective actions. The resolution of “Official Action Indicated” can usually happen only after a re-inspection.
While the facility can continue selling the approved drugs, it will not receive approvals for new drugs until the violations are addressed to the satisfaction of the USFDA.
This month, Aurobindo Pharma inaugurated TheraNym, a dedicated biologics contract manufacturing organisation (CMO), marking its entry into the biologics contract manufacturing segment.
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The company said that the facility, located in Borapatla near Hyderabad, was inaugurated by Telangana Minister for IT, Industries & Commerce and Legislative Affairs D. Sridhar Babu and Telangana Minister for Science and Technology Damodar Raja Narasimha.
The company added that TheraNym has been positioned as one of India’s largest dedicated biologics contract manufacturing facilities, with MSD (known as Merck & Co. in the US and Canada) joining as its anchor customer.
Satakarni Makkapati, CEO, Biologics and Director, Aurobindo Pharma Limited, said, “TheraNym represents a defining moment in large-scale biologics manufacturing in India and a proud milestone for Aurobindo Pharma. Designed and built to the highest international standards, the facility is positioned to serve the supply chains of leading global pharmaceutical companies.”
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Shares of Aurobindo Pharma Ltd ended at ₹1,469.30, up by ₹5.20, or 0.36%, on the BSE.
