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Aurobindo Pharma’s Unit Receives FDA Warning, Shares Drop

Aurobindo's unit gets FDA warning; shares fall after regulatory concerns raised at Hyderabad facility.

Mrudula Kulkarni
Von Mrudula Kulkarni
Redaktionsleiter – Pharma Now
17. Aug. 2024Updated Jun 26, 2025 · 2 Min. Lesezeit
Aurobindo Pharma’s Unit Receives FDA Warning, Shares Drop
https://www.aurobindo.com/media/media-kit/official-logos
KI-unterstützte Berichterstattung
Reviewed by Mrudula Kulkarni, Redaktionsleiter – Pharma Now

A warning letter has been sent by the US Food and Drug Administration to a formulation manufacturing plant owned by Aurobindo Pharma's subsidiary, Eugia Pharma Specialities, located close to Hyderabad.A warning letter has been sent by the US Food and Drug Administration to a formulation manufacturing plant owned by Aurobindo Pharma's subsidiary, Eugia Pharma Specialities, located close to Hyderabad.

The U.S. FDA had granted the facility (Unit-III) Official Action Indicated (OAI) designation in May. "The unit has received a warning letter following the OAI. The parent business stated in a filing on Friday that there is no effect on the current shipments to the U.S. markets.

On the BSE, Aurobindo Pharma shares ended the day 1.11% down at ₹1,502.30 each. Within a day, it had fallen to ₹1,422 per unit.

The firm added that it is still dedicated to maintaining strong cooperation with the US FDA and that it keeps improving its compliance. The formulation production plant, located in Pashamylaram, Sangareddy district, Telangana, was examined by the regulator between January 22 and February 2.

 

Mrudula Kulkarni
Written by
Mrudula Kulkarni
Redaktionsleiter – Pharma Now

My international experience as a researcher in Taiwan for three years has equipped me with a global perspective, enabling me to create content that resonates with an international audience.



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