Aurobindo Pharma’s Unit Receives FDA Warning, Shares Drop
Aurobindo's unit gets FDA warning; shares fall after regulatory concerns raised at Hyderabad facility.
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.
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