Aurobindo Pharma Business Update
Aurobindo Pharma disclosed that US FDA classified its Lannett facility inspection as Official Action Indicated (OAI). The company states there is no quantifiable financial or operational impact.
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Aurobindo Pharma disclosed that US FDA classified its Lannett facility inspection as Official Action Indicated (OAI). The company states there is no quantifiable financial or operational impact.
Aurobindo Pharma received USFDA final approval for Perampanel Tablets in multiple strengths. The product will be manufactured by its subsidiary and launched in Q3FY27.
Aurobindo Pharma announced that the US FDA inspection of its subsidiary Apitoria Pharma's Unit-IV concluded with zero observations. This signals continued regulatory compliance for the facility.
Aurobindo Pharma reported the completion of a US FDA inspection at its subsidiary, Lannett Company LLC, which resulted in four procedural observations.
Aurobindo Pharma's subsidiary, Eugia Pharma Specialities Ltd., received a US FDA Warning Letter for its Unit I manufacturing facility. The unit contributes approximately 2% to group revenue.