Pen-G ramp-up delays
Pen-G plant faced teething problems in Q1; any further delays could impact margin improvement expectations.
AUROPHARMA / Q1-FY25 / risks
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Aurobindo Pharma · Material risks, their source context, and severity in the latest available quarter.
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Material risks this quarter
high
Injectables remediation and FDA compliance
Eugia Unit III remediation cost $9M in Q1; Bhiwadi plant received OAI. Further regulatory actions could disrupt injectable sales.
US price erosion and competition
Management expects current US pricing scenario to continue; low single-digit price erosion in injectables could pressure margins.
Biosimilar approval delays
Biosimilar filings with EMA and FDA are subject to regulatory uncertainties; delays could push revenue contribution beyond FY26.