U.S. FDA issues warning letter to Aurobindo Pharma's subsidiary
Summary
- The U.S. FDA has issued a warning letter to Aurobindo Pharma's subsidiary Eugia Pharma Specialities.
- The warning letter is related to a formulation manufacturing unit near Hyderabad.
- The unit had earlier received four observations and an Official Action Indicated (OAI) status from the regulator.
Key Facts
- · Aurobindo Pharma's subsidiary Eugia Pharma Specialities received a warning letter from the U.S. FDA.
- · The warning letter is related to a formulation manufacturing unit.
- · The unit is located near Hyderabad.
- · The unit had earlier received four observations from the regulator.
Why it matters
The warning letter may impact Aurobindo Pharma's exports to the U.S. and its overall business.
#Pharma#US FDA#Aurobindo Pharma#Eugia Pharma#Regulatory Action