U.S. FDA issues 4 observations to Aurobindo arm’s formulation unit

The U.S. Food and Drug Administration (U.S. FDA) has issued four observations to a formulation manufacturing facility of Aurobindo Pharma subsidiary Eugia Pharma Specialities near Hyderabad.

The facility (Unit-I), in Ranga Reddy district, was inspected from February 16-27 and on conclusion the observations were issued. It is the third facility of the generic drugmaker and its subsidiary to receive U.S. FDA observations this month.

On February 6, the U.S. FDA had issued 11 observations to another formulation manufacturing facility (Unit III) of Eugia Pharma Specialities in Hyderabad and within a week issued nine observations to the oral solid dosage manufacturing unit of Aurobindo Pharma near Hyderabad.

In a filing on Friday, on the latest development, Aurobindo Pharma said there is no impact on the company’s financials or operations due to the said action. It will respond to the regulator within the stipulated timelines.