Eugia Steriles Gets First FDA Approval for New Injectable Facility

Aurobindo Pharma Ltd announced that Eugia Steriles Private Limited, a subsidiary, received FDA approval for its new injectable facility. The FDA inspected the Andhra Pradesh plant from March 28 to April 5, approving Lidocaine Hydrochloride Injection. This approval was part of a supplemental Abbreviated New Drug Application.

Aurobindo Pharma Ltd announced on Wednesday that its subsidiary, Eugia Steriles Private Limited, has received FDA approval for its new injectable facility.

This facility, located in Andhra Pradesh, was inspected by the U.S. FDA from March 28 to April 5. Following the inspection, the FDA approved Lidocaine Hydrochloride Injection, USP, at concentrations of 1% and 2%.

The supplemental Abbreviated New Drug Application (sANDA) for this product was submitted to gain approval for an alternative facility dedicated to manufacturing, labeling, packaging, and testing.

(With inputs from agencies.)