Aurobindo Pharma's Eugia Steriles Gets USFDA Nod for Lidocaine Injection

12 Sep 2024 , 11:30 AM

Aurobindo Pharma Ltd. announced that its new injectable facility in Andhra Pradesh, Eugia Steriles, received its first USFDA product approval. Eugia Steriles is a 100% subsidiary of Eugia Pharma Specialities, a stepdown subsidiary of Aurobindo Pharma.

The USFDA has approved Lidocaine Hydrochloride injection for the facility, following an inspection from March 28 to April 5, 2024.

The submission for the USFDA approval was made under “Prior Approval Supplement” for adding a new facility for drug manufacturing, labeling, packaging, and testing.

At the time of writing, shares of Aurobindo Pharma Ltd are trading at ₹1567.50 which is a 3.99% gain than the previous close. Aurobindo Pharma Ltd has gained a total of 79% in the last one year, and almost 45% since the beginning of the year.

In the previous month, Eugia Pharma’s formulations manufacturing facility, Unit-III, received a warning letter from the USFDA. Earlier, in May 2024, the same unit in Pashamylaram was given Official Action Indicated (OAI) status after a USFDA inspection.

Aurobindo Pharma’s management expressed confidence in achieving $600 million in sales for Eugia by FY 2025, while stating that the remediation of Unit-II and Unit-III is progressing well.

Aurobindo Pharma is a Hyderabad-based Indian multinational company specializing in generic pharmaceuticals and active pharmaceutical ingredients, with products in six therapeutic areas and a global market presence across 125 countries.