Aurobindo Pharma new Eugia facility gets first USFDA approval

11 Sep 2024 , 07:17 PM

On Wednesday, Aurobindo Pharma Ltd. told the exchanges that its new injectable plant in Andhra Pradesh has acquired its first product approval from the USFDA.

Eugia Steriles, a 100% subsidiary of Eugia Pharma Specialities and a step down arm of Aurobindo Pharma, operates the new plant.

Eugia Steriles has acquired USFDA approval for Lidocaine Hydrochloride injectable. The factory was inspected by the US FDA from March 28 to April 5, 2024.

The ANDA was submitted as a “Prior Approval Supplement” to include an alternative drug product manufacturing, labelling, packaging, and testing facility.

Last month, the USFDA sent a warning notice to Aurobindo Pharma’s formulations manufacturing unit at Eugia Pharma, known as Unit-III.

Following the USFDA inspection, the Pashamylaram-based unit was granted Official Action Indicated (OAI) status in May of this year.

In an August discussion, Aurobindo Pharma’s management stated that the company’s business team is confident of Eugia’s revenues of $600 million in Fiscal Year 2025, and that the remediation of Eugia’s Units II and III is progressing well.

At around closing, Aurobindo Pharma was trading marginally higher at ₹1,519.85 per piece, against the previous close of ₹1,518.40 on NSE. The counter touched an intraday high and low of ₹1,546.20, and ₹1,502.40, respectively.

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