USFDA issues OAI status to Eugia Pharma of Aurobindo

However, the USFDA's OAI classification for Unit III casts a shadow over this positive financial performance

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USFDA Inspection audit
USFDA Inspection

Last Updated on June 12, 2024 by The Health Master

USFDA

Aurobindo Pharma, a major player in the pharmaceutical industry, faces potential roadblocks after a recent inspection by the US Food and Drug Administration (USFDA) at its Eugia Pharma Specialities Ltd. Unit III facility in Telangana, India.

The inspection, conducted from January 22nd to February 2nd, 2024, resulted in an “Official Action Indicated (OAI)” classification from the USFDA.

USFDA Inspection – A Cause for Concern

This news comes amidst a period of strong financial performance for Aurobindo Pharma.

The company reported an impressive 80% increase in consolidated net profit for the January-March quarter of FY24, reaching Rs 909 crore compared to Rs 508 crore in the same period last year.

Revenue also grew by 19%, reaching Rs 7,580 crore, and EBITDA (Earnings Before Interest, Tax, Depreciation, and Amortization) jumped 68% year-on-year to Rs 1687 crore.

However, the USFDA’s OAI classification for Unit III casts a shadow over this positive financial performance.

An OAI designation indicates that the USFDA identified objectionable conditions or practices during the inspection.

This could potentially lead to import restrictions or even a suspension of product approvals for Eugia Pharma Specialities Ltd.

Recent Product Recalls by Aurobindo Pharma

Adding to the concern is a recent USFDA Enforcement Report which revealed product recalls by Aurobindo Pharma in the American market due to manufacturing issues.

The company recalled 13,605 bottles of Clorazepate Dipotassium Tablets used to treat anxiety, citing “Discoloration: Dotted and yellow spots on tablets” as the reason.

This incident highlights potential quality control concerns that may be linked to the issues identified during the USFDA inspection of Unit III.

Looking Ahead

Aurobindo Pharma must now address the concerns raised by the USFDA inspection at Unit III.

This will likely involve a comprehensive review of manufacturing processes, implementation of corrective actions, and close collaboration with the USFDA to ensure compliance with regulations.

The company’s reputation in the US market hinges on its ability to swiftly and effectively address these issues.

Maintaining high-quality standards is crucial for regaining the trust of the USFDA and ensuring continued access to the American market.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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