US FDA Raises Concerns at Aurobindo Pharma Unit

19 Mar 2024 , 09:59 AM

The US FDA flags procedural and cleanliness issues at Aurobindo Pharma’s Eugia Pharma SEZ unit in Telangana.

Aurobindo Pharma’s shares dip nearly 2% on NSE following the news, trading at ₹993.85 at 12.30pm on March 15. At the time of writing, the stock was trading at ₹915.80 which is a 1.26% gain than the previous close.

Telangana plant receives seven observations in Form 483 after US FDA inspection from February 19 to 29. FDA notes lack of contamination prevention procedures, absence of written records causing discrepancies, and inadequately located equipment hindering operations.

Employees involved in manufacturing lack sufficient training, and the plant lacks procedures to validate manufacturing process performance.

Production restarts in terminally sterilised product lines at Unit-III on February 29, addressing some FDA observations.

On February 29, the company resumed production in its terminally sterilized product lines at its Unit-III, which had been temporarily halted to address observations made by the US FDA during a recent inspection.

Subsequently, the company also resumed operations in its aseptic lines. Aurobindo Pharmaceuticals informed the exchanges on March 12 that it anticipates commencing commercial production from the aseptic lines of the facility in a phased manner starting the following week, with plans to restart all lines by April 15, 2024.

Aurobindo Pharmaceuticals reported that it manufactured over 40 billion dosage forms in fiscal year 2023.

Aseptic lines also resume shortly after, with plans to commence commercial production in a phased manner, aiming to restart all lines by April 15, 2024, as per the company’s disclosure to exchanges on March 12. Aurobindo Pharma reports manufacturing over 40 billion dosage forms in fiscal year 2023.

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