US FDA Raises Concerns at Aurobindo Pharma Unit, Shares Dip 2%

15 Mar 2024 , 03:45 PM

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 ₹1001.35 which is a 0.98% dip 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.

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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