USFDA Flags 5 Procedural Issues at Aurobindo Pharma’s Andhra Unit; Company Assures Timely Response

Aurobindo Pharma on Thursday said the US Food and Drug Administration (USFDA) has issued a Form 483 with 5 observations after inspecting Unit-IV of its subsidiary, APL Healthcare, located in Andhra Pradesh. The inspection was carried out between December 8 and December 17, 2025.

Nature of Observations

The company clarified that all 5 observations mentioned in the Form 483 are procedural in nature. Aurobindo Pharma said it will submit its response to the USFDA within the prescribed timelines, as required under regulatory norms.

Company’s Statement

Aurobindo Pharma reiterated its commitment to maintaining high-quality manufacturing standards across all its facilities worldwide. The company assured that it takes regulatory feedback seriously and follows strict compliance processes.

What is Form 483?

As per the USFDA, a Form 483 is issued at the end of an inspection when investigators note conditions that may violate the Food, Drug and Cosmetic (FD&C) Act or related regulations. It does not indicate a final enforcement action.

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Aurobindo Pharma Share Price Movement

Aurobindo Pharma share price (NSE: AUROPHARMA) was trading at ₹1,210.20 on the NSE at around 12:23 pm on December 18, 2025, up 1.44% or ₹17.20 from the previous close. The stock opened at ₹1,190 and moved in a day’s range of ₹1,176.60 to ₹1,213.70. The company’s market capitalisation stood at about ₹70,400 crore, with a price-to-earnings ratio of 20.78. Aurobindo Pharma has a 52-week high of ₹1,356.20 and a 52-week low of ₹1,010.00. The stock offers a dividend yield of 0.33%, with a quarterly dividend amount of ₹1 per share.

Conclusion

While the USFDA has raised 5 procedural observations at Aurobindo Pharma’s Unit-IV, the company has confirmed that it will address them within the required timelines. The issue does not appear to have caused immediate concern among investors.

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