Shares of Sun Pharmaceutical Industries Ltd were trading in the red and 0.5% lower on 10 September after the company’s Halol manufacturing facility received OAI status from the USFDA. 

In its regulatory filing, the company said that its manufacturing facility in Halol, Gujarat, was inspected by the US Food and Drug Administration (USFDA) between 2 June and 13 June 2025. After the inspection was completed, the USFDA classified the facility as “Official Action Indicated” (OAI) as the FDA found that the facility was not properly compliant with the current Good Manufacturing Practices (CGMP).

Halol remains one of Sun Pharma’s key manufacturing plants, but since December 2022, the USFDA has placed it under import alert, blocking shipments to the US except for certain exempted products in shortage cases.

Earlier, the FDA had issued a warning letter to the Halol facility. Sun Pharma must bring the plant into full compliance with FDA and CGMP standards before it can resume shipments to the US market.

At 12:25 pm, the shares of Sun Pharma were trading flat at Rs 1,591.70 on NSE.

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