Sun Pharma's Halol plant gets OAI classification from US FDA inspection

US FDA has classified Sun Pharma's Halol facility in Gujarat as OAI, keeping it under import alert, signalling possible enforcement action unless corrective steps are taken

Sun Pharmaceutical Industries on Tuesday said the US Food and Drug Administration (FDA) has classified its Halol manufacturing facility in Gujarat as “Official Action Indicated” (OAI) following an inspection conducted between 2 and 13 June 2025.

 

In a stock exchange filing, the company said the OAI status means the facility is not fully compliant with certain current good manufacturing practices (CGMP).

 

The Halol plant, which has long been under regulatory scrutiny, is already under import alert, leading to refusal of shipments from the site into the US, except for certain exempted products in cases of drug shortages.

 

Sun Pharma said it remains committed to working closely with the FDA and ensuring compliance at all its facilities. “The company is focused on maintaining CGMP standards to provide high-quality medicines to patients globally,” it noted.

 

 

The Halol facility is a key site for Sun Pharma, India’s largest drugmaker, and has faced repeated FDA observations in the past. The OAI classification indicates that regulatory or enforcement action may be forthcoming unless corrective measures are implemented to the agency’s satisfaction.