Sun Pharmaceutical Industries has announced that the US Food and Drug Administration (FDA) has classified its Halol facility as “Official Action Indicated” (OAI) following an inspection conducted between June 2 and June 13, 2025.

The OAI status indicates that the FDA has identified certain lapses in current good manufacturing practices (cGMP), considering the facility not fully compliant.

The Halol site also remains under an Import Alert, restricting shipments from the facility to the US market except for select products exempted due to drug shortages. These restrictions will continue until the facility becomes fully compliant with FDA and CGMP standards.

Sun Pharma reaffirmed its commitment to working with the FDA and maintaining CGMP standards at all of its facilities to provide high-quality medicines to patients globally.

A leading global specialty generic company with global revenue of USD 5.8 billion, Sun Pharma provides medicines to more than 100 countries, supported by 41 manufacturing facilities.