Sun Pharma’s Halol Plant Receives OAI Classification from U.S. FDA

Sun Pharmaceutical Industries, India’s largest drugmaker, announced that its Halol manufacturing facility in Gujarat has been classified as “Official Action Indicated” (OAI) by the United States Food and Drug Administration (USFDA), following an inspection carried out from June 2 to June 13, 2025.

The OAI status implies that the regulator has found significant violations of current Good Manufacturing Practices (cGMP) at the site, and that regulatory or enforcement actions may follow if the company fails to address the concerns adequately.

The Halol plant is already operating under an import alert issued by the USFDA, which restricts most of its products from entering the U.S. market, except for select medicines exempted due to medical necessity or shortage. The new classification further complicates Sun Pharma’s efforts to bring the facility back into full regulatory compliance.

In a regulatory filing, Sun Pharma said it remains committed to working closely with the USFDA to resolve the issues. “The company is taking all necessary steps to address the observations and ensure sustained compliance,” it stated.

The Halol facility has been a key site for Sun Pharma’s exports to the U.S., one of its largest markets. However, it has faced recurring regulatory challenges over the years, impacting product approvals and supply timelines.

An OAI classification does not permit the approval of any pending drug applications linked to the site until the concerns are resolved, which could affect the company’s pipeline in the U.S.

Despite the regulatory setback, Sun Pharma said it continues to prioritize product quality and patient safety across all its manufacturing locations.