The Halol facility in India that Sun Pharma owns is considered the OAI by the FDA, which underscores the compliance challenges of the largest pharmaceutical firm in India in the face of the persistent regulatory review.

The US Food and Drug Administration (FDA) has declared that its manufacturing plant in Gujarat called Halol is at an "Official Action Indicated" (OAI) status after an inspection of the facility in June 2025.

The stock exchange filing made by the pharmaceutical company states that the OAI status means the site is not fully compliant with current good manufacturing practices (CGMP). Such classification creates the threat of regulatory or enforcement action unless corrective actions are undertaken.

The Halol plant, which has been on an FDA import alert, has come under longstanding regulatory scrutiny. The site continues to restrict shipments to the US, with some exceptions for certain products to relieve drug shortages.

The failure notwithstanding, Sun Pharmaceutical reiterated its dedication to making the operations comply with the global regulatory standards. The company has concentrated on the quality of its medicines through maintaining CGMP standards to offer high-quality medicines to its patients across the globe.

The Halol plant of Sun Pharma is the biggest pharmaceutical manufacturer in India and therefore contributes immensely to the production infrastructure. Experts in the industry watch that responding promptly to the observations by the FDA will be essential in regaining full categories of compliance by the company and reverting to exporting goods freely.