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December 18, 2025

US FDA flags Sun Pharma Baska plant with OAI

Sun Pharmaceutical Industries Ltd on Thursday said the US Food and Drug Administration (FDA) has classified its Baska manufacturing facility under Official Action Indicated (OAI) following a recent inspection, even as the company said supplies to the US market from the plant will continue.In an exchange filing, Sun Pharma said, “This is to inform that the US FDA conducted an inspection at the Company’s Baska facility from 8 September 2025 to 19 September 2025. The US FDA has subsequently determined that the inspection classification status of this facility is Official Action Indicated (OAI).”The drugmaker, however, sought to reassure investors on business continuity. “We continue to manufacture and supply approved products from the facility to the US market. We will work with the r

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