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Sun Pharma gets OAI classification

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Sun Pharma gets OAI classification
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19 Dec 2025 9:15 AM IST

New Delhi: Sun Pharma on Thursday said the US health regulator has classified its Baska facility in Gujarat under Official Action Indicated (OAI) category following an inspection. The US Food and Drug Administration (USFDA) conducted the inspection at the plant from September 8 to September 19, 2025. The USFDA has subsequently determined that the inspection classification status of this facility is Official Action Indicated (OAI), the Mumbai-based drug major said in a regulatory filing. As per the USFDA, OAI implies that the regulator may withhold approval of any pending product applications or supplements filed from such facility.

Sun Pharma USFDA inspection Baska facility Gujarat Official Action Indicated OAI classification drug manufacturing India regulatory filing US health regulator pending product applications pharmaceutical compliance Sun Pharma US operations Mumbai-based pharma company 
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