Glenmark Pharma Monroe, North Carolina (USA) based Facility has received a communication from the US FDA indicating the inspection classification as Official Action Indicated (OAI).
The OAI classification implies interalia that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.
- Read more about Glenmark Pharma gets OAI for US based plant
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source https://www.pharmatutor.org/pharma-news/2022/glenmark-pharma-gets-official-action-indicated-oai-for-monroe-usa-based-plant
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