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Lupin gets warning from US FDA after inspection of Mandideep facility

Lupin Ltd. said the U.S. Food and Drug Administration recommended taking action against the company after inspecting its Mandideep facility in Madhya Pradesh, India.

Following the December inspection, the regulator warned the Indian drugmaker that it may withhold approval of its pending applications or supplements related to the facility.

The Mumbai-based company said no applications related to the facility are pending with the FDA and the warning will not have any impact on revenues and operations from the facility.

The maker of generic drugs added that it will send updates of its corrective actions to the agency and expects a positive outcome.