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Lupin gets 2nd US FDA warning about its Mandideep facility

Lupin Ltd. received a second warning letter from the U.S. Food and Drug Administration regarding its Mandideep facility in Madhya Pradesh, India.

The FDA told the Mumbai-based drugmaker in March that it may withhold approval of pending drug applications related to the facility, following a failed inspection in December 2018.

Lupin said in a Sept. 19 news release to the Bombay Stock Exchange that no applications related to the facility are pending with the FDA and that the warning will have no impact on revenues and operations from the facility.