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Lupin: USFDA classifies Pithampur 2 facility as OAI

Advait Dharmadhikari 0 1042 Article rating: 5.0

The company has received a letter from the USFDA classifying the inspection conducted at its Pithampur (Indore) Unit-2 facility in January 2019 as Official Action Indicated (OAI). The USFDA has stated that this facility may be subject to regulatory or administrative action and it may withhold approval of any pending applications or supplements in which this facility is listed.

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