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Lupin’s formulation manufacturing facilities at Goa and Indore (Pithampur Unit II), has received warning letter from USFDA.
Earlier, Lupin received 3 Form 483 observations in Goa on April 7, 2017 and 6 Form 483 observations in Pithampur (Unit II) on May 19, 2017.
In a release Lupin stated, “We are deeply disappointed to have received these outcome. While there will be no disruption of existing product supplies from either of these locations, there will likely be a delay on new product approvals from these two facilities.”
Further it stated, “We plan to address the concerns raised by the USFDA expeditiously and will work with USFDA to resolve these issues at the earliest.”
