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Lupin receives US FDA warning letters


The company states that it will try to resolve the issues at the earliest

Lupin’s formulation manufacturing facilities at Goa and Indore (Pithampur Unit II) has received warning letter from the US FDA. The company earlier had received 3 Form 483 observations in Goa on April 7, 2017 and 6 Form 483 observations in Pithampur (Unit II) on May 19, 2017.

A company release states, “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 be likely to be delay on new product approvals from these two facilities.”

The release also mentioned that the company will address the concerns raised by the US FDA expeditiously and will work with US FDA to resolve these issues at the earliest.

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