Lupin Receives FDA Warning Letter for Dosage-Form Manufacturing Plants

Lupin, a Mumbai, India-headquartered pharmaceutical company, received a combined Warning Letter from the US Food and Drug Administration (FDA) on November 6, 2017 for two of its formulation manufacturing plants in Goa and Indore, India.

Lupin had earlier received three Form 483 observations from the FDA for its facility in Goa in April 2017 and six Form 483 observations for its facility in Indore (Pithampur Unit II) in May 2017. The company said that it responded to all the observations.

In a letter to the National Stock Exchange of India, Lupin said that there will be no disruption of existing product supplies from either of the locations, but there will likely by a delay of a new product approval from the two facilities. The company said that it will work with the FDA to resolve the issues at the plant.

Source: Lupin


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