Lupin has received a warning letter issued by the United States Food and Drug Administration (USFDA) on November 6, 2017, for its formulation manufacturing facilities at Goa and Indore (Pithampur Unit II). While there will be no disruption of existing product supplies from either of these locations, there will likely be a delay of new product approvals from these two facilities.
Earlier, the company had received three Form 483 observations in Goa on April 7, 2017 and six Form 483 observations in Pithampur (Unit II) on May 19, 2017.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.
