Lupin receives US FDA warnings at two Indian manufacturing plants
In a filing with the Bombay Stock Exchange Tuesday, Lupin said it has received a US Food and Drug Administration (FDA) warning letter on November 6 concerning its formulation facilities in Goa and Indore (Pithampur unit II).
“We had earlier received three Form 483 observations in Goa on April 7, 2017 and six Form 483 observation in Pithampur (Unit II) on May 19, 2017,” the firm said. “We had responded to all the observations.”
Details of the observations and subsequent GMP violations were not divulged.
“We are deeply disappointed to have received this outcome. While there will be no disruption of existing products supplies from either of these locations, there will likely be a delay of new product approvals from these two facilities,” Lupin said.
Lupin's stock hit a three year low, falling 15% following the announcement.
The Goa plant, which makes finished drug formulations – including oral and injectable drug products – for the US market, has been subject to previous FDA criticism, including nine observations “on aspects such as inadequacy and adherence to SOPs” following an inspection in March 2016.
The facility received an establishment inspection report (EIR) nine months later clearing Lupin to supply the US with products made from the site.
Meanwhile Lupin’s manufacturing facility in Aurangabad received an FDA 483 in July this year, citing a single observation. However, the firm said at the time this was “procedural in nature,” and that it had been corrected during the inspection.
