India’s Lupin, which has been trying to dig itself out of a regulatory hole that has kept it from launching some new drugs in the U.S., has instead slid in deeper. The FDA slammed two of its Indian plants with a warning letter, including one that is key to U.S. sales.
The drugmaker announced (PDF) that the FDA Monday issued a combined warning letter for plants in Goa and a facility in Indore. It said the warning letter followed inspections at the plants in the spring, in which the Goa facility received a Form 483 with three observations. The facility that Lupin refers to as Pithampur Unit II in Indore was cited with six.
Lupin said it was working with the FDA to resolve issues as quickly as possible.
“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,” the company said in a statement.
Lupin had already been dealing with issues at its key Goa plant, which in 2015 was issued a Form 483 with 9 observations. The action had impaired its ability to get new drugs approved at the facility, which Lupin executives have said will be the source of many of its new drugs for the U.S. It derives about 40% of its revenues from U.S. sales.
Last year, Lupin Managing Director Nilesh Gupta said after months of work, the company thought the FDA was close to clearing the regulatory overhang from the facility.