Lupin's troubles compounded as FDA escalates actions with warning letter for 2 plants

Lupin, India's second largest drugmaker, says the FDA has issued a warning letter for two plants in India, including its key plant in Goa.

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.

RELATED: Lupin leader crosses fingers for fast resolution of Form 483


Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

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.  

RELATED: Lupin plant problems weigh on Q4 results for Indian drugmaker

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. 


Suggested Articles

The FDA has lambasted the Torrent Pharmaceuticals in a warning letter for making OTC meds using water tainted with bacteria.

Eli Lilly is investing $400 million in its Indianapolis site to expand production of insulin and other diabetes meds, and add 100 jobs.

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.