The hits just keep on coming for India manufacturing giant Lupin as it continues to run afoul of the FDA.
In a regulatory filing late last month with the Bombay Stock Exchange, the drugmaker said it received a Form 483 notice from the FDA citing problems at its injectables facility in Nagpur. The notice flagged five observations and came after a preapproval inspection of the site from Oct. 17 to Oct. 29.
“We are committed to addressing the observations at the earliest and gaining approval for injectable manufacturing for the U.S.,” Lupin wrote in the filing.
It was the third time in the span of five weeks that Lupin revealed a compliance reprimand from the FDA in a regulatory filing.
A warning letter sent to Lupin Sept. 27 and posted on the FDA website Nov. 1 revealed that the company had ceased manufacture of products bound for the U.S. from its active pharmaceutical ingredients plant in Tarapur.
A month ago, the FDA pinged Lupin’s biosimilars plant in Pune, identifying a whopping 18 observations from an inspection conducted from Oct. 3 to Oct. 14.