Lupin has been trying for two years to get its plant in Goa, India, up to FDA standards so it can again release new drugs from there. But the Indian drugmaker has a ways to go yet, according to the FDA, which says Lupin seems unable to learn from past mistakes.
The agency this week posted a warning letter that applies both to Lupin’s key finished products plant in Goa and a plant in Indore, India. The warning, which Lupin acknowledged earlier this month, indicated Lupin’s efforts to make improvements so far have fallen short and recommended it get a consultant to not only help fix these two plants but to assess its entire manufacturing network.
Despite having been given direction in earlier Form 483s, the FDA said the company keeps repeating its missteps.
“These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the Nov. 6 warning letter says. It said Lupin should comprehensively assess its “global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements at all your sites.”
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When Lupin reported it had received the warning letter, it insisted it is working closely with the FDA to resolve issues as quickly as possible but it also warned that the ongoing fixes will continue likely keep it from getting new products to the U.S. market, its largest.
“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.
That has been a huge issue for Lupin, which has a pipeline full of generic drugs it wants to sell in the U.S. but has been unable to launch because they were approved to be produced in the plant in Goa. It had expected those new launches to help offset pricing pressures that have taken a toll across the entire U.S. generics industry.
The drugmaker last month reported that in the last quarter, U.S. sales fell 32% to about $204 million. Total revenues were off 8%, EBITDA was down 12.3% and its profit caved by 31.3% to about ($69.7 million from $101.4 million in the same quarter a year ago.
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Most of the issues raised in the warning were tied to its product testing. The FDA ordered Lupin to retest batches of drugs that the drugmaker had released for sale in the U.S. even though repeated testing found they failed to meet specifications, test results that Lupin employees disregarded as “outliers.” At Lupin’s plant in Indore, analysts ignored nearly all of the initial out-of-spec testing results, 134 of 139 in a two-year period, the FDA said.
The agency pointed out that so far Lupin has tried to resolve most of the issues by simply “retraining your analysts” instead of making changes to its testing methods or equipment so that errors might not occur in the first place.
On top of testing issues, the FDA criticized the Indore plant for “excessive” hold times on APIs that might be contributing to some of the OSS issues and then releasing batches made with those APIs without including them in its stability testing program.