FDA Warns India's Lupin Over Generic Drug Quality Violations

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  • Lupin among largest Indian drugmakers that send meds to U.S.
  • Mumbai company ignored more than 100 out-of-spec findings
An employee holds Ramipril capsules for a photograph inside a coating unit at the Lupin Ltd. pharmaceutical plant in Salcette, Goa, India, on Friday, Feb. 7, 2014. Lupin, founded by billionaire Desh Bandhu Gupta, expects to gain share in the U.S. amid increased regulatory oversight and curbs on competitors including Ranbaxy Laboratories Ltd. Photographer: Dhiraj Singh

Lupin Ltd., which makes generic antibiotics, antidepressants and heart medications for sale in the U.S., was warned by the Food and Drug Administration for repeatedly ignoring tests showing that pills made at two of its facilities didn’t meet quality standards.

In 2015 and 2016, the FDA found 134 instances when drugs or active ingredients failed initial testing but the company chose to override the results. Lupin called the failed tests at the plant “laboratory error” even when evidence suggested that wasn’t the case.

At another Lupin plant, the company deemed failed quality tests outliers, and retested the samples to get a passing result. In a warning letter to Lupin, the FDA called the issues “significant violations.”

Lupin shares dropped as much as 2 percent Wednesday, touching a four-year low.

“These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” FDA staff wrote in the letter sent Nov. 6 and released Tuesday in a redacted version. “You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements at all your sites.”

India and China make a large share of the drugs and drug ingredients used by U.S. patients. The FDA has repeatedly cited manufacturers in both countries for quality problems, such as deleting failing sample results and then retesting and shipping those products to the U.S.

Drug Supplier

Lupin has 11 facilities that manufacture generics globally, according to its website. Its products belong to categories in wide use by patients, including cephalosporin antibiotics, oral contraceptives and cardiovascular and depression drugs, including generic versions of the depression treatment Cymbalta.

“We are deeply disappointed to have received this warning letter,” Lupin Managing Director Nilesh Gupta said in an emailed statement. “Making high quality products is the foundation of our business and we are confident of our capabilities in addressing this warning letter.”

The company disclosed Nov. 7 that it received an FDA warning on the company’s facilities at Goa and Indore. The company warned there will likely be a delay in new product approvals from the two facilities. The company did not make the letter public or provide many details.

Generic Drugs

According to a review of generic Cymbalta by Bloomberg News this year that included several other drugmakers, Lupin’s generic version was the subject of the most complaints to the FDA about the drug not working properly.

The FDA inspected Lupin’s Indian facilities in Goa and Indore between the end of March and middle of May this year, according to the warning letter. The two facilities are “big meaningful plants for us,” Gupta said during a Nov. 7 call with analysts.

In Goa, FDA inspectors found failed tests to check if one drug’s ingredients were mixed well enough. According to the FDA report, the company didn’t find a reason for the issue, but “surmised” that the probable cause was inadequate cleaning. It retested the pills and reported a passing result.

Lupin also held products at each phase of production for too long, which can cause quality problems, the agency said.

On the conference call with analysts this month, Gupta said it would take about six months to address the FDA’s concerns. Meanwhile, FDA-approved drugs already made at the plant will continue to be made there, Gupta said.

Alok Ghosh, president of technical operations at Lupin, said on the earnings call that the problems aren’t with data integrity but with FDA’s decision to change its procedures and to require more broad testing and follow up.

Lupin has about as many as 50 products awaiting FDA approval that could be affected by the issues. It plans to transfer about a dozen that it deems the most important while it addresses the concerns, Gupta said on the call.

— With assistance by P R Sanjai

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