Home Correction letter Lupine Receives USFDA Warning Letter for Tarapur API Plant

Lupine Receives USFDA Warning Letter for Tarapur API Plant

Pharmaceutical company Lupine said on Thursday it had received a warning letter from the US health regulator for its Tarapur-based manufacturing plant in Maharashtra. The United States Food and Drug Administration (USFDA) inspected the site from March 22, 2022 through April 4, 2022.

The company manufactures both fermentation-based and synthetic APIs (active pharmaceutical ingredients) in the plant.

“The company does not believe that the warning letter will have any impact on the disruption of supplies or existing revenue from the operation of this facility,” the Mumbai-based company said in a regulatory filing.

The pharmaceutical company is committed to addressing the concerns raised by the USFDA and will work with the agency to resolve the issues as soon as possible, he added.

Lupine did not share details of the issues reported by the US health regulator.

A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.

The letter identifies the violation, such as poor manufacturing practices, issues with claims about what a product can do, or incorrect user instructions.

The letter also clearly states that the company needs to correct the problem and provides instructions and a timeline for its remediation plans.

The FDA then verifies that the company’s corrections are adequate.

On Thursday, shares of Lupine ended down 2.46% at Rs 654 each on BSE.