Natco Pharma on Tuesday announced that it has received a warning letter from the US health regulator for its Telangana-based manufacturing plant.
According to the company’s regulatory filing, the US Food and Drug Administration (USFDA) had issued eight observations under Form 483 after inspecting the company’s Kothur-based formulation facility.
The inspection was conducted by USFDA from October 9 to October 18, 2023.
“We wish to inform you that the company has received a warning letter dated April 8, 2024 from the USFDA,” the drug firm said in the regulatory filing.
It also stated that the company does not believe that the warning letter will have an impact on supplies or the existing revenues from this facility.
“It may cause delay/withholding of pending product approvals from this site,” Natco Pharma said.
According to the company, the drug firm will respond to the letter within the stipulated timelines and work closely with the USFDA to address the concerns in a holistic and timely manner to ensure sustained compliance.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
The Natco Pharma stock saw more than a 2 percent loss in intraday trade on Tuesday.
