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- 18, last year.
“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 a regulatory filing.
The company does not believe that the warning letter will have an impact on supplies or the existing revenues from this facility, it added.
“It may cause delay/withholding of pending product approvals from this site,” Natco Pharma said. 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, it said. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
Shares of Natco Pharma were trading 0.5 per cent up at Rs 1,004 a piece on BSE.
