Natco Pharma has received a warning letter from the US health regulator for its Telangana-based manufacturing plant. 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. 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.
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.
Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.
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