By: IPP Bureau
Last updated : April 10, 2024 11:21 am
The company will respond to the Warning Letter within the stipulated timelines
NATCO Pharma Limited has received a Warning Leter dated 8th April, 2024 from the United States Food and Drug Administration (USFDA). The Company does not believe that the Warning Leter will have an impact on disruption of supplies or existing revenues from this facility. It may cause delay/withholding of pending product approvals from this site.
The company will respond to the Warning 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. The Company also remains committed to being cGMP compliant and in supplying high-quality products to its customers and patents globally.
The above warning letter is related to Good Manufacturing Practices (cGMP) inspection at its Kothur (Pharma Division) manufacturing facility in October 2023.