Last Updated on October 11, 2024 by The Health Master
USFDA directive
Drugmaker Sun Pharmaceuticals has said it received a letter from the United States Food and Drug Administration (USFDA) calling for corrective action at its Mohali plant following non-compliance with its Consent Decree.
The company said it received a letter from the USFDA titled “consent decree correspondence/non-compliance” that directed it to take corrective actions at the said facility before releasing further final product batches into the US.
Sun said it was taking the required corrective steps but added that there would be a temporary pause in the release of batches from Mohali until the USFDA-mandated measures were implemented.
“US shipments from Mohali will resume once these measures are in place,” Sun said in a communication to the stock exchanges on Sunday.
The Mohali plant entered the Sun Pharma fold following its $4 billion buyout of the troubled-durgmaker Ranbaxy from Daiichi Sankyo (2015).
In late 2011, Ranbaxy signed a consent decree with the USFDA for its plants in Paonta Sahib and Dewas, also facing import alerts since 2008 over data integrity and falsification issues. Mohali was subjected to this consent decree in 2013.
Sun was hopeful of some reprieve on this plant in 2018. But certain conditions of the consent decree continue to be applicable to the Mohali facility, Sun had then said, without giving details.
Corrective action
On the latest USFDA communication and corrective action, Sun said, “These actions include, among others, retaining an independent CGMP (Current Good Manufacturing Practices) expert to conduct batch certifications of drugs manufactured at the Mohali facility.”
In earlier communications (dated November 8, 2022 and August 13, 2022) on the USFDA inspection at its Mohali facility from August 3 to August 12, 2022, Sun had said, the outcome was Official Action Indicated” or an OAI.
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