By: IPP Bureau
Last updated : June 01, 2023 10:29 am
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant HollisterStier General Partnership (JHSGP) announced that it received a communication from the USFDA through which the latter intimated that pursuant to its February 2023 audit of the Contract Manufacturing (CMO) facility at Montreal Canada, the US FDA has determined inspection classification of the facility as “Official Action Indicated” (OAI).
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
The company is engaging closely with the USFDA and is committed to address the observations within the stipulated time.