USFDA inspection update on Jubilant HollisterStier’s Montreal facility
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
The Government of Quebec, through its agent Investissement Quebec, is granting a loan of CAD 25 million
This agreement is in addition to the $92 million filling line expansion announced in November 2021
The 50,000 square foot expansion will house a high-speed filling line and lyophilizers, which will increase the facility’s sterile injectable capacity by 50%
Entered into a manufacturing partnership with Ocugen, Inc. for manufacturing of COVID-19 vaccine COVAXIN for the US and Canadian markets
Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding
The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
This loan is in addition to earlier announced CAD 25 million loan committed by the Province of Quebec
This investment is being made to set up a high speed 400 vials a minute injectable fill line with isolator technology
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