Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal
The USFDA has issued 5 observations pursuant to the completion of audit
The USFDA has issued 5 observations pursuant to the completion of audit
The US Generics market has been witnessing significant pricing pressure leading to significant losses at Jubilant Cadista since FY2022 onwards.
FDA has concluded that this inspection is 'closed'
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 has reported total income of Rs. 1682.45 crores during the period ended March 31, 2023
This loan is in addition to earlier announced CAD 25 million loan committed by the Province of Quebec
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities
The company will submit an action plan on the observations and will engage with US FDA for next steps.
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
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