Drug Approval | April 28, 2024
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'
JPL plans to sell its entire 25.8% equity stake in Sofie for aggregate proceeds of about US$ 139.43 million
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
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
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
The company has reported total income of Rs. 1612.60 crores during the period ended September 30, 2022.
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