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USFDA concludes pre-approval inspection of Jubilant Generics' Roorkee site

02-Aug-2025, 12:47

Jubilant Pharmova announced that the United States Food and Drug Administration (USFDA) has concluded pre-approval inspection (PAI) of the solid dosage formulations facility on August 01, 2025 at Roorkee site, India of Jubilant Generics ('Company'), a subsidiary of its wholly owned subsidiary Jubilant Pharma.

The USFDA has issued 4 observations pursuant to the completion of audit. The company will submit an action plan on the observations.

The site's revenue from the US market in the trailing twelve month period (July'24 to June'25) is less than one percent of Jubilant Pharmova revenues in the same period.