Jubilant Pharmova Limited's subsidiary, Jubilant Pharma Limited, has announced that its subsidiary Jubilant Generics Limited (JGL) has received communication from the US Food and Drug Administration (USFDA) regarding the regulatory status of its Solid dosage manufacturing facility in Roorkee, India.
Following an audit conducted by the USFDA from January 25 to February 2, 2024, the regulatory agency has determined the inspection classification of JGL's Roorkee facility as 'Voluntary Action Indicated (VAI).' This classification signifies that the facility is deemed to be in an acceptable state of compliance with current good manufacturing practices (cGMP).
The USFDA's VAI classification reflects the agency's acknowledgment of JGL's efforts to address any identified issues and maintain compliance standards. Consequently, the FDA has closed the inspection, marking a positive outcome for JGL and its commitment to quality manufacturing practices.
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