Jubilant Generics Roorkee facility determined as official action indicated
Noida: Jubilant Pharmova Limited's wholly owned subsidiary Jubilant Pharma Limited, today announced that its subsidiary Jubilant Generics Limited (JGL) has received a communication from the US Food and Drug Administration (USFDA) through which the latter intimated that pursuant to its July-Aug 2022 audit of JGL's Solid Dosage Manufacturing facility at Roorkee it has determined...
Noida: Jubilant Pharmova Limited's wholly owned subsidiary Jubilant Pharma Limited, today announced that its subsidiary Jubilant Generics Limited (JGL) has received a communication from the US Food and Drug Administration (USFDA) through which the latter intimated that pursuant to its July-Aug 2022 audit of JGL's Solid Dosage Manufacturing facility at Roorkee it has determined inspection classification of the facility as "official action indicated".
The Company currently supplies one product to US market that contributes low- single digit revenue to Jubilant Pharmova revenues.
"The Company has been continuously cooperating with the USFDA and will undertake all necessary steps to resolve regulatory status at the Roorkee facility," Jubilant Pharmova stated.
Read also: USFDA issues 6 observations for Jubilant Pharmova Roorkee facility
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