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Jubilant Generics Roorkee facility receives USFDA's communication on classification report

Jubilant Generics Roorkee facility receives USFDA's communication on classification report

Jubilant Pharmova's wholly owned subsidiary Jubilant Pharma, has announced that its subsidiary Jubilant Generics Limited (JGL) received a communication from the 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”.

As per the filing, the company currently supplies one product to the US market that contributes low single-digit revenue to Jubilant Pharmova revenues.

"The company has been continuously cooperating with the US FDA and will undertake all necessary steps to resolve regulatory status at the Roorkee facility," Jubilant Pharmova said.

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Jubilant Pharmova US FDA
More news about: quality / gmp | Published by Sudeep Soparkar | October - 31 - 2022 | 912

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