USFDA issues import alert on Jubilant Pharmova’s Roorkee manufacturing facility

16 Jul 2021 Evaluate

The United States Food and Drug Administration (USFDA) has placed an import alert on Jubilant Pharmova’s Roorkee-based manufacturing facility, affecting its exports to the American market. USFDA has taken the action after conducting an inspection of the formulations plant in March this year. Earlier, the Roorkee facility had received an OAI (Official Action Indicated) from the USFDA in December 2018, followed by a warning letter in March 2019. The company will engage with the agency to resolve the import alert at the earliest and ensure Current Good Manufacturing Practice (cGMP) compliance.

The agency has exempted Meclizine tablets, Olanzapine orally disintegrating tablets, Risperidone orally disintegrating tablets, Spironolactone tablets, and Valsartan tablets from the import alert subject to the company meeting a few conditions.

Jubilant Pharmova (formerly Jubilant Life Sciences) is a company engaged in pharmaceuticals, contract research and development services and proprietary novel drugs businesses.

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