Jubilant Pharmova announced that in response to the US FDA inspection conducted at its dosage formulations facility at Roorkee during March 2021, the agency has placed the facility under import alert. Earlier, the Roorkee facility received an OAI in December 2018 and then a Warning Letter in March 2019.
The Company will engage with the agency to resolve the import alert at the earliest and ensure 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. The products that get impacted due to the import alert contributed to less than 3% of FY21 total revenues for the Company
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