USFDA removes Jubilant Generics' Olanzapine, Spironolactone and Valsartan from the excepted products list
Drug Approval

USFDA removes Jubilant Generics' Olanzapine, Spironolactone and Valsartan from the excepted products list

Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.

  • By IPP Bureau | July 14, 2022

Jubilant Pharmova Limited's wholly owned subsidiary Jubilant Pharma Limited, has announced that its subsidiary Jubilant Generics Limited (JGL) received a communication from the USFDA through which the latter intimated that it has decided to remove olanzapine orally disintegrating tablets, spironolactone tablets, and valsartan tablets from the list of excepted products from the Import Alert at the Roorkee facility of JGL. The USFDA mentioned its review of the product supply situation in the market and company's compliance status as the reasons for this decision. The current revenue from these three products is less than 1% of the consolidated revenues of the Company.

Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.

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