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Jubilant Pharmova Ltd. announced that it has received import alert from U.S. Food and Drug Administration for its Roorkee facility.
U.S. FDA re-inspected the plant in March 2021 and subsequently has issued an import alert to it.
It is a solid dosage formulations manufacturing facility with supplies to U.S. in addition to rest of world markets.
U.S. FDA has exempted certain products from purview of import alert subject to fulfilment of certain conditions by the company.
We view this development to be negative for Jubilant Pharmova as supplies of non-exempted approved products will have to be withheld which contributed ~3% of total revenue in FY21 and new approvals would be delayed until resolution.
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