Shilpa Medicare Gets U.S. FDA Import Alert For Formulations Unit In Jadcherla: ICICI Securities
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ICICI Securities Report
Shilpa Medicare Ltd. announced that U.S. Food and Drug Administration has imposed an import alert on its Jadcherla unit, its only oncology formulation manufacturing facility.
This facility was inspected by the U.S. FDA in February 2020 with fifteen observations, of which, four were repeat observations and was later issued a warning letter in October-20.
The revenue contribution from this facility was approximately 23% of total sales in nine months FY21.
Three large products (Azacitidine, Erlotinib and Cyclophosphamide) have been exempted and company can continue to sell them considering potential shortage in U.S. market, however, U.S. FDA has the option to reconsider its stance as the demand and supply for these product normalises.
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