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ICICI Securities Report
Shilpa Medicare Ltd. announced that U.S. Food and Drug Administration has issued a warning letter to its Jadcherla unit, its only formulation manufacturing facility.
This facility was inspected by the U.S. FDA in February 2020 and had received 15 observations, of which, four were repeat observations.
Management clarified the warning letter would have minimal impact in the existing product supplies though new approvals would be delayed.
Management’s focus is on strengthening the oncology pipeline for regulated markets and foray into biosimilars, transdermals, etc.
Further, formulations revenue of approximately Rs 200 crore in FY20 from just six products indicates revenue per product of approximately $6 million (nearly Rs 44 crore at current exchange rate), better than peers.
We believe any success in biosimilars or transdermals may provide a meaningful upside.
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