FDA warning letters at three facilities
Halol, Mohali, and Dadra facilities remain under FDA warning letters, limiting generic approvals and U.S. supply flexibility.
SUNPHARMA / Q1-FY26 / risks
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Sunpharma · Material risks, their source context, and severity in the latest available quarter.
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Risk intelligence
Material risks this quarter
high
Lenalidomide pricing pressure
Generic lenalidomide continues to face pricing erosion, impacting U.S. generic business performance.
Leqselvi and UNLOXCYT launch execution risk
New product launches may face slower-than-expected formulary coverage or market adoption, impacting revenue ramp.
Potential U.S. tariffs on pharmaceuticals
While currently exempt, pharma may face tariffs after the 232 investigation, which could impact U.S. business margins.