US Tariff and Policy Uncertainty
Potential US tariff changes and new administration policies could impact Sun Pharma's US generics and specialty business.
SUNPHARMA / Q3-FY25 / risks
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Sunpharma · Material risks, their source context, and severity in the latest available quarter.
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Material risks this quarter
medium
FDA Compliance at Halol Facility
Halol facility remains under FDA scrutiny; reinspection has been invited but not scheduled, delaying new product approvals.
Leqselvi Litigation Risk
If the patent litigation outcome is unfavorable, Leqselvi launch could be delayed until December 2026, impacting specialty growth.
Clinical Trial Delays Impacting R&D Pipeline
Delays in finalizing protocols and starting clinical trials have led to lower R&D spend and may push back pipeline milestones.