USFDA Warning Letter for Nacharam formulation facility
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Cohance Lifesciences has received a USFDA Warning Letter for its Nacharam formulation facility (FDF Unit-I) in Hyderabad, following an inspection conducted from August 4 to 12, 2025. The facility was previously classified as Official Action Indicated (OAI). The company notes that US revenues from this facility contributed less than 2% of consolidated revenues in FY2025, with related EBITDA contribution below 1%, indicating no material financial impact.
Limited near-term financial impact due to low revenue contribution from this facility, but regulatory overhang may persist until concerns are resolved with USFDA.