USFDA warning letter for Cohance's Hyderabad FDF Unit-I
COHANCE · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
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Cohance Lifesciences shared details on the USFDA warning letter for its FDF Unit-I facility in Nacharam, Hyderabad. Inspected August 4-12, 2025, it received a Form 483 with 6 observations and was classified as Official Action Indicated. Warning letter received February 4, 2026. No penalty or restriction imposed; response being prepared. US revenues from this facility contributed under 2% of FY25 consolidated revenues, with EBITDA below 1%.
Regulatory setback but limited financial impact since the facility is under 2% of revenue. Short-term sentiment may turn negative.