Announced Thu, 6 Aug · 16:30 IST
Alkem Labs Daman facility gets OAI status from US FDA after inspection
ALKEM · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
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AI summary
US FDA has classified Alkem Labs' Amaliya, Daman manufacturing facility as Official Action Indicated (OAI), following an inspection from April 20 to May 1, 2026 that resulted in a Form 483 with seven observations. The company says it will continue manufacturing and supplying approved products from this facility to the US market and will work with the regulator to achieve fully compliant status.
Likely market impact
Negative: OAI status may delay new US product approvals from this plant and could pressure export revenue going forward.