Announced Tue, 21 Apr · 08:23 IST
Partner gets tentative U.S. FDA approval for generic Ozempic; OneSource is CDMO
Compliance View source PDF
ONESOURCE · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Price reaction · full curve 14 horizons · vs prior close
+3.9%1-day move
₹1545.10
prior close
₹1565.00
base price
After-mkt
timing
5m10m15m30m1D2D3D4D5D7D15D1M2M3M
-1.9-2.1-2.2-2.0+3.9+15.5+14.7+17.9+14.2+13.4+16.0+20.6+4.5+6.6
Up moveDown movePending
AI summary
OneSource's partner Orbicular, along with its U.S. front-end partner, has secured tentative U.S. FDA approval for an ANDA for a generic version of Ozempic (Semaglutide Injection). OneSource served as the CDMO partner, providing end-to-end manufacturing at its US-FDA approved Bangalore site. This highlights a development-to-submission model for complex peptides and positions OneSource for commercial supply to the U.S. market.
Likely market impact
Positive - validates OneSource's CDMO capabilities in complex peptides; positions company for U.S. commercial supply of a high-value generic.