USFDA final approval for Oseltamivir Phosphate oral suspension

Regulatory Product ApprovalExport Order Hard CurrencyBusiness Updates View source PDF

APLLTD · price

Loading chart…

▲ 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

+6.9%1-day move

₹768.95

prior close

₹778.10

base price

After-mkt

timing

5m10m15m30m1D2D3D4D5D7D15D1M2M3M

-0.0-0.4-0.0+0.8+6.9+7.9+6.6+7.7+8.6+6.4+10.5———

Up moveDown movePending

AI summary

Alembic Pharmaceuticals has received USFDA final approval for its generic Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, which is therapeutically equivalent to Roche's Tamiflu. The drug is used for treatment and prevention of influenza A and B. The US market for this product is estimated at US$27 million for the 12 months ending March 2026, per IQVIA. With this, Alembic's cumulative ANDA approvals from USFDA rise to 243 (223 final and 20 tentative).

Likely market impact

Approval enables Alembic to launch a generic Tamiflu in the US, adding to its US revenue pipeline and supporting its growing export business.