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Pharmaceuticals
USFDA26 Jun 2026, 10:32 am

Alembic Pharma gets USFDA Final Approval for Oseltamivir Phosphate Oral Suspension

AI Summary

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. This generic drug is therapeutically equivalent to Hoffmann-La Roche's Tamiflu Oral Suspension, 6 mg/mL. Oseltamivir Phosphate is used for the treatment and prophylaxis of influenza A and B. The estimated market size for this product is US$ 27 million for the twelve months ending March 2026. This approval adds to Alembic's portfolio of 243 USFDA ANDA approvals.

Key Highlights

  • USFDA final approval received for Oseltamivir Phosphate Oral Suspension.
  • Product is therapeutically equivalent to Tamiflu Oral Suspension.
  • Target market estimated at US$ 27 million.
  • Adds to Alembic's 243 total USFDA ANDA approvals.