# Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Dapagliflozin.

*business · news · 2026-04-07 · Free Press Journal*

## Key points

- Alembic Pharmaceuticals received final USFDA approval for generic Dapagliflozin Tablets in 5 mg and 10 mg.
- The approval allows Alembic to launch a generic version of AstraZeneca's Farxiga in the US market.
- Alembic is eligible for 180 days of shared generic exclusivity due to its early ANDA filing.
- The US market for this product is estimated at $10.5 billion for the year ending December 2025.
- Alembic's total USFDA approvals now stand at 235, including 217 final and 18 tentative approvals.

**Companies:** Alembic Pharmaceuticals
**Countries:** United States, India

[Read the full story on Free Press Journal](https://www.freepressjournal.in/business/alembic-pharma-secures-usfda-approval-for-diabetes-heart-failure-treatment-tablets)

---

Canonical: https://newsio.io/n/26cdbb1f-846d-4ebf-a800-d9e59509cbcf/alembic-pharmaceuticals-limited-has-received-final-approval-from-the-us-food-and
Summarized by Newsio from Free Press Journal. https://newsio.io/how-it-works