Drug
Who makes ledipasvir and sofosbuvir?
2 companies list ledipasvir and sofosbuvir as a human prescription drug, including under the names Harvoni. Forms: pellet; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing ledipasvir and sofosbuvir
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Gilead Sciences, Inc.United States | pellet; tablet, film coated | NDANDA205834, NDA212477 | 4 | 4 |
| Asegua Therapeutics LLC | tablet, film coated | NDA AUTHORIZED GENERICNDA205834 | 1 | 0 |
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Common questions
- Who makes ledipasvir and sofosbuvir?
- 2 companies list ledipasvir and sofosbuvir as a human prescription drug in the openFDA NDC Directory, led by Gilead Sciences, Inc., Asegua Therapeutics LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.