Drug
Who makes pralsetinib?
2 companies list pralsetinib as a human prescription drug, including under the names Gavreto. Forms: capsule. 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 pralsetinib
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Genentech, Inc.United States | capsule | NDANDA213721 | 1 | 8 |
| Rigel Pharmaceuticals, Inc.United States | capsule | NDANDA213721 | 1 | 1 |
Bulk ingredient listings
- OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITEDIndia · 1 NDC
- Valary Lab Private LimitedIndia · 1 NDC
Orange Book patents
8 unexpired patents list pralsetinib as the active ingredient, expiring between Nov 2036 and Apr 2043. Application holder: RIGEL PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes pralsetinib?
- 2 companies list pralsetinib as a human prescription drug in the openFDA NDC Directory, led by Genentech, Inc., Rigel Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Who supplies pralsetinib active ingredient?
- 2 companies list pralsetinib as a bulk ingredient, including OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITED, Valary Lab Private Limited.