Drug
Who makes bosutinib?
4 companies list bosutinib as a human prescription drug, including under the names BOSULIF. Forms: capsule; 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 bosutinib
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | capsule; tablet, film coated | NDANDA203341, NDA217729 | 5 | 0 |
| Alembic Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA209543 | 4 | 7 |
| Dr. Reddy's Laboratories LimitedIndia | tablet, film coated | ANDAANDA209624 | 1 | 15 |
| U.S. Pharmaceuticals | tablet, film coated | NDANDA203341 | 1 | 0 |
Bulk ingredient listings
- MSN Laboratories Private Limited,India · 3 NDC
- Hetero Labs LimitedIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes bosutinib?
- 4 companies list bosutinib as a human prescription drug in the openFDA NDC Directory, led by Pfizer Laboratories Div Pfizer Inc, Alembic Pharmaceuticals Limited, Dr. Reddy's Laboratories Limited, U.S. Pharmaceuticals. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic BOSULIF?
- 2 companies list bosutinib under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies bosutinib active ingredient?
- 3 companies list bosutinib as a bulk ingredient, including MSN Laboratories Private Limited,, Hetero Labs Limited, Sun Pharmaceutical Industries Limited.