Drug
Who makes sunitinib malate?
10 companies list sunitinib malate as a human prescription drug, including under the names SUTENT. 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 sunitinib malate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | capsule | ANDAANDA213914 | 4 | 13 |
| Aurobindo Pharma LimitedIndia | capsule | ANDAANDA218615 | 4 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule | ANDAANDA213803 | 4 | 6 |
| Novugen Pharma Sdn. Bhd.Malaysia | capsule | ANDAANDA218012 | 4 | 1 |
| AvKARE | capsule | ANDAANDA213803 | 4 | 0 |
| Dr. Reddys Laboratories Limited | capsule | ANDAANDA215843 | 4 | 0 |
| Mylan Pharmaceuticals, Inc. | capsule | ANDAANDA201275 | 4 | 0 |
| NorthStar RxLLC | capsule | ANDAANDA213914 | 4 | 0 |
| Novadoz Pharmaceuticals LLC | capsule | ANDAANDA214824 | 4 | 0 |
| Pfizer Laboratories Div Pfizer Inc | capsule | NDANDA021938 | 4 | 0 |
Bulk ingredient listings
- Hetero Labs LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Medichem Manufacturing (Malta) Ltd. · 1 NDC
- Medichem SASpain · 1 NDC
- Pfizer IncUnited States · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- Sicor S.r.l. · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes sunitinib malate?
- 10 companies list sunitinib malate as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Aurobindo Pharma Limited, Teva Pharmaceutical Industries Ltd., Novugen Pharma Sdn. Bhd., AvKARE. 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 SUTENT?
- 9 companies list sunitinib malate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies sunitinib malate active ingredient?
- 8 companies list sunitinib malate as a bulk ingredient, including Hetero Labs Limited, MSN Laboratories Private Limited,, Medichem Manufacturing (Malta) Ltd., Medichem SA.