Drug
Who makes bicalutamide?
8 companies list bicalutamide as a human prescription drug, including under the names CASODEX. Forms: tablet; 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 bicalutamide
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| ANI Pharmaceuticals, Inc.United States | tablet | NDANDA020498 | 2 | 1 |
| Proficient Rx LPUnited States | tablet; tablet, film coated | ANDAANDA078917, ANDA079110 | 2 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA079110 | 1 | 13 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet | ANDAANDA078917 | 1 | 2 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA078917 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet | NDANDA020498 | 1 | 1 |
| PINNACLE LIFE SCIENCE PRIVATE LIMITEDIndia | tablet | ANDAANDA079089 | 1 | 1 |
| Viona Pharmaceuticals Inc. | tablet | ANDAANDA079089 | 1 | 0 |
Bulk ingredient listings
- AARTI PHARMALABS LIMITEDIndia · 1 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Excella GmbH & Co. KGGermany · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- TAPI Hungary Industries Kft. · 1 NDC
- Teva Pharmaceutical Works Private Limited CompanyHungary · 1 NDC
Enquiry
Common questions
- Who makes bicalutamide?
- 8 companies list bicalutamide as a human prescription drug in the openFDA NDC Directory, led by ANI Pharmaceuticals, Inc., Proficient Rx LP, Sun Pharmaceutical Industries Limited, ACCORD HEALTHCARE LIMITED, Bryant Ranch Prepack. 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 CASODEX?
- 6 companies list bicalutamide 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 bicalutamide active ingredient?
- 8 companies list bicalutamide as a bulk ingredient, including AARTI PHARMALABS LIMITED, AX Pharmaceutical Corp, Excella GmbH & Co. KG, MSN Laboratories Private Limited,.