Drug
Who makes abiraterone acetate?
20 companies list abiraterone acetate as a human prescription drug, including under the names YONSA, Zytiga, Abirtega. 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 abiraterone acetate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Dr. Reddys Laboratories Limited | tablet | ANDAANDA208416 | 3 | 0 |
| Northstar Rx, LLC, | tablet | ANDAANDA208416, ANDA209227 | 3 | 0 |
| Novadoz Pharmaceuticals LLC | tablet; tablet, film coated | ANDAANDA210686 | 3 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet | ANDAANDA209227 | 2 | 9 |
| Apotex Inc.Canada | tablet; tablet, film coated | ANDAANDA208453, ANDA212462 | 2 | 6 |
| Florida Pharmaceutical Products LLCUnited States | tablet; tablet, film coated | ANDAANDA212462, ANDA215086 | 2 | 1 |
| Golden State Medical Supply Inc.United States | tablet; tablet, film coated | ANDA, NDAANDA208446, NDA210308 | 2 | 1 |
| Novugen Pharma Sdn. Bhd.Malaysia | tablet, film coated | ANDAANDA215947 | 2 | 1 |
| BluePoint Laboratories Inc. | tablet | ANDAANDA210686 | 2 | 0 |
| CivicaScript, LLC | tablet | ANDAANDA208339 | 2 | 0 |
| Janssen Pharmaceuticals, Inc. | tablet; tablet, film coated | NDANDA202379 | 2 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet; tablet, film coated | ANDAANDA208446 | 2 | 0 |
| Quallent Pharmaceuticals Health, LLC | tablet; tablet, film coated | ANDAANDA210686 | 2 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | tablet | NDANDA210308 | 1 | 13 |
| Hikma Pharmaceuticals USA Inc.United States | tablet | ANDAANDA208339 | 1 | 4 |
| Bryant Ranch PrepackUnited States | tablet, film coated | ANDAANDA208446 | 1 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA208339 | 1 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet | ANDAANDA208371 | 1 | 1 |
| AvPAK | tablet | ANDAANDA208416 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA208453 | 1 | 0 |
Bulk ingredient listings
- Chemo Biosynthesis s.r.l.Italy · 2 NDC
- Olon USA LLCItaly · 2 NDC
- Sterling Chemical Malta LtdMalta · 2 NDC
- Sterling Pharmaceutical Services, LLCUnited States · 2 NDC
- Aurisco Pharmaceutical Co.,LtdChina · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Curia India Private LimitedItaly · 1 NDC
- Hetero Labs LimitedIndia · 1 NDC
- Hubei Biocause Heilen Pharmaceutical Co., LtdChina · 1 NDC
- Hubei Zhuxi Humanwell Pharmaceutical Co. Ltd.China · 1 NDC
- Industriale Chimica SRLItaly · 1 NDC
- Janssen Pharmaceuticals, Inc. · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- QUIMICA SINTETICA SASpain · 1 NDC
- RAKS Pharma Pvt. LimitedIndia · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Sicor S.r.l. · 1 NDC
- Sicor de Mexico S.A. de C.V.Mexico · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Symbiotec Pharmalab LimitedIndia · 1 NDC
- Tianjin Pacific Chemical & Pharmaceutical Co., Ltd.China · 1 NDC
- Zhejiang Shenzhou Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
2 unexpired patents list abiraterone acetate as the active ingredient, expiring between Mar 2034 and May 2034. Application holder: SUN PHARMACEUTICAL INDUSTRIES LTD.
Enquiry
Common questions
- Who makes abiraterone acetate?
- 20 companies list abiraterone acetate as a human prescription drug in the openFDA NDC Directory, led by Dr. Reddys Laboratories Limited, Northstar Rx, LLC,, Novadoz Pharmaceuticals LLC, Glenmark Pharmaceuticals Inc., USA, Apotex Inc.. 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 YONSA?
- 18 companies list abiraterone acetate under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies abiraterone acetate active ingredient?
- 22 companies list abiraterone acetate as a bulk ingredient, including Chemo Biosynthesis s.r.l., Olon USA LLC, Sterling Chemical Malta Ltd, Sterling Pharmaceutical Services, LLC.