Drug
Who makes fulvestrant?
21 companies list fulvestrant as a human prescription drug, including under the names CLIGAVYX, FASLODEX. Forms: injection; injection, solution. Routes: intramuscular, intravenous.
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 fulvestrant
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| BluePoint Laboratories Inc. | injection; injection, solution | ANDAANDA210044, ANDA211689, ANDA215077 | 3 | 0 |
| Sandoz Industrial Products S.AAustria | injection | ANDAANDA205935 | 2 | 5 |
| AstraZeneca PLCUnited States | injection | NDANDA021344 | 1 | 15 |
| Dr. Reddy's Laboratories LimitedIndia | injection, solution | ANDAANDA209246 | 1 | 15 |
| Zydus Lifesciences LimitedIndia | injection, solution | ANDAANDA215234 | 1 | 12 |
| Glenmark Pharmaceuticals Inc., USAIndia | injection | ANDAANDA207754 | 1 | 9 |
| Alembic Pharmaceuticals LimitedIndia | injection | ANDAANDA215077 | 1 | 7 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | NDANDA210326 | 1 | 6 |
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA214682 | 1 | 4 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection | ANDAANDA211689 | 1 | 2 |
| Amneal Ireland LimitedIreland | injection, solution | ANDAANDA210044 | 1 | 1 |
| Avyxa GmbHSwitzerland | injection | NDANDA210063 | 1 | 1 |
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd.China | injection | ANDAANDA211422 | 1 | 1 |
| Xiromed LLCIndia | injection, solution | ANDAANDA213553 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | injection, solution | ANDAANDA215234 | 1 | 1 |
| Athenex Pharmaceutical Division, LLC. | injection, solution | ANDAANDA211422 | 1 | 0 |
| Avenacy, Inc. | injection, solution | ANDAANDA211422 | 1 | 0 |
| Eugia US LLC | injection | ANDAANDA215169 | 1 | 0 |
| Meitheal Pharmaceuticals, Inc. | injection | ANDAANDA209714 | 1 | 0 |
| Northstar Rx, LLC, | injection, solution | ANDAANDA213553 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA211422 | 1 | 0 |
Bulk ingredient listings
- Ajinomoto OmniChem N.V.Belgium · 1 NDC
- Farmabios S.p.A.Italy · 1 NDC
- Industriale Chimica SRLItaly · 1 NDC
- Jiangsu Hansoh Pharmaceutical Group Co., Ltd.China · 1 NDC
- Lianyungang Runzhong Pharmaceutical Co., Ltd.,China · 1 NDC
- Minakem High PotentBelgium · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Sicor S.r.l. · 1 NDC
- Sinopep-Allsino Biopharmaceutical Co., Ltd.China · 1 NDC
- Sterling Chemical Malta LtdMalta · 1 NDC
- Sterling Pharmaceutical Services, LLCUnited States · 1 NDC
- Steroid S.p.A.Italy · 1 NDC
- WAVELENGTH ENTERPRISES LTDIsrael · 1 NDC
Orange Book patents
3 unexpired patents list fulvestrant as the active ingredient, expiring between Feb 2034 and May 2034. Application holder: FRESENIUS KABI USA LLC.
Enquiry
Common questions
- Who makes fulvestrant?
- 21 companies list fulvestrant as a human prescription drug in the openFDA NDC Directory, led by BluePoint Laboratories Inc., Sandoz Industrial Products S.A, AstraZeneca PLC, Dr. Reddy's Laboratories Limited, Zydus Lifesciences Limited. 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 CLIGAVYX?
- 18 companies list fulvestrant 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 fulvestrant active ingredient?
- 13 companies list fulvestrant as a bulk ingredient, including Ajinomoto OmniChem N.V., Farmabios S.p.A., Industriale Chimica SRL, Jiangsu Hansoh Pharmaceutical Group Co., Ltd..