Estrogen Receptor Antagonist
Where is Fulvestrant made?
21 companies sell it under their own name. Their labels name 14 factories in India, China, the United States, Austria and Spain.
India 7China 3United States 2Austria 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.250 mg per 5 mL · NDC 16729-436 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| BluePoint Laboratories.50 mg per 1 mL, 250 mg per 5 mL · NDC 68001-484, 68001-626 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Amneal Pharmaceuticals Private LimitedMakes it and tests it | Ahmedabad, India | No problems foundJun 2024 | |
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd.50 mg per 1 mL · NDC 71731-6121 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Makes it, tests it, packages it and labels it | Lianyungang, China | Problems found, fixed voluntarilyJan 2026 |
| Lianyungang Runzhong Pharmaceutical Co., Ltd.Makes the active ingredient | Lianyungang, China | No problems foundJan 2024 | |
| Glenmark Pharmaceuticals Inc., USA50 mg per 1 mL · NDC 68462-317 | Glenmark Pharmaceuticals Inc., USAMakes it | Monroe, NC, United States | Problems found, fixed voluntarilyJun 2025 |
| PCI San Diego, Inc.Makes it | San Diego, CA, United States | Problems found, fixed voluntarilyMay 2025 | |
| Alembic Pharmaceuticals Inc.50 mg per 1 mL · NDC 62332-650 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| AuroMedics Pharma LLC50 mg per 1 mL · NDC 55150-394 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Cadila Healthcare Limited50 mg per 1 mL · NDC 70771-1626 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMay 2026 |
| Dr. Reddy's Laboratories Inc.50 mg per 1 mL · NDC 43598-262 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Fresenius Kabi, LLC50 mg per 1 mL · NDC 63323-715 | Fresenius Kabi AustriaMakes it, tests it and packages it | Austria 8055, Austria | Problems found, fixed voluntarilyMar 2024 |
| Hikma Pharmaceuticals USA Inc.50 mg per 1 mL · NDC 0143-9022 | Jiangsu Hansoh Pharmaceutical Group Co., Ltd. FDF siteMakes it, tests it, packages it and labels it | Lianyungang, China | Serious problems, FDA actionApr 2026 |
| Northstar Rx LLC.50 mg per 1 mL · NDC 16714-070 | Laboratorios Farmalan, S.A.Makes it and tests it | Villaquilambre, Spain | Problems found, fixed voluntarilyOct 2024 |
| Xiromed, LLC.50 mg per 1 mL · NDC 70700-284 | Laboratorios Farmalan, S.A.Makes it and tests it | Villaquilambre, Spain | Problems found, fixed voluntarilyOct 2024 |
| Zydus Pharmaceuticals (USA) Inc.50 mg per 1 mL · NDC 70710-1688 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMay 2026 |
| Amneal Pharmaceuticals LLC250 mg per 5 mL · NDC 70121-1463 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AstraZeneca Pharmaceuticals LP Faslodex50 mg per 1 mL · NDC 0310-0720 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Athenex Pharmaceutical Division, LLC.50 mg per 1 mL · NDC 70860-211 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Avenacy Inc.50 mg per 1 mL · NDC 83634-203 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Avyxa Pharma, LLC Cligavyx250 mg per 5 mL · NDC 83831-159 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Meitheal Pharmaceuticals Inc.50 mg per 1 mL · NDC 71288-555 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals50 mg per 1 mL · NDC 25021-471 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.50 mg per 1 mL · NDC 0781-3532, 0781-9055 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jul 15, 2022 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications - Aug 27, 2021 · Class II · Glenmark Pharmaceuticals Inc., USA
Lack of Assurance of Sterility
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.