Medicine
Fulvestrant 250 mg/5 mL injection
Fulvestrant 250 mg/5 mL injection is a generic prescription medicine for intramuscular use, made by 17 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
REFRIGERATE, 2°C to 8°C (36°F to 46°F). TO PROTECT FROM LIGHT, STORE IN THE…
Key facts
- Active ingredient (INN)
- Fulvestrant
- Brand
- Sold under the generic name
- Strength
- 250 mg/5 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 2 syringes of 5 mL and 19 more
- Manufacturers
- Zydus LifesciencesIndiaAccord HealthcareIndiaAlembic PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaGlenmark PharmaceuticalsIndiaAmneal PharmaceuticalsBluePoint LaboratoriesSagent PharmaceuticalsSandozAthenex Pharmaceutical Division
- Origin register
- US FDA, United States
- Storage
- REFRIGERATE, 2°C to 8°C (36°F to 46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L02BA03 Fulvestrant
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 March 2019
- Identifiers
- RxCUI 727762DailyMed set ID 99cf8b69-4c23-4886-80e9-b23e348b5bd7, 994edf79-20a5-4e3a-bb35-c4fe3e65acba, 151b948a-3106-497a-b1c7-479307faeb89 +19NDC 68462-317, 70710-1688, 70771-1626 +17Application ANDA207754, ANDA215234, ANDA211422 +9
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 70710-1688-8 | Zydus LifesciencesIndia | 14 December 2021 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 70771-1626-8 | Zydus LifesciencesIndia | 14 December 2021 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 16729-436-30 | Accord HealthcareIndia | 21 January 2021 |
| 2 syringe in 1 carton / 5 mL in 1 syringe | 62332-650-10 | Alembic PharmaceuticalsIndia | 22 December 2022 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 43598-262-23 | Dr. Reddy's LaboratoriesIndia | 5 September 2024 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 68462-317-32 | Glenmark PharmaceuticalsIndia | 22 August 2019 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 70121-1463-2 | Amneal Pharmaceuticals | 4 March 2019 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 70121-1463-9 | Amneal Pharmaceuticals | 3 June 2025 |
| 2 syringe in 1 carton / 5 mL in 1 syringe | 25021-471-66 | Sagent Pharmaceuticals | 15 April 2026 |
| 2 syringe in 1 carton / 5 mL in 1 syringe | 25021-471-74 | Sagent Pharmaceuticals | 15 September 2024 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 0781-3532-12 | Sandoz | 1 November 2023 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 0781-9055-12 | Sandoz | 1 July 2023 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 70860-211-74 | Athenex Pharmaceutical Division | 18 February 2020 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 71731-6121-1 | Chia Tai Tianqing Pharmaceutical Group | 1 April 2021 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 63323-715-05 | Fresenius Kabi | 20 May 2019 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 0143-9022-02 | Hikma Pharmaceuticals | 10 February 2022 |
| 2 syringe in 1 carton / 5 mL in 1 syringe | 71288-555-86 | Meitheal Pharmaceuticals | 21 November 2019 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 70700-284-98 | Xiromed | 19 August 2021 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 68001-484-85 | BluePoint Laboratories | 1 March 2021 |
| 2 syringe in 1 carton / 5 mL in 1 syringe | 68001-626-85 | BluePoint Laboratories | 17 January 2025 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 83634-203-74 | Avenacy | 28 February 2024 |
| 2 syringe, glass in 1 carton / 5 mL in 1 syringe, glass | 16714-070-02 | Northstar Rx | 23 August 2021 |
| 2 syringe in 1 carton / 5 mL in 1 syringe | 55150-394-02 | — | 30 June 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Fulvestrant 250 mg/5 mL injection.
Clinical summary
Fulvestrant is an estrogen receptor antagonist indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or. MedsAcross supplies Fulvestrant for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about FulvestrantFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FASLODEX prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Faslodex: European public assessment report (EPAR) · European Medicines Agency
- Fulvestrant Mylan: European public assessment report (EPAR) · European Medicines Agency
Need Fulvestrant 250 mg/5 mL injection for your hospital or patient?
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