Medicine
Injectafer 100 mg/2 mL injection
Injectafer 100 mg/2 mL injection is a prescription medicine containing Ferric carboxymaltose for intravenous use, marketed by American Regent, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to…
Key facts
- Active ingredient (INN)
- Ferric carboxymaltose
- Brand
- Injectafer
- Strength
- 100 mg/2 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 2 mL
- Marketing authorisation holder
- American Regent
- Manufacturer
- American Regent
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2022
- Identifiers
- RxCUI 1435169, 1435174, 2552400 +3DailyMed set ID 517b4a19-45b3-4286-9f6a-ced4e10447deNDC 0517-0602Application NDA203565
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-dose in 1 box / 2 mL in 1 vial, single-dose | 0517-0602-01 | American Regent | 28 July 2022 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 25 July 2013 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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 Ferric carboxymaltose 100 mg/2 mL injection.
Other strengths and forms of Ferric carboxymaltose
Clinical summary
Ferric carboxymaltose is a parenteral iron replacement indicated for the treatment of iron deficiency anemia (IDA) in, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Ferric carboxymaltose 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 Ferric carboxymaltoseFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ferric Carboxymaltose prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need Injectafer 100 mg/2 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.