Medicine
Margenza 250 mg/10 mL injection
Margenza 250 mg/10 mL injection is a prescription medicine containing Margetuximab for intravenous use, marketed by MacroGenics, 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
Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to…
Key facts
- Active ingredient (INN)
- Margetuximab
- Brand
- Margenza
- Strength
- 250 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 10 mL, 4 vials of 10 mL
- Marketing authorisation holder
- MacroGenics
- Manufacturer
- MacroGenics
- Origin register
- US FDA, United States
- Storage
- Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light until time of use. Do not freeze. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 January 2021
- Identifiers
- RxCUI 2474028, 2474033DailyMed set ID e97a5872-eabf-463b-8f4c-5b5aed9c7bf0NDC 74527-022Application BLA761150
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 carton / 10 mL in 1 vial, single-dose | 74527-022-02 | MacroGenics | 15 January 2021 |
| 4 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 74527-022-03 | MacroGenics | 15 January 2021 |
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 16 December 2020 | 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
Other strengths and forms of Margetuximab
Clinical summary
Margetuximab is an HER2/neu receptor antagonist indicated , in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, among other approved uses. MedsAcross supplies Margetuximab 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 MargetuximabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- MARGENZA prescribing information (TerSera Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Margenza 250 mg/10 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.