Medicine
Enhertu 100 mg/5 mL powder for injection
Enhertu 100 mg/5 mL powder for injection is a prescription medicine containing Trastuzumab deruxtecan for intravenous use, marketed by Daiichi Sankyo, 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 in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original…
Key facts
- Active ingredient (INN)
- Trastuzumab deruxtecan
- Brand
- Enhertu
- Strength
- 100 mg/5 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Daiichi Sankyo
- Manufacturer
- Daiichi Sankyo
- Origin register
- US FDA, United States
- Storage
- Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Do not shake the reconstituted or diluted solution.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01FD04 Trastuzumab deruxtecan
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 December 2019
- Identifiers
- RxCUI 2267576, 2267581DailyMed set ID 7e67e73e-ddf4-4e4d-8b50-09d7514910b6NDC 65597-406Application BLA761139
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 / 5 mL in 1 vial, single-dose | 65597-406-01 | Daiichi Sankyo | 20 December 2019 |
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
Clinical summary
Trastuzumab deruxtecan is a prescription medicine indicated for hER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, among other approved uses. MedsAcross supplies Trastuzumab deruxtecan 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 Trastuzumab deruxtecanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Enhertu prescribing information (Daiichi Sankyo) · U.S. National Library of Medicine, DailyMed
- Enhertu: European public assessment report (EPAR) · European Medicines Agency
Need Enhertu 100 mg/5 mL powder for 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.