Medicine
Nplate 125 mcg/0.25 mL powder for injection
Nplate 125 mcg/0.25 mL powder for injection is a prescription medicine containing Romiplostim for subcutaneous use, marketed by Amgen, 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 Nplate vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the…
Key facts
- Active ingredient (INN)
- Romiplostim
- Brand
- Nplate
- Strength
- 125 mcg/0.25 mL
- Dosage form
- Powder for injection
- Route
- Subcutaneous
- Packs
- 1 vial and 3 more
- Marketing authorisation holder
- Amgen
- Manufacturer
- Amgen
- Origin register
- US FDA, United States
- Storage
- Store Nplate vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Once stored at room temperature, do not place back in the refrigerator. If needed, unopened Nplate vials may be stored in the original carton at room temperature up to a maximum of 25°C (77°F) for a single period of up to 30 days.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B02BX04 Romiplostim
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 August 2008
- Identifiers
- RxCUI 1728092, 1728095, 1728097 +3DailyMed set ID c45f9a58-37c1-4f76-8e36-97d38c577037NDC 55513-222, 55513-223, 55513-221Application BLA125268
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 in 1 carton / .5 mL in 1 vial | 55513-221-01 | Amgen | 25 August 2008 |
| 1 vial in 1 carton / .5 mL in 1 vial | 55513-221-21 | Amgen | 1 August 2025 |
| 1 vial in 1 carton / 1 mL in 1 vial | 55513-222-01 | Amgen | 25 August 2008 |
| 1 vial in 1 carton / 1 mL in 1 vial | 55513-222-21 | Amgen | 1 August 2025 |
| 1 vial, single-dose in 1 carton / .25 mL in 1 vial, single-dose | 55513-223-01 | Amgen | 2 August 2019 |
| 1 vial, single-dose in 1 carton / .25 mL in 1 vial, single-dose | 55513-223-21 | Amgen | 1 August 2025 |
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
Romiplostim is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy, among other approved uses. MedsAcross supplies Romiplostim 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 RomiplostimFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nplate prescribing information (Amgen) · U.S. National Library of Medicine, DailyMed
- Nplate: European public assessment report (EPAR) · European Medicines Agency
Need Nplate 125 mcg/0.25 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.