Romiplostim Injection Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 250mcg/vial, 500 mcg/vial
Reference Brands: Nplate®(US & EU)
Category: Orphan Drugs
Romiplostim injection is available in Injection and strengths such as 250mcg/vial, 500 mcg/vial. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Romiplostim injection is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Romiplostim injection can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: Romiplostim injection, marketed as Nplate®, is approved by the FDA and EMA for treating chronic immune thrombocytopenic purpura (ITP). Regulatory dossiers include comprehensive clinical trial data, manufacturing standards, and safety profiles, ensuring high-quality product approval. The dossiers support its efficacy in increasing platelet counts and reducing bleeding risk. Nplate® is administered as a subcutaneous injection, with dosing tailored to patient needs. For detailed information on regulatory processes, dossier submissions, and market approvals in the EU and US, visit PharmaTradz, your trusted source for pharmaceutical regulatory insights and industry updates.
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