
Irinotecan Infusion Suppliers & Bulk Manufacturers
Available Forms: Liposomal injection (intravenous infusion)
Available Strengths: 43 mg/ml
Reference Brands: Onivyde
Category: Liposomal Drug Delivery
Irinotecan infusion is available in Liposomal injection (intravenous infusion) and strengths such as 43 mg/ml. 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, Irinotecan infusion 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) |
Irinotecan infusion 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:
Liposomal irinotecan (Onivyde) is regulated in the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in accordance with GMP and MDR standards. In the US, FDA approval involved extensive clinical validation and safety assessments. In the EU, CE marking certifies conformity with MDR regulations. These formulations undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to high-quality liposomal irinotecan, supporting effective cancer treatment and improved patient outcomes worldwide.
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