
Cytarabine Iv/Sq/Intrathecal Injection Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 100 mg/mL(IV & SQ); 50 mg/mL(intrathecal use)
Reference Brands: DepoCyt(US)
Category: Blood Disorder
Cytarabine IV/SQ/Intrathecal Injection is available in Injection and strengths such as 100 mg/mL(IV & SQ); 50 mg/mL(intrathecal use). 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, Cytarabine IV/SQ/Intrathecal 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) |
Cytarabine IV/SQ/Intrathecal 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:
Cytarabine injection is approved in the US by the FDA and in the EU via EMA for treating leukemia and lymphoma. Regulatory approval requires a comprehensive dossier featuring clinical trial data, manufacturing quality, safety, efficacy, and pharmacovigilance plans. In the US, the FDA reviews detailed submissions, while EMA ensures compliance with regional standards. For expert guidance on dossier preparation, regulatory pathways, and successful market entry, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of cytarabine injection worldwide, supporting optimal patient outcomes and expanded access in oncology treatments.
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