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 inhibits DNA synthesis by incorporating into DNA strands, disrupting cell replication. It effectively treats leukemia and lymphoma by targeting rapidly dividing cancer cells. Benefits include rapid tumor reduction, improved remission rates, and enhanced survival, making it a key chemotherapeutic agent in hematologic malignancies.
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.
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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