Mesna Injection Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 100 mg/mL
Reference Brands: Mesnex(US)
Category:
Blood Disorder
Mesna inactivates harmful metabolites of cyclophosphamide and ifosfamide, reducing the risk of hemorrhagic cystitis. It binds to acrolein in the urinary bladder, protecting the lining. Benefits include preventing bladder toxicity, supporting continuous chemotherapy, and ensuring patient safety during high-dose cyclophosphamide or ifosfamide treatment.
Mesna Injection is available in Injection
and strengths such as 100 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, Mesna 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) |
Mesna 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:
Mesna injection, marketed as Mesnex, is approved in the US by the FDA and in the EU via EMA to prevent hemorrhagic cystitis during chemotherapy. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA conducts a comprehensive review, while the EMA assesses compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and successful market access, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of mesna injection worldwide, supporting optimal patient care in oncology treatments.
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