Mitomycin pyelocalyceal bulk supplier for pharma manufacturers

Mitomycin Pyelocalyceal Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 40 mg

Reference Brands: Jelmyto (USA/EU)

Category: Oncology Cancer Care

Mitomycin pyelocalyceal is a formulation of mitomycin designed as a reverse-thermal hydrogel that becomes semi-solid at body temperature, allowing prolonged contact with the upper urinary tract. It is used for the treatment of low-grade upper tract urothelial cancer. The gel is instilled directly into the renal pelvis and calyces through a catheter and gradually dissolves to release the active drug. Mitomycin pyelocalyceal is available in Injection and strengths such as 40 mg. 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, Mitomycin pyelocalyceal 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)

Mitomycin pyelocalyceal 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.

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Frequently Asked Questions

Mitomycin pyelocalyceal solution is used to treat low-grade upper tract urothelial cancer (LG-UTUC) in the renal pelvis or calyces. It works by directly targeting cancer cells within the upper urinary tract.

It is made from mitomycin C formulated in a thermosensitive gel. The gel remains liquid during preparation and becomes semi-solid at body temperature, allowing it to stay in place within the pyelocalyceal system for sustained drug exposure.

The trade name is Jelmyto.

It is developed and manufactured by UroGen Pharma.

The generic name is Mitomycin for pyelocalyceal solution (mitomycin C).

The brand name is Jelmyto.

It is manufactured by UroGen Pharma in its regulated pharmaceutical production facilities and supplied to hospitals and clinics for administration through a catheter into the renal pelvis.

Yes, Mitomycin pyelocalyceal is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Mitomycin pyelocalyceal is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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