Suppliers and packagers for jelmyto

jelmyto

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728	NDA	UroGen Pharma, Inc.	72493-103-03	1 KIT in 1 CARTON (72493-103-03) * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72493-101-40) * 20 mL in 1 VIAL, SINGLE-DOSE (72493-102-20)	2020-05-01

Suppliers and packagers for jelmyto

Last updated: May 27, 2026

JELMYTO (mitomycin gel) Suppliers and Supply-Chain Coverage: Who Manufactures Jelmyto and What’s the Orange Book/IP Status?

Jelmyto (mitomycin) is supplied in the US by UroGen Pharma under the marketed product Jelmyto (mitomycin for pyelocalyceal solution, UroGel formulation). Commercial supply is tied to the licensed product manufacturing network for the specific gel/solution system and to any licensed component manufacturing used for the UroGel formulation.

Who supplies Jelmyto (mitomycin gel) to the US market?

Primary branded product supplier (US):

• UroGen Pharma is the marketing authorization holder and the company that supplies branded Jelmyto in the US distribution channel.

Drug substance vs. drug product sourcing (what typically matters operationally):

• Jelmyto is a formulated mitomycin gel system delivered as an intraluminal instillation product. In practice, “supplier” in a procurement sense usually splits into:
  1. Drug product manufacturer for the finished sterile gel/kit system.
  2. Component suppliers for sterile processing materials (container/closure, medical device or delivery components if applicable, viscosity-control and formulation excipients).
  3. Commercial packaging and labeling site(s) for the US market.

Why supply questions are constrained for Jelmyto:

• Product-specific manufacturing-site details (drug product and sterile fill-finish) are usually visible in:
  • FDA establishment records tied to the approved application,
  • supplier qualification packages used by wholesalers,
  • and procurement documentation for kit components.
• Those data points are not determinable from the single prompt alone.

What manufacturing sites make Jelmyto (UroGel) for Mitomycin instillation?

What buyers need operationally:

• Jelmyto production is constrained by sterile manufacture and the stability requirements of the UroGel mitomycin formulation.
• Finished product manufacture generally includes:
  • sterile processing controls,
  • formulation hold-time and temperature controls,
  • packaging integrity for the instillation system.

Supply-chain mapping requirements:

• For a procurement or vendor-selection analysis, the relevant artifacts are:
  • FDA facility listing under the approved marketing application,
  • inspection history of those sites,
  • and confirmable release/sterility testing controls.

Is there any generic or biosimilar Jelmyto supply in the US yet?

There is no basis in this prompt to assert:

• whether a generic mitomycin gel or authorized substitute exists,
• whether any ANDA has been approved for Jelmyto-equivalent product,
• or whether any interchangeable product exists.

For exclusivity and substitution questions, the correct data source is the FDA Orange Book listing for the Jelmyto NDA and any related patents plus regulatory exclusivity periods.

What does Orange Book say about Jelmyto suppliers and manufacturing constraints?

Orange Book listings drive:

• which applicants can legally market,
• what patents cover composition, method of use, and formulation attributes,
• and which patents would control Paragraph IV and licensing strategies.

From the single prompt, Orange Book patent and exclusivity details are not determinable.

What companies produce mitomycin gels for urologic use that compete with Jelmyto supply?

Competition can be:

• other mitomycin intravesical or intraluminal formulations (not necessarily Jelmyto-equivalent),
• other agents in the same NMIBC upper tract pathway (not necessarily substitutable).

From the single prompt, there is no factual basis to enumerate specific competing suppliers, their NDA status, or their manufacturing sites.

How do licensing deals affect Jelmyto supply availability?

Branded supply is typically governed by:

• technology transfer terms,
• manufacturing slot reservation,
• minimum batch commitments,
• and distribution agreements.

In Jelmyto’s case, without the specific licensing agreement or establishment-level manufacturing history, the prompt does not support identification of named upstream suppliers or contract manufacturers.

When do Jelmyto exclusivity and patent cliffs change the supplier landscape?

Supplier landscape changes usually track:

• NDA exclusivity periods,
• patent expiration for composition/formulation/method,
• and the timing of any generic approval.

A timeline requires Orange Book patent expiration and exclusivity dates tied to Jelmyto’s specific NDA. Those dates are not available from the prompt alone.

Which supply risks matter most for Jelmyto procurement (sterile gel products)?

For sterile intraluminal gel systems, procurement risk typically concentrates on:

• sterile fill-finish capacity and batch release timelines,
• raw material sourcing for mitomycin and excipient systems,
• stability and cold-chain needs (if any),
• regulatory inspection outcomes at the release sites,
• and component supply continuity.

A named supplier risk assessment requires facility- and lot-level sourcing visibility that is not available from the prompt alone.

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Key Takeaways

• The branded Jelmyto product in the US is marketed/supplied through UroGen Pharma.
• For named manufacturing-site suppliers (drug product, component, sterile fill-finish, packaging), the required factual basis is the FDA establishment listing and Orange Book-linked application details, which are not provided in the prompt.
• Any shift in the supplier landscape depends on Orange Book patent and exclusivity timing, plus regulatory approvals for substitutes, which cannot be stated without the Jelmyto NDA-specific regulatory dataset.

FAQs

1. Who is the manufacturer of Jelmyto in the US supply chain?
2. Are there any FDA-approved generic alternatives to Jelmyto (mitomycin gel)?
3. What are the key suppliers for sterile gel manufacturing components used in Jelmyto-type products?
4. Do Jelmyto patent expirations trigger new supplier entries, and when?
5. Does Jelmyto have any licensing arrangements that constrain manufacturing capacity?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
2. FDA. Drugs@FDA. (Accessed via Drugs@FDA database).