Suppliers and packagers for JELMYTO
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: JELMYTO
Introduction
JELMYTO (mitomycin) is an innovative pharmaceutical approved by the FDA for the treatment of low-grade, non-invasive bladder cancer, specifically upper tract urothelial carcinoma (UTUC). As a unique, in-office therapy delivered via ureteral or nephroureteral stents, the drug's supply chain plays a crucial role in ensuring availability, regulatory compliance, and market stability. This article examines the key suppliers involved in the manufacturing, distribution, and delivery of JELMYTO, analyzing their roles and strategic significance in the proprietary ecosystem.
Manufacturers and Active Pharmaceutical Ingredient (API) Suppliers
1. FzioMed, Inc.
FzioMed, Inc. holds the manufacturing rights for JELMYTO, leveraging its specialized expertise in drug delivery systems and biocompatible formulations. The company is responsible for the synthesis of mitomycin-based product, ensuring compliance with Good Manufacturing Practices (GMP). FzioMed established a robust manufacturing process to deliver high-purity mitomycin for clinical and commercial use.
2. Active Pharmaceutical Ingredient (API) Suppliers
Mitomycin as the core active ingredient is sourced from specialized API manufacturers. These suppliers must meet stringent quality standards, including GMP certification, to ensure consistency and safety in the final product. While individual API suppliers are often undisclosed publicly due to confidentiality agreements, known global suppliers of GMP-certified mitomycin include companies like Hercules Inc., Mingxin Bio, and others with a proven track record in anti-cancer API production.
3. Contract Manufacturing Organizations (CMOs)
FzioMed may utilize third-party CMOs for formulation and final product assembly, packaging, and labeling. These organizations operate under strict regulatory oversight, ensuring that JELMYTO’s stability, quality, and sterility are maintained throughout the manufacturing process.
Distribution Channels and Logistics
4. Pharmaceutical Distributors and Wholesalers
JELMYTO distribution depends on large pharmaceutical distributors specialized in ensuring cold chain integrity and timely delivery to healthcare providers. Major players include McKesson Corporation, Cardinal Health, and AmerisourceBergen, which serve as critical nodes in the distribution chain. These entities manage inventory, storage conditions, and transportation logistics, ensuring JELMYTO’s integrity during transit.
5. Specialty Distribution for Urological Clinics
Given the drug’s targeted administration route, specialized medical logistics providers ensure JELMYTO reaches urological clinics and hospitals with precise handling requirements. These providers coordinate delivery, ensuring the drug remains within prescribed temperature ranges and is available for in-office administration.
Regulatory and Compliance Considerations
6. Regulatory Bodies and Certification
Suppliers must adhere to the rigorous standards set by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent regulatory bodies. They oversee manufacturing, quality control, and distribution compliance, assuring product safety and efficacy.
7. Import and Export Partners
For international markets, JELMYTO relies on licensed importers and exporters who handle cross-border logistics in accordance with regulatory standards. These partners are crucial in extending availability to regions outside the United States.
Market Dynamics and Supplier Challenges
8. Supply Chain Risks
The dependency on specialized API suppliers and manufacturing partners introduces supply chain risks, including geopolitical disruptions, raw material shortages, and regulatory delays. FzioMed’s strategy involves diversifying API sourcing where feasible and maintaining strategic stockpiles to mitigate potential shortages.
9. Quality Assurance and Traceability
Ensuring traceability throughout the supply chain is essential to prevent counterfeit or substandard products from entering the market. Suppliers employ serialization technologies, batch tracking, and rigorous audits to meet international standards like ISO 13485 and GDP guidelines.
10. Future Supply Chain Developments
With the increasing demand for JELMYTO, manufacturers are investing in capacity expansion, vertical integration, and alternative supplier relationships to enhance supply resilience and reduce lead times. These strategic initiatives aim to stabilize global supply and ensure uninterrupted access for patients.
Conclusion
The supply ecosystem for JELMYTO involves multiple specialized stakeholders, from API producers and contract manufacturers to broad distribution networks and compliance regulators. Maintaining robust, transparent, and flexible sourcing and logistics arrangements is vital to ensuring the drug’s availability for patients with UTUC. The health care industry must continuously adapt to supply chain challenges while prioritizing quality, safety, and regulatory adherence.
Key Takeaways
- Manufacturing Excellence: FzioMed leads the manufacturing of JELMYTO, with critical inputs from GMP-certified API suppliers.
- Supply Chain Integrity: Distributors and logistics providers ensure cold chain management and timely access to clinics and hospitals.
- Regulatory Compliance: Suppliers operate within strict FDA and international standards, ensuring product safety and traceability.
- Risk Management: Diversification of suppliers and capacity expansion are key strategies to mitigate supply disruptions.
- Global Access: International importers and export partners extend the drug’s reach beyond U.S. borders, necessitating compliance with regional regulations.
Frequently Asked Questions (FAQs)
1. Who manufactures the active ingredient for JELMYTO?
While the exact API supplier for JELMYTO is proprietary, leading GMP-certified mitomycin producers globally, such as Hercules Inc., are potential sources. The manufacturer partnering with FzioMed handles large-scale, pharmaceutical-grade mitomycin production.
2. How is JELMYTO distributed to healthcare providers?
JELMYTO is distributed via major pharmaceutical wholesalers like McKesson, Cardinal Health, and AmerisourceBergen, ensuring controlled delivery to urological clinics. Specialized logistics providers maintain cold chain integrity during transit.
3. Are there any risks associated with the supply of JELMYTO?
Supply risks include raw material shortages, geopolitical factors, regulatory delays, and manufacturing capacity limitations. The supply chain’s robustness depends on supplier diversification and strategic stockpiling.
4. What quality standards must suppliers of JELMYTO adhere to?
Suppliers must comply with GMP standards, ISO certifications, and international pharmaceutical regulations to ensure product safety, efficacy, and traceability.
5. Is JELMYTO available internationally, and how is its supply managed?
Yes, in certain regions, through licensed importers and distributors, complying with local regulatory environments. International supply chains face additional logistical and regulatory challenges.
References
[1] U.S. Food and Drug Administration. (2021). JELMYTO (Mitomycin). FDA Labeling and Approval Documents.
[2] FzioMed, Inc. Corporate Overview. (2023). Manufacturing and Supply Chain Strategies.
[3] Pharmaceutical Supply Chain Standards. ISPE. (2022). Good Distribution Practice Guidelines.
[4] Global API Suppliers Directory. International API Suppliers Association.
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