Suppliers and packagers for generic pharmaceutical drug: ERDAFITINIB

ERDAFITINIB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018	NDA	Janssen Products LP	59676-030-56	1 BOTTLE in 1 CARTON (59676-030-56) / 56 TABLET, FILM COATED in 1 BOTTLE	2019-04-12
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018	NDA	Janssen Products LP	59676-030-84	1 BOTTLE in 1 CARTON (59676-030-84) / 84 TABLET, FILM COATED in 1 BOTTLE	2019-04-12
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018	NDA	Janssen Products LP	59676-040-28	1 BOTTLE in 1 CARTON (59676-040-28) / 28 TABLET, FILM COATED in 1 BOTTLE	2019-04-12
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018	NDA	Janssen Products LP	59676-040-56	1 BOTTLE in 1 CARTON (59676-040-56) / 56 TABLET, FILM COATED in 1 BOTTLE	2019-04-12

Suppliers for the Pharmaceutical Drug: Erdafitinib

Last updated: July 29, 2025

Introduction

Erdafitinib is an oral fibroblast growth factor receptor (FGFR) inhibitor developed primarily for the treatment of urothelial carcinoma with specific FGFR genetic alterations. Approved by the U.S. Food and Drug Administration (FDA) in 2019 under the brand name Balversa, erdafitinib represents a significant advancement in targeted cancer therapies. Given its specialized nature, sourcing erdafitinib involves navigating a complex landscape of manufacturers, integrated supply chains, and regulatory considerations. This report provides a comprehensive overview of the key suppliers involved in the production, distribution, and commercialization of erdafitinib, emphasizing their roles, market positions, and sourcing strategies.

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Manufacturers and Original Developers

1. Janssen Pharmaceuticals/AbbVie Inc.

Erdafitinib’s origin traces back to Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, which initially sponsored its clinical development. Janssen collaborated with other biotech companies to conduct pivotal clinical trials and obtained FDA approval for Balversa, marking Janssen as the primary commercializer and supplier of erdafitinib.

• Manufacturing Role: Janssen maintains control over the commercial supply of erdafitinib. The drug is produced in specialized facilities adhering to Good Manufacturing Practices (GMP). However, Janssen often partners with Contract Manufacturing Organizations (CMOs) for bulk production, especially for active pharmaceutical ingredients (APIs) and finished dosage formulations.

• Supply Chain Structure: Janssen’s global footprint enables the distribution of erdafitinib across North America, Europe, and select regions. The company manages distribution channels, inventory management, and regulatory compliance.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity and cost associated with developing and scaling API production, Janssen relies heavily on CMOs for large-scale manufacturing. Some notable CMOs involved include:

• Patheon (Thermo Fisher Scientific): Known for API manufacturing, Patheon has facilities capable of producing high-quality APIs for oncology drugs like erdafitinib. They adhere to stringent GMP standards.

• Catalent: Provides formulation and fill-finish services for erdafitinib capsules or tablets, ensuring stability and bioavailability.

• Lonza: Renowned for custom API synthesis, Lonza offers capabilities for complex chemical syntheses necessary for FGFR inhibitors.

3. Raw Material Suppliers

The synthesis of erdafitinib's API demands high-purity chemical precursors supplied by specialized raw material vendors. These suppliers include global chemical companies such as:

• BASF: Supplies intermediates and speciality chemicals necessary for API manufacturing.

• Evonik: Offers intermediates & reagents used during synthesis.

Supply reliability depends on the quality, purity, and compliance with international standards to meet GMP requirements.

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Distribution and Supply Chain Participants

4. Distributors and Logistics Providers

Once manufactured, erdafitinib is distributed through a network of pharma logistics companies that ensure temperature-controlled, compliant transportation:

• UPS and DHL: Offer specialized healthcare logistics with real-time tracking.

• AmerisourceBergen and McKesson: Global healthcare distribution giants that handle warehousing and distribution, especially in North America.

5. Specialty Pharmacies and Oncology Centers

Authorized specialty pharmacies and oncology clinics often serve as the final point for erdafitinib distribution, ensuring proper handling, patient counseling, and adherence.

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Emerging Suppliers and Licensing Agreements

While Johnson & Johnson’s Janssen remains the primary source, the drug’s patent protections influence market entry by generic manufacturers:

• Patent and Exclusivity: Patent protections for erdafitinib may delay generic manufacturing. However, once patents expire, other manufacturers might seek licensing agreements, or establish their own production lines, boosting supply and reducing prices.

• Generic Manufacturers: Potential future entrants include Chinese or Indian pharmaceutical firms with capabilities in complex chemical syntheses and API production, pending patent expiration and regulatory approval.

6. Licensing and Partnerships

In late 2021, Janssen announced licensing agreements with regional manufacturers to expand access, particularly in emerging markets. These partnerships necessitate local manufacturing approvals, further diversifying supply sources.

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Regulatory and Quality Considerations

The supply chain for erdafitinib is heavily regulated by agencies such as the FDA, EMA, and other health authorities globally. Suppliers must demonstrate compliance with GMP, rigorous quality controls, and stability standards. Any disruption or deviation can influence supply reliability and pricing.

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Market Dynamics and Future Outlook

• Supply Chain Resilience: The complexity of erdafitinib’s synthesis and manufacturing necessitates a resilient supply chain with multiple suppliers for APIs, intermediates, and finished products.

• Patent Expiry & Generics: As patents approach expiry (expected around 2029–2030), additional suppliers potentialize entry into the market, diversifying sources and stabilizing supply.

• Research & Development: Biosimilar or alternative FGFR inhibitors in development could impact erdafitinib’s market share and supply landscape.

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Key Takeaways

• Primary Supplier: Janssen Pharmaceuticals is the main commercial supplier of erdafitinib, overseeing global manufacturing and distribution.

• Contract Manufacturing: CMOs like Patheon, Lonza, and Catalent are integral to API synthesis, formulation, and packaging processes.

• Raw Material Supply: High-purity intermediates are secured from chemical giants such as BASF and Evonik, ensuring consistent quality.

• Distribution Network: Logistics partners like UPS, DHL, and major distributors like AmerisourceBergen facilitate global reach, especially within regulated markets.

• Market Evolution: Patent expiry and licensing agreements will likely enhance supply diversity, reduce procurement costs, and improve access in emerging markets.

Understanding these supply dynamics helps stakeholders assess risks, identify potential suppliers post-patent expiration, and strategize procurement or partnership opportunities.

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FAQs

1. Who are the primary manufacturers of erdafitinib?
Janssen Pharmaceuticals primarily manufactures and supplies erdafitinib globally, utilizing both internal facilities and CMOs specializing in API production and formulation.

2. Are there any generic or alternative suppliers for erdafitinib?
Currently, erdafitinib retains patent protection, limiting generic manufacturing. Future entries may emerge post-patent expiry, especially from licensed regional manufacturers.

3. Which CMOs are involved in erdafitinib’s supply chain?
Key CMOs include Patheon (Thermo Fisher Scientific), Lonza, and Catalent, which handle API synthesis, formulation, and fill-finish operations.

4. What raw materials are used in erdafitinib synthesis, and who supplies them?
High-purity chemical intermediates sourced from companies such as BASF and Evonik are essential, providing the specialized precursors required for API manufacturing.

5. How does the supply chain ensure quality and compliance?
Suppliers adhere to GMP standards regulated by authorities like the FDA and EMA, implementing rigorous quality controls throughout manufacturing, packaging, and distribution processes.

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References

[1] U.S. Food and Drug Administration (FDA). "Balversa (erdafitinib) approval." FDA, 2019.
[2] Johnson & Johnson. "Janssen Announces FDA Approval of Balversa (Erdafitinib) for Urothelial Carcinoma." Janssen, 2019.
[3] PharmSource. "Contract manufacturing for oncology drugs." PharmSource, 2021.
[4] MarketWatch. "Erdafitinib market analysis and future outlook." MarketWatch, 2022.
[5] World Health Organization. "GMP guidelines for pharmaceutical manufacturing." WHO, 2019.