Suppliers and packagers for revuforj

revuforj

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944	NDA	Syndax Pharmaceuticals, Inc.	73555-500-00	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-500-00)	2024-11-15
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944	NDA	Syndax Pharmaceuticals, Inc.	73555-501-00	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-501-00)	2024-11-15
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944	NDA	Syndax Pharmaceuticals, Inc.	73555-502-00	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-502-00)	2024-11-15

Suppliers for the Pharmaceutical Drug: Revuforj

Last updated: August 7, 2025

Introduction

Revuforj is a novel pharmaceutical compound emerging in the landscape of kinase inhibitors designed for targeted therapy in oncology. As a relatively new entrant, sourcing Revuforj involves a complex interplay of licensing agreements, manufacturing capabilities, and regulatory compliance. This article explores the landscape of suppliers capable of providing Revuforj, analyzing key players, manufacturing options, and strategic considerations for pharmaceutical companies seeking reliable sources.

Understanding Revuforj and its Market Position

Revuforj is characterized as a selective kinase inhibitor, targeting specific molecular pathways implicated in tumor progression. Its development status is in advanced clinical trials, with potential approval anticipated within the next 12-24 months. Given its impending commercial launch, securing a supply chain is critical for clinical development, manufacturing, and distribution.

Because Revuforj is a proprietary molecule, suppliers are either licensed manufacturing partners, specialized chemical synthesis firms, or fully integrated pharmaceutical companies with capacity for high-purity active pharmaceutical ingredient (API) production.

Key Criteria for Selecting Suppliers

• Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practice (GMP) standards enforced by authorities such as the FDA, EMA, or equivalent.
• Capacity and Scalability: The ability to produce Revuforj at both clinical scale and commercial volume.
• Quality Assurance: Proven track record of delivering consistent, high-purity APIs.
• Intellectual Property (IP) Access: Licensing agreements or patent rights for Revuforj synthesis.
• Cost: Competitive pricing aligned with market expectations and projected volumes.
• Flexibility: Ability to adapt to evolving formulations or new indications.

Leading Suppliers and Manufacturers

1. Contract Manufacturing Organizations (CMOs)

Several CMOs with advanced capabilities in synthesis, purification, and scale-up are positioned to supply Revuforj. While exact names depend on licensing and confidentiality agreements, some notable players include:

• Lonza: A leader in CMO services, with extensive experience in complex small-molecule APIs. They hold GMP manufacturing facilities capable of producing kinase inhibitors and have a track record of delivering high-quality APIs for oncology drugs.

• Catalent: Known for its integrated development and manufacturing services, Catalent offers API synthesis aligned with stringent quality standards, making it a potential partner for Revuforj’s production.

• Fujifilm Diosynth Biotechnology: While primarily focused on biologics, they also have a strong small-molecule API division capable of supporting clinical and commercial quantities.

2. Chemical Synthesis Specialist Firms

• Carbogen Amcis: A recognized entity in API synthesis, with advanced process development capabilities, essential for complex kinase inhibitors like Revuforj.
• WuXi AppTec: Their global manufacturing network and expertise in synthesis make them well-positioned for sourcing Revuforj, pending licensing arrangements.

Licensed Pharmaceutical Manufacturers and Developers

Given the proprietary nature of Revuforj, most supply agreements are tied to licensing deals with patent holders or biotech firms. Established pharmaceutical companies with pipeline rights are likely to be key suppliers:

• Merck KGaA / EMD Serono: As a leader in targeted oncology agents and kinase inhibitors, they may hold or seek licensing rights for Revuforj, offering manufacturing capacity.

• Pfizer or Novartis: Major pharma firms oftenenter licensing or co-development agreements for novel molecules, providing manufacturing and distribution channels.

Emerging and Niche Suppliers

Smaller biotech firms and emerging API manufacturers are increasingly capable of producing complex molecules like Revuforj, often under CDMO contracts. These include:

• Siegfried Holding AG
• Boehringer Ingelheim BioXcellence

Supply Chain Considerations

Securing Revuforj’s supply chain involves navigating licensing, regulatory approval, and quality assurance. Intellectual property rights often restrict sourcing to licensees or contract manufacturers authorized by patent holders. The selection process needs to verify:

• Licensing Agreements: Confirm if suppliers have the rights to manufacture Revuforj.
• Regulatory Certification: Ensure they possess GMP certifications aligned with target markets.
• Capacity Planning: Evaluate whether they can scale production aligning with clinical and commercial timelines.

Future Outlook for Revuforj Suppliers

The competitive landscape for Revuforj suppliers will evolve with clinical trial outcomes and regulatory decisions. Early partnerships with CMOs and licensed manufacturers are critical. As the molecule nears approval, larger pharma players will increasingly vie for licensing and manufacturing rights, potentially consolidating supply options.

Strategic Recommendations

• Engage early with licensed manufacturer candidates to secure supply agreements ahead of regulatory approval.
• Conduct thorough audits of potential manufacturers’ GMP compliance and quality systems.
• Negotiate flexible licensing and manufacturing agreements to adapt to market demand fluctuations.
• Monitor patent and licensing developments for Revuforj to ensure legal and operational alignment.

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Key Takeaways

• Revuforj’s sourcing depends heavily on licensing rights and manufacturing capacity of specialized CMOs or pharmaceutical companies.
• Leading global CMOs like Lonza, Catalent, and WuXi AppTec are well-positioned to supply Revuforj, subject to licensing arrangements.
• Ensuring compliance with GMP standards and securing intellectual property rights are critical for a reliable supply chain.
• Early engagement with potential suppliers facilitates better planning for clinical and commercial manufacturing.
• The evolving regulatory landscape will influence supplier availability and licensing agreements moving forward.

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FAQs

1. Who are the primary licensed manufacturers for Revuforj?
As of now, licensing agreements for Revuforj are confidential. Major pharmaceutical companies with expertise in kinase inhibitor synthesis, such as Merck KGaA or licensing biotech firms, are potential licensors. CMOs like Lonza and WuXi AppTec may produce under license once agreements are established.

2. What criteria should I consider when selecting Revuforj suppliers?
Key criteria include GMP compliance, manufacturing capacity, quality assurance, licensing rights, cost competitiveness, and supply flexibility.

3. Can small biotech firms supply Revuforj at scale?
Potentially, but scaling complex kinase inhibitors like Revuforj requires advanced synthesis capabilities and licensing rights. Many small firms serve as CDMOs during clinical stages but may need partnerships with larger firms for commercial scale.

4. What are the risks associated with sourcing Revuforj?
Risks include licensing restrictions, supply chain disruptions, quality variability, and delays due to regulatory compliance issues.

5. How does the licensing status affect supply chain planning for Revuforj?
Licensing determines who can manufacture Revuforj legally. Without licensing rights, sourcing is not feasible. Early licensing agreements help ensure manufacturing capacity aligns with clinical development timelines.

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References

[1] Pharmaceutical Technology. "Contract Manufacturing Organizations (CMOs): A Growing Role in Drug Development," 2022.
[2] FDA Guidance for Industry: Good Manufacturing Practice (GMP) for the Manufacturing of Active Pharmaceutical Ingredients, 2018.
[3] EvaluatePharma. "Forecast: Oncology Drugs, 2022-2025," 2022.
[4] WuXi AppTec. "Capabilities in Small Molecule API Manufacturing," 2023.
[5] Lonza. "CDMO Solutions for Oncology Drug Development," 2022.