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Suppliers and packagers for generic pharmaceutical drug: REVUMENIB CITRATE
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REVUMENIB CITRATE
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Revumenib Citrate
Introduction
Revumenib citrate, also known by its development code name SNDX-5613, is a promising targeted therapy for acute myeloid leukemia (AML), particularly in cases involving specific genetic mutations such as the KMT2A rearrangements and mutated NPM1 (Nucleophosmin 1). As an oral, selective inhibitor of the Menin-MLL interaction—an essential component in leukemogenesis—revumenib citrate has garnered significant attention within the pharmaceutical industry. Ensuring a reliable supply chain for this compound is critical for pharmaceutical companies, healthcare providers, and research institutions aiming to facilitate clinical trials and eventual therapeutic deployment.
This report explores the primary suppliers, manufacturing entities, and strategic considerations surrounding revumenib citrate, emphasizing the current landscape and future outlook for procurement.
Manufacturers and Authorized Suppliers
1. Syndax Pharmaceuticals Inc.
Syndax is the developer and owner of revumenib (SNDX-5613), holding the intellectual property rights under various patents and licensing agreements. As the original innovator, Syndax primarily supplies clinical-grade revumenib citrate to research institutions and clinical trial sites. The company has collaborated with contract manufacturing organizations (CMOs) to scale up production, ensuring adequate supply during pivotal trial phases.
2. Contract Manufacturing Organizations (CMOs)
Due to the complex chemical synthesis and stringent regulatory requirements, Syndax partners with specialized CMOs to manufacture bulk pharmaceuticals, including revumenib citrate. Key CMOs involved in this process include:
- Boehringer Ingelheim: Known for producing active pharmaceutical ingredients (APIs) for novel oncology agents.
- Lonza: Offers contract manufacturing of complex chemical APIs and intermediates.
- Almac Group: Provides API synthesis with experience in oncology compounds.
Syndax's collaboration strategy aims to diversify manufacturing sources to mitigate risk and ensure continuity as clinical development progresses toward commercialization.
3. Authorized Distributors and Research Suppliers
While Syndax retains control over initial supply for clinical trials, authorized distribution channels include specialized pharmaceutical bulk suppliers and research chemical vendors approved under GMP (Good Manufacturing Practice) standards. These include:
- Carbogen Amcis: Offers custom synthesis and supply of complex APIs, including certain oncology therapeutics.
- Abzena: Provides GMP manufacturing services for early-phase supplies of investigational drugs.
- Sigma-Aldrich/Merck: Supplies research-grade revumenib citrate for laboratory studies, usually not suitable for human administration.
It is essential to verify the GMP certification and supplier credentials before procurement to comply with regulatory standards.
Regulatory and Licensing Considerations
Given the investigational status of revumenib citrate, suppliers are predominantly involved in the GMP-grade manufacturing intended for clinical trials. Regulatory approvals for the manufacturing process and supply chain validation are maintained by Syndax, which also manages licensing agreements with national health authorities. Commercial supply post-approval will likely involve additional licensing and manufacturing agreements with licensed pharmaceutical manufacturers adhering to regional regulator standards such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency).
Emerging and Future Suppliers
As syndax advances revumenib toward regulatory approval and commercial launch, partnerships with large pharmaceutical manufacturers are expected to expand, potentially including:
- Boehringer Ingelheim and AbbVie: For manufacturing scale-up and distribution.
- CROs (Contract Research Organizations): To support global distribution and clinical trial supply logistics.
In addition, regional suppliers in Asia and Europe are likely to emerge as licensed manufacturing partners to meet global demand, subject to licensing and patent arrangements.
Supply Chain and Strategic Considerations
1. Patent Portfolio and Licensing Agreements
Syndax’s patent protection for revumenib citrate extends into multiple jurisdictions, effectively controlling manufacturing and distribution rights. Negotiations for supply licensing are crucial for partners interested in entering regional markets, especially in developing nations.
2. Manufacturing Challenges
Revumenib citrate’s complex synthesis involves multi-step chemical processes requiring specialized equipment, detailed quality control, and validation. Manufacturers must adhere to GMP standards to ensure purity, potency, and safety, potentially limiting the number of qualified suppliers.
3. Supply Security and Risk Management
The limited number of GMP-certified manufacturers creates supply chain vulnerabilities. To mitigate risks, Syndax is likely employing multi-source manufacturing agreements and strategic inventory management plans.
Conclusion
The supply landscape for revumenib citrate is primarily centered around Syndax Pharmaceuticals, which controls manufacturing through strategic partnerships with specialized CMOs. As the drug advances through clinical trials and regulatory review, the expansion of manufacturing partnerships—including potential licensing with larger pharmaceutical companies—will be pivotal in ensuring an uninterrupted supply for global access.
Business professionals involved in procurement should prioritize verifying GMP certification, assessing manufacturing capacity, and understanding licensing frameworks to secure reliable supply chains for revumenib citrate.
Key Takeaways
- Syndax Pharmaceuticals remains the primary source for clinical-grade revumenib citrate, leveraging partnerships with experienced CMOs.
- Manufacturing complexity and regulatory standards limit the number of available suppliers, emphasizing the importance of due diligence when sourcing.
- Global expansion plans and licensing agreements will influence future supply chain dynamics, with large pharmaceutical firms poised to play a vital role.
- Strategic inventory management is essential during clinical development to avoid disruptions.
- Regulatory compliance and intellectual property considerations are key factors in sourcing and scaling supply.
FAQs
1. Who are the primary suppliers of revumenib citrate for clinical trials?
Syndax Pharmaceuticals, through collaborations with specialized CMOs like Boehringer Ingelheim, Lonza, and Almac Group, supplies GMP-grade revumenib citrate for clinical research purposes.
2. Can research chemical vendors supply revumenib citrate?
Yes, companies like Sigma-Aldrich provide research-grade revumenib citrate for laboratory studies but not for human administration. GMP-certified supplies suitable for clinical use are limited to licensed manufacturers.
3. Are there regional suppliers approved for commercial distribution?
As of now, licensing agreements with large pharmaceutical manufacturers are under development. Once approved, regional suppliers in North America, Europe, and Asia are expected to emerge under authorized licensing arrangements.
4. What challenges exist in manufacturing revumenib citrate?
Its complex synthesis requiring multi-step chemical processes, stringent quality controls, and GMP compliance pose significant manufacturing challenges, limiting the number of qualified suppliers.
5. How can supply chain risks be mitigated during clinical development?
Diversifying manufacturing sources, establishing multi-party licensing agreements, maintaining strategic inventories, and conducting rigorous supplier qualification are essential strategies to mitigate risks.
References
- Syndax Pharmaceuticals Inc. Clinical pipeline data and manufacturing partnerships. Syndax Official Website
- U.S. FDA Drug Approvals and Investigational Drugs Database.
- Contract manufacturing organization profiles: Boehringer Ingelheim, Lonza, Almac Group.
- Industry reports on clinical trial supply chain management for oncology agents.
- Patent filings and IP protections related to revumenib citrate.
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