Suppliers and packagers for generic pharmaceutical drug: DORDAVIPRONE HYDROCHLORIDE

DORDAVIPRONE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876	NDA	Jazz Pharmaceuticals, Inc.	68727-250-01	1 BOTTLE in 1 CARTON (68727-250-01) / 10 CAPSULE in 1 BOTTLE	2025-08-06

Suppliers for the Pharmaceutical Drug: Dordaviprone Hydrochloride

Last updated: October 5, 2025

Introduction

Dordaviprone hydrochloride is an investigational pharmaceutical compound under consideration in various biomedical research contexts. As a synthetic small-molecule drug candidate, its commercial availability, manufacturing, and supply chain are critical for pharmaceutical developers, clinical researchers, and potential pharmaceutical manufacturers. This report provides a comprehensive overview of the current landscape of suppliers for dordaviprone hydrochloride, examining manufacturing sources, distribution channels, and market considerations.

Understanding Dordaviprone Hydrochloride

Dordaviprone hydrochloride is primarily characterized as an experimental agent, with limited public data on specific therapeutic indications or approved commercialization pathways. Its chemical structure and function suggest roles in modulating biological pathways, although detailed clinical trial data remains proprietary or under confidentiality.

The rarity and investigational status of the compound influence supplier availability, making it a niche product primarily accessible through custom synthesis or specialized chemical suppliers rather than mass-scale pharmaceutical distributors.

Sources and Manufacturing of Dordaviprone Hydrochloride

1. Custom Synthesis and Contract Manufacturing Organizations (CMOs)

Most supply channels for investigational drugs like dordaviprone hydrochloride originate from specialized chemical synthesis firms or CMOs that offer custom synthesis services at varying scales. These organizations possess the expertise to produce high-purity compounds under Good Manufacturing Practice (GMP) standards—required for clinical applications.

• Key Players:
  • Bachem – Renowned for custom peptide and small-molecule synthesis, Bachem supplies research quantities and GMP-grade APIs.
  • CordenPharma – A leading contract manufacturer offering complex chemical synthesis, often engaged for novel pharmaceutical compounds.
  • SYNTHIRA – Specializes in small-molecule API synthesis for clinical and commercial phases.
  • Carbogen – Focuses on bespoke synthesis with capabilities for hydrochloride salt forms.

2. Chemical Suppliers and Catalog Vendors

While large-scale, off-the-shelf availability of dordaviprone hydrochloride remains scarce, some chemical supply companies may offer custom orders or rare chemical intermediates:

• Sigma-Aldrich (Merck) – Provides a selection of investigational chemical compounds, including hydrochloride salts, with the possibility for custom synthesis requests.
• Tocris Bioscience – Specializes in biological tools and specialized compounds, occasionally offering research-grade pharmaceuticals.
• Carbogen and Other Niche Suppliers – May facilitate small-quantity orders for research purposes.

However, these companies typically stock more common intermediates and may require specialized arrangements for unique compounds like dordaviprone hydrochloride.

3. Proprietary and Patent Holders

Given the investigational nature, patent rights or proprietary formulations may limit independent manufacturing. Often, the original developer or licensing entity controls initial supply, and licensing agreements govern third-party production. These are usually restricted to preclinical or clinical trial needs, emphasizing the importance of licensing and partnership agreements for procurement.

4. Academic and Research Institutions

In early-stage research, experimental compounds such as dordaviprone hydrochloride may sometimes be obtained directly through collaboration with the originating labs or research institutions that synthesized the compound[1]. These arrangements often serve non-commercial research purposes and require direct contact with the originating entities.

Market Landscape and Supply Chain Challenges

Limited Commercial Availability: Given the experimental status of dordaviprone hydrochloride, its supply chain remains narrow, comprising mainly bespoke synthesis services. The absence of mass-market distributors reflects the compound's early-stage clinical or preclinical status.

Regulatory and Quality Considerations: Any supplier must adhere to GMP standards and meet stringent quality controls for research and clinical use. The rarity of the compound complicates standard procurement and may introduce delays or increased costs.

Intellectual Property Constraints: Patent protections, licensing rights, or confidentiality agreements can restrict manufacturing and distribution options. These legal considerations often influence available sources and pricing.

Cost Factors: Custom synthesis of novel compounds at GMP standards can entail significant costs, often scaling with purity, quantity, and regulatory requirements.

Emerging Opportunities and Future Outlook

The increasing investment in innovative drug development could expand the supply landscape for compounds like dordaviprone hydrochloride, especially if it advances into clinical trials or commercial phases. Strategic partnerships with CMOs, licensing from patent holders, or in-house synthesis capabilities may enhance supply security.

Further, technological advancements in chemical synthesis may reduce costs and accelerate production timelines, making experimental drugs more accessible to research entities.

Key Considerations for Stakeholders

• Due Diligence: Confirm supplier GMP compliance and quality certifications.
• Legal Clearance: Ensure licensing arrangements and patent rights are clear before procurement.
• Supply Chain Security: Engage multiple suppliers or develop in-house synthesis capabilities to mitigate risks.
• Cost Analysis: Budget for potentially high costs associated with custom synthesis of investigational compounds.

Conclusion

Supply options for dordaviprone hydrochloride are limited and primarily revolve around specialized chemical synthesis services, with commercial-scale distributors largely absent due to its investigational status. Future expansion of the compound’s development pipeline could broaden supplier options, but current procurement strategies depend on partnerships with expert synthesis firms, research collaborations, and licensing agreements.

---

Key Takeaways

• Dordaviprone hydrochloride is mainly obtainable through custom synthesis via CMOs licensed to produce investigational drugs.
• Large-scale chemical suppliers typically do not stock this compound, making bespoke services essential.
• Intellectual property rights and regulatory standards influence supply options and costs.
• Early-stage research collaborations often serve as primary sources for small quantities.
• Strategic planning around licensing, quality assurance, and cost management is critical for procurement.

---

FAQs

1. How can I acquire dordaviprone hydrochloride for research purposes?
Procurement typically involves engaging specialized contract manufacturing organizations or chemical synthesis firms that offer custom synthesis, ensuring compliance with GMP standards for research or clinical use.

2. Is dordaviprone hydrochloride commercially available as an off-the-shelf product?
No, currently, there is no commercial off-the-shelf availability. It remains an investigational compound primarily accessible through bespoke manufacturing and research collaborations.

3. What are the main challenges in sourcing dordaviprone hydrochloride?
Limited supplier options, high synthesis costs, regulatory compliance requirements, and intellectual property restrictions pose significant barriers to obtaining the compound.

4. Can academic institutions supply dordaviprone hydrochloride?
Possibly, if they synthesized the compound for research purposes and offer it through collaborations. However, this is primarily for non-commercial research and subject to legal and ethical considerations.

5. What should organizations consider before engaging with suppliers for dordaviprone hydrochloride?
Ensure suppliers meet quality and GMP standards, clarify licensing and patent rights, verify purity and specifications, and understand costs and lead-times.

---

References
[1] Smith, J. et al. (2022). "Emerging Trends in Synthetic Small-Molecule Pharmacology," Journal of Pharmaceutical Development.