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Suppliers and packagers for generic pharmaceutical drug: diroximel fumarate
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diroximel fumarate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Biogen Inc | VUMERITY | diroximel fumarate | CAPSULE, DELAYED RELEASE;ORAL | 211855 | NDA | Biogen Inc. | 64406-020-03 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-03) / 120 CAPSULE in 1 BOTTLE, PLASTIC | 2019-10-29 |
| Biogen Inc | VUMERITY | diroximel fumarate | CAPSULE, DELAYED RELEASE;ORAL | 211855 | NDA | Biogen Inc. | 64406-020-07 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-07) / 14 CAPSULE in 1 BOTTLE, PLASTIC | 2019-10-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DIROXIMEL FUMARATE
Introduction
Diroximel fumarate is an oral medication primarily used in the management of relapsing forms of multiple sclerosis (MS). Marketed under brand names such as Vumerity, it is a prodrug converted into monomethyl fumarate (MMF), which exerts immunomodulatory effects to reduce MS relapses. Its supply chain involves multiple manufacturers and regulatory authorities ensuring quality, availability, and compliance. This article provides an in-depth analysis of key suppliers for diroximel fumarate, examining manufacturing sources, global distribution, and strategic considerations for stakeholders.
Manufacturers and Patent Holders
The primary commercial source of diroximel fumarate is Biogen Inc., which developed Vumerity and holds key patent rights. Biogen’s extensive clinical development and manufacturing infrastructure position it as the leading supplier globally. The drug's production involves complex synthesis pathways requiring specialized chemical processes, stringent quality control, and compliance with regulatory standards such as the US FDA and EMA.
Contract Manufacturing Organizations (CMOs) play a vital role in the supply chain. Biogen utilizes CMOs to bolster manufacturing capacity, ensure supply continuity, and mitigate risks associated with scale-up and production. Notable CMOs include:
- Cytovance Biologics: Involved in the formulation and fill-finish stages, ensuring sterile and stable product output.
- Samsung Biologics: Known for high-volume capacity manufacturing, potentially supporting diroximel fumarate’s bulk and finished dosage forms (source: industry reports).
Raw Material Suppliers
The synthesis of diroximel fumarate relies on high-purity raw materials such as fumaric acid derivatives, which are commercially sourced from specialized chemical suppliers. These include:
- BASF and Evonik Industries: Major providers of fumaric acid derivatives with global supply networks.
- Sigma-Aldrich (Merck): Supplies starting reagents and intermediates used in synthesis.
The availability of pharmaceutical-grade raw materials is critical for maintaining consistent manufacturing and compliance with Good Manufacturing Practice (GMP) standards.
Distribution and Global Supply Chain
Post-manufacture, diroximel fumarate is distributed through a network of Licensed distributors and wholesalers. These entities operate under strict regulatory oversight to maintain product integrity during transport and storage.
Key regional distributors include:
- Americas: Cardinal Health, McKesson Corporation, and AmerisourceBergen.
- Europe: Alliance Healthcare, Phoenix Pharmahandel.
- Asia-Pacific: Local wholesale distributors compliant with regional standards.
Biogen’s regional offices coordinate with these distributors, ensuring timely supply and availability.
Regulatory and Supply Approvals
The approval status influences supplier and distribution channels. Diroximel fumarate received regulatory approval from the US FDA in 2019 and the EMA in 2020. These approvals mandate adherence to strict manufacturing and quality standards, limiting the number of authorized suppliers and third-party CMOs.
Regulatory bodies such as the FDA apply stringent inspections and quality audits to ensure consistent manufacturing practices, thereby narrowing the pool of qualified suppliers.
Strategic Supplier Considerations
- Supply Security: The complexity of synthesis and limited number of qualified raw material suppliers constrains supply chain flexibility. Diversification of raw material sourcing and manufacturing facilities mitigates risk.
- Pricing Dynamics: Patent protection (extended through patent filings and supplementary protection certificates) affects market competition and supplier pricing.
- Manufacturing Capacity Expansion: Biogen has announced plans to increase production capacity through strategic partnerships and investments in new facilities, which may involve collaborations with additional CMOs.
Emerging Market Opportunities
In developing countries, local manufacturing regulations and licensing affect supplier availability. Biogen partners with regional distributors in markets like India and China, often relying on licensed generics or authorized generics to meet local demand.
Additionally, biosimilar manufacturers are exploring structurally similar fumarate-based products to expand access, though direct generics for diroximel fumarate remain limited due to patent protections.
Supply Chain Challenges and Risks
The primary risks include:
- Supply Disruptions: Dependence on few raw material sources can lead to shortages.
- Regulatory Delays: Changes in approval processes or regulations can impact manufacturing licenses.
- Patent Litigation: Ongoing patent disputes may temporarily restrict manufacturing or introduce biosimilar competition.
Proactive supply chain management and strategic stockpiling are crucial for ensuring patient access.
Conclusion
The supply ecosystem for diroximel fumarate is predominantly controlled by Biogen, leveraging a network of CMOs and global distributors. Key raw material suppliers include major chemical companies with specialized fumarate derivatives. Maintaining a resilient supply chain involves diversified sourcing, capacity expansion, and close regulatory oversight. As biosimilars and generics evolve, market dynamics may shift, necessitating continuous monitoring of supplier relationships and regulatory developments.
Key Takeaways
- Biogen remains the principal supplier of diroximel fumarate, utilizing strategic partnerships with CMOs to meet global demand.
- Raw material sourcing is concentrated among a few large chemical producers, requiring careful supply chain oversight.
- Distribution networks across North America, Europe, and Asia ensure product availability but are susceptible to regional regulatory and logistical challenges.
- Patent protections currently limit generic competition, but biosimilar development could alter supply dynamics in the future.
- Business stakeholders should prioritize supplier diversification, regulatory compliance, and strategic capacity planning to mitigate supply risks.
FAQs
-
Who are the primary manufacturers of diroximel fumarate?
Biogen Inc. is the primary developer and manufacturer, employing contractual manufacturing organizations to support production. -
What raw materials are used in the synthesis of diroximel fumarate?
High-purity fumaric acid derivatives obtained from chemical suppliers like BASF and Evonik are essential raw materials. -
Are there multiple suppliers for diroximel fumarate?
Currently, manufacturing is concentrated under Biogen, with limited third-party suppliers; raw materials are sourced from key chemical companies. -
How does patent protection influence the supply chain for diroximel fumarate?
Patent rights restrict generic manufacturing, ensuring a limited number of authorized suppliers and maintaining market exclusivity. -
What risks threaten the supply stability of diroximel fumarate?
Risks include raw material shortages, regulatory delays, patent disputes, and manufacturing capacity constraints.
References
[1] Biogen. (2019). Vumerity (Diroximel fumarate) prescribing information.
[2] European Medicines Agency. (2020). Vumerity approval details.
[3] Industry Reports on Pharmaceutical Supply Chains.
[4] Chemical Suppliers' Product Catalogs: BASF, Evonik, Sigma-Aldrich.
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